Couple Communication Clinical Trial
— PrenahtestOfficial title:
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.
| Status | Completed |
| Enrollment | 1943 |
| Est. completion date | October 2011 |
| Est. primary completion date | August 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 15 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Cameroon | Centre Mère - Enfant Chantal Biya | Yaoundé | |
| Dominican Republic | Hospital Materno-Infantil "San Lorenzo" de los Mina | Santo Domingo | |
| Georgia | Maternity Hospital N°5 | Tbilisi | |
| India | Sane Guruji Hospital | Pune |
| Lead Sponsor | Collaborator |
|---|---|
| French National Agency for Research on AIDS and Viral Hepatitis | Elizabeth Glaser Pediatric AIDS Foundation |
Cameroon, Dominican Republic, Georgia, India,
Orne-Gliemann J, Tchendjou PT, Miric M, Gadgil M, Butsashvili M, Eboko F, Perez-Then E, Darak S, Kulkarni S, Kamkamidze G, Balestre E, du Loû AD, Dabis F. Couple-oriented prenatal HIV counseling for HIV primary prevention: an acceptability study. BMC Publ — View Citation
Tchendjou PT, Koki PN, Eboko F, Malateste K, Essounga AN, Amassana D, Mossus T, Tejiokem M, Boisier P, Orne-Gliemann J. Factors associated with history of HIV testing among pregnant women and their partners in Cameroon: baseline data from a Behavioral Int — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |