Trial Outcomes & Findings for Optimizing PrEP Uptake & Adherence Among Male Sex Workers (MSW) Using a 2-stage Randomization Design (NCT NCT03086057)

NCT ID: NCT03086057

Last Updated: 2021-03-15

Results Overview

Number of participants with attendance at initial appointment at PrEP Clinic verified using medical records

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 111 participants
• Primary outcome timeframe: 2-month post Stage 1 randomization
• Results posted on: 2021-03-15

Participant Flow

One participant was partially enrolled and never completed enrollment. Only participants who completed Stage 1 AND who initiated PrEP were included in Stage 2.

Participant milestones

Measure	Strength Based Case Management Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications. PrEPare for Work: Strength Based Case Management (Stage 1): Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.	Standard of Care:Stage 1 Stage 1: Referral to The Miriam Hospital PrEP Clinic.	PrEP Adherence Training and Counseling Stage 2: Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist. PrEPare for Work: Adherence Training and Counseling (Stage 2): Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist.	Standard of Care: Stage 2 Stage 2: Doctor visit every three months to assess for side effects and receive a HIV test.
Stage 1: PrEP Uptake STARTED	55	55	0	0
Stage 1: PrEP Uptake COMPLETED	44	45	0	0
Stage 1: PrEP Uptake NOT COMPLETED	11	10	0	0
Stage 2: PrEP Adherence STARTED	0	0	17	18
Stage 2: PrEP Adherence COMPLETED	0	0	11	16
Stage 2: PrEP Adherence NOT COMPLETED	0	0	6	2

Reasons for withdrawal

Measure	Strength Based Case Management Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications. PrEPare for Work: Strength Based Case Management (Stage 1): Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.	Standard of Care:Stage 1 Stage 1: Referral to The Miriam Hospital PrEP Clinic.	PrEP Adherence Training and Counseling Stage 2: Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist. PrEPare for Work: Adherence Training and Counseling (Stage 2): Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist.	Standard of Care: Stage 2 Stage 2: Doctor visit every three months to assess for side effects and receive a HIV test.
Stage 1: PrEP Uptake Incarcerated	3	1	0	0
Stage 1: PrEP Uptake Withdrawal by Subject	1	4	0	0
Stage 1: PrEP Uptake Lost to Follow-up	6	5	0	0
Stage 1: PrEP Uptake Death	1	0	0	0
Stage 2: PrEP Adherence Incarcerated	0	0	2	0
Stage 2: PrEP Adherence Withdrawal by Subject	0	0	1	0
Stage 2: PrEP Adherence Lost to Follow-up	0	0	3	2

Baseline Characteristics

Optimizing PrEP Uptake & Adherence Among Male Sex Workers (MSW) Using a 2-stage Randomization Design

Baseline characteristics by cohort

Measure	Strength Based Case Management n=55 Participants Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications. PrEPare for Work: Strength Based Case Management (Stage 1): Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.	Standard of Care:Stage 1 n=55 Participants Stage 1: Referral to The Miriam Hospital PrEP Clinic.	PrEP Adherence Training and Counseling Stage 2: Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist. PrEPare for Work: Adherence Training and Counseling (Stage 2): Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist.	Standard of Care: Stage 2 Stage 2: Doctor visit every three months to assess for side effects and receive a HIV test.	Total n=110 Participants Total of all reporting groups
Age, Continuous	33.6 years STANDARD_DEVIATION 7.8 • n=93 Participants	34.6 years STANDARD_DEVIATION 9.2 • n=4 Participants	—	—	34.2 years STANDARD_DEVIATION 8.5 • n=36 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	—	—	0 Participants n=36 Participants
Sex: Female, Male Male	55 Participants n=93 Participants	55 Participants n=4 Participants	—	—	110 Participants n=36 Participants
Race/Ethnicity, Customized White, non-Hispanic	27 Participants n=93 Participants	35 Participants n=4 Participants	—	—	62 Participants n=36 Participants
Race/Ethnicity, Customized Black, non-Hispanic	8 Participants n=93 Participants	7 Participants n=4 Participants	—	—	15 Participants n=36 Participants
Race/Ethnicity, Customized Hispanic/Latino	15 Participants n=93 Participants	9 Participants n=4 Participants	—	—	24 Participants n=36 Participants
Race/Ethnicity, Customized Other	5 Participants n=93 Participants	4 Participants n=4 Participants	—	—	9 Participants n=36 Participants
Region of Enrollment United States	55 participants n=93 Participants	55 participants n=4 Participants	—	—	110 participants n=36 Participants
PrEP Use Self-Efficacy	7.1 units on a scale STANDARD_DEVIATION 3.2 • n=93 Participants	7.7 units on a scale STANDARD_DEVIATION 2.1 • n=4 Participants	—	—	7.4 units on a scale STANDARD_DEVIATION 2.7 • n=36 Participants

PRIMARY outcome

Timeframe: 2-month post Stage 1 randomization

Population: Per study design, linkage to PrEP care was only assessed in Stage 1; Additionally, because this was based on medical records we could include anyone that was not withdrawn or incarcerated or had died (n=5 in each arm).

