Status:
COMPLETED
Developing and Assessing a Male Engagement Intervention in Option B+ in Malawi
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Hiv
Eligibility:
All Genders
15+ years
Phase:
NA
Brief Summary
There is promising evidence that couple-based approaches within Malawi's Option B+ prevention of mother to child transmission program could address help address 1) poor male engagement in the HIV cont...
Detailed Description
In sub-Saharan Africa, engaging HIV-infected men in HIV care and treatment and engaging HIV-uninfected men in prevention has proven challenging. Along all steps of the HIV care-seeking cascade, men ex...
Eligibility Criteria
Inclusion
- Inclusion Criteria (HIV-infected Women):
- HIV-infected and eligible for Option B+
- \>18 years old or 15-17 years old and married
- Planning to remain in the Bwaila catchment area for the next year or notify the study team if they leave the area or change facilities
- Part of a heterosexual relationship for \>3 months
- Expects the partner to be in the relevant catchment area for at least one week in the next six months.
- Able and willing to give locator information for this partner
- Willing to have study staff conduct phone and physical tracing of that partner
- Willing to undergo a couple-based intervention with this partner
- Able and willing to provide informed consent
- Inclusion Criteria (Male Partners of HIV-infected women)
- \>18 years old or 15-17 years old and married
- In a relationship with the female partner for \>3 months
- Willing to undergo a couples-based intervention with their female partner
- Able and willing to provide informed consent
- Inclusion Criteria (HIV-uninfected Women):
- HIV-uninfected
- \>18 years old or 15-17 years old and married
- Part of a heterosexual relationship for \>3 months
- Expects the partner to be in the relevant catchment area for at least one week in the next six months.
- Willing to receive couples-based HIV testing and counseling with this partner
- Able and willing to provide informed consent
- Exclusion Criteria (all Women and Male Partners):
- • Any condition that in the opinion of the study investigator would compromise the ability of the prospective participant to provide informed consent, undergo study procedures safely, or would prevent proper conduct of the study.
Exclusion
Key Trial Info
Start Date :
September 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2020
Estimated Enrollment :
1116 Patients enrolled
Trial Details
Trial ID
NCT03477279
Start Date
September 25 2017
End Date
September 30 2020
Last Update
June 24 2021
Active Locations (1)
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1
Bwaila District Hospital Antenatal Unit
Lilongwe, Central District, Malawi