PrEP Implementation for Mothers in Antenatal Care
- Conditions
- HIV InfectionsPregnancy Related
- Interventions
- Other: Universal PrEP CounselingOther: Targeted PrEP Counseling
- Registration Number
- NCT03070600
- Lead Sponsor
- University of Washington
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 4447
- 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.
- HIV+ at time of enrollment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Universal PrEP Counselling Universal PrEP Counseling 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. Targeted PrEP Clinics Targeted PrEP Counseling 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.
- Primary Outcome Measures
Name Time Method Maternal HIV Incidence 6 weeks, 6 months, 9 months postpartum Maternal HIV Incidence
Appropriate PrEP Decision 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
- Secondary Outcome Measures
Name Time Method Infant Birthweight time of delivery Infant Birthweight
PrEP Adherence 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.
PrEP Duration Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30). Number of months on PrEP
Preterm Birth At birth Birth \<37 weeks gestation
Partner With Known HIV Status At 9 months postpartum Participants report of partner's HIV status
Infant Growth 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.
PrEP Acceptance Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30). PrEP accepted by participants
PrEP Use Enrollment to 9 months postpartum, the median gestational age at enrollment was 24 weeks (IQR: 20, 30). PrEP Utilization by participants
Trial Locations
- Locations (20)
Homabay Teaching and Referral Hospital
🇰🇪Homa Bay, Kenya
Malanga Subcounty Hospital
🇰🇪Malanga, Kenya
Kendu Bay Subcounty Hospital
🇰🇪Kendu Bay, Kenya
Ndhiwa Subcounty Hospital
🇰🇪Ndhiwa, Kenya
Rachuonyo South Subcounty Hospital
🇰🇪Rachuonyo South, Kenya
Kandiege Subcounty Hospital
🇰🇪Kandiege, Kenya
Ongielo Subcounty Hospital
🇰🇪Ongielo, Kenya
Suba Subcounty Hospital
🇰🇪Suba, Kenya
Uyawi Subcounty Hospital
🇰🇪Uyawi, Kenya
Ober Subcounty Hospital
🇰🇪Ober, Kenya
Siaya Teaching and Referral Hospital
🇰🇪Siaya, Kenya
Usigu Subcounty Hospital
🇰🇪Usigu, Kenya
Yala Subcounty Hospital
🇰🇪Yala, Kenya
Marindi Subcounty Hospital
🇰🇪Marindi, Kenya
Ambira Hospital
🇰🇪Ambira, Kenya
Bondo Subcounty Hospital
🇰🇪Bondo, Kenya
Madiany Subcounty Hospital
🇰🇪Madiany, Kenya
Mbita Subcounty Hospital
🇰🇪Mbita, Kenya
Rwambwa Subcounty Hospital
🇰🇪Rwambwa, Kenya
Rangwe Subcounty Hospital
🇰🇪Rangwe, Kenya