Developing an HIV Disclosure Intervention for Men in Uganda (DASH)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: HIV Infections; Sexually Transmitted Infections (Not HIV or Hepatitis)
• Intervention / Treatment: Behavioral: HIV disclosure intervention

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pooja Chitneni, MD; Phone Number: 563-650-2245; Email: pchitneni@mgh.harvard.edu
• Study Contact Backup: Name: Jessica Haberer, MD; Phone Number: 408-605-3500; Email: jhaberer@partners.org

Study Locations

• Uganda
  • Mbarara, Uganda
    • Mbarara University of Science and Technology
    • Contact: Winnie Muyindike, MBChB, MMED

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

For all 3 Aims, "index participants" inclusion criteria will include:

• 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

Aims 2 and 3 have the additional inclusion criteria:

• men living with HIV without HIV disclosure to at least one partner.

In Aims 2 and 3, male participants will be encouraged to invite sexual partners for enrollment. These "partner participants" will have the following inclusion criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIV disclosure intervention; 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; 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.
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
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.	6 months
HIV viral suppression	Participant HIV viral suppression measured by nucleic acid amplification testing.	6 months

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Institute of Mental Health (NIMH); Mbarara University of Science and Technology
• Investigators: Principal Investigator: Pooja Chitneni, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Pathological Conditions, Signs and Symptoms; Hepatitis; HIV Infections; Sexually Transmitted Diseases
• Other Study ID Numbers: 2022P003409; K23MH126771 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No