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

This study is currently recruiting participants.
Verified January 2014 by University of California, San Francisco
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01882998
First received: June 17, 2013
Last updated: January 6, 2014
Last verified: January 2014

June 17, 2013
January 6, 2014
February 2013
March 2016   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01882998 on ClinicalTrials.gov Archive Site
  • STI incidence [ Time Frame: 27 months ] [ Designated as safety issue: No ]
    Incidence of N. gonorrhea, C. trachomatis and T. vaginalis 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
Same as current
Not Provided
Not Provided
 
Primary HIV Prevention in Pregnant and Lactating Ugandan Women
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Primary Prevention of HIV Acquisition
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: 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.
    Intervention: Behavioral: Extended repeat HIV testing and enhanced counseling
  • 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.
    Intervention: Behavioral: Extended repeat HIV testing and enhanced counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1230
June 2016
March 2016   (final data collection date for primary outcome measure)

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
Both
15 Years to 49 Years
Yes
Contact: Jaco Homsy, MD, MPH +256-414-541044 jaco251099@vtx.ch
Contact: Elly Katabira, MBChB, FRCP +256-414-541044 katabira@imul.com
Uganda
 
NCT01882998
R01HD070767, 1R01HD070767-01A1
No
University of California, San Francisco
University of California, San Francisco
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Jaco Homsy, MD, MPH University of California, San Francisco
University of California, San Francisco
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP