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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01494961
Acronym
Prenahtest
Enrollment
1943
Registered
2011-12-19
Start date
2009-02-28
Completion date
2011-10-31
Last updated
2011-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Partner HIV testing, Couple HIV counseling, Couple communication on sexual and reproductive health, HIV incidence, Incidence of pregnancies, Disclosure, Condom use

Brief summary

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.

Interventions

BEHAVIORALCouple-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.

Sponsors

Elizabeth Glaser Pediatric AIDS Foundation
CollaboratorOTHER
French National Agency for Research on AIDS and Viral Hepatitis
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Partner HIV testing6 months postpartumProportion 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

MeasureTime frameDescription
Couple HIV counseling6 months postpartumProportion 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 incidence6 months postpartumProportion 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 health6 months postpartumProportion 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

Countries

Cameroon, Dominican Republic, Georgia, India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026