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

This study has been completed.
Sponsor:
Collaborator:
Elizabeth Glaser Pediatric AIDS Foundation
Information provided by (Responsible Party):
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT01494961
First received: December 15, 2011
Last updated: December 16, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Partner HIV Testing
Couple HIV Counseling
Couple Communication
HIV Incidence
Behavioral: Couple-oriented post-test HIV counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Public Health Impact of Couple-oriented Prenatal HIV Counseling in Low and Medium HIV Prevalence Countries

Resource links provided by NLM:


Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:
  • Partner HIV testing [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Couple HIV counseling [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]
    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

  • HIV incidence [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]
    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

  • Couple communication of sexual and reproductive health [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]
    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


Enrollment: 1943
Study Start Date: February 2009
Study Completion Date: October 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01494961

Locations
Cameroon
Centre Mère - Enfant Chantal Biya
Yaoundé, Cameroon
Dominican Republic
Hospital Materno-Infantil "San Lorenzo" de los Mina
Santo Domingo, Dominican Republic
Georgia
Maternity Hospital N°5
Tbilisi, Georgia
India
Sane Guruji Hospital
Pune, India
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
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
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier: NCT01494961     History of Changes
Other Study ID Numbers: ANRS 12127 Prenahtest
Study First Received: December 15, 2011
Last Updated: December 16, 2011
Health Authority: Cameroon: Ministry of Public Health
Dominican Republic: Comité de Etica Indepediente, Fundacion Dominica de Insectoligia
Georgia: Maternal and Child Care Union
India: Independent Ethics Committee for Prayas Health Group

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
Partner HIV testing
Couple HIV counseling
Couple communication on sexual and reproductive health
HIV incidence
Incidence of pregnancies
Disclosure
Condom use

ClinicalTrials.gov processed this record on July 29, 2014