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NCT Number: NCT01494961

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.

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Key information

Conditions

Partner HIV Testing Couple Communication Couple HIV Counseling HIV Incidence

Age range

15 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Mère - Enfant Chantal Biya, Yaoundé, Cameroon

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Couple-oriented post-test HIV counseling

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Other Gov

Collaborators

  • Elizabeth Glaser Pediatric AIDS Foundation

Registry information

Official study title

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

Acronym: Prenahtest

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 19, 2011
Registry last updated
Dec 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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