Number of participants with attendance at initial appointment at PrEP Clinic verified using medical records

Outcome measures

Measure	Strength Based Case Management n=50 Participants Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications. PrEPare for Work: Strength Based Case Management (Stage 1): Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.	Standard of Care:Stage 1 n=50 Participants Stage 1: Referral to The Miriam Hospital PrEP Clinic.
Number of Participants With Verified Attendance at Initial Appointment at PrEP Clinic	30 Participants	13 Participants

PRIMARY outcome

Timeframe: 2-month post Stage 1 randomization

Population: Per study design, PrEP initiation was only assessed in Stage 1; Additionally, because this required proof of prescription, we excluded those who were loss to follow up for Stage 1.

Initial prescription from provider filled and shown to study staff

Outcome measures

Measure	Strength Based Case Management n=44 Participants Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications. PrEPare for Work: Strength Based Case Management (Stage 1): Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.	Standard of Care:Stage 1 n=45 Participants Stage 1: Referral to The Miriam Hospital PrEP Clinic.
Number of Participants Who Initiated PrEP	26 Participants	9 Participants

PRIMARY outcome

Timeframe: 6-months post Stage 2 randomization

Population: Per study design, PrEP adherence was only assessed in Stage 2 (and among Stage 2 participants); Additionally, because this was based on self-report, PrEP adherence was only assessed among those with follow up data.

Self-reporting missing 0 PrEP pills in the past week

Outcome measures

Measure	Strength Based Case Management n=11 Participants Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications. PrEPare for Work: Strength Based Case Management (Stage 1): Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.	Standard of Care:Stage 1 n=16 Participants Stage 1: Referral to The Miriam Hospital PrEP Clinic.
Number of Participants Reporting Optimal PrEP Adherence	5 Participants	5 Participants

Adverse Events

Strength Based Case Management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Standard of Care:Stage 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

PrEP Adherence Training and Counseling

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Standard of Care: Stage 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Strength Based Case Management n=55 participants at risk Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications. PrEPare for Work: Strength Based Case Management (Stage 1): Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.	Standard of Care:Stage 1 n=55 participants at risk Stage 1: Referral to The Miriam Hospital PrEP Clinic.	PrEP Adherence Training and Counseling n=17 participants at risk Stage 2: Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist. PrEPare for Work: Adherence Training and Counseling (Stage 2): Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist.	Standard of Care: Stage 2 n=18 participants at risk Stage 2: Doctor visit every three months to assess for side effects and receive a HIV test.
Social circumstances Potential Disclosure	0.00% 0/55 • For participants only in Stage 1, adverse event data were collected for approximately 2 months for each participant. For participants subsequently randomized into Stage 2, adverse event data were collected for an additional 6 months for each participant.	0.00% 0/55 • For participants only in Stage 1, adverse event data were collected for approximately 2 months for each participant. For participants subsequently randomized into Stage 2, adverse event data were collected for an additional 6 months for each participant.	5.9% 1/17 • Number of events 1 • For participants only in Stage 1, adverse event data were collected for approximately 2 months for each participant. For participants subsequently randomized into Stage 2, adverse event data were collected for an additional 6 months for each participant.	0.00% 0/18 • For participants only in Stage 1, adverse event data were collected for approximately 2 months for each participant. For participants subsequently randomized into Stage 2, adverse event data were collected for an additional 6 months for each participant.
Social circumstances Homicidal ideation	0.00% 0/55 • For participants only in Stage 1, adverse event data were collected for approximately 2 months for each participant. For participants subsequently randomized into Stage 2, adverse event data were collected for an additional 6 months for each participant.	0.00% 0/55 • For participants only in Stage 1, adverse event data were collected for approximately 2 months for each participant. For participants subsequently randomized into Stage 2, adverse event data were collected for an additional 6 months for each participant.	5.9% 1/17 • Number of events 1 • For participants only in Stage 1, adverse event data were collected for approximately 2 months for each participant. For participants subsequently randomized into Stage 2, adverse event data were collected for an additional 6 months for each participant.	0.00% 0/18 • For participants only in Stage 1, adverse event data were collected for approximately 2 months for each participant. For participants subsequently randomized into Stage 2, adverse event data were collected for an additional 6 months for each participant.
Social circumstances Police involvement	0.00% 0/55 • For participants only in Stage 1, adverse event data were collected for approximately 2 months for each participant. For participants subsequently randomized into Stage 2, adverse event data were collected for an additional 6 months for each participant.	0.00% 0/55 • For participants only in Stage 1, adverse event data were collected for approximately 2 months for each participant. For participants subsequently randomized into Stage 2, adverse event data were collected for an additional 6 months for each participant.	5.9% 1/17 • Number of events 2 • For participants only in Stage 1, adverse event data were collected for approximately 2 months for each participant. For participants subsequently randomized into Stage 2, adverse event data were collected for an additional 6 months for each participant.	0.00% 0/18 • For participants only in Stage 1, adverse event data were collected for approximately 2 months for each participant. For participants subsequently randomized into Stage 2, adverse event data were collected for an additional 6 months for each participant.

Additional Information

Dr. Katie Biello

Brown University

Phone: 401-863-3082

Email: katie_biello@brown.edu

Results disclosure agreements

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