Trial Outcomes & Findings for Pre-Exposure Prophylaxis for Transgender Women in the US and South America (NCT NCT04742491)

NCT ID: NCT04742491

Last Updated: 2025-12-17

Results Overview

Time to PrEP initiation is defined as the duration from enrollment to the PrEP start date.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 304 participants
• Primary outcome timeframe: 0-18 months
• Results posted on: 2025-12-17

Participant Flow

All enrolled participants were randomized to study arms.

Participant milestones

Measure	Immediate Intervention Arm PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Overall Study STARTED	149	155
Overall Study Week 13 Follow-up	133	139
Overall Study Week 26 Follow-up	125	136
Overall Study Week 39 Follow-up	118	128
Overall Study Week 52 Follow-up	116	123
Overall Study Week 65 Follow-up	114	126
Overall Study COMPLETED	126	128
Overall Study NOT COMPLETED	23	27

Reasons for withdrawal

Measure	Immediate Intervention Arm PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Overall Study Death	2	0
Overall Study Participant unwilling or unable to comply with required study procedures	1	1
Overall Study Lost to Follow-up	6	8
Overall Study Withdrawal by Subject	4	2
Overall Study One or more reactive HIV test results or acute HIV infection suspected	2	1
Overall Study Participant refused further participation	2	7
Overall Study Participant unable to adhere to visit schedule	3	4
Overall Study Other reasons	3	4

Baseline Characteristics

Pre-Exposure Prophylaxis for Transgender Women in the US and South America

Baseline characteristics by cohort

Measure	Immediate Intervention Arm n=149 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=155 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.	Total n=304 Participants Total of all reporting groups
Race (NIH/OMB) Asian	2 Participants n=6 Participants	7 Participants n=5 Participants	9 Participants n=5 Participants
Age, Continuous	30.3 years STANDARD_DEVIATION 8.8 • n=6 Participants	30.9 years STANDARD_DEVIATION 8.8 • n=5 Participants	30.6 years STANDARD_DEVIATION 8.8 • n=5 Participants
Age, Customized 25 and below	57 Participants n=6 Participants	47 Participants n=5 Participants	104 Participants n=5 Participants
Age, Customized 26 and above	92 Participants n=6 Participants	108 Participants n=5 Participants	200 Participants n=5 Participants
Sex/Gender, Customized Gender · Missing	0 Participants n=6 Participants	1 Participants n=5 Participants	1 Participants n=5 Participants
Sex/Gender, Customized Gender · Female	28 Participants n=6 Participants	20 Participants n=5 Participants	48 Participants n=5 Participants
Sex/Gender, Customized Gender · Transgender Female/Transgender Woman	65 Participants n=6 Participants	76 Participants n=5 Participants	141 Participants n=5 Participants
Sex/Gender, Customized Gender · Gender nonbinary/Genderfluid/Gender Nonconforming	3 Participants n=6 Participants	9 Participants n=5 Participants	12 Participants n=5 Participants
Sex/Gender, Customized Gender · Another gender identity	4 Participants n=6 Participants	5 Participants n=5 Participants	9 Participants n=5 Participants
Sex/Gender, Customized Gender · Prefer not to answer	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Sex/Gender, Customized Gender · Multiple gender identities selected	49 Participants n=6 Participants	44 Participants n=5 Participants	93 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	149 Participants n=6 Participants	155 Participants n=5 Participants	304 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	82 Participants n=6 Participants	81 Participants n=5 Participants	163 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	62 Participants n=6 Participants	72 Participants n=5 Participants	134 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=6 Participants	2 Participants n=5 Participants	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=6 Participants	4 Participants n=5 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=6 Participants	0 Participants n=5 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	46 Participants n=6 Participants	50 Participants n=5 Participants	96 Participants n=5 Participants
Race (NIH/OMB) White	53 Participants n=6 Participants	54 Participants n=5 Participants	107 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	45 Participants n=6 Participants	40 Participants n=5 Participants	85 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0-18 months

Population: Limited to participants who obtained PrEP at the study clinic

Time to PrEP initiation is defined as the duration from enrollment to the PrEP start date.

Outcome measures

Measure	Immediate Intervention Arm n=131 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=137 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
PrEP Uptake	16.2 days Standard Deviation 66.7	11.4 days Standard Deviation 4.3

PRIMARY outcome

Timeframe: 0-18 months

Population: Number of participants who completed CASI at each study visit. Due to missingness, this number may be lower than the number of participants enrolled in the study.

Self-reported adherence to daily PrEP by study visit

Outcome measures

Measure	Immediate Intervention Arm n=149 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=155 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
PrEP Adherence Week 52 · 7 doses per week	53 Participants	63 Participants
PrEP Adherence Week 78 · 4-6 doses per week	17 Participants	16 Participants
PrEP Adherence Week 78 · 7 doses per week	51 Participants	61 Participants
PrEP Adherence Week 78 · Missing	47 Participants	36 Participants
PrEP Adherence Enrollment · 2-3 doses per week	2 Participants	3 Participants
PrEP Adherence Enrollment · 4-6 doses per week	6 Participants	4 Participants
PrEP Adherence Enrollment · 7 doses per week	19 Participants	20 Participants
PrEP Adherence Enrollment · Missing	118 Participants	125 Participants
PrEP Adherence Week 13 · < 2 doses per week	3 Participants	8 Participants
PrEP Adherence Week 13 · 2-3 doses per week	2 Participants	3 Participants
PrEP Adherence Week 13 · 4-6 doses per week	19 Participants	27 Participants
PrEP Adherence Week 13 · 7 doses per week	79 Participants	75 Participants
PrEP Adherence Week 13 · Missing	30 Participants	26 Participants
PrEP Adherence Week 26 · < 2 doses per week	7 Participants	7 Participants
PrEP Adherence Week 26 · 2-3 doses per week	7 Participants	2 Participants
PrEP Adherence Week 26 · 4-6 doses per week	12 Participants	21 Participants
PrEP Adherence Week 26 · 7 doses per week	76 Participants	72 Participants
PrEP Adherence Week 26 · Missing	22 Participants	29 Participants
PrEP Adherence Week 39 · < 2 doses per week	4 Participants	4 Participants
PrEP Adherence Week 39 · 2-3 doses per week	3 Participants	5 Participants
PrEP Adherence Week 39 · 4-6 doses per week	16 Participants	23 Participants
PrEP Adherence Week 39 · 7 doses per week	61 Participants	71 Participants
PrEP Adherence Week 39 · Missing	30 Participants	25 Participants
PrEP Adherence Week 52 · < 2 doses per week	4 Participants	5 Participants
PrEP Adherence Week 52 · 2-3 doses per week	3 Participants	5 Participants
PrEP Adherence Week 52 · 4-6 doses per week	18 Participants	16 Participants
PrEP Adherence Week 52 · Missing	37 Participants	31 Participants
PrEP Adherence Week 65 · < 2 doses per week	2 Participants	5 Participants
PrEP Adherence Week 65 · 2-3 doses per week	1 Participants	5 Participants
PrEP Adherence Week 65 · 4-6 doses per week	16 Participants	21 Participants
PrEP Adherence Week 65 · 7 doses per week	57 Participants	61 Participants
PrEP Adherence Week 65 · Missing	33 Participants	30 Participants
PrEP Adherence Week 78 · < 2 doses per week	3 Participants	9 Participants
PrEP Adherence Week 78 · 2-3 doses per week	7 Participants	7 Participants
PrEP Adherence Enrollment · < 2 doses per week	2 Participants	1 Participants

