Clinical trial NCT01882998: Primary HIV Prevention in Pregnant and Lactating Ugandan Women
Official title: PRIMARY HIV PREVENTION IN PREGNANT AND LACTATING UGANDAN WOMEN: A RANDOMIZED TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Prevention of HIV Acquisition
Keywords: HIV and pregnancy
HIV and breastfeeding
Mother-to-child transmission of HIV
Africa
Uganda
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2013-06-21
Enrollment: 1230
Sex: ALL
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Women: 15-49 years old, confirmed HIV negative, confirmed pregnant, living within 30kms /19 miles of hospital, willingness to sign informed consent
* Men: \> or = 15 years old, being an established partner of a woman participant, living within 30kms /19 miles of hospital, willingness to sign informed consent

Exclusion Criteria:

* condition requiring hospitalization

Primary outcomes:
measure: Frequency of unprotected sex
timeFrame: 27 months
Secondary outcomes:
measure: STI incidence
timeFrame: 27 months
measure: HIV incidence
timeFrame: 27 months
measure: Incidence of recurrent wanted and unwanted pregnancy
timeFrame: 24 months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago Hospital
Study officials:
affiliation: University of California, San Francisco
name: Jaco Homsy, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: King R, Bannink F, Mwambi K, Achiro S, Namusoke B, Ajok M, Oweka B, Akot C, Nalubega MG, Adengo M, Namukwaya Z, Homsy J. Primary prevention of HIV among pregnant and lactating women; the neglected PMTCT prong. 7th ICASA Conference, Cape Town, South Africa, 7-11 December 2013. Abstract 2420101.
citation: Bannink Mbazzi F, Namukwaya Z, Amone A, Ojok F, Etima J, Byamugisha J, Katabira E, Fowler MG, Homsy J, King R; PRIMAL Study Team. "[Repeat] testing and counseling is one of the key [services] that the government should continue providing": participants' perceptions on extended repeat HIV testing and enhanced counseling (ERHTEC) for primary HIV prevention in pregnant and lactating women in the PRIMAL study, Uganda. BMC Public Health. 2020 May 15;20(1):694. doi: 10.1186/s12889-020-08738-x.
citation: Homsy J, King R, Bannink F, Namukwaya Z, Vittinghof E, Amone A, Ojok F, Rukundo G, Amama S, Etima J, Matovu J, Weissglas F, Ojom L, Atim P, Darbes L, Byamugisha J, Rutherford G, Katabira E, Fowler MG; PRIMAL Study Team. Primary HIV prevention in pregnant and lactating Ugandan women: A randomized trial. PLoS One. 2019 Feb 25;14(2):e0212119. doi: 10.1371/journal.pone.0212119. eCollection 2019.