Primary HIV Prevention in Pregnant and Lactating Ugandan Women
Condition: Primary Prevention of HIV Acquisition
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Extended repeat HIV testing and enhanced counseling
Intervention type(s): Behavioral
Intervention description(s): Pregnant/breastfeeding women in the intervention arm and their male partners if present will receive extended repeat HIV testing and enhanced counseling around the time of labor and delivery and throughout the breastfeeding period.
Other intervention name(s): ERHTEC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV and pregnancy; HIV and breastfeeding; Mother-to-child transmission of HIV; Africa; Uganda