Couple-oriented Prenatal HIV Counseling in Low and Medium HIV Prevalence Countries (Prenahtest)

December 16, 2011 updated by: French National Agency for Research on AIDS and Viral Hepatitis

The Public Health Impact of Couple-oriented Prenatal HIV Counseling in Low and Medium HIV Prevalence Countries

ANRS 12127 Prenahtest is an intervention trial conducted in four countries (Cameroon, Dominican Republic, Georgia and India), where pregnant women are randomized during prenatal care to receive either standard post-test HIV counseling, or an innovative intervention called couple-oriented post-test HIV counseling (COC).

The aim of the COC intervention is to empower women to communicate with her male partner about HIV, and HIV testing in particular, and encourage him to return for HIV testing and/or couple HIV counseling (where both couple members are counseled together).

Prenahtest is the first randomised trial testing a prenatal intervention to increase partner HIV testing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1943

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cameroon
      • Yaoundé, Cameroon
        • Centre Mère - Enfant Chantal Biya
  • Dominican Republic
      • Santo Domingo, Dominican Republic
        • Hospital Materno-Infantil "San Lorenzo" de los Mina
  • Georgia
      • Tbilisi, Georgia
        • Maternity Hospital N°5
  • India
      • Pune, India
        • Sane Guruji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Attending her first ANC visit for the current pregnancy in the study centre
  • Accepting to participate in the study and being able to give informed consent ii
  • Currently having a partner (the man who the woman considers as her regular partner on the day of inclusion, even if this person is not the baby's father) iii
  • Accepting follow-up (including home visits if necessary) by the project staff until 15 months after delivery

Exclusion Criteria:

  • Having been tested for HIV during her current pregnancy
  • Having a male partner who was tested for HIV during her gestational period v
  • Having a partner who works out of the predefined study area or is absent for more then 6 months
  • Being unwilling/unable to provide address/contact information
  • Having an intoxication and/or mental impairment at the moment of recruitment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Couple-oriented post-test HIV counseling
Women received couple-oriented post-test HIV counseling
Behavioral: Couple-oriented post-test HIV counseling
COC is an individual behavioural intervention, strengthening standard post-test HIV counselling delivered to pregnant women after prenatal HIV testing. COC was based on the assumption that developing women's communication skills and self-efficacy during HIV counselling would enable them to discuss HIV and sexual issues with their partners, and yield tangible effects on partner HIV testing. The structure of the COC intervention was adapted from a WHO PMTCT counselling manual and was described in a COC manual, which was used to train the COC counsellors and could also be used during the counselling session. Tested during the pilot phase of the trial, COC was shown to be feasible and acceptable in the four study sites.
No Intervention: Standard post-test HIV counseling
Women received post-test HIV counseling as per standard site protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Partner HIV testing
Time Frame: 6 months postpartum
Proportion of male partners tested for HIV during the study follow-up period (from post-test HIV counseling to the last follow-up visit at 6 months postpartum) among the pregnant women enrolled in the trial
6 months postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Couple HIV counseling
Time Frame: 6 months postpartum
Proportion of women receiving couple HIV counseling uring the study follow-up period (from post-test HIV counseling to the last follow-up visit at 6 months postpartum) among the pregnant women enrolled in the trial
6 months postpartum
HIV incidence
Time Frame: 6 months postpartum
Proportion of women tested HIV-positive during the study follow-up period (from post-test HIV counseling to the last follow-up visit at 6 months postpartum) among the pregnant women tested HIV-negative at enrolment
6 months postpartum
Couple communication of sexual and reproductive health
Time Frame: 6 months postpartum
Proportion of women reporting having discussed sexual and reproductive health issues (family planning, HIV, condom) during the study follow-up period (from post-test HIV counseling to the last follow-up visit at 6 months postpartum) among the pregnant women enrolled in the trial
6 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Collaborators

Elizabeth Glaser Pediatric AIDS Foundation

Investigators

  • Principal Investigator: Francois Dabis, MD - PhD, INSERM U897, Institut de Santé Publique Epidémiologie Développement
  • Principal Investigator: Patrice T Tchendjou, MD - MPH, Centre Pasteur du Cameroon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

December 15, 2011

First Submitted That Met QC Criteria

December 16, 2011

First Posted (Estimate)

December 19, 2011

Study Record Updates

Last Update Posted (Estimate)

December 19, 2011

Last Update Submitted That Met QC Criteria

December 16, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ANRS 12127 Prenahtest

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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