PRIMARY outcome

Timeframe: 0-18 months

Population: Enrolled participants. Deferred arm participants receive co-located services at 6 months.

Number of participants accepting co-located GAHT services at baseline and subsequent quarterly study visits.

Outcome measures

Measure	Immediate Intervention Arm n=149 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=155 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Acceptability and Feasibility of Co-located Services Enrollment	68 Participants	0 Participants
Acceptability and Feasibility of Co-located Services Week 13	106 Participants	0 Participants
Acceptability and Feasibility of Co-located Services Week 26	109 Participants	66 Participants
Acceptability and Feasibility of Co-located Services Week 39	113 Participants	90 Participants
Acceptability and Feasibility of Co-located Services Week 52	114 Participants	93 Participants
Acceptability and Feasibility of Co-located Services Week 65	115 Participants	93 Participants
Acceptability and Feasibility of Co-located Services Week 78	116 Participants	93 Participants

PRIMARY outcome

Timeframe: Weeks 26, 52, 78

Population: The denominators in the table differ from the overall number analyzed because the denominator excludes any participants who have terminated from the study or seroconverted at the time of the visit.

Participant retention at weeks 26, 52 and 78 by study arm. Retention defined as the number of participants who completed the visit divided by the number of participants who are expected or have completed the visit.

Outcome measures

Measure	Immediate Intervention Arm n=149 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=155 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Participant Retention at Weeks 26, 52 and 78 Week 26	125 Participants	135 Participants
Participant Retention at Weeks 26, 52 and 78 Week 52	115 Participants	123 Participants
Participant Retention at Weeks 26, 52 and 78 Week 78	126 Participants	128 Participants

PRIMARY outcome

Timeframe: 0-18 months

Population: Enrolled population

The average number of peer health navigator encounters.

Outcome measures

Measure	Immediate Intervention Arm n=149 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=155 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Acceptability and Feasibility of Peer Health Navigation	5.7 encounters Standard Deviation 1.6	5.5 encounters Standard Deviation 1.2

PRIMARY outcome

Timeframe: 0-18 months

Population: Total number of peer health navigation encounters by arm.

Number of each type of peer health navigation encounter.

Outcome measures

Measure	Immediate Intervention Arm n=839 Encounters PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=737 Encounters PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Acceptability and Feasibility of Peer Health Navigation In-person	519 Encounters	427 Encounters
Acceptability and Feasibility of Peer Health Navigation Email	0 Encounters	0 Encounters
Acceptability and Feasibility of Peer Health Navigation Text	16 Encounters	7 Encounters
Acceptability and Feasibility of Peer Health Navigation Phone	258 Encounters	256 Encounters
Acceptability and Feasibility of Peer Health Navigation Video encounter	46 Encounters	47 Encounters

PRIMARY outcome

Timeframe: 0-18 months

Population: Participants with a non-missing response to the CASI question concerning desire for co-located services at the end of the study.

Percentage of participants who report desire for co-located services at the end of the study

Outcome measures

Measure	Immediate Intervention Arm n=145 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=149 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Acceptability and Feasibility of Co-located Services	106 Participants	107 Participants

PRIMARY outcome

Timeframe: 0-18 months

Population: Participants who initiated PrEP and had at least one permanent discontinuation prior to study exit or termination.

The average number of days to first PrEP permanent discontinuation.

Outcome measures

Measure	Immediate Intervention Arm n=28 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=18 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
PrEP Adherence	364.1 days Standard Deviation 185.2	361.1 days Standard Deviation 255.2

PRIMARY outcome

Timeframe: 0-18 months

Population: Participants who initiated PrEP and had at least one permanent discontinuation prior to study exit or termination.

The median number of days to first PrEP permanent discontinuation.

Outcome measures

Measure	Immediate Intervention Arm n=28 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=18 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
PrEP Adherence	373 days Interval 245.0 to 499.0	409 days Interval 141.0 to 533.0

PRIMARY outcome

Timeframe: 0-18 months

Population: TFVDP levels of participants who obtained PrEP at the study clinic.

Participants with different levels of TFV-DP concentrations in DBS measured at quarterly follow-up visits after PrEP initiation.

Outcome measures

Measure	Immediate Intervention Arm n=131 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=137 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
PrEP Adherence Week 13 · Less than 2 doses per week	23 Participants	25 Participants
PrEP Adherence Week 26 · Unquantifiable	21 Participants	20 Participants
PrEP Adherence Week 78 · Less than 2 doses per week	22 Participants	20 Participants
PrEP Adherence Enrollment · Unquantifiable	80 Participants	83 Participants
PrEP Adherence Enrollment · Less than 2 doses per week	10 Participants	15 Participants
PrEP Adherence Enrollment · 2-3 doses per week	5 Participants	3 Participants
PrEP Adherence Enrollment · 4-6 doses per week	5 Participants	12 Participants
PrEP Adherence Enrollment · 7 doses per week	5 Participants	4 Participants
PrEP Adherence Week 13 · Unquantifiable	19 Participants	10 Participants
PrEP Adherence Week 13 · 2-3 doses per week	6 Participants	10 Participants
PrEP Adherence Week 13 · 4-6 doses per week	28 Participants	27 Participants
PrEP Adherence Week 13 · 7 doses per week	35 Participants	43 Participants
PrEP Adherence Week 26 · Less than 2 doses per week	23 Participants	28 Participants
PrEP Adherence Week 26 · 2-3 doses per week	8 Participants	12 Participants
PrEP Adherence Week 26 · 4-6 doses per week	32 Participants	26 Participants
PrEP Adherence Week 26 · 7 doses per week	24 Participants	34 Participants
PrEP Adherence Week 39 · Unquantifiable	31 Participants	23 Participants
PrEP Adherence Week 39 · Less than 2 doses per week	19 Participants	19 Participants
PrEP Adherence Week 39 · 2-3 doses per week	6 Participants	9 Participants
PrEP Adherence Week 39 · 4-6 doses per week	22 Participants	27 Participants
PrEP Adherence Week 39 · 7 doses per week	22 Participants	34 Participants
PrEP Adherence Week 52 · Unquantifiable	29 Participants	22 Participants
PrEP Adherence Week 52 · Less than 2 doses per week	18 Participants	17 Participants
PrEP Adherence Week 52 · 2-3 doses per week	14 Participants	8 Participants
PrEP Adherence Week 52 · 4-6 doses per week	19 Participants	32 Participants
PrEP Adherence Week 52 · 7 doses per week	20 Participants	31 Participants
PrEP Adherence Week 65 · Unquantifiable	27 Participants	21 Participants
PrEP Adherence Week 65 · Less than 2 doses per week	19 Participants	26 Participants
PrEP Adherence Week 65 · 2-3 doses per week	12 Participants	9 Participants
PrEP Adherence Week 65 · 4-6 doses per week	17 Participants	22 Participants
PrEP Adherence Week 65 · 7 doses per week	23 Participants	35 Participants
PrEP Adherence Week 78 · Unquantifiable	39 Participants	32 Participants
PrEP Adherence Week 78 · 2-3 doses per week	10 Participants	12 Participants
PrEP Adherence Week 78 · 4-6 doses per week	16 Participants	23 Participants
PrEP Adherence Week 78 · 7 doses per week	23 Participants	27 Participants

PRIMARY outcome

Timeframe: 0-18 months

Population: FTC-TP levels of participants who obtained PrEP at the study clinic.

Participants with different levels FTC-TP concentrations in DBS measured at quarterly follow-up visits after PrEP initiation.

Outcome measures

Measure	Immediate Intervention Arm n=131 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=137 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
PrEP Adherence Week 65	55 Participants	70 Participants
PrEP Adherence Week 78	51 Participants	59 Participants
PrEP Adherence Enrollment	15 Participants	20 Participants
PrEP Adherence Week 13	73 Participants	87 Participants
PrEP Adherence Week 26	67 Participants	74 Participants
PrEP Adherence Week 39	51 Participants	75 Participants
PrEP Adherence Week 52	52 Participants	75 Participants

PRIMARY outcome

Timeframe: Week 26

Population: Participants who obtained PrEP at the study clinic.

The proportion of TGW determined to be adherent at the Week 26 visit was compared by study arm. PrEP adherence was defined as having a detectable concentration of PrEP (Truvada or Descovy) in DBS sample.

Outcome measures

Measure	Immediate Intervention Arm n=108 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=120 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
PrEP Adherence	87 Participants	100 Participants

PRIMARY outcome

Timeframe: 0-18 months

Population: Participants who obtained PrEP at the study clinic.

PrEP persistent is defined as the proportion of study visits where a participant demonstrates high adherence to PrEP among those who initiated PrEP at the study clinic. High adherence at a visit is based on drug concentrations in dried blood spots (DBS):

Truvada (TDF/FTC): TFV-DP ≥ 900 fmol/punch Descovy (TAF/FTC): TFV-DP ≥ 950 fmol/punch PrEP persistent reflects sustained high PrEP adherence across multiple visits over time, rather than high PrEP adherence at a single point.

Outcome measures

Measure	Immediate Intervention Arm n=131 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=137 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
PrEP Persistent	41.7 percent of visits Standard Deviation 40.9	50.5 percent of visits Standard Deviation 43.2

PRIMARY outcome

Timeframe: Week 26

Comparison of PrEP uptake between study arms at the end of Week 26. PrEP uptake is defined as whether the participant initiated PrEP at the study clinic..

Outcome measures

Measure	Immediate Intervention Arm n=149 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=155 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
PrEP Uptake	127 Participants	135 Participants

SECONDARY outcome

Timeframe: 0-18 months

Population: The numbers presented in "Overall Number of Participants Analyzed" represent the total number of participants enrolled in the study. For each visit (row), only participants who completed the CASI questionnaire were included in the analysis. For both questions "condom use with HIV+ people" and "condom use with HIV unknown people" analyses were restricted to participants who completed the CASI questionnaire at that visit.

Describing condom use with HIV+ people, measured by assessments at enrollment and quarterly through Week 78.

