Partner HIV TestingPrenahtestNCT01494961
Couple-oriented Prenatal HIV Counseling in Low and Medium HIV Prevalence Countries
A study testing Couple-oriented post-test HIV counseling in people with Partner HIV Testing and Couple HIV Counseling, run by French National Agency for Research on AIDS and Viral Hepatitis at 4 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Partner HIV Testing, Couple HIV Counseling, Couple Communication
- What is being tested?
- Couple-oriented post-test HIV counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,943 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Feb 2009to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Dominican Republic1 site
Hospital Materno-Infantil "San Lorenzo" de los Mina
Santo Domingo
About this study
Official title: The Public Health Impact of Couple-oriented Prenatal HIV Counseling in Low and Medium HIV Prevalence Countries
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.
- Being tested
- Couple-oriented post-test HIV counseling
- Keywords
- Partner HIV testing, Couple HIV counseling, Couple communication on sexual and reproductive health, HIV incidence, Incidence of pregnancies, Disclosure, Condom use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couple-oriented post-test HIV counselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Couple-oriented post-test HIV counseling | Experimental | Women received couple-oriented post-test HIV counseling Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months postpartum
Secondary outcomes (3)
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
Measured: 6 months postpartum
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
Measured: 6 months postpartum
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
Measured: 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startFeb 2009
- Primary completionAug 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Partner HIV TestingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,943 participants (actual)
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Collaborators
- Elizabeth Glaser Pediatric AIDS Foundation
- Responsible party
- Sponsor
- Investigators
- Francois Dabis, MD - PhD, Principal investigator, INSERM U897, Institut de Santé Publique Epidémiologie DéveloppementPatrice T Tchendjou, MD - MPH, Principal investigator, Centre Pasteur du Cameroon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494961
- Sponsor's protocol ID
- ANRS 12127 Prenahtest
- Acronym
- Prenahtest
- Status last verified
- Dec 2011
- First submitted
- 15 Dec 2011
- Last updated
- 19 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
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 20403152Tchendjou 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 21857289Kengne-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 34329355Tiendrebeogo 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 29178852Orne-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
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Public Health Impact of Couple-oriented Prenatal HIV Counseling in Low and Medium HIV Prevalence Countries
- ClinicalTrials.gov ID
- NCT01494961
- Acronym / sponsor ID
- Prenahtest / ANRS 12127 Prenahtest
- Keywords
- Partner HIV testing, Couple HIV counseling, Couple communication on sexual and reproductive health, HIV incidence, Incidence of pregnancies, Disclosure, Condom use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,943 participants (actual)
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Collaborators
- Elizabeth Glaser Pediatric AIDS Foundation
- Study start
- Feb 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 19 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Couple-oriented post-test HIV counseling | Experimental | Behavioral: Couple-oriented post-test HIV counselingWomen received couple-oriented post-test HIV counseling |
| Standard post-test HIV counseling | No intervention | –Women received post-test HIV counseling as per standard site protocol |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Couple-oriented post-test HIV counselingCOC 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. | Behavioural | Couple-oriented post-test HIV counseling |
Primary outcome
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
3 secondary outcomes
Couple HIV counseling
Time frame: 6 months postpartum
HIV incidence
Time frame: 6 months postpartum
Couple communication of sexual and reproductive health
Time frame: 6 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2011.
- Results publication: PubMed 20403152Orne-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.
- Results publication: PubMed 21857289Tchendjou 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.
- Derived from this study: PubMed 34329355Kengne-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.
- Derived from this study: PubMed 29178852Tiendrebeogo 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.
- Derived from this study: PubMed 23343912Orne-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.
Related trials for Partner HIV Testing
Not yet recruiting
The ACT-PrEP Study
HIV, PrEP
Recruiting
HIV Self-testing for Partners of HIV-uninfected Postpartum Women
HIV Self-testing, Male Partners of HIV-negative Postpartum Women
Enrolling by invitationPhase 2
Peer Delivered HIV/Syphilis Self-Testing With Assisted Partner Notification Services
HIV, Syphilis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Couple-oriented post-test HIV counseling in people with Partner HIV Testing and Couple HIV Counseling, run by French National Agency for Research on AIDS and Viral Hepatitis at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Cameroon, Dominican Republic, Georgia, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partner HIV testing (time frame: 6 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01494961, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2011.