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NCT Number: NCT05771519

Developing 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

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Digestive System Diseases Disease Attributes Genital