PrEP Implementation for Mothers in Antenatal Care (PrIMA)

• ClinicalTrials.gov Identifier: NCT03070600
• Recruitment Status: Completed
• First Posted: March 3, 2017
• Results First Posted: May 10, 2022
• Last Update Posted: July 12, 2022
• Sponsor: University of Washington
• Collaborators: Kenyatta National Hospital; National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): Grace John-Stewart, University of Washington

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Conditions: HIV Infections; Pregnancy Related
• Interventions: Other: Universal PrEP Counseling; Other: Targeted PrEP Counseling
• Enrollment: 4447

Participant Flow

Recruitment Details
Pre-assignment Details	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.

Arm/Group Title	Universal PrEP Counselling	Targeted PrEP Clinics
Arm/Group Description	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.	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: 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; participant declines partner self-tests regardless of partner HIV status, and/or; their partner declines self-testing or tests positive.
Period Title: Overall Study
Started	2250	2197
Completed	2156	2032
Not Completed	94	165

Baseline Characteristics

Arm/Group Title		Universal PrEP Counselling	Targeted PrEP Clinics	Total
Arm/Group Description		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.	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: 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; participant declines partner self-tests regardless of partner HIV status, and/or; their partner declines self-testing or tests positive.	Total of all reporting groups
Overall Number of Baseline Participants		2250	2197	4447
Baseline Analysis Population Description		Enrollment for this study ended on July 31, 2019. At the time that enrollment ended, 4,447 participants had enrolled (consented) into the study out of an anticipated 4,500.
Age, Continuous; Median (Inter-Quartile Range); Unit of measure: Years
	Number Analyzed	2250 participants	2197 participants	4447 participants
		23.9; (20.7 to 28.2)	24.1; (21.0 to 28.5)	24.0; (20.9 to 28.3)
Age, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	2250 participants	2197 participants	4447 participants
<25 years of age		1307 58.1%	1238 56.3%	2545 57.2%
25-35		830 36.9%	850 38.7%	1680 37.8%
35+		112 5.0%	108 4.9%	220 4.9%
Age missing		1 0.0%	1 0.0%	2 0.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	2250 participants	2197 participants	4447 participants
	Female	2250 100.0%	2197 100.0%	4447 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	2250 participants	2197 participants	4447 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	2250 100.0%	2197 100.0%	4447 100.0%
	White	0 0.0%	0 0.0%	0 0.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Kenya	Number Analyzed	2250 participants	2197 participants	4447 participants
		2250	2197	4447

Outcome Measures

1. Primary Outcome

Title	Maternal HIV Incidence
Description	Maternal HIV Incidence
Time Frame	6 weeks, 6 months, 9 months postpartum

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Universal PrEP Counselling	Targeted PrEP Clinics
Arm/Group Description:	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.	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: 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; participant declines partner self-tests regardless of partner HIV status, and/or; their partner declines self-testing or tests positive.
Overall Number of Participants Analyzed	2250	2197
Overall Number of Units Analyzed; Type of Units Analyzed: Person-Time (years)	2372	2266
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: incidence/100 Person years
	0.38; (0.20 to 0.73)	0.31; (0.15 to 0.65)

2. Primary Outcome

Title	Appropriate PrEP Decision
Description	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
Time Frame	Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Universal PrEP Counselling	Targeted PrEP Clinics
Arm/Group Description:	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.	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: 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; participant declines partner self-tests regardless of partner HIV status, and/or; their partner declines self-testing or tests positive.
Overall Number of Participants Analyzed	2250	2197
Measure Type: Count of Participants; Unit of Measure: Participants
	1535 68.2%	1299 59.1%

3. Secondary Outcome

Title	PrEP Adherence
Description	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.
Time Frame	Enrollment to 9 months postpartum

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Universal Arm- DBS Samples Selected	Targeted Arm- DBS Samples Selected
Arm/Group Description:	Participants in the universal arm who initiated PrEP at any time during the study, with DBS randomly selected for analysis.	Participants in the targeted arm who initiated PrEP at any time during the study, with DBS randomly selected for analysis.
Overall Number of Participants Analyzed	100	86
Overall Number of Units Analyzed; Type of Units Analyzed: DBS Samples	232	195
Measure Type: Number; Unit of Measure: Samples w/ adherence at ~7dose/week
	7	9

