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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01882998
First received: June 17, 2013
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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.

Condition Intervention
Primary Prevention of HIV Acquisition
Behavioral: Extended repeat HIV testing and enhanced counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: PRIMARY HIV PREVENTION IN PREGNANT AND LACTATING UGANDAN WOMEN: A RANDOMIZED TRIAL

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Frequency of unprotected sex [ Time Frame: 27 months ] [ Designated as safety issue: No ]
    Self-reported number of unprotected sex episodes among women participants validated by detection of semen (Y chromosome) in vaginal swabs


Secondary Outcome Measures:
  • STI incidence [ Time Frame: 27 months ] [ Designated as safety issue: No ]
    Incidence of Syphilis, N. gonorrhea, C. trachomatis and T. vaginalis infections among women and men participants

  • HIV incidence [ Time Frame: 27 months ] [ Designated as safety issue: No ]
    Incidence of HIV infection among women and men participants

  • Incidence of recurrent wanted and unwanted pregnancy [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Incidence of wanted and unwanted recurrent pregnancy within 24 months of delivery


Enrollment: 1230
Study Start Date: February 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: ERHTEC

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

Ages Eligible for Study:   15 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01882998

Locations
Uganda
Mulago Hospital
Kampala, Uganda
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Jaco Homsy, MD, MPH University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01882998     History of Changes
Other Study ID Numbers: R01HD070767, 1R01HD070767-01A1
Study First Received: June 17, 2013
Last Updated: April 29, 2014
Health Authority: United States: Institutional Review Board
Uganda: Makerere University College of Health Sciences School of Medicine Research Ethics Committee
Uganda: National Council for Science and Technology

Keywords provided by University of California, San Francisco:
HIV and pregnancy
HIV and breastfeeding
Mother-to-child transmission of HIV
Africa
Uganda

Additional relevant MeSH terms:
HIV Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014