N/A
N=1,116
Developing and Assessing a Male Engagement Intervention in Option B+ in Malawi
Hiv
Bottom Line
View on ClinicalTrials.gov: NCT03477279 ↗Enrolled (actual)
1,116
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Number of Women Retained in Care — 160; 164 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Enhanced Couple HIV Testing and Counseling (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Women Retained in Care |
160; 164 | — |
| PRIMARY Number of Women With Viral Suppression |
145; 162 | — |
| PRIMARY Number of HIV-positive Male Partners Aware of Their HIV-positive Status |
44; 67 | — |
| PRIMARY Number of HIV-positive Male Partners Retained in Care |
34; 59 | — |
| PRIMARY Number of HIV-positive Male Partners With Viral Suppression |
31; 53 | — |
| PRIMARY Number of HIV-negative Men Without HIV Exposure From Their Primary Partner |
39; 59 | — |
| SECONDARY Number of HIV-positive Female Participants Who Reported Early Infant Diagnosis |
162; 158 | — |
| SECONDARY Predictors of Recent HIV Infection |
38; 338; 6; 11 | — |
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 continuum of care, 2) low male adoption of biomedical HIV prevention approaches, 3) sub-optimal female engagement in the continuum of care, and 4) poor or uncertain infant outcomes. Our team has developed an intervention to address these challenges, and will conduct a randomized controlled trial (N=500 couples) to assess intervention effectiveness at one year. Women with recent HIV infections enrolled in this trial will be compared against a cohort of 350 HIV-uninfected women to explore predictors of HIV acquisition in pregnancy in Malawi.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03477279). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.