Developing an HIV Disclosure Intervention for Men in Uganda
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorBrigham and Women's Hospital
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
men living with HIV
with sexually transmitted infection symptoms (e.g., urethral discharge, genital lesions)
either not accessing antiretroviral therapy (per self-report109 and/or clinic documentation) or accessing antiretroviral therapy without HIV viral suppression
age ≥18 years,
Disqualifiers
an inability to speak the local language (Runyankole) or English
an inability to provide informed consent
Trial design
Design model
Parallel
Treatments tested in this trial
HIV disclosure intervention
BehavioralThis will be a biobehavioral intervention focused on helping men with HIV to disclose their HIV status to a personal confidant inclusive with specific focus on sexual partners.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: HIV disclosure interventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
HIV disclosure intervention acceptability
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.
Time frame
6 months2
HIV disclosure intervention feasibility
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.
Time frame
6 monthsSecondary outcomes
1
Index participant-reported disclosure
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.
Time frame
6 months2
Partner participant HIV study site/clinic testing and counseling
The investigators will measure the percentage of partners that participants bring to clinic for HIV testing.
Time frame
6 months3
HIV viral suppression
Participant HIV viral suppression measured by nucleic acid amplification testing.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Brigham and Women's Hospital
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Mbarara University of Science and Technology
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: