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Clinical Trials/NCT05771519
NCT05771519
Not yet recruiting
Not Applicable

Development and Assessment of an HIV Disclosure Intervention for Men in Uganda

Brigham and Women's Hospital1 site in 1 country70 target enrollmentMay 1, 2026

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Infections
Sponsor
Brigham and Women's Hospital
Enrollment
70
Locations
1
Primary Endpoint
HIV disclosure intervention acceptability
Status
Not yet recruiting
Last Updated
4 months ago

Overview

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
Registry
clinicaltrials.gov
Start Date
May 1, 2026
End Date
July 1, 2027
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pooja R. Chitneni.,MD

Instructor

Brigham and Women's Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • an inability to speak the local language (Runyankole) or English
  • an inability to provide informed consent

Outcomes

Primary Outcomes

HIV disclosure intervention acceptability

Time Frame: 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

Time Frame: 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 Outcomes

  • Partner participant HIV study site/clinic testing and counseling(6 months)
  • HIV viral suppression(6 months)
  • Index participant-reported disclosure(6 months)

Study Sites (1)

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