MedPath

Developing an HIV Disclosure Intervention for Men in Uganda

Not Applicable
Not yet recruiting
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
Inclusion Criteria

Not provided

Exclusion Criteria
  • 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
NameTimeMethod
HIV disclosure intervention acceptability6 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 feasibility6 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
NameTimeMethod
Partner participant HIV study site/clinic testing and counseling6 months

The investigators will measure the percentage of partners that participants bring to clinic for HIV testing.

HIV viral suppression6 months

Participant HIV viral suppression measured by nucleic acid amplification testing.

Index participant-reported disclosure6 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, Uganda
Winnie Muyindike, MBChB, MMED
Contact
© Copyright 2025. All Rights Reserved by MedPath