Primary HIV Prevention in Pregnant and Lactating Ugandan Women - Full Text View

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:

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
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:

MedlinePlus related topics: Breastfeeding HIV/AIDS HIV/AIDS and Pregnancy

U.S. FDA Resources

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
Study Completion Date:	May 2016
Primary Completion Date:	May 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

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 (Child, Adult)
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

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

Additional Information:

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

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.


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:	May 20, 2016
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

ClinicalTrials.gov processed this record on September 26, 2016

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