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

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ClinicalTrials.gov Identifier: NCT01882998
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : May 24, 2016
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Primary Prevention of HIV Acquisition Behavioral: Extended repeat HIV testing and enhanced counseling Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PRIMARY HIV PREVENTION IN PREGNANT AND LACTATING UGANDAN WOMEN: A RANDOMIZED TRIAL
Study Start Date : February 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of unprotected sex [ Time Frame: 27 months ]
    Self-reported number of unprotected sex episodes among women participants validated by detection of semen (Y chromosome) in vaginal swabs


Secondary Outcome Measures :
  1. STI incidence [ Time Frame: 27 months ]
    Incidence of Syphilis, N. gonorrhea, C. trachomatis and T. vaginalis infections among women and men participants

  2. HIV incidence [ Time Frame: 27 months ]
    Incidence of HIV infection among women and men participants

  3. Incidence of recurrent wanted and unwanted pregnancy [ Time Frame: 24 months ]
    Incidence of wanted and unwanted recurrent pregnancy within 24 months of delivery


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01882998


Locations
Uganda
Mulago Hospital
Kampala, Uganda
Sponsors and Collaborators
University of California, San Francisco
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Jaco Homsy, MD, MPH University of California, San Francisco
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Makerere University - Johns Hopkins University Research Collaboration  This link exits the ClinicalTrials.gov site

Publications of Results:
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.

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01882998     History of Changes
Other Study ID Numbers: R01HD070767 ( U.S. NIH Grant/Contract )
1R01HD070767-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: May 2016

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