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

Study Overview
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Brief Summary
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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.

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

Conditions
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Partner HIV Testing, Couple HIV Counseling, Couple Communication, HIV Incidence

Intervention / Treatment
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* Behavioral: Couple-oriented post-test HIV counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Couple-oriented post-test HIV counseling<br>Women received couple-oriented post-test HIV counseling | Behavioral: Couple-oriented post-test HIV counseling<br>* 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.<br>|
| No Intervention: Standard post-test HIV counseling<br>Women received post-test HIV counseling as per standard site protocol | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partner HIV testing | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Partner HIV testing, Couple HIV counseling, Couple communication on sexual and reproductive health, HIV incidence, Incidence of pregnancies, Disclosure, Condom use