Couple-oriented Prenatal HIV Counseling in Low and Medium HIV Prevalence Countries (Prenahtest)
This study has been completed.
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborator:
Elizabeth Glaser Pediatric AIDS Foundation
Information provided by (Responsible Party):
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT01494961
First received: December 15, 2011
Last updated: December 16, 2011
Last verified: December 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Partner HIV Testing Couple HIV Counseling Couple Communication HIV Incidence |
Behavioral: Couple-oriented post-test HIV counseling |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | The Public Health Impact of Couple-oriented Prenatal HIV Counseling in Low and Medium HIV Prevalence Countries |
Resource links provided by NLM:
Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:
Primary Outcome Measures:
- Partner HIV testing [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]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 Outcome Measures:
- Couple HIV counseling [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]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
- HIV incidence [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]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
- Couple communication of sexual and reproductive health [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]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
| Enrollment: | 1943 |
| Study Start Date: | February 2009 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Couple-oriented post-test HIV counseling
Women received couple-oriented post-test HIV counseling
|
Behavioral: Couple-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.
|
|
No Intervention: Standard post-test HIV counseling
Women received post-test HIV counseling as per standard site protocol
|
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01494961
Locations
| Cameroon | |
| Centre Mère - Enfant Chantal Biya | |
| Yaoundé, Cameroon | |
| Dominican Republic | |
| Hospital Materno-Infantil "San Lorenzo" de los Mina | |
| Santo Domingo, Dominican Republic | |
| Georgia | |
| Maternity Hospital N°5 | |
| Tbilisi, Georgia | |
| India | |
| Sane Guruji Hospital | |
| Pune, India | |
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Elizabeth Glaser Pediatric AIDS Foundation
Investigators
| Principal Investigator: | Francois Dabis, MD - PhD | INSERM U897, Institut de Santé Publique Epidémiologie Développement |
| Principal Investigator: | Patrice T Tchendjou, MD - MPH | Centre Pasteur du Cameroon |
More Information
Additional Information:
Publications:
| Responsible Party: | French National Agency for Research on AIDS and Viral Hepatitis |
| ClinicalTrials.gov Identifier: | NCT01494961 History of Changes |
| Other Study ID Numbers: | ANRS 12127 Prenahtest |
| Study First Received: | December 15, 2011 |
| Last Updated: | December 16, 2011 |
| Health Authority: | Cameroon: Ministry of Public Health Dominican Republic: Comité de Etica Indepediente, Fundacion Dominica de Insectoligia Georgia: Maternal and Child Care Union India: Independent Ethics Committee for Prayas Health Group |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
|
Partner HIV testing Couple HIV counseling Couple communication on sexual and reproductive health HIV incidence |
Incidence of pregnancies Disclosure Condom use |
ClinicalTrials.gov processed this record on March 14, 2013
