PrEP Implementation for Mothers in Antenatal Care (PrIMA)

July 11, 2022 updated by: Grace John-Stewart, University of Washington

Delivering PrEP in Pregnancy

In a region with 15-20% HIV prevalence, an estimated 20% of HIV-uninfected women could have HIV exposures in pregnancy. In a theoretical scenario of perfect PrEP coverage, all women at risk receive PrEP while no women not at HIV risk receive PrEP (Figure 4). With mandatory PrEP given to all women (similar to the approaches used for malaria prophylaxis), all women at risk would be covered but many women not at risk receive unnecessary PrEP. Our premise is that a targeted PrEP model may be closer to perfect coverage than a universal offer/self-select model. Implementing targeted PrEP through strategies that include facilitation of partner testing with self-tests could add HIV prevention benefit by increasing partner HIV diagnosis and treatment similar to the initiation of PrEP among pregnant women. By implementing these strategies and measuring uptake, use, and HIV incidence, we can inform the best health systems model for PrEP delivery in pregnancy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Women living in regions with high HIV prevalence are at high risk of HIV acquisition in pregnancy and postpartum because they infrequently use condoms, do not know their partner's HIV status, and have biologic changes or changes in their partner's sexual partnerships that increase susceptibility. Oral pre-exposure antiretroviral prophylaxis (PrEP) may be an attractive strategy for HIV prevention in pregnancy/postpartum; however, it is important to ensure PrEP reaches women who are at risk for acquiring HIV during pregnancy while avoiding unnecessary PrEP use during pregnancy. Clinicians and women are using PrEP in pregnancy; in qualitative studies, women, health workers and policy-makers support use of PrEP in pregnancy but advocate for models of PrEP delivery that ensure women at risk receive PrEP while minimizing unnecessary PrEP use in women not at risk. Targeting PrEP to women at greatest risk of HIV may maximize benefits, minimize potential risks, and optimize cost-effectiveness. This cluster-randomized clinical trial (RCT) in 20 Maternal Child Health (MCH) clinics in western Kenya (10 clinics per arm, up to 250 women per clinic, up to 5000 women overall), will compare 2 models of PrEP delivery in pregnancy. Clinics will offer universal availability of PrEP (and women self-select whether to use) or targeted offer of PrEP (i.e., offer to women identified as high risk through a standardized risk assessment and partner self-testing, and then women identified as high-risk select whether to use). Leveraging the pre-existing MCH clinic visit schedule will enable programmatically relevant assessment of PrEP uptake, use, and HIV incidence. The outcome of the study will be a model of PrEP delivery in pregnancy that optimizes effectiveness, safety, and cost-effectiveness. Our team has expertise in maternal-child HIV (John-Stewart, Kinuthia), PrEP clinical trials and implementation science (Baeten, Richardson), partner self-testing (Thirumurthy), economics and qualitative research (Barnabas, O'Malley).

AIM 1a. In a cluster-RCT, compare universal PrEP (offer to all; women self-select PrEP) to targeted PrEP (limit the offer to women identified as high risk through a standardized risk assessment and partner self-testing) for outcomes reflecting the balance of PrEP effectiveness and avoiding unnecessary PrEP exposure to women at low or no risk of HIV: HIV incidence at 9 months postpartum among all women (including those who did and did not receive PrEP) and proportion of women exposed to PrEP.

AIM 1b. To compare trial arms for proportion of women 'appropriately' on PrEP (risk factors), PrEP adherence (drug levels) and duration, partners with known HIV status, partners on ART; infant outcomes (growth, birth outcomes, HIV status).

AIM 2. To estimate the incremental cost-effectiveness of targeted PrEP compared to universal PrEP for women during pregnancy and postpartum, per HIV infection and disability-adjusted life-year (DALY) averted.

AIM 3. To qualitatively assess barriers and facilitators to uptake, adherence, acceptability, and feasibility in universal and targeted PrEP models at the organizational, provider, and individual woman level.

Study Type

Interventional

Enrollment (Actual)

4447

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Ambira, Kenya
        • Ambira Hospital
      • Bondo, Kenya
        • Bondo Subcounty Hospital
      • Homa Bay, Kenya
        • Homabay Teaching and Referral Hospital
      • Kandiege, Kenya
        • Kandiege Subcounty Hospital
      • Kendu Bay, Kenya
        • Kendu Bay Subcounty Hospital
      • Madiany, Kenya
        • Madiany Subcounty Hospital
      • Malanga, Kenya
        • Malanga Subcounty Hospital
      • Marindi, Kenya
        • Marindi Subcounty Hospital
      • Mbita, Kenya
        • Mbita Subcounty Hospital
      • Ndhiwa, Kenya
        • Ndhiwa Subcounty Hospital
      • Ober, Kenya
        • Ober Subcounty Hospital
      • Ongielo, Kenya
        • Ongielo Subcounty Hospital
      • Rachuonyo South, Kenya
        • Rachuonyo South Subcounty Hospital
      • Rangwe, Kenya
        • Rangwe Subcounty Hospital
      • Rwambwa, Kenya
        • Rwambwa Subcounty Hospital
      • Siaya, Kenya
        • Siaya Teaching and Referral Hospital
      • Suba, Kenya
        • Suba Subcounty Hospital
      • Usigu, Kenya
        • Usigu Subcounty Hospital
      • Uyawi, Kenya
        • Uyawi Subcounty Hospital
      • Yala, Kenya
        • Yala Subcounty Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Eligibility for enrollment will include age ≥15 years
  • Pregnant at any gestational age
  • Tuberculosis negative
  • Plans to reside in area for at least one year postpartum
  • Plans to receive postnatal and infant care at the study facility
  • Not currently enrolled in any other studies.

Exclusion Criteria:

  • HIV+ at time of enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Other: 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.
EXPERIMENTAL: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal HIV Incidence
Time Frame: 6 weeks, 6 months, 9 months postpartum
Maternal HIV Incidence
6 weeks, 6 months, 9 months postpartum
Appropriate PrEP Decision
Time Frame: 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
Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PrEP Adherence
Time Frame: Enrollment to 9 months postpartum
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.
Enrollment to 9 months postpartum
PrEP Duration
Time Frame: Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).
Number of months on PrEP
Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).
Partner With Known HIV Status
Time Frame: At 9 months postpartum
Participants report of partner's HIV status
At 9 months postpartum
Infant Birthweight
Time Frame: time of delivery
Infant Birthweight
time of delivery
Infant Growth
Time Frame: 9 months of age
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.
9 months of age
PrEP Use
Time Frame: Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).
PrEP Utilization by participants
Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).
PrEP Acceptance
Time Frame: Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).
PrEP accepted by participants
Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30).
Preterm Birth
Time Frame: At birth
Birth <37 weeks gestation
At birth

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
Kenyatta National Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 15, 2018

Primary Completion (ACTUAL)

January 15, 2021

Study Completion (ACTUAL)

January 15, 2021

Study Registration Dates

First Submitted

February 27, 2017

First Submitted That Met QC Criteria

February 27, 2017

First Posted (ACTUAL)

March 3, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 12, 2022

Last Update Submitted That Met QC Criteria

July 11, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000438
  • 1R01AI125498 (NIH)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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