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Clinical Trials/NCT01494961
NCT01494961CompletedNot Applicable

The Public Health Impact of Couple-oriented Prenatal HIV Counseling in Low and Medium HIV Prevalence Countries

French National Agency for Research on AIDS and Viral Hepatitis4 sites in 4 countries1,943 target enrollmentStarted: February 1, 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
1,943
Locations
4
Primary Endpoint
Partner HIV testing

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
15 Years to — (Child, Adult, Older Adult)
Sex
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

  • 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

Outcomes

Primary Outcomes

Partner HIV testing

Time Frame: 6 months postpartum

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

Secondary Outcomes

  • Couple HIV counseling(6 months postpartum)
  • HIV incidence(6 months postpartum)
  • Couple communication of sexual and reproductive health(6 months postpartum)

Investigators

Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (4)

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