NCT01494961

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,943

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2009

Typical duration for not_applicable

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2011

Completed
Last Updated

December 19, 2011

Status Verified

December 1, 2011

Enrollment Period

2.5 years

First QC Date

December 15, 2011

Last Update Submit

December 16, 2011

Conditions

Partner HIV TestingCouple HIV CounselingCouple CommunicationHIV Incidence

Keywords

Partner HIV testingCouple HIV counselingCouple communication on sexual and reproductive healthHIV incidenceIncidence of pregnanciesDisclosureCondom use

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Couple HIV counseling

    6 months postpartum

  • HIV incidence

    6 months postpartum

  • Couple communication of sexual and reproductive health

    6 months postpartum

Study Arms (2)

Couple-oriented post-test HIV counseling

EXPERIMENTAL

Women received couple-oriented post-test HIV counseling

Behavioral: Couple-oriented post-test HIV counseling

Standard post-test HIV counseling

NO INTERVENTION

Women received post-test HIV counseling as per standard site protocol

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.

Couple-oriented post-test HIV counseling

Eligibility Criteria

Age15 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Accepting follow-up (including home visits if necessary) by the project staff until 15 months after delivery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centre Mère - Enfant Chantal Biya

Yaoundé, Cameroon

Location

Hospital Materno-Infantil "San Lorenzo" de los Mina

Santo Domingo, Dominican Republic

Location

Maternity Hospital N°5

Tbilisi, Georgia

Location

Sane Guruji Hospital

Pune, India

Location

Related Publications (5)

  • 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.

    PMID: 20403152RESULT

  • 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.

    PMID: 21857289RESULT

  • 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.

    PMID: 34329355DERIVED

  • 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.

    PMID: 29178852DERIVED

  • 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.

    PMID: 23343912DERIVED

Study Officials

  • Francois Dabis, MD - PhD

    INSERM U897, Institut de Santé Publique Epidémiologie Développement

    PRINCIPAL INVESTIGATOR

  • Patrice T Tchendjou, MD - MPH

    Centre Pasteur du Cameroon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2011

First Posted

December 19, 2011

Study Start

February 1, 2009

Primary Completion

August 1, 2011

Study Completion

October 1, 2011

Last Updated

December 19, 2011

Record last verified: 2011-12

Locations

GE(1)IN(1)CA(1)DO(1)