CClinicalTrials.gg
CompletedNCT01494961PrenahtestUpdated Dec 19, 2011

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

An interventional study of Couple-oriented post-test HIV counseling in Partner HIV Testing, Couple HIV Counseling and Couple Communication, sponsored by French National Agency for Research on AIDS and Viral Hepatitis. Completed at 4 sites in 4 countries. Open to female participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-12-19.

Sponsored by French National Agency for Research on AIDS and Viral Hepatitis · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,943
Allocation
Randomized
Ages
15 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • 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
03

In context

Lead sponsor

French National Agency for Research on AIDS and Viral Hepatitis is the lead sponsor of 83 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
Female
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,943 participants (actual)

Study arms

  • Experimental
    Couple-oriented post-test HIV counseling

    Women received couple-oriented post-test HIV counseling

    Behavioral: Couple-oriented post-test HIV counseling

  • No intervention
    Standard post-test HIV counseling

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

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.

06

What researchers measure

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

    Time frame: 6 months postpartum

Secondary outcomes

  1. 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

  2. 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

  3. 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

07

Study locations

4 sites
  • 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
08

References and documents

Publications

  • 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. PubMed 20403152 ↗
  • 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. PubMed 21857289 ↗
  • 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. PubMed 34329355 ↗
  • 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. PubMed 29178852 ↗
  • 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. PubMed 23343912 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01494961
Lead sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators
Elizabeth Glaser Pediatric AIDS Foundation
Responsible party
Sponsor
First posted
Dec 19, 2011
Start date
Feb 2009
Primary completion
Aug 2011
Completion
Oct 2011
Last update
Dec 19, 2011

Study contacts

Francois Dabis, MD - PhD
principal investigator · INSERM U897, Institut de Santé Publique Epidémiologie Développement
Patrice T Tchendjou, MD - MPH
principal investigator · Centre Pasteur du Cameroon

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion