Developing an HIV Disclosure Intervention for Men in Uganda

NCT05771519 | Not Yet Recruiting DMC

• 2 other identifiers: 2022P003409K23MH126771
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

HIV Infections; Sexually Transmitted Infections (Not HIV or Hepatitis)

Outcome Measures

Primary Outcomes (2)

• 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.

  6 months

• 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.

  6 months

Secondary Outcomes (3)

• Index participant-reported disclosure

  6 months

• Partner participant HIV study site/clinic testing and counseling

  6 months

• HIV viral suppression

  6 months

Study Arms (2)

HIV disclosure intervention

EXPERIMENTAL

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 Procedures in both arms will encompass 3-5 individual sessions lasting 30-60 minutes over 2-3 months. There may also be a booster session at approximately the six-month timepoint.

Behavioral: HIV disclosure intervention

Control

NO INTERVENTION

Participants assigned to the control group will likely participate in educational topics related to healthy living for men living with HIV. Procedures in both arms will encompass 3-5 individual sessions lasting 30-60 minutes over 2-3 months. There may also be a booster session at approximately the six-month timepoint.

Interventions

HIV disclosure intervention BEHAVIORAL

This 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.

HIV disclosure intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All index participants will self-identify as male. Partner participants who men disclose to and bring into the study can be either male or female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• with at least one sexual partner in the past three months
• men living with HIV without HIV disclosure to at least one partner.
• age ≥18 years
• partnered with an enrolled man who reports HIV disclosure or plans for HIV disclosure with study support
• referred by the male participant.

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute of Mental Health (NIMH): collaborator
• Mbarara University of Science and Technology: collaborator

Study Sites (1)

Mbarara University of Science and Technology

Mbarara, Uganda

Location

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases; Hepatitis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Study Officials

• Pooja Chitneni, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pooja Chitneni, MD

CONTACT

563-650-2245; pchitneni@mgh.harvard.edu

Jessica Haberer, MD

CONTACT

408-605-3500; jhaberer@partners.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 16, 2023
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)