Developing an HIV Disclosure Intervention for Men in Uganda
- Conditions
- Sexually Transmitted Infections (Not HIV or Hepatitis)HIV Infections
- Registration Number
- NCT05771519
- Lead Sponsor
- Brigham and Women's Hospital
- Brief Summary
The goal of this clinical trial is to test an HIV disclosure intervention that the investigators are developing focused on men living with HIV in Uganda. The main questions the investigators are trying to answer is whether the HIV disclosure intervention the investigators develop will help men who receive this intervention to disclose their HIV status to a greater extent than men who receive standard care.
Participants assigned to the intervention group will likely participate in the following:
* Sexual health education
* Cognitive behavioral therapy strategies
* Problem-solving skills building
* Motivational interviewing
* Developing a personalized HIV disclosure plan
* Communication skills building
* Role-playing disclosure strategies
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 70
Not provided
- an inability to speak the local language (Runyankole) or English
- an inability to provide informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method HIV disclosure intervention acceptability 6 months Of 35 intervention participants, ≥70% (25 participants) rate all 4 items on the Acceptability of Intervention Measure (a 5-point Likert scales) as "agree" or higher. I will also assess intervention acceptability through qualitative interviews with participants and counselors.
HIV disclosure intervention feasibility 6 months Feasibility is defined by the Feasibility of Intervention Measure, intervention fidelity, and session completion. A) Feasibility of Intervention Measure: Of 35 intervention participants, ≥70% (25 participants) rate all 4 items on the Feasibility of Intervention Measure (a 5-point Likert scale) as "agree" or higher, B) Fidelity: Assuming a five-session intervention with 25% English-transcribed (44/175 sessions), intervention fidelity is attained when ≥70% (31 sessions) achieve ≥90% fidelity to the protocol adherence checklist, C) Session completion: Of the 35 intervention participants, ≥70% attend ≥50% of sessions. I will also assess intervention acceptability through qualitative interviews with participants and counselors.
- Secondary Outcome Measures
Name Time Method Partner participant HIV study site/clinic testing and counseling 6 months The investigators will measure the percentage of partners that participants bring to clinic for HIV testing.
HIV viral suppression 6 months Participant HIV viral suppression measured by nucleic acid amplification testing.
Index participant-reported disclosure 6 months Index participant-reported disclosure (measured by an expanded disclosure measurement tool and a Center For AIDS Research-funded HIV Disclosure Processes Model Measurement Scale in development.
Trial Locations
- Locations (1)
Mbarara University of Science and Technology
🇺🇬Mbarara, Uganda
Mbarara University of Science and Technology🇺🇬Mbarara, UgandaWinnie Muyindike, MBChB, MMEDContact