Primary Prevention of HIV Acquisition Clinical Trial
Official title:
PRIMARY HIV PREVENTION IN PREGNANT AND LACTATING UGANDAN WOMEN: A RANDOMIZED TRIAL
This study aims to test the effectiveness of a behavioral intervention aimed at preventing
the primary acquisition of HIV by uninfected pregnant and lactating women in Uganda, East
Africa where HIV transmission is high. Women who acquire HIV during pregnancy or lactation
are at higher risk of adverse health and pregnancy outcomes and their baby is at high risk
of acquiring HIV and dying.
Keeping HIV-uninfected women uninfected during pregnancy and lactation is an important
component of the global World Health Organization (WHO) strategy to eliminate
mother-to-child transmission of HIV but there has been no study to date to assess
interventions that can effectively keep these women uninfected.
In this study, the investigators will test the hypotheses that:
1. extended repeat HIV testing and enhanced counseling (ERHTEC) during late pregnancy (>36
weeks) and breastfeeding can increase and sustain risk reduction behaviors and prevent
incident STI and HIV infections among HIV-uninfected pregnant women, and
2. that couple HIV testing and counseling (HTC) can further enhance this effect through
improved couple communication and emotional and economic support from male partners.
The specific aims of the study are:
- Aim 1: to assess the effect of an extended repeat HIV testing and enhanced counseling
(ERHTEC) intervention on sexual risk behavior and sexually transmitted infections (STI)
and HIV acquisition in HIV-uninfected pregnant and lactating women enrolled
individually
- Aim 2: to assess the effect of ERHTEC on sexual risk behavior and the incidence of STI
and HIV in uninfected pregnant and lactating women enrolled with their partner, and
- Aim 3: to assess the costs and estimate the cost-effectiveness of the intervention.
We will conduct a stratified randomized trial of 410 HIV-negative pregnant Ugandan women
enrolled individually and 410 HIV-negative pregnant women enrolled with their male partners
in Mulago Hospital, Kampala and St Joseph Hospital, Kitgum, Northern Uganda. In each site,
205 women enrolled individually and 205 couples will be randomized to be either retested and
counseled for HIV in late pregnancy only (>36 weeks) as per the WHO/Ministry of Health (MOH)
recommendation, or to receive ERHTEC throughout pregnancy and breastfeeding.
Individual women and couples randomized to the intervention arm will receive the ERHTEC
intervention at 3, 6, 12, and 18 months postpartum. Follow-up will end at 24 months
postpartum or 6 weeks after the end of breastfeeding, whichever occurs first.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention