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

December 15, 2011
December 16, 2011
February 2009
August 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01494961 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Couple-oriented Prenatal HIV Counseling in Low and Medium HIV Prevalence Countries
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Partner HIV Testing
  • Couple HIV Counseling
  • Couple Communication
  • HIV Incidence
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.
  • Experimental: Couple-oriented post-test HIV counseling
    Women received couple-oriented post-test HIV counseling
    Intervention: Behavioral: Couple-oriented post-test HIV counseling
  • No Intervention: Standard post-test HIV counseling
    Women received post-test HIV counseling as per standard site protocol

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1943
October 2011
August 2011   (final data collection date for primary outcome measure)

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
Female
15 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Cameroon,   Dominican Republic,   Georgia,   India
 
NCT01494961
ANRS 12127 Prenahtest
No
French National Agency for Research on AIDS and Viral Hepatitis
French National Agency for Research on AIDS and Viral Hepatitis
Elizabeth Glaser Pediatric AIDS Foundation
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
French National Agency for Research on AIDS and Viral Hepatitis
December 2011

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