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Phase 4 N=4,447 Prevention

PrEP Implementation for Mothers in Antenatal Care

HIV Infections · Pregnancy Related

Enrolled (actual)
4,447
Serious AEs
5.6%
Results posted
May 2022
Primary outcome: Primary: Maternal HIV Incidence — 0.38; 0.31 incidence/100 Person years

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Universal PrEP Counseling (Other); Targeted PrEP Counseling (Other)
Age
Pediatric, Adult, Older Adult · 15+ yrs
Sex
Female
Sponsor
University of Washington
Primary completion
Jan 2021

Outcome Measures

OutcomeResultp-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

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03070600). 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.

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