Developing and Assessing a Male Engagement Intervention in Option B+ in Malawi (NCT03477279) | Clinical Trial Compass
CompletedNot Applicable
Developing and Assessing a Male Engagement Intervention in Option B+ in Malawi
Malawi1,116 participantsStarted 2017-09-25
Plain-language 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.
Who can participate
Age range
15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Women Retained in Care
Timeframe: 12 months
2
Number of Women With Viral Suppression
Timeframe: 12 months
3
Number of HIV-positive Male Partners Aware of Their HIV-positive Status
Timeframe: 12 months
4
Number of HIV-positive Male Partners Retained in Care
Timeframe: 12 months
5
Number of HIV-positive Male Partners With Viral Suppression
Timeframe: 12 months
6
Number of HIV-negative Men Without HIV Exposure From Their Primary Partner