Outcome measures

Measure	Immediate Intervention Arm n=149 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=155 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Examining Changes in Sexual Risk-taking Behavior Week 39 · I did not have sex with anyone whom I knew was HIV+	68 Participants	75 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · None of the time	6 Participants	12 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · Less than half the time	3 Participants	3 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · About half the time	2 Participants	3 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · All of the time	5 Participants	8 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · Missing	4 Participants	6 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · No sex	18 Participants	12 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · Oral sex only	2 Participants	9 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · I did not have sex with anyone whom I knew was HIV+	65 Participants	67 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · None of the time	7 Participants	12 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · Less than half the time	4 Participants	5 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · About half the time	1 Participants	2 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · More than half the time	5 Participants	1 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · All of the time	9 Participants	6 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · Missing	4 Participants	7 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · No sex	16 Participants	18 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · Oral sex only	6 Participants	2 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · I did not have sex with anyone whom I knew was HIV+	62 Participants	70 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · None of the time	5 Participants	9 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · Less than half the time	4 Participants	3 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · About half the time	2 Participants	1 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · Missing	9 Participants	4 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · No sex	23 Participants	20 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · Oral sex only	2 Participants	0 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · I did not have sex with anyone whom I knew was HIV+	70 Participants	79 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · None of the time	4 Participants	12 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · Less than half the time	3 Participants	3 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · About half the time	6 Participants	1 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · More than half the time	1 Participants	2 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · All of the time	7 Participants	8 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · Missing	0 Participants	1 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · More than half the time	5 Participants	4 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · All of the time	8 Participants	12 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · More than half the time	4 Participants	3 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · More than half the time	3 Participants	0 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · All of the time	7 Participants	12 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · Oral sex only	10 Participants	8 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · I did not have sex with anyone whom I knew was HIV+	81 Participants	87 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · None of the time	7 Participants	8 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · Less than half the time	6 Participants	3 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · About half the time	1 Participants	3 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · More than half the time	9 Participants	1 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · Missing	0 Participants	1 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · No sex	18 Participants	14 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · Oral sex only	17 Participants	9 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · I did not have sex with anyone whom I knew was HIV+	69 Participants	80 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · None of the time	6 Participants	8 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · Less than half the time	3 Participants	6 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · About half the time	3 Participants	1 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · More than half the time	1 Participants	3 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · All of the time	7 Participants	9 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · Missing	0 Participants	2 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · No sex	13 Participants	13 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · Oral sex only	13 Participants	9 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · No sex	9 Participants	12 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · Oral sex only	10 Participants	7 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · I did not have sex with anyone whom I knew was HIV+	101 Participants	88 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · None of the time	11 Participants	19 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · Less than half the time	3 Participants	7 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · About half the time	2 Participants	4 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · All of the time	6 Participants	11 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · Missing	0 Participants	1 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · No sex	11 Participants	16 Participants

SECONDARY outcome

Timeframe: 0-18 months

Population: The numbers presented in "Overall Number of Participants Analyzed" represent the total number of participants enrolled in the study. For each visit (row), only participants who completed the CASI questionnaire were included in the analysis. For both questions "condom use with HIV+ people" and "condom use with HIV unknown people" analyses were restricted to participants who completed the CASI questionnaire at that visit.

Describing condom use with HIV unknown people, measured by assessments at enrollment and quarterly through Week 78.

Outcome measures

Measure	Immediate Intervention Arm n=149 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=155 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Examining Changes in Sexual Risk-taking Behavior Enrollment · Missing	0 Participants	1 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · No sex	9 Participants	12 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · Oral sex only	10 Participants	7 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · No sex with anyone whose HIV status was unknown	30 Participants	37 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · None of the time	20 Participants	17 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · Less than half the time	20 Participants	19 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · About half the time	13 Participants	9 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · More than half of the time	18 Participants	22 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · All of the time	27 Participants	29 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · Missing	0 Participants	1 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · No sex	11 Participants	16 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · Oral sex only	10 Participants	8 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · No sex with anyone whose HIV status was unknown	34 Participants	34 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · None of the time	24 Participants	19 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · Less than half the time	9 Participants	15 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · About half the time	10 Participants	5 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · More than half of the time	16 Participants	19 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · All of the time	19 Participants	22 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · Missing	0 Participants	1 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · No sex	18 Participants	14 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · Oral sex only	17 Participants	9 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · No sex with anyone whose HIV status was unknown	28 Participants	40 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · None of the time	14 Participants	21 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · Less than half the time	11 Participants	13 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · About half the time	7 Participants	6 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · More than half of the time	13 Participants	10 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · All of the time	16 Participants	17 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · Missing	0 Participants	2 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · No sex	13 Participants	13 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · Oral sex only	13 Participants	9 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · No sex with anyone whose HIV status was unknown	37 Participants	50 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · None of the time	13 Participants	10 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · About half the time	6 Participants	3 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · More than half of the time	9 Participants	10 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · All of the time	13 Participants	21 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · Missing	4 Participants	6 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · No sex	18 Participants	12 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · Less than half the time	10 Participants	10 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · Oral sex only	2 Participants	9 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · No sex with anyone whose HIV status was unknown	40 Participants	53 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · None of the time	11 Participants	9 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · Less than half the time	8 Participants	6 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · About half the time	5 Participants	3 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · More than half of the time	13 Participants	4 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · All of the time	14 Participants	18 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · Missing	4 Participants	7 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · No sex	16 Participants	18 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · Oral sex only	6 Participants	2 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · No sex with anyone whose HIV status was unknown	42 Participants	46 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · None of the time	16 Participants	15 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · Less than half the time	6 Participants	3 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · About half the time	2 Participants	6 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · More than half of the time	7 Participants	9 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · All of the time	10 Participants	16 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · Missing	9 Participants	4 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · No sex	23 Participants	20 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · Oral sex only	2 Participants	0 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · No sex with anyone whose HIV status was unknown	44 Participants	53 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · None of the time	15 Participants	15 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · Less than half the time	11 Participants	5 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · About half the time	2 Participants	7 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · More than half of the time	9 Participants	8 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · All of the time	10 Participants	17 Participants

SECONDARY outcome

Timeframe: 0-18 months

Population: Number of participants who completed CASI questionnaire per visit.

Frequency of being high on drugs/drunk during sex, measured by assessments at enrollment and quarterly through Week 78.

