Primary HIV Prevention in Pregnant and Lactating Ugandan Women

Primary Prevention of HIV Acquisition Clinical Trial

— PRIMAL  

Official title:

PRIMARY HIV PREVENTION IN PREGNANT AND LACTATING UGANDAN WOMEN: A RANDOMIZED TRIAL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01882998
• Other study ID #: R01HD070767
• Secondary ID: 1R01HD070767-01A
• Status: Completed
• Phase: N/A
• First received: June 17, 2013
• Last updated: May 20, 2016
• Start date: February 2013
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUganda: Makerere University College of Health Sciences School of Medicine Research Ethics CommitteeUganda: National Council for Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1230
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 49 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Primary Prevention of HIV Acquisition

Intervention

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.

Locations

Country	Name	City	State
Uganda	Mulago Hospital	Kampala

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

Uganda, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	STI incidence	Incidence of Syphilis, N. gonorrhea, C. trachomatis and T. vaginalis infections among women and men participants	27 months	No
Secondary	HIV incidence	Incidence of HIV infection among women and men participants	27 months	No
Secondary	Incidence of recurrent wanted and unwanted pregnancy	Incidence of wanted and unwanted recurrent pregnancy within 24 months of delivery	24 months	No

External Links

•   Makerere University - Johns Hopkins University Research Collaboration