Trial Outcomes & Findings for PrEP Implementation for Mothers in Antenatal Care (NCT NCT03070600)

NCT ID: NCT03070600

Last Updated: 2022-07-12

Results Overview

Maternal HIV Incidence

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 4447 participants
• Primary outcome timeframe: 6 weeks, 6 months, 9 months postpartum
• Results posted on: 2022-07-12

Participant Flow

Enrollment ended on July 31, 2019. At that time 4,447 women had enrolled (consented) into the PrIMA study out of an anticipated 4,500.

Participant milestones

Measure	Universal PrEP Counselling All enrolled women receiving antenatal care at facilities assigned to Universal PrEP arm will receive standardized HIV risk counseling and then self-select whether they want to use PrEP. Universal PrEP Counseling: Counseling at universal sites, will use a standardized counseling script to state that PrEP is available for women at risk for HIV, explain that HIV prevalence in the region is high, and will note that women with HIV positive partners or who don't know their partner's status may be at risk. Counseling will specify that women may have their own reasons to feel at risk or to want PrEP. Following standardized counseling, women will select PrEP at the same visit or will be allowed to deliberate on the decision and come back at the next visit with a decision. Women will be informed that it is advisable to use PrEP if they know their partner is HIV positive or if they do not know their partner's status and will be encouraged to bring untested partners to clinic if status is unknown.	Targeted PrEP Clinics All enrolled women receiving antenatal care at facilities assigned to the Targeted PrEP arm will be assessed for HIV-risk prior to receiving targeted PrEP counseling. Targeted PrEP Counseling: Following enrollment, the targeted PrEP clinics will provide two inter-related innovations over two ANC visits. In the targeted PrEP clinics, any of the following three criteria can trigger enhanced PrEP counseling. A participant that meets any one of these criteria will receive PrEP counseling during the study visit where the criteria is met: 1. Risk Score \>6 (Risk score includes male partner status known/unknown, syphilis infection, and lifetime number of male partners) or any National AIDS and STI Control Programme (NASCOP) risk factors 2. participant declines partner self-tests regardless of partner HIV status, and/or 3. their partner declines self-testing or tests positive.
Overall Study STARTED	2250	2197
Overall Study COMPLETED	2156	2032
Overall Study NOT COMPLETED	94	165

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PrEP Implementation for Mothers in Antenatal Care

Baseline characteristics by cohort

Measure	Universal PrEP Counselling n=2250 Participants All enrolled women receiving antenatal care at facilities assigned to Universal PrEP arm will receive standardized HIV risk counseling and then self-select whether they want to use PrEP. Universal PrEP Counseling: Counseling at universal sites, will use a standardized counseling script to state that PrEP is available for women at risk for HIV, explain that HIV prevalence in the region is high, and will note that women with HIV positive partners or who don't know their partner's status may be at risk. Counseling will specify that women may have their own reasons to feel at risk or to want PrEP. Following standardized counseling, women will select PrEP at the same visit or will be allowed to deliberate on the decision and come back at the next visit with a decision. Women will be informed that it is advisable to use PrEP if they know their partner is HIV positive or if they do not know their partner's status and will be encouraged to bring untested partners to clinic if status is unknown.	Targeted PrEP Clinics n=2197 Participants All enrolled women receiving antenatal care at facilities assigned to the Targeted PrEP arm will be assessed for HIV-risk prior to receiving targeted PrEP counseling. Targeted PrEP Counseling: Following enrollment, the targeted PrEP clinics will provide two inter-related innovations over two ANC visits. In the targeted PrEP clinics, any of the following three criteria can trigger enhanced PrEP counseling. A participant that meets any one of these criteria will receive PrEP counseling during the study visit where the criteria is met: 1. Risk Score \>6 (Risk score includes male partner status known/unknown, syphilis infection, and lifetime number of male partners) or any National AIDS and STI Control Programme (NASCOP) risk factors 2. participant declines partner self-tests regardless of partner HIV status, and/or 3. their partner declines self-testing or tests positive.	Total n=4447 Participants Total of all reporting groups
Age, Continuous	23.9 years n=5 Participants	24.1 years n=7 Participants	24.0 years n=5 Participants
Age, Customized <25 years of age	1307 Participants n=5 Participants	1238 Participants n=7 Participants	2545 Participants n=5 Participants
Age, Customized 25-35	830 Participants n=5 Participants	850 Participants n=7 Participants	1680 Participants n=5 Participants
Age, Customized 35+	112 Participants n=5 Participants	108 Participants n=7 Participants	220 Participants n=5 Participants
Age, Customized Age missing	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	2250 Participants n=5 Participants	2197 Participants n=7 Participants	4447 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2250 Participants n=5 Participants	2197 Participants n=7 Participants	4447 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Kenya	2250 participants n=5 Participants	2197 participants n=7 Participants	4447 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks, 6 months, 9 months postpartum