Outcome measures

Measure	Immediate Intervention Arm n=149 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=155 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Examining Changes in Sexual Risk-taking Behavior Enrollment · Less than half the time	34 Participants	40 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · About half the time	6 Participants	13 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · More than half of the time	12 Participants	15 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · All of the time	7 Participants	10 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · Prefer not to answer	1 Participants	3 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · Missing	0 Participants	1 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · No sex	11 Participants	16 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · Oral sex only	10 Participants	8 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · None of the time	72 Participants	53 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · Less than half the time	19 Participants	27 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · About half the time	9 Participants	16 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · More than half of the time	4 Participants	12 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · All of the time	7 Participants	3 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · Prefer not to answer	1 Participants	3 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · Missing	0 Participants	1 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · No sex	18 Participants	14 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · Oral sex only	17 Participants	9 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · None of the time	57 Participants	54 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · Less than half the time	21 Participants	33 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · Missing	0 Participants	1 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · No sex	9 Participants	12 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · Oral sex only	10 Participants	7 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · None of the time	68 Participants	52 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · About half the time	2 Participants	8 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · More than half of the time	2 Participants	6 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · All of the time	5 Participants	6 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · Prefer not to answer	2 Participants	0 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · Missing	0 Participants	2 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · No sex	13 Participants	13 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · Oral sex only	13 Participants	9 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · None of the time	51 Participants	51 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · Less than half the time	18 Participants	28 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · About half the time	8 Participants	11 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · More than half of the time	5 Participants	7 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · All of the time	3 Participants	6 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · Prefer not to answer	3 Participants	1 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · Missing	4 Participants	6 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · No sex	18 Participants	12 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · Oral sex only	2 Participants	9 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · None of the time	54 Participants	47 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · Less than half the time	21 Participants	25 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · About half the time	6 Participants	8 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · More than half of the time	3 Participants	6 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · All of the time	4 Participants	6 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · Prefer not to answer	3 Participants	1 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · Missing	4 Participants	7 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · No sex	16 Participants	18 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · Oral sex only	6 Participants	2 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · None of the time	58 Participants	51 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · Less than half the time	15 Participants	22 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · About half the time	5 Participants	11 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · More than half of the time	2 Participants	3 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · All of the time	2 Participants	4 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · Prefer not to answer	1 Participants	4 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · Missing	9 Participants	4 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · No sex	23 Participants	20 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · Oral sex only	2 Participants	0 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · None of the time	57 Participants	55 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · Less than half the time	18 Participants	29 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · About half the time	5 Participants	11 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · More than half of the time	6 Participants	5 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · All of the time	4 Participants	4 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · Prefer not to answer	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 0-18 months

Population: Number of participants who completed CASI questionnaire per visit.

Had sex for money/drugs/housing/food/other things, measured by assessments at enrollment and quarterly through Week 78.

Outcome measures

Measure	Immediate Intervention Arm n=149 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=155 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Examining Changes in Sexual Risk-taking Behavior Enrollment · Missing	147 Participants	153 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · No	0 Participants	0 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · Yes	0 Participants	0 Participants
Examining Changes in Sexual Risk-taking Behavior Enrollment · Prefer not to answer	0 Participants	0 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · Missing	0 Participants	1 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · No	90 Participants	101 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · Yes	40 Participants	32 Participants
Examining Changes in Sexual Risk-taking Behavior Week 13 · Prefer not to answer	3 Participants	5 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · Missing	0 Participants	1 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · No	85 Participants	101 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · Yes	36 Participants	24 Participants
Examining Changes in Sexual Risk-taking Behavior Week 26 · Prefer not to answer	3 Participants	5 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · Missing	0 Participants	0 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · No	83 Participants	104 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · Yes	29 Participants	21 Participants
Examining Changes in Sexual Risk-taking Behavior Week 39 · Prefer not to answer	2 Participants	3 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · Missing	2 Participants	0 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · No	75 Participants	92 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · Yes	37 Participants	23 Participants
Examining Changes in Sexual Risk-taking Behavior Week 52 · Prefer not to answer	1 Participants	5 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · Missing	0 Participants	0 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · No	77 Participants	99 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · Yes	29 Participants	21 Participants
Examining Changes in Sexual Risk-taking Behavior Week 65 · Prefer not to answer	3 Participants	2 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · Missing	0 Participants	0 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · No	90 Participants	107 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · Yes	32 Participants	19 Participants
Examining Changes in Sexual Risk-taking Behavior Week 78 · Prefer not to answer	3 Participants	3 Participants

SECONDARY outcome

Timeframe: 0 months

Population: Enrolled participants

To determine baseline prevalence of STIs (Neisseria gonorrhoeae [GC], Chlamydia trachomatis [CT], and Treponema pallidum (syphilis)) by study arm

Outcome measures

Measure	Immediate Intervention Arm n=149 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=155 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Prevalence of STI Infection (GC, CT, Syphilis) at Baseline Gonorrhea	15 Participants	15 Participants
Prevalence of STI Infection (GC, CT, Syphilis) at Baseline Chlamydia Trachomatis	15 Participants	15 Participants
Prevalence of STI Infection (GC, CT, Syphilis) at Baseline Syphilis (Positive/Reactive)	38 Participants	32 Participants

SECONDARY outcome

Timeframe: 0 months

Population: Enrolled participants. There is insufficient data (below the lower limit of quantification) to perform valid logistic regression modelling on participants with Hepatitis B or renal insufficiency at baseline.

To obtain baseline laboratory data to evaluate the cohort's suitability for future PrEP intervention studies (e.g., prevalence of renal insufficiency, hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, etc.). Logistic regression models will be used for estimating prevalence of baseline conditions.

Outcome measures

Measure	Immediate Intervention Arm n=149 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=155 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Estimate Prevalence of Baseline Laboratory Values. Hepatitis C Infection	2 Participants	3 Participants
Estimate Prevalence of Baseline Laboratory Values. Renal Insufficiency	0 Participants	0 Participants
Estimate Prevalence of Baseline Laboratory Values. Hepatitis B Infection	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 0-18 months

Population: Number of participants who completed the CASI form at each study visit.

