Phase 4
Completed N=4,447
PrEP Implementation for Mothers in Antenatal Care
HIV · Pregnancy Related
Source: ClinicalTrials.gov NCT03070600 ↗
Enrolled (actual)
4,447
Serious AEs
5.6%
Results posted
May 2022
Primary outcomePrimary: Maternal HIV Incidence — 0.38; 0.31 incidence/100 Person years
◆ Published Evidence
Established
63citations · ~13 / year
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.
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.
Linked Publications (5)
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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.
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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.
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Community Perceptions About Use of Pre-exposure Prophylaxis Among Adolescent Girls and Young Women in Kenya.
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Prevalence and correlates of pregnancy self-testing among pregnant women attending antenatal care in western Kenya.
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maternal HIV Incidence |
0.38; 0.31 | — |
| PRIMARY Appropriate PrEP Decision |
1535; 1299 | — |
| SECONDARY PrEP Adherence |
7; 9 | — |
| SECONDARY PrEP Duration |
8.6; 9.0 | — |
| SECONDARY Partner With Known HIV Status |
1680; 1648 | — |
| SECONDARY Infant Birthweight |
3.5; 3.5 | — |
| SECONDARY Infant Growth |
0.12; -0.01; -0.35; -0.47; 0.42; 0.29 | — |
| SECONDARY PrEP Use |
397; 323 | — |
| SECONDARY PrEP Acceptance |
441; 387 | — |
| SECONDARY Preterm Birth |
506; 309 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03070600) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.