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

French National Agency for Research on AIDS and Viral Hepatitis1,943 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,943

Conditions

Partner HIV Testing Couple HIV Counseling Couple Communication HIV Incidence

Interventions

Couple-oriented post-test HIV counselingBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Centre Mère - Enfant Chantal Biya

Yaoundé, Cameroon

Hospital Materno-Infantil "San Lorenzo" de los Mina

Santo Domingo, Dominican Republic

Maternity Hospital N°5

Tbilisi, Georgia

Sane Guruji Hospital

Pune, India

Outcomes

Primary Outcomes

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

Time frame: 6 months postpartum

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 6 months postpartum