Maternal HIV Incidence

Outcome measures

Measure	Universal PrEP Counselling n=2372 Person-Time (years) All enrolled women receiving antenatal care at facilities assigned to Universal PrEP arm will receive standardized HIV risk counseling and then self-select whether they want to use PrEP. Universal PrEP Counseling: Counseling at universal sites, will use a standardized counseling script to state that PrEP is available for women at risk for HIV, explain that HIV prevalence in the region is high, and will note that women with HIV positive partners or who don't know their partner's status may be at risk. Counseling will specify that women may have their own reasons to feel at risk or to want PrEP. Following standardized counseling, women will select PrEP at the same visit or will be allowed to deliberate on the decision and come back at the next visit with a decision. Women will be informed that it is advisable to use PrEP if they know their partner is HIV positive or if they do not know their partner's status and will be encouraged to bring untested partners to clinic if status is unknown.	Targeted PrEP Clinics n=2266 Person-Time (years) All enrolled women receiving antenatal care at facilities assigned to the Targeted PrEP arm will be assessed for HIV-risk prior to receiving targeted PrEP counseling. Targeted PrEP Counseling: Following enrollment, the targeted PrEP clinics will provide two inter-related innovations over two ANC visits. In the targeted PrEP clinics, any of the following three criteria can trigger enhanced PrEP counseling. A participant that meets any one of these criteria will receive PrEP counseling during the study visit where the criteria is met: 1. Risk Score \>6 (Risk score includes male partner status known/unknown, syphilis infection, and lifetime number of male partners) or any National AIDS and STI Control Programme (NASCOP) risk factors 2. participant declines partner self-tests regardless of partner HIV status, and/or 3. their partner declines self-testing or tests positive.
Maternal HIV Incidence	0.38 incidence/100 Person years Interval 0.2 to 0.73	0.31 incidence/100 Person years Interval 0.15 to 0.65

PRIMARY outcome

Timeframe: Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).

Scored 1 for high risk women using PrEP and low risk women not using PrEP; 0 for high risk women NOT on PrEP and low risk women using PrEP

Outcome measures

Measure	Universal PrEP Counselling n=2250 Participants All enrolled women receiving antenatal care at facilities assigned to Universal PrEP arm will receive standardized HIV risk counseling and then self-select whether they want to use PrEP. Universal PrEP Counseling: Counseling at universal sites, will use a standardized counseling script to state that PrEP is available for women at risk for HIV, explain that HIV prevalence in the region is high, and will note that women with HIV positive partners or who don't know their partner's status may be at risk. Counseling will specify that women may have their own reasons to feel at risk or to want PrEP. Following standardized counseling, women will select PrEP at the same visit or will be allowed to deliberate on the decision and come back at the next visit with a decision. Women will be informed that it is advisable to use PrEP if they know their partner is HIV positive or if they do not know their partner's status and will be encouraged to bring untested partners to clinic if status is unknown.	Targeted PrEP Clinics n=2197 Participants All enrolled women receiving antenatal care at facilities assigned to the Targeted PrEP arm will be assessed for HIV-risk prior to receiving targeted PrEP counseling. Targeted PrEP Counseling: Following enrollment, the targeted PrEP clinics will provide two inter-related innovations over two ANC visits. In the targeted PrEP clinics, any of the following three criteria can trigger enhanced PrEP counseling. A participant that meets any one of these criteria will receive PrEP counseling during the study visit where the criteria is met: 1. Risk Score \>6 (Risk score includes male partner status known/unknown, syphilis infection, and lifetime number of male partners) or any National AIDS and STI Control Programme (NASCOP) risk factors 2. participant declines partner self-tests regardless of partner HIV status, and/or 3. their partner declines self-testing or tests positive.
Appropriate PrEP Decision	1535 Participants	1299 Participants

SECONDARY outcome

Timeframe: Enrollment to 9 months postpartum

Population: Of the 186 participants sampled for this analyses, 427 DBS samples were analyzed (232 universal arm, 195 targeted arm).

Sequential dried blood spots, PrEP adherence by DBS dichotomous by pregnancy or postpartum thresholds equivalent to ~7 doses per week (≥650 fmol/punch during pregnancy or ≥950 fmol/punch postpartum) based on the thresholds established by the 2009 IMPAACT directly observed PrEP PK study.

Outcome measures

Measure	Universal PrEP Counselling n=232 DBS Samples All enrolled women receiving antenatal care at facilities assigned to Universal PrEP arm will receive standardized HIV risk counseling and then self-select whether they want to use PrEP. Universal PrEP Counseling: Counseling at universal sites, will use a standardized counseling script to state that PrEP is available for women at risk for HIV, explain that HIV prevalence in the region is high, and will note that women with HIV positive partners or who don't know their partner's status may be at risk. Counseling will specify that women may have their own reasons to feel at risk or to want PrEP. Following standardized counseling, women will select PrEP at the same visit or will be allowed to deliberate on the decision and come back at the next visit with a decision. Women will be informed that it is advisable to use PrEP if they know their partner is HIV positive or if they do not know their partner's status and will be encouraged to bring untested partners to clinic if status is unknown.	Targeted PrEP Clinics n=195 DBS Samples All enrolled women receiving antenatal care at facilities assigned to the Targeted PrEP arm will be assessed for HIV-risk prior to receiving targeted PrEP counseling. Targeted PrEP Counseling: Following enrollment, the targeted PrEP clinics will provide two inter-related innovations over two ANC visits. In the targeted PrEP clinics, any of the following three criteria can trigger enhanced PrEP counseling. A participant that meets any one of these criteria will receive PrEP counseling during the study visit where the criteria is met: 1. Risk Score \>6 (Risk score includes male partner status known/unknown, syphilis infection, and lifetime number of male partners) or any National AIDS and STI Control Programme (NASCOP) risk factors 2. participant declines partner self-tests regardless of partner HIV status, and/or 3. their partner declines self-testing or tests positive.
PrEP Adherence	7 Samples w/ adherence at ~7dose/week	9 Samples w/ adherence at ~7dose/week

SECONDARY outcome

Timeframe: Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).

Population: This analysis is restricted to participants who initiated PrEP during the study period.

Number of months on PrEP

Outcome measures

Measure	Universal PrEP Counselling n=397 Participants All enrolled women receiving antenatal care at facilities assigned to Universal PrEP arm will receive standardized HIV risk counseling and then self-select whether they want to use PrEP. Universal PrEP Counseling: Counseling at universal sites, will use a standardized counseling script to state that PrEP is available for women at risk for HIV, explain that HIV prevalence in the region is high, and will note that women with HIV positive partners or who don't know their partner's status may be at risk. Counseling will specify that women may have their own reasons to feel at risk or to want PrEP. Following standardized counseling, women will select PrEP at the same visit or will be allowed to deliberate on the decision and come back at the next visit with a decision. Women will be informed that it is advisable to use PrEP if they know their partner is HIV positive or if they do not know their partner's status and will be encouraged to bring untested partners to clinic if status is unknown.	Targeted PrEP Clinics n=323 Participants All enrolled women receiving antenatal care at facilities assigned to the Targeted PrEP arm will be assessed for HIV-risk prior to receiving targeted PrEP counseling. Targeted PrEP Counseling: Following enrollment, the targeted PrEP clinics will provide two inter-related innovations over two ANC visits. In the targeted PrEP clinics, any of the following three criteria can trigger enhanced PrEP counseling. A participant that meets any one of these criteria will receive PrEP counseling during the study visit where the criteria is met: 1. Risk Score \>6 (Risk score includes male partner status known/unknown, syphilis infection, and lifetime number of male partners) or any National AIDS and STI Control Programme (NASCOP) risk factors 2. participant declines partner self-tests regardless of partner HIV status, and/or 3. their partner declines self-testing or tests positive.
PrEP Duration	8.6 months Interval 3.2 to 11.4	9.0 months Interval 3.8 to 11.9

SECONDARY outcome

Timeframe: At 9 months postpartum

Population: This analysis is restricted to participants who reported having a partner at 9-months postpartum.

Participants report of partner's HIV status

Outcome measures

Measure	Universal PrEP Counselling n=2155 Participants All enrolled women receiving antenatal care at facilities assigned to Universal PrEP arm will receive standardized HIV risk counseling and then self-select whether they want to use PrEP. Universal PrEP Counseling: Counseling at universal sites, will use a standardized counseling script to state that PrEP is available for women at risk for HIV, explain that HIV prevalence in the region is high, and will note that women with HIV positive partners or who don't know their partner's status may be at risk. Counseling will specify that women may have their own reasons to feel at risk or to want PrEP. Following standardized counseling, women will select PrEP at the same visit or will be allowed to deliberate on the decision and come back at the next visit with a decision. Women will be informed that it is advisable to use PrEP if they know their partner is HIV positive or if they do not know their partner's status and will be encouraged to bring untested partners to clinic if status is unknown.	Targeted PrEP Clinics n=2030 Participants All enrolled women receiving antenatal care at facilities assigned to the Targeted PrEP arm will be assessed for HIV-risk prior to receiving targeted PrEP counseling. Targeted PrEP Counseling: Following enrollment, the targeted PrEP clinics will provide two inter-related innovations over two ANC visits. In the targeted PrEP clinics, any of the following three criteria can trigger enhanced PrEP counseling. A participant that meets any one of these criteria will receive PrEP counseling during the study visit where the criteria is met: 1. Risk Score \>6 (Risk score includes male partner status known/unknown, syphilis infection, and lifetime number of male partners) or any National AIDS and STI Control Programme (NASCOP) risk factors 2. participant declines partner self-tests regardless of partner HIV status, and/or 3. their partner declines self-testing or tests positive.
Partner With Known HIV Status	1680 Participants	1648 Participants

SECONDARY outcome

Timeframe: time of delivery

Population: This analysis is restricted to mothers with live born infants with birth weight data available in their clinical records.

Infant Birthweight

Outcome measures

Measure	Universal PrEP Counselling n=1497 Participants All enrolled women receiving antenatal care at facilities assigned to Universal PrEP arm will receive standardized HIV risk counseling and then self-select whether they want to use PrEP. Universal PrEP Counseling: Counseling at universal sites, will use a standardized counseling script to state that PrEP is available for women at risk for HIV, explain that HIV prevalence in the region is high, and will note that women with HIV positive partners or who don't know their partner's status may be at risk. Counseling will specify that women may have their own reasons to feel at risk or to want PrEP. Following standardized counseling, women will select PrEP at the same visit or will be allowed to deliberate on the decision and come back at the next visit with a decision. Women will be informed that it is advisable to use PrEP if they know their partner is HIV positive or if they do not know their partner's status and will be encouraged to bring untested partners to clinic if status is unknown.	Targeted PrEP Clinics n=1370 Participants All enrolled women receiving antenatal care at facilities assigned to the Targeted PrEP arm will be assessed for HIV-risk prior to receiving targeted PrEP counseling. Targeted PrEP Counseling: Following enrollment, the targeted PrEP clinics will provide two inter-related innovations over two ANC visits. In the targeted PrEP clinics, any of the following three criteria can trigger enhanced PrEP counseling. A participant that meets any one of these criteria will receive PrEP counseling during the study visit where the criteria is met: 1. Risk Score \>6 (Risk score includes male partner status known/unknown, syphilis infection, and lifetime number of male partners) or any National AIDS and STI Control Programme (NASCOP) risk factors 2. participant declines partner self-tests regardless of partner HIV status, and/or 3. their partner declines self-testing or tests positive.
Infant Birthweight	3.5 kg Interval 3.1 to 3.8	3.5 kg Interval 3.1 to 3.8

SECONDARY outcome

Timeframe: 9 months of age

Population: Length measurements could not be ascertained from all infants

Infant height, weight, and age (Weight-for-Age [WAZ], Height-for-Age [HAZ], Weight-for-Height [WHZ] Z-scores). A Z-score of 0 represents the population mean. Indicators of infant malnutrition are defined as Underweight- WAZ Z-score<-2; Stunting-HAZ Z-Score <-2; Wasting- WHZ Z-Score <-2.

Outcome measures

Measure	Universal PrEP Counselling n=1847 Participants All enrolled women receiving antenatal care at facilities assigned to Universal PrEP arm will receive standardized HIV risk counseling and then self-select whether they want to use PrEP. Universal PrEP Counseling: Counseling at universal sites, will use a standardized counseling script to state that PrEP is available for women at risk for HIV, explain that HIV prevalence in the region is high, and will note that women with HIV positive partners or who don't know their partner's status may be at risk. Counseling will specify that women may have their own reasons to feel at risk or to want PrEP. Following standardized counseling, women will select PrEP at the same visit or will be allowed to deliberate on the decision and come back at the next visit with a decision. Women will be informed that it is advisable to use PrEP if they know their partner is HIV positive or if they do not know their partner's status and will be encouraged to bring untested partners to clinic if status is unknown.	Targeted PrEP Clinics n=1659 Participants All enrolled women receiving antenatal care at facilities assigned to the Targeted PrEP arm will be assessed for HIV-risk prior to receiving targeted PrEP counseling. Targeted PrEP Counseling: Following enrollment, the targeted PrEP clinics will provide two inter-related innovations over two ANC visits. In the targeted PrEP clinics, any of the following three criteria can trigger enhanced PrEP counseling. A participant that meets any one of these criteria will receive PrEP counseling during the study visit where the criteria is met: 1. Risk Score \>6 (Risk score includes male partner status known/unknown, syphilis infection, and lifetime number of male partners) or any National AIDS and STI Control Programme (NASCOP) risk factors 2. participant declines partner self-tests regardless of partner HIV status, and/or 3. their partner declines self-testing or tests positive.
Infant Growth Infant HAZ at 9mo PP	-0.35 z-score Interval -1.25 to 0.5	-0.47 z-score Interval -1.31 to 0.48
Infant Growth Infant WHZ at 9mo PP	0.42 z-score Interval -0.48 to 1.37	0.29 z-score Interval -0.59 to 1.26
Infant Growth Infant WAZ at 9mo PP	0.12 z-score Interval -0.61 to 0.88	-0.01 z-score Interval -0.77 to 0.86

SECONDARY outcome

Timeframe: Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).

PrEP Utilization by participants

Outcome measures

Measure	Universal PrEP Counselling n=2250 Participants All enrolled women receiving antenatal care at facilities assigned to Universal PrEP arm will receive standardized HIV risk counseling and then self-select whether they want to use PrEP. Universal PrEP Counseling: Counseling at universal sites, will use a standardized counseling script to state that PrEP is available for women at risk for HIV, explain that HIV prevalence in the region is high, and will note that women with HIV positive partners or who don't know their partner's status may be at risk. Counseling will specify that women may have their own reasons to feel at risk or to want PrEP. Following standardized counseling, women will select PrEP at the same visit or will be allowed to deliberate on the decision and come back at the next visit with a decision. Women will be informed that it is advisable to use PrEP if they know their partner is HIV positive or if they do not know their partner's status and will be encouraged to bring untested partners to clinic if status is unknown.	Targeted PrEP Clinics n=2197 Participants All enrolled women receiving antenatal care at facilities assigned to the Targeted PrEP arm will be assessed for HIV-risk prior to receiving targeted PrEP counseling. Targeted PrEP Counseling: Following enrollment, the targeted PrEP clinics will provide two inter-related innovations over two ANC visits. In the targeted PrEP clinics, any of the following three criteria can trigger enhanced PrEP counseling. A participant that meets any one of these criteria will receive PrEP counseling during the study visit where the criteria is met: 1. Risk Score \>6 (Risk score includes male partner status known/unknown, syphilis infection, and lifetime number of male partners) or any National AIDS and STI Control Programme (NASCOP) risk factors 2. participant declines partner self-tests regardless of partner HIV status, and/or 3. their partner declines self-testing or tests positive.
PrEP Use	397 Participants	323 Participants

SECONDARY outcome

Timeframe: Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).

PrEP accepted by participants

Outcome measures

Measure	Universal PrEP Counselling n=2250 Participants All enrolled women receiving antenatal care at facilities assigned to Universal PrEP arm will receive standardized HIV risk counseling and then self-select whether they want to use PrEP. Universal PrEP Counseling: Counseling at universal sites, will use a standardized counseling script to state that PrEP is available for women at risk for HIV, explain that HIV prevalence in the region is high, and will note that women with HIV positive partners or who don't know their partner's status may be at risk. Counseling will specify that women may have their own reasons to feel at risk or to want PrEP. Following standardized counseling, women will select PrEP at the same visit or will be allowed to deliberate on the decision and come back at the next visit with a decision. Women will be informed that it is advisable to use PrEP if they know their partner is HIV positive or if they do not know their partner's status and will be encouraged to bring untested partners to clinic if status is unknown.	Targeted PrEP Clinics n=2197 Participants All enrolled women receiving antenatal care at facilities assigned to the Targeted PrEP arm will be assessed for HIV-risk prior to receiving targeted PrEP counseling. Targeted PrEP Counseling: Following enrollment, the targeted PrEP clinics will provide two inter-related innovations over two ANC visits. In the targeted PrEP clinics, any of the following three criteria can trigger enhanced PrEP counseling. A participant that meets any one of these criteria will receive PrEP counseling during the study visit where the criteria is met: 1. Risk Score \>6 (Risk score includes male partner status known/unknown, syphilis infection, and lifetime number of male partners) or any National AIDS and STI Control Programme (NASCOP) risk factors 2. participant declines partner self-tests regardless of partner HIV status, and/or 3. their partner declines self-testing or tests positive.
PrEP Acceptance	441 Participants	387 Participants

SECONDARY outcome

Timeframe: At birth

Population: This analysis is restricted to participants who reported a live birth and had gestational age at birth data available.

Birth <37 weeks gestation

Outcome measures

Measure	Universal PrEP Counselling n=2205 Participants All enrolled women receiving antenatal care at facilities assigned to Universal PrEP arm will receive standardized HIV risk counseling and then self-select whether they want to use PrEP. Universal PrEP Counseling: Counseling at universal sites, will use a standardized counseling script to state that PrEP is available for women at risk for HIV, explain that HIV prevalence in the region is high, and will note that women with HIV positive partners or who don't know their partner's status may be at risk. Counseling will specify that women may have their own reasons to feel at risk or to want PrEP. Following standardized counseling, women will select PrEP at the same visit or will be allowed to deliberate on the decision and come back at the next visit with a decision. Women will be informed that it is advisable to use PrEP if they know their partner is HIV positive or if they do not know their partner's status and will be encouraged to bring untested partners to clinic if status is unknown.	Targeted PrEP Clinics n=2101 Participants All enrolled women receiving antenatal care at facilities assigned to the Targeted PrEP arm will be assessed for HIV-risk prior to receiving targeted PrEP counseling. Targeted PrEP Counseling: Following enrollment, the targeted PrEP clinics will provide two inter-related innovations over two ANC visits. In the targeted PrEP clinics, any of the following three criteria can trigger enhanced PrEP counseling. A participant that meets any one of these criteria will receive PrEP counseling during the study visit where the criteria is met: 1. Risk Score \>6 (Risk score includes male partner status known/unknown, syphilis infection, and lifetime number of male partners) or any National AIDS and STI Control Programme (NASCOP) risk factors 2. participant declines partner self-tests regardless of partner HIV status, and/or 3. their partner declines self-testing or tests positive.
Preterm Birth	506 Participants	309 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).

Any missed doses in the last month reported by participants

Outcome measures

Measure	Universal PrEP Counselling n=390 Participants All enrolled women receiving antenatal care at facilities assigned to Universal PrEP arm will receive standardized HIV risk counseling and then self-select whether they want to use PrEP. Universal PrEP Counseling: Counseling at universal sites, will use a standardized counseling script to state that PrEP is available for women at risk for HIV, explain that HIV prevalence in the region is high, and will note that women with HIV positive partners or who don't know their partner's status may be at risk. Counseling will specify that women may have their own reasons to feel at risk or to want PrEP. Following standardized counseling, women will select PrEP at the same visit or will be allowed to deliberate on the decision and come back at the next visit with a decision. Women will be informed that it is advisable to use PrEP if they know their partner is HIV positive or if they do not know their partner's status and will be encouraged to bring untested partners to clinic if status is unknown.	Targeted PrEP Clinics n=320 Participants All enrolled women receiving antenatal care at facilities assigned to the Targeted PrEP arm will be assessed for HIV-risk prior to receiving targeted PrEP counseling. Targeted PrEP Counseling: Following enrollment, the targeted PrEP clinics will provide two inter-related innovations over two ANC visits. In the targeted PrEP clinics, any of the following three criteria can trigger enhanced PrEP counseling. A participant that meets any one of these criteria will receive PrEP counseling during the study visit where the criteria is met: 1. Risk Score \>6 (Risk score includes male partner status known/unknown, syphilis infection, and lifetime number of male partners) or any National AIDS and STI Control Programme (NASCOP) risk factors 2. participant declines partner self-tests regardless of partner HIV status, and/or 3. their partner declines self-testing or tests positive.
PrEP Adherence by Self-report	184 Participants	120 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).

Population: This analysis is restricted to participants with a partner known to be living with HIV.

Participant report of partner ART use if partner is HIV positive

Outcome measures

Measure	Universal PrEP Counselling n=39 Participants All enrolled women receiving antenatal care at facilities assigned to Universal PrEP arm will receive standardized HIV risk counseling and then self-select whether they want to use PrEP. Universal PrEP Counseling: Counseling at universal sites, will use a standardized counseling script to state that PrEP is available for women at risk for HIV, explain that HIV prevalence in the region is high, and will note that women with HIV positive partners or who don't know their partner's status may be at risk. Counseling will specify that women may have their own reasons to feel at risk or to want PrEP. Following standardized counseling, women will select PrEP at the same visit or will be allowed to deliberate on the decision and come back at the next visit with a decision. Women will be informed that it is advisable to use PrEP if they know their partner is HIV positive or if they do not know their partner's status and will be encouraged to bring untested partners to clinic if status is unknown.	Targeted PrEP Clinics n=33 Participants All enrolled women receiving antenatal care at facilities assigned to the Targeted PrEP arm will be assessed for HIV-risk prior to receiving targeted PrEP counseling. Targeted PrEP Counseling: Following enrollment, the targeted PrEP clinics will provide two inter-related innovations over two ANC visits. In the targeted PrEP clinics, any of the following three criteria can trigger enhanced PrEP counseling. A participant that meets any one of these criteria will receive PrEP counseling during the study visit where the criteria is met: 1. Risk Score \>6 (Risk score includes male partner status known/unknown, syphilis infection, and lifetime number of male partners) or any National AIDS and STI Control Programme (NASCOP) risk factors 2. participant declines partner self-tests regardless of partner HIV status, and/or 3. their partner declines self-testing or tests positive.
Partner on ART if HIV Positive	37 Participants	31 Participants

Adverse Events

Universal PrEP Counselling

Serious events: 132 serious events

Other events: 7 other events

Deaths: 2 deaths

Targeted PrEP Clinics

Serious events: 118 serious events

Other events: 7 other events

Deaths: 2 deaths

Serious adverse events

Measure	Universal PrEP Counselling n=2250 participants at risk All enrolled women receiving antenatal care at facilities assigned to Universal PrEP arm will receive standardized HIV risk counseling and then self-select whether they want to use PrEP. Universal PrEP Counseling: Counseling at universal sites, will use a standardized counseling script to state that PrEP is available for women at risk for HIV, explain that HIV prevalence in the region is high, and will note that women with HIV positive partners or who don't know their partner's status may be at risk. Counseling will specify that women may have their own reasons to feel at risk or to want PrEP. Following standardized counseling, women will select PrEP at the same visit or will be allowed to deliberate on the decision and come back at the next visit with a decision. Women will be informed that it is advisable to use PrEP if they know their partner is HIV positive or if they do not know their partner's status and will be encouraged to bring untested partners to clinic if status is unknown.	Targeted PrEP Clinics n=2197 participants at risk All enrolled women receiving antenatal care at facilities assigned to the Targeted PrEP arm will be assessed for HIV-risk prior to receiving targeted PrEP counseling. Targeted PrEP Counseling: Following enrollment, the targeted PrEP clinics will provide two inter-related innovations over two ANC visits. In the targeted PrEP clinics, any of the following three criteria can trigger enhanced PrEP counseling. A participant that meets any one of these criteria will receive PrEP counseling during the study visit where the criteria is met: 1. Risk Score \>6 (Risk score includes male partner status known/unknown, syphilis infection, and lifetime number of male partners) or any National AIDS and STI Control Programme (NASCOP) risk factors 2. participant declines partner self-tests regardless of partner HIV status, and/or 3. their partner declines self-testing or tests positive.
Pregnancy, puerperium and perinatal conditions Infant Death	2.3% 51/2250 • Number of events 51 • Data on adverse events were monitored and data collected on all adverse events from participants at all study visits or via a phone call to study staff (monthly during antenatal care and 6 weeks, 3 months, 6 months, and 9 months postpartum). The median gestational age at enrollment was 24 weeks (IQR: 20, 30).	2.1% 47/2197 • Number of events 47 • Data on adverse events were monitored and data collected on all adverse events from participants at all study visits or via a phone call to study staff (monthly during antenatal care and 6 weeks, 3 months, 6 months, and 9 months postpartum). The median gestational age at enrollment was 24 weeks (IQR: 20, 30).
Pregnancy, puerperium and perinatal conditions Infant Hospitalization	0.58% 13/2250 • Number of events 13 • Data on adverse events were monitored and data collected on all adverse events from participants at all study visits or via a phone call to study staff (monthly during antenatal care and 6 weeks, 3 months, 6 months, and 9 months postpartum). The median gestational age at enrollment was 24 weeks (IQR: 20, 30).	0.14% 3/2197 • Number of events 3 • Data on adverse events were monitored and data collected on all adverse events from participants at all study visits or via a phone call to study staff (monthly during antenatal care and 6 weeks, 3 months, 6 months, and 9 months postpartum). The median gestational age at enrollment was 24 weeks (IQR: 20, 30).
Pregnancy, puerperium and perinatal conditions Maternal Hospitalization	0.49% 11/2250 • Number of events 11 • Data on adverse events were monitored and data collected on all adverse events from participants at all study visits or via a phone call to study staff (monthly during antenatal care and 6 weeks, 3 months, 6 months, and 9 months postpartum). The median gestational age at enrollment was 24 weeks (IQR: 20, 30).	0.82% 18/2197 • Number of events 18 • Data on adverse events were monitored and data collected on all adverse events from participants at all study visits or via a phone call to study staff (monthly during antenatal care and 6 weeks, 3 months, 6 months, and 9 months postpartum). The median gestational age at enrollment was 24 weeks (IQR: 20, 30).
Pregnancy, puerperium and perinatal conditions Miscarriage	0.40% 9/2250 • Number of events 9 • Data on adverse events were monitored and data collected on all adverse events from participants at all study visits or via a phone call to study staff (monthly during antenatal care and 6 weeks, 3 months, 6 months, and 9 months postpartum). The median gestational age at enrollment was 24 weeks (IQR: 20, 30).	0.36% 8/2197 • Number of events 8 • Data on adverse events were monitored and data collected on all adverse events from participants at all study visits or via a phone call to study staff (monthly during antenatal care and 6 weeks, 3 months, 6 months, and 9 months postpartum). The median gestational age at enrollment was 24 weeks (IQR: 20, 30).
Pregnancy, puerperium and perinatal conditions Stillbirth	2.3% 51/2250 • Number of events 51 • Data on adverse events were monitored and data collected on all adverse events from participants at all study visits or via a phone call to study staff (monthly during antenatal care and 6 weeks, 3 months, 6 months, and 9 months postpartum). The median gestational age at enrollment was 24 weeks (IQR: 20, 30).	1.9% 41/2197 • Number of events 41 • Data on adverse events were monitored and data collected on all adverse events from participants at all study visits or via a phone call to study staff (monthly during antenatal care and 6 weeks, 3 months, 6 months, and 9 months postpartum). The median gestational age at enrollment was 24 weeks (IQR: 20, 30).
Pregnancy, puerperium and perinatal conditions Molar Pregnancy	0.00% 0/2250 • Data on adverse events were monitored and data collected on all adverse events from participants at all study visits or via a phone call to study staff (monthly during antenatal care and 6 weeks, 3 months, 6 months, and 9 months postpartum). The median gestational age at enrollment was 24 weeks (IQR: 20, 30).	0.05% 1/2197 • Number of events 1 • Data on adverse events were monitored and data collected on all adverse events from participants at all study visits or via a phone call to study staff (monthly during antenatal care and 6 weeks, 3 months, 6 months, and 9 months postpartum). The median gestational age at enrollment was 24 weeks (IQR: 20, 30).

Other adverse events

Measure	Universal PrEP Counselling n=2250 participants at risk All enrolled women receiving antenatal care at facilities assigned to Universal PrEP arm will receive standardized HIV risk counseling and then self-select whether they want to use PrEP. Universal PrEP Counseling: Counseling at universal sites, will use a standardized counseling script to state that PrEP is available for women at risk for HIV, explain that HIV prevalence in the region is high, and will note that women with HIV positive partners or who don't know their partner's status may be at risk. Counseling will specify that women may have their own reasons to feel at risk or to want PrEP. Following standardized counseling, women will select PrEP at the same visit or will be allowed to deliberate on the decision and come back at the next visit with a decision. Women will be informed that it is advisable to use PrEP if they know their partner is HIV positive or if they do not know their partner's status and will be encouraged to bring untested partners to clinic if status is unknown.	Targeted PrEP Clinics n=2197 participants at risk All enrolled women receiving antenatal care at facilities assigned to the Targeted PrEP arm will be assessed for HIV-risk prior to receiving targeted PrEP counseling. Targeted PrEP Counseling: Following enrollment, the targeted PrEP clinics will provide two inter-related innovations over two ANC visits. In the targeted PrEP clinics, any of the following three criteria can trigger enhanced PrEP counseling. A participant that meets any one of these criteria will receive PrEP counseling during the study visit where the criteria is met: 1. Risk Score \>6 (Risk score includes male partner status known/unknown, syphilis infection, and lifetime number of male partners) or any National AIDS and STI Control Programme (NASCOP) risk factors 2. participant declines partner self-tests regardless of partner HIV status, and/or 3. their partner declines self-testing or tests positive.
Pregnancy, puerperium and perinatal conditions Kicked out of home	0.09% 2/2250 • Number of events 2 • Data on adverse events were monitored and data collected on all adverse events from participants at all study visits or via a phone call to study staff (monthly during antenatal care and 6 weeks, 3 months, 6 months, and 9 months postpartum). The median gestational age at enrollment was 24 weeks (IQR: 20, 30).	0.14% 3/2197 • Number of events 3 • Data on adverse events were monitored and data collected on all adverse events from participants at all study visits or via a phone call to study staff (monthly during antenatal care and 6 weeks, 3 months, 6 months, and 9 months postpartum). The median gestational age at enrollment was 24 weeks (IQR: 20, 30).
Pregnancy, puerperium and perinatal conditions Experienced violence of abuse	0.22% 5/2250 • Number of events 5 • Data on adverse events were monitored and data collected on all adverse events from participants at all study visits or via a phone call to study staff (monthly during antenatal care and 6 weeks, 3 months, 6 months, and 9 months postpartum). The median gestational age at enrollment was 24 weeks (IQR: 20, 30).	0.18% 4/2197 • Number of events 4 • Data on adverse events were monitored and data collected on all adverse events from participants at all study visits or via a phone call to study staff (monthly during antenatal care and 6 weeks, 3 months, 6 months, and 9 months postpartum). The median gestational age at enrollment was 24 weeks (IQR: 20, 30).
Pregnancy, puerperium and perinatal conditions Breach of confidentiality	0.00% 0/2250 • Data on adverse events were monitored and data collected on all adverse events from participants at all study visits or via a phone call to study staff (monthly during antenatal care and 6 weeks, 3 months, 6 months, and 9 months postpartum). The median gestational age at enrollment was 24 weeks (IQR: 20, 30).	0.05% 1/2197 • Number of events 1 • Data on adverse events were monitored and data collected on all adverse events from participants at all study visits or via a phone call to study staff (monthly during antenatal care and 6 weeks, 3 months, 6 months, and 9 months postpartum). The median gestational age at enrollment was 24 weeks (IQR: 20, 30).
Psychiatric disorders Suicidal behavior	0.00% 0/2250 • Data on adverse events were monitored and data collected on all adverse events from participants at all study visits or via a phone call to study staff (monthly during antenatal care and 6 weeks, 3 months, 6 months, and 9 months postpartum). The median gestational age at enrollment was 24 weeks (IQR: 20, 30).	0.05% 1/2197 • Number of events 1 • Data on adverse events were monitored and data collected on all adverse events from participants at all study visits or via a phone call to study staff (monthly during antenatal care and 6 weeks, 3 months, 6 months, and 9 months postpartum). The median gestational age at enrollment was 24 weeks (IQR: 20, 30).
Psychiatric disorders Persistent or significant psychosocial distress	0.13% 3/2250 • Number of events 3 • Data on adverse events were monitored and data collected on all adverse events from participants at all study visits or via a phone call to study staff (monthly during antenatal care and 6 weeks, 3 months, 6 months, and 9 months postpartum). The median gestational age at enrollment was 24 weeks (IQR: 20, 30).	0.05% 1/2197 • Number of events 1 • Data on adverse events were monitored and data collected on all adverse events from participants at all study visits or via a phone call to study staff (monthly during antenatal care and 6 weeks, 3 months, 6 months, and 9 months postpartum). The median gestational age at enrollment was 24 weeks (IQR: 20, 30).
Infections and infestations Partner thought participant was HIV positive	0.04% 1/2250 • Number of events 1 • Data on adverse events were monitored and data collected on all adverse events from participants at all study visits or via a phone call to study staff (monthly during antenatal care and 6 weeks, 3 months, 6 months, and 9 months postpartum). The median gestational age at enrollment was 24 weeks (IQR: 20, 30).	0.00% 0/2197 • Data on adverse events were monitored and data collected on all adverse events from participants at all study visits or via a phone call to study staff (monthly during antenatal care and 6 weeks, 3 months, 6 months, and 9 months postpartum). The median gestational age at enrollment was 24 weeks (IQR: 20, 30).

Additional Information

Grace John-Stewart

University of Washington

Phone: 206-543-4278

Email: gjohn@uw.edu

Results disclosure agreements

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