Clinical trial NCT01494961: Couple-oriented Prenatal HIV Counseling in Low and Medium HIV Prevalence Countries
Official title: The Public Health Impact of Couple-oriented Prenatal HIV Counseling in Low and Medium HIV Prevalence Countries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partner HIV Testing
Couple HIV Counseling
Couple Communication
HIV Incidence
Keywords: Partner HIV testing
Couple HIV counseling
Couple communication on sexual and reproductive health
HIV incidence
Incidence of pregnancies
Disclosure
Condom use
Lead sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Sponsor class: OTHER_GOV
Collaborators: name: Elizabeth Glaser Pediatric AIDS Foundation
First posted: 2011-12-19
Enrollment: 1943
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Partner HIV testing
timeFrame: 6 months postpartum
Secondary outcomes:
measure: Couple HIV counseling
timeFrame: 6 months postpartum
measure: HIV incidence
timeFrame: 6 months postpartum
measure: Couple communication of sexual and reproductive health
timeFrame: 6 months postpartum
Other outcomes:
Locations:
city: Yaoundé
country: Cameroon
facility: Centre Mère - Enfant Chantal Biya
city: Santo Domingo
country: Dominican Republic
facility: Hospital Materno-Infantil "San Lorenzo" de los Mina
city: Tbilisi
country: Georgia
facility: Maternity Hospital N°5
city: Pune
country: India
facility: Sane Guruji Hospital
Study officials:
affiliation: INSERM U897, Institut de Santé Publique Epidémiologie Développement
name: Francois Dabis, MD - PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Pasteur du Cameroon
name: Patrice T Tchendjou, MD - MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Lou AD, Dabis F. Couple-oriented prenatal HIV counseling for HIV primary prevention: an acceptability study. BMC Public Health. 2010 Apr 19;10:197. doi: 10.1186/1471-2458-10-197.
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 Intervention Trial (ANRS 12127 Prenahtest). J Acquir Immune Defic Syndr. 2011 Jul 1;57 Suppl 1:S9-15. doi: 10.1097/QAI.0b013e31821ec6e2.
citation: Kengne-Nde C, Tejiokem MC, Orne-Gliemann J, Melingui B, Koki Ndombo P, Essounga NA, Bissek AC, Cauchemez S, Tchendjou PT. Couple oriented counselling improves male partner involvement in sexual and reproductive health of a couple: Evidence from the ANRS PRENAHTEST randomized trial. PLoS One. 2021 Jul 30;16(7):e0255330. doi: 10.1371/journal.pone.0255330. eCollection 2021.
citation: Tiendrebeogo T, Plazy M, Darak S, Miric M, Perez-Then E, Butsashvili M, Tchendjou P, Dabis F, Orne-Gliemann J. Couples HIV counselling and couple relationships in India, Georgia and the Dominican Republic. BMC Public Health. 2017 Nov 25;17(1):901. doi: 10.1186/s12889-017-4901-8.
citation: Orne-Gliemann J, Balestre E, Tchendjou P, Miric M, Darak S, Butsashvili M, Perez-Then E, Eboko F, Plazy M, Kulkarni S, Desgrees du Lou A, Dabis F; Prenahtest ANRS 12127 Study Group. Increasing HIV testing among male partners. AIDS. 2013 Apr 24;27(7):1167-77. doi: 10.1097/QAD.0b013e32835f1d8c.