Primary HIV Prevention in Pregnant and Lactating Ugandan Women (PRIMAL)

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.

Study Overview

• Status: Completed
• Conditions: Primary Prevention of HIV Acquisition
• Intervention / Treatment: Behavioral: Extended repeat HIV testing and enhanced counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 1230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Kampala, Uganda
    • Mulago Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Women-Extended Repeat Testing and Enhanced Counseling; Pregnant/breastfeeding women enrolled individually and randomized to the intervention arm will receive extended repeat HIV testing and enhanced counseling at the time of labor and delivery and throughout the lactation period at 3, 6, 12, 18 and 24 months postpartum or until cessation of breastfeeding, whichever occurs first.	Behavioral: Extended repeat HIV testing and enhanced counseling; 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 Names: ERHTEC
Experimental: Couples-Extended Repeat Testing and Enhanced Counseling; Pregnant/breastfeeding women enrolled in couples with their male partners and randomized to the intervention arm will receive extended repeat HIV testing and enhanced counseling at the time of labor and delivery and throughout the lactation period at 3, 6, 12, 18 and 24 months postpartum or until cessation of breastfeeding, whichever occurs first.	Behavioral: Extended repeat HIV testing and enhanced counseling; 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 Names: ERHTEC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of unprotected sex	Self-reported number of unprotected sex episodes among women participants validated by detection of semen (Y chromosome) in vaginal swabs	27 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
STI incidence	Incidence of Syphilis, N. gonorrhea, C. trachomatis and T. vaginalis infections among women and men participants	27 months
HIV incidence	Incidence of HIV infection among women and men participants	27 months
Incidence of recurrent wanted and unwanted pregnancy	Incidence of wanted and unwanted recurrent pregnancy within 24 months of delivery	24 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Jaco Homsy, MD, MPH, University of California, San Francisco

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Makerere University - Johns Hopkins University Research Collaboration

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: June 17, 2013
• First Submitted That Met QC Criteria: June 20, 2013
• First Posted (Estimate): June 21, 2013

Study Record Updates

• Last Update Posted (Estimate): May 24, 2016
• Last Update Submitted That Met QC Criteria: May 20, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Africa; Uganda; Mother-to-child transmission of HIV; HIV and pregnancy; HIV and breastfeeding
• Other Study ID Numbers: R01HD070767 (U.S. NIH Grant/Contract); 1R01HD070767-01A1 (U.S. NIH Grant/Contract)