Taken hormones for gender identity/transition

Outcome measures

Measure	Immediate Intervention Arm n=149 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=155 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Gender-Affirming Hormone Therapy by Visit Enrollment	96 Participants	101 Participants
Gender-Affirming Hormone Therapy by Visit Week 13	91 Participants	96 Participants
Gender-Affirming Hormone Therapy by Visit Week 26	93 Participants	93 Participants
Gender-Affirming Hormone Therapy by Visit Week 39	85 Participants	96 Participants
Gender-Affirming Hormone Therapy by Visit Week 52	86 Participants	93 Participants
Gender-Affirming Hormone Therapy by Visit Week 65	82 Participants	90 Participants
Gender-Affirming Hormone Therapy by Visit Week 78	93 Participants	96 Participants

SECONDARY outcome

Timeframe: 0-18 months

Population: Number of participants who completed the CASI form at each study visit.

Currently taking hormones for gender identity/transition

Outcome measures

Measure	Immediate Intervention Arm n=149 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=155 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Gender-Affirming Hormone Therapy by Visit Enrollment	83 Participants	90 Participants
Gender-Affirming Hormone Therapy by Visit Week 13	88 Participants	92 Participants
Gender-Affirming Hormone Therapy by Visit Week 26	89 Participants	91 Participants
Gender-Affirming Hormone Therapy by Visit Week 39	84 Participants	90 Participants
Gender-Affirming Hormone Therapy by Visit Week 52	85 Participants	88 Participants
Gender-Affirming Hormone Therapy by Visit Week 65	79 Participants	88 Participants
Gender-Affirming Hormone Therapy by Visit Week 78	90 Participants	91 Participants

SECONDARY outcome

Timeframe: 0-18 months

Population: Number of participants who reported they were currently taking hormones.

Where do you currently get your hormones?

Outcome measures

Measure	Immediate Intervention Arm n=149 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=155 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Gender-Affirming Hormone Therapy by Visit Enrollment · Missing	0 Participants	0 Participants
Gender-Affirming Hormone Therapy by Visit Enrollment · Only from medical providers	47 Participants	50 Participants
Gender-Affirming Hormone Therapy by Visit Enrollment · Medical providers and from friends, online, or other sources	14 Participants	11 Participants
Gender-Affirming Hormone Therapy by Visit Enrollment · Only from friends, online, or other non-licensed sources	16 Participants	21 Participants
Gender-Affirming Hormone Therapy by Visit Enrollment · Some other source	6 Participants	8 Participants
Gender-Affirming Hormone Therapy by Visit Week 13 · Missing	0 Participants	0 Participants
Gender-Affirming Hormone Therapy by Visit Week 13 · Only from medical providers	70 Participants	72 Participants
Gender-Affirming Hormone Therapy by Visit Week 13 · Medical providers and from friends, online, or other sources	11 Participants	13 Participants
Gender-Affirming Hormone Therapy by Visit Week 13 · Only from friends, online, or other non-licensed sources	1 Participants	3 Participants
Gender-Affirming Hormone Therapy by Visit Week 13 · Some other source	6 Participants	4 Participants
Gender-Affirming Hormone Therapy by Visit Week 26 · Missing	0 Participants	0 Participants
Gender-Affirming Hormone Therapy by Visit Week 26 · Only from medical providers	68 Participants	80 Participants
Gender-Affirming Hormone Therapy by Visit Week 26 · Medical providers and from friends, online, or other sources	13 Participants	7 Participants
Gender-Affirming Hormone Therapy by Visit Week 26 · Only from friends, online, or other non-licensed sources	1 Participants	4 Participants
Gender-Affirming Hormone Therapy by Visit Week 26 · Some other source	7 Participants	0 Participants
Gender-Affirming Hormone Therapy by Visit Week 39 · Missing	0 Participants	0 Participants
Gender-Affirming Hormone Therapy by Visit Week 39 · Only from medical providers	65 Participants	78 Participants
Gender-Affirming Hormone Therapy by Visit Week 39 · Medical providers and from friends, online, or other sources	14 Participants	9 Participants
Gender-Affirming Hormone Therapy by Visit Week 39 · Only from friends, online, or other non-licensed sources	3 Participants	0 Participants
Gender-Affirming Hormone Therapy by Visit Week 39 · Some other source	2 Participants	3 Participants
Gender-Affirming Hormone Therapy by Visit Week 52 · Missing	0 Participants	0 Participants
Gender-Affirming Hormone Therapy by Visit Week 52 · Only from medical providers	69 Participants	74 Participants
Gender-Affirming Hormone Therapy by Visit Week 52 · Medical providers and from friends, online, or other sources	10 Participants	13 Participants
Gender-Affirming Hormone Therapy by Visit Week 52 · Only from friends, online, or other non-licensed sources	4 Participants	1 Participants
Gender-Affirming Hormone Therapy by Visit Week 52 · Some other source	2 Participants	0 Participants
Gender-Affirming Hormone Therapy by Visit Week 65 · Missing	0 Participants	0 Participants
Gender-Affirming Hormone Therapy by Visit Week 65 · Only from medical providers	59 Participants	70 Participants
Gender-Affirming Hormone Therapy by Visit Week 65 · Medical providers and from friends, online, or other sources	17 Participants	17 Participants
Gender-Affirming Hormone Therapy by Visit Week 65 · Only from friends, online, or other non-licensed sources	2 Participants	1 Participants
Gender-Affirming Hormone Therapy by Visit Week 65 · Some other source	1 Participants	0 Participants
Gender-Affirming Hormone Therapy by Visit Week 78 · Missing	0 Participants	0 Participants
Gender-Affirming Hormone Therapy by Visit Week 78 · Only from medical providers	68 Participants	71 Participants
Gender-Affirming Hormone Therapy by Visit Week 78 · Medical providers and from friends, online, or other sources	17 Participants	18 Participants
Gender-Affirming Hormone Therapy by Visit Week 78 · Only from friends, online, or other non-licensed sources	5 Participants	2 Participants
Gender-Affirming Hormone Therapy by Visit Week 78 · Some other source	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 0-18 months

Population: Number of participants who completed the CASI form at each study visit.

Ever had a substance (like silicone or other fillers) injected to fill out face or make figure look more womanly

Outcome measures

Measure	Immediate Intervention Arm n=149 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=155 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Gender-Affirming Hormone Therapy by Visit Enrollment	27 Participants	29 Participants
Gender-Affirming Hormone Therapy by Visit Week 13	2 Participants	5 Participants
Gender-Affirming Hormone Therapy by Visit Week 26	5 Participants	4 Participants
Gender-Affirming Hormone Therapy by Visit Week 39	5 Participants	3 Participants
Gender-Affirming Hormone Therapy by Visit Week 52	6 Participants	7 Participants
Gender-Affirming Hormone Therapy by Visit Week 65	3 Participants	3 Participants
Gender-Affirming Hormone Therapy by Visit Week 78	4 Participants	5 Participants

SECONDARY outcome

Timeframe: 0-18 months

Population: Number of participants who completed the CASI form at each study visit.

Ever had breast augmentation/surgery

Outcome measures

Measure	Immediate Intervention Arm n=149 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=155 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Gender-Affirming Hormone Therapy by Visit Enrollment	36 Participants	25 Participants
Gender-Affirming Hormone Therapy by Visit Week 13	3 Participants	1 Participants
Gender-Affirming Hormone Therapy by Visit Week 26	5 Participants	1 Participants
Gender-Affirming Hormone Therapy by Visit Week 39	3 Participants	1 Participants
Gender-Affirming Hormone Therapy by Visit Week 52	5 Participants	0 Participants
Gender-Affirming Hormone Therapy by Visit Week 65	4 Participants	0 Participants
Gender-Affirming Hormone Therapy by Visit Week 78	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 0-18 months

Population: Number of participants who completed the CASI form at each study visit.

Ever had vaginoplasty/labiaplasty/SRS/GRS/GCS

Outcome measures

Measure	Immediate Intervention Arm n=149 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=155 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Gender-Affirming Hormone Therapy by Visit Enrollment	7 Participants	7 Participants
Gender-Affirming Hormone Therapy by Visit Week 13	1 Participants	0 Participants
Gender-Affirming Hormone Therapy by Visit Week 26	1 Participants	0 Participants
Gender-Affirming Hormone Therapy by Visit Week 39	1 Participants	1 Participants
Gender-Affirming Hormone Therapy by Visit Week 52	1 Participants	0 Participants
Gender-Affirming Hormone Therapy by Visit Week 65	1 Participants	0 Participants
Gender-Affirming Hormone Therapy by Visit Week 78	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 0-18 months

Population: Enrolled participants

The number of incident HIV infections at each time point by arm.

Note: The HIV infection reported at Week 26 occurred during an interim visit between Week 26 and Week 39.

Outcome measures

Measure	Immediate Intervention Arm n=149 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=155 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Annual Incidence of HIV Infections Enrollment	0 participants	0 participants
Annual Incidence of HIV Infections Week 13	0 participants	0 participants
Annual Incidence of HIV Infections Week 26	1 participants	0 participants
Annual Incidence of HIV Infections Week 39	2 participants	1 participants
Annual Incidence of HIV Infections Week 52	0 participants	0 participants
Annual Incidence of HIV Infections Week 65	0 participants	0 participants
Annual Incidence of HIV Infections Week 78	2 participants	0 participants

SECONDARY outcome

Timeframe: 0-18 months

Population: Enrolled participants

To determine annual incidence of STIs (Neisseria gonorrhoeae [GC], Chlamydia trachomatis [CT], and Treponema pallidum (syphilis)) and to examine changes in STI over time by study arm.

Outcome measures

Measure	Immediate Intervention Arm n=149 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=155 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Incidence of STI Infection (GC, CT, Syphilis) Number of STI infections (first incidence)	51 participants	51 participants
Incidence of STI Infection (GC, CT, Syphilis) Week 13	8 participants	21 participants
Incidence of STI Infection (GC, CT, Syphilis) Week 26	17 participants	10 participants
Incidence of STI Infection (GC, CT, Syphilis) Week 39	4 participants	8 participants
Incidence of STI Infection (GC, CT, Syphilis) Week 52	7 participants	1 participants
Incidence of STI Infection (GC, CT, Syphilis) Week 65	7 participants	6 participants
Incidence of STI Infection (GC, CT, Syphilis) Week 78	8 participants	5 participants

SECONDARY outcome

Timeframe: 0-18 months

PrEP uptake is defined as whether the participant initiated PrEP at the study clinic during the study cycle.

Outcome measures

Measure	Immediate Intervention Arm n=149 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=155 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to PrEP Uptake	131 Participants	137 Participants

SECONDARY outcome

Timeframe: 0-18 months

Population: A total of 268 participants initiated PrEP at the study clinic. High PrEP adherence was assessed across 1,533 study visits.

The number of study visits at which participants were highly adherent to PrEP, among those who initiated PrEP at the study clinic. High adherence at a given visit is determined using drug concentrations in dried blood spots (DBS):

Truvada: TFV-DP ≥ 900 fmol/punch Descovy: TFV-DP ≥ 950 fmol/punch

Arm-level results are presented as the total number of visits at which participants in each arm were highly adherent to PrEP, reported as the number and percentage of visits.

Outcome measures

Measure	Immediate Intervention Arm n=732 Visits PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=801 Visits PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Associated With PrEP Adherence Across Study Visits.	291 Visits	377 Visits

SECONDARY outcome

Timeframe: 0-18 months

Population: Participants who obtained PrEP at the study clinic.

PrEP persistence is defined as the proportion of study visits at which a participant demonstrates high adherence to PrEP among participants who initiated PrEP at the study clinic. High adherence at a given visit is determined using drug concentrations in dried blood spots (DBS):

Truvada: TFV-DP ≥ 900 fmol/punch

Descovy: TFV-DP ≥ 950 fmol/punch

PrEP persistence reflects sustained high adherence across multiple visits over time per participant, rather than overall high adherence at all time points. For each participant, this proportion was converted to a percentage; arm-level results are presented as the mean of participant-level percentages in each arm in the outcome measure data table.

Outcome measures

Measure	Immediate Intervention Arm n=131 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=137 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to PrEP Persistence	41.7 Percentage of Visits Standard Error 40.9	50.5 Percentage of Visits Standard Error 43.2

SECONDARY outcome

Timeframe: 0-18 months

Population: All enrolled participants.

An overall composite flag (Yes/No) for interest in future HIV research was created at the end of study using participant responses collected at enrollment, weeks 26, 52, and 78. Those who showed interest in future HIV research (Yes) were reported in the outcome measure data table.

Outcome measures

Measure	Immediate Intervention Arm n=149 Participants PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm n=155 Participants PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Identify Demographic, Behavioral, Socioeconomic, and Psychosocial Factors Related to Interest in Future HIV Research	149 Participants	153 Participants

Adverse Events

Immediate Intervention Arm

Serious events: 13 serious events

Other events: 25 other events

Deaths: 2 deaths

Deferred Intervention Arm (0-6 Months)

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Deferred Intervention Arm (6-18 Months)

Serious events: 3 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	Immediate Intervention Arm n=149 participants at risk PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm (0-6 Months) n=155 participants at risk PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.	Deferred Intervention Arm (6-18 Months) n=155 participants at risk PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Cardiac disorders Atrial fibrillation	0.67% 1/149 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Gastrointestinal disorders Acute abdomen	0.67% 1/149 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.67% 1/149 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/149 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.65% 1/155 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
General disorders Death	0.67% 1/149 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
General disorders Multiple organ dysfunction syndrome	0.67% 1/149 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Hepatobiliary disorders Hepatitis acute	0.67% 1/149 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Hepatobiliary disorders Hepatotoxicity	0.67% 1/149 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Infections and infestations Diverticulitis	0.67% 1/149 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Infections and infestations Nosocomial infection	0.67% 1/149 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Infections and infestations Pelvic abscess	0.00% 0/149 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.65% 1/155 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Infections and infestations Postoperative wound infection	0.00% 0/149 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.65% 1/155 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Infections and infestations Septic shock	0.67% 1/149 • Number of events 2 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Infections and infestations Staphylococcal infection	0.67% 1/149 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Injury, poisoning and procedural complications Overdose	0.00% 0/149 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.65% 1/155 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/149 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.65% 1/155 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Nervous system disorders Guillain-Barre syndrome	0.67% 1/149 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Nervous system disorders Seizure	0.00% 0/149 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.65% 1/155 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Psychiatric disorders Acute psychosis	0.67% 1/149 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Psychiatric disorders Mental disorder	0.67% 1/149 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Psychiatric disorders Substance-induced psychotic disorder	0.67% 1/149 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Psychiatric disorders Suicidal ideation	0.00% 0/149 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.65% 1/155 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Psychiatric disorders Suicide attempt	0.67% 1/149 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.65% 1/155 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Renal and urinary disorders Chronic kidney disease	0.00% 0/149 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.65% 1/155 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.

Other adverse events

Measure	Immediate Intervention Arm n=149 participants at risk PrEP, GAHT and peer-health management was provided from enrollment to study exit.	Deferred Intervention Arm (0-6 Months) n=155 participants at risk PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.	Deferred Intervention Arm (6-18 Months) n=155 participants at risk PrEP was provided from enrollment to study exit. GAHT and peer-health management were offered from month 6 (week 26) to study exit.
Blood and lymphatic system disorders Lymphopenia	0.67% 1/149 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Gastrointestinal disorders Abdominal discomfort	0.67% 1/149 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Gastrointestinal disorders Nausea	0.67% 1/149 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	1.3% 2/155 • Number of events 2 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Gastrointestinal disorders Oesophagitis	0.00% 0/149 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.65% 1/155 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Hepatobiliary disorders Hepatic fibrosis	0.00% 0/149 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.65% 1/155 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Immune system disorders Hypersensitivity	0.00% 0/149 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.65% 1/155 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Investigations Aspartate aminotransferase increased	0.00% 0/149 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.65% 1/155 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Investigations Blood bilirubin increased	0.67% 1/149 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Investigations Blood cholesterol increased	0.67% 1/149 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.65% 1/155 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Investigations Blood creatinine increased	3.4% 5/149 • Number of events 5 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	1.9% 3/155 • Number of events 3 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	3.2% 5/155 • Number of events 5 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Investigations Blood pressure increased	0.00% 0/149 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	1.3% 2/155 • Number of events 2 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Investigations Creatinine renal clearance decreased	8.7% 13/149 • Number of events 14 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	3.2% 5/155 • Number of events 5 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	8.4% 13/155 • Number of events 15 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Investigations Haemoglobin decreased	0.67% 1/149 • Number of events 3 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.65% 1/155 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Investigations Low density lipoprotein increased	0.67% 1/149 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.65% 1/155 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.67% 1/149 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.65% 1/155 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.67% 1/149 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Nervous system disorders Headache	0.67% 1/149 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Psychiatric disorders Anxiety	0.00% 0/149 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.65% 1/155 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Psychiatric disorders Depression	0.00% 0/149 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.65% 1/155 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Psychiatric disorders Suicidal ideation	1.3% 2/149 • Number of events 2 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Reproductive system and breast disorders Pruritus genital	0.67% 1/149 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.
Vascular disorders Hypotension	0.67% 1/149 • Number of events 1 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.	0.00% 0/155 • From enrollment until end of follow-up (0-18 months) Adverse events were reported by intervention. Immediate Arm participants received PrEP, GAHT, and peer-health management from enrollment to study exit. Deferred Arm participants received PrEP throughout, but GAHT and peer-health management only from month 6 onward. Therefore, adverse events for the Deferred Arm were split into 0-6 and 6-18 month periods, using the same denominator for both.

Additional Information

HPTN Statistical Manager

HPTN Statistical & Data Management Center

Phone: 206-667-4004

Email: HPTN-Data-Access@scharp.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place