4. Secondary Outcome

Title	PrEP Duration
Description	Number of months on PrEP
Time Frame	Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Universal Arm- PrEP Initiated	Targeted Arm- PrEP Initiated
Arm/Group Description:	Participants in the Universal Arm that initiated PrEP at any point during the study	Participants in the Targeted Arm that initiated PrEP at any point during the study period
Overall Number of Participants Analyzed	397	323
Median (Inter-Quartile Range); Unit of Measure: months
	8.6; (3.2 to 11.4)	9.0; (3.8 to 11.9)

5. Secondary Outcome

Title	Partner With Known HIV Status
Description	Participants report of partner's HIV status
Time Frame	At 9 months postpartum

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Universal PrEP Counselling	Targeted PrEP Clinics
Arm/Group Description:	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.	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: 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; participant declines partner self-tests regardless of partner HIV status, and/or; their partner declines self-testing or tests positive.
Overall Number of Participants Analyzed	2155	2030
Measure Type: Count of Participants; Unit of Measure: Participants
	1680 78.0%	1648 81.2%

6. Secondary Outcome

Title	Infant Birthweight
Description	Infant Birthweight
Time Frame	time of delivery

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Universal PrEP Counselling	Targeted PrEP Clinics
Arm/Group Description:	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.	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: 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; participant declines partner self-tests regardless of partner HIV status, and/or; their partner declines self-testing or tests positive.
Overall Number of Participants Analyzed	1497	1370
Median (Inter-Quartile Range); Unit of Measure: kg
	3.5; (3.1 to 3.8)	3.5; (3.1 to 3.8)

7. Secondary Outcome

Title	Infant Growth
Description	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.
Time Frame	9 months of age

Outcome Measure Data

Analysis Population Description

Length measurements could not be ascertained from all infants

Arm/Group Title		Universal PrEP Counselling	Targeted PrEP Clinics
Arm/Group Description:		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.	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: 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; participant declines partner self-tests regardless of partner HIV status, and/or; their partner declines self-testing or tests positive.
Overall Number of Participants Analyzed		1847	1659
Median (Inter-Quartile Range); Unit of Measure: z-score
Infant WAZ at 9mo PP	Number Analyzed	1847 participants	1659 participants
		0.12; (-0.61 to 0.88)	-0.01; (-0.77 to 0.86)
Infant HAZ at 9mo PP	Number Analyzed	1777 participants	1575 participants
		-0.35; (-1.25 to 0.50)	-0.47; (-1.31 to 0.48)
Infant WHZ at 9mo PP	Number Analyzed	1774 participants	1586 participants
		0.42; (-0.48 to 1.37)	0.29; (-0.59 to 1.26)

8. Secondary Outcome

Title	PrEP Use
Description	PrEP Utilization by participants
Time Frame	Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Universal PrEP Counselling	Targeted PrEP Clinics
Arm/Group Description:	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.	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: 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; participant declines partner self-tests regardless of partner HIV status, and/or; their partner declines self-testing or tests positive.
Overall Number of Participants Analyzed	2250	2197
Measure Type: Count of Participants; Unit of Measure: Participants
	397 17.6%	323 14.7%

9. Secondary Outcome

Title	PrEP Acceptance
Description	PrEP accepted by participants
Time Frame	Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Universal PrEP Counselling	Targeted PrEP Clinics
Arm/Group Description:	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.	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: 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; participant declines partner self-tests regardless of partner HIV status, and/or; their partner declines self-testing or tests positive.
Overall Number of Participants Analyzed	2250	2197
Measure Type: Count of Participants; Unit of Measure: Participants
	441 19.6%	387 17.6%

10. Secondary Outcome

Title	Preterm Birth
Description	Birth <37 weeks gestation
Time Frame	At birth

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Universal PrEP Counselling	Targeted PrEP Clinics
Arm/Group Description:	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.	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: 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; participant declines partner self-tests regardless of partner HIV status, and/or; their partner declines self-testing or tests positive.
Overall Number of Participants Analyzed	2205	2101
Measure Type: Count of Participants; Unit of Measure: Participants
	506 22.9%	309 14.7%

11. Other Pre-specified Outcome

Title	PrEP Adherence by Self-report
Description	Any missed doses in the last month reported by participants
Time Frame	Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Universal Arm- PrEP Initiated	Targeted Arm- PrEP Initiated
Arm/Group Description:	This analysis is restricted to participants who initiated PrEP during the study period.	This analysis is restricted to participants who initiated PrEP during the study period.
Overall Number of Participants Analyzed	390	320
Measure Type: Count of Participants; Unit of Measure: Participants
	184 47.2%	120 37.5%

12. Other Pre-specified Outcome

Title	Partner on ART if HIV Positive
Description	Participant report of partner ART use if partner is HIV positive
Time Frame	Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Universal PrEP Counselling	Targeted PrEP Clinics
Arm/Group Description:	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.	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: 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; participant declines partner self-tests regardless of partner HIV status, and/or; their partner declines self-testing or tests positive.
Overall Number of Participants Analyzed	39	33
Measure Type: Count of Participants; Unit of Measure: Participants
	37 94.9%	31 93.9%

Adverse Events

Time Frame	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).
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Universal PrEP Counselling		Targeted PrEP Clinics
Arm/Group Description	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.		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: 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; participant declines partner self-tests regardless of partner HIV status, and/or; their partner declines self-testing or tests positive.
All-Cause Mortality
	Universal PrEP Counselling		Targeted PrEP Clinics
	Affected / at Risk (%)		Affected / at Risk (%)
Total	2/2250 (0.09%)		2/2197 (0.09%)
Serious Adverse Events
	Universal PrEP Counselling		Targeted PrEP Clinics
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	132/2250 (5.87%)		118/2197 (5.37%)
Pregnancy, puerperium and perinatal conditions
Infant Death † [1]	51/2250 (2.27%)	51	47/2197 (2.14%)	47
Infant Hospitalization * [2]	13/2250 (0.58%)	13	3/2197 (0.14%)	3
Maternal Hospitalization * [3]	11/2250 (0.49%)	11	18/2197 (0.82%)	18
Miscarriage * [4]	9/2250 (0.40%)	9	8/2197 (0.36%)	8
Stillbirth * [5]	51/2250 (2.27%)	51	41/2197 (1.87%)	41
Molar Pregnancy *	0/2250 (0.00%)	0	1/2197 (0.05%)	1
† Indicates events were collected by systematic assessment; [1] Participant experienced a neonatal or infant death during the study period; * Indicates events were collected by non-systematic assessment; [2] Participant experienced an infant hospitalization during the study period; [3] Participant was hospitalized during the study period; [4] Loss of pregnancy before 20 weeks gestational age; [5] Loss of pregnancy after 20 weeks gestational age
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Universal PrEP Counselling		Targeted PrEP Clinics
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/2250 (0.31%)		7/2197 (0.32%)
Infections and infestations
Partner thought participant was HIV positive *	1/2250 (0.04%)	1	0/2197 (0.00%)	0
Pregnancy, puerperium and perinatal conditions
Kicked out of home *	2/2250 (0.09%)	2	3/2197 (0.14%)	3
Experienced violence of abuse *	5/2250 (0.22%)	5	4/2197 (0.18%)	4
Breach of confidentiality *	0/2250 (0.00%)	0	1/2197 (0.05%)	1
Psychiatric disorders
Suicidal behavior *	0/2250 (0.00%)	0	1/2197 (0.05%)	1
Persistent or significant psychosocial distress *	3/2250 (0.13%)	3	1/2197 (0.05%)	1
* Indicates events were collected by non-systematic assessment

Limitations and Caveats

Low HIV incidence limited power of the primary outcome; however, similar HIV incidence in both arms suggest that meaningful differences are unlikely. Changing MoH policies and the COVID-19 pandemic affected study operations. Our observed rates of PrEP adherence and persistence could have been influenced by efforts to optimize study retention, and PrEP adherence relied on self-report, which can overestimate adherence.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Grace John-Stewart
• Organization: University of Washington
• Phone: 206-543-4278
• EMail: gjohn@uw.edu

Publications of Results:

Dettinger JC, Pintye J, Dollah A, Awuor M, Abuna F, Lagat H, Kohler P, John-Stewart G, O'Malley G, Kinuthia J, Beima-Sofie K. Brief Report: "What Is This PrEP?"-Sources and Accuracy of HIV Pre-Exposure Prophylaxis (PrEP) Awareness Among Adolescent Girls and Young Women Attending Family Planning and Maternal Child Health Clinics in Western Kenya. J Acquir Immune Defic Syndr. 2021 Dec 1;88(4):356-360. doi: 10.1097/QAI.0000000000002782.

Nganga N, Dettinger J, Kinuthia J, Baeten J, John-Stewart G, Gomez L, Marwa M, Ochieng B, Pintye J, Mugwanya K, Mugambi M. Prevalence and correlates of pregnancy self-testing among pregnant women attending antenatal care in western Kenya. PLoS One. 2021 Nov 12;16(11):e0258578. doi: 10.1371/journal.pone.0258578. eCollection 2021.

Escudero JN, Dettinger JC, Pintye J, Kinuthia J, Lagat H, Abuna F, Kohler P, Baeten JM, O'Malley G, John-Stewart GC, Beima-Sofie KM. Community Perceptions About Use of Pre-exposure Prophylaxis Among Adolescent Girls and Young Women in Kenya. J Assoc Nurses AIDS Care. 2020 Nov-Dec;31(6):669-677. doi: 10.1097/JNC.0000000000000191.

Pintye J, O'Malley G, Kinuthia J, Abuna F, Escudero JN, Mugambi M, Awuor M, Dollah A, Dettinger JC, Kohler P, John-Stewart G, Beima-Sofie K. Influences on Early Discontinuation and Persistence of Daily Oral PrEP Use Among Kenyan Adolescent Girls and Young Women: A Qualitative Evaluation From a PrEP Implementation Program. J Acquir Immune Defic Syndr. 2021 Apr 1;86(4):e83-e89. doi: 10.1097/QAI.0000000000002587.

Rogers Z, Pintye J, Kinuthia J, O'Malley G, Abuna F, Escudero J, Mugambi M, Awuor M, Dollah A, Dettinger JC, Kohler P, John-Stewart G, Beima-Sofie K. Key influences on the decision to initiate PrEP among adolescent girls and young women within routine maternal child health and family planning clinics in Western Kenya. AIDS Care. 2022 Mar;34(3):363-370. doi: 10.1080/09540121.2021.1981217. Epub 2021 Sep 20.

Other Publications:

Dettinger JC, Kinuthia J, Pintye J, Mwongeli N, Gomez L, Richardson BA, Barnabas R, Wagner AD, O'Malley G, Baeten JM, John-Stewart G. PrEP Implementation for Mothers in Antenatal Care (PrIMA): study protocol of a cluster randomised trial. BMJ Open. 2019 Mar 7;9(3):e025122. doi: 10.1136/bmjopen-2018-025122.

Wagner AD, Kinuthia J, Dettinger J, Mwongeli N, Gomez L, Watoyi S, Drake AL, Abuna F, Pintye J, Ochieng B, Odinga D, John-Stewart G, Baeten JM. Challenges of Discrepant HIV Tests in Pregnant Women in the PrEP era-to Treat or Not to Treat? J Infect Dis. 2021 Feb 3;223(2):234-237. doi: 10.1093/infdis/jiaa343.

Pintye J, Davey DLJ, Wagner AD, John-Stewart G, Baggaley R, Bekker LG, Celum C, Chi BH, Coates TJ, Groves AK, Haberer JE, Heffron R, Kinuthia J, Matthews LT, McIntyre JA, Moodley D, Mofenson LM, Mugo N, Mujugira A, Myer L, Shoptaw S, Stranix-Chibanda L, Baeten JM; PrEP in Pregnancy Working Group. Defining gaps in pre-exposure prophylaxis delivery for pregnant and post-partum women in high-burden settings using an implementation science framework. Lancet HIV. 2020 Aug;7(8):e582-e592. doi: 10.1016/S2352-3018(20)30102-8.

Joseph Davey DL, Pintye J, Baeten JM, Aldrovandi G, Baggaley R, Bekker LG, Celum C, Chi BH, Coates TJ, Haberer JE, Heffron R, Kinuthia J, Matthews LT, McIntyre J, Moodley D, Mofenson LM, Mugo N, Myer L, Mujugira A, Shoptaw S, Stranix-Chibanda L, John-Stewart G; PrEP in Pregnancy Working Group. Emerging evidence from a systematic review of safety of pre-exposure prophylaxis for pregnant and postpartum women: where are we now and where are we heading? J Int AIDS Soc. 2020 Jan;23(1):e25426. doi: 10.1002/jia2.25426.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chen S, Pawelec G, Trompet S, Goldeck D, Mortensen LH, Slagboom PE, Christensen K, Gussekloo J, Kearney P, Buckley BM, Ford I, Jukema JW, Westendorp RGJ, Maier AB. Associations of Cytomegalovirus Infection With All-Cause and Cardiovascular Mortality in Multiple Observational Cohort Studies of Older Adults. J Infect Dis. 2021 Feb 3;223(2):238-246. doi: 10.1093/infdis/jiaa480.

• Responsible Party: Grace John-Stewart, University of Washington
• ClinicalTrials.gov Identifier: NCT03070600
• Other Study ID Numbers: STUDY00000438; 1R01AI125498 ( U.S. NIH Grant/Contract )
• First Submitted: February 27, 2017
• First Posted: March 3, 2017
• Results First Submitted: January 10, 2022
• Results First Posted: May 10, 2022
• Last Update Posted: July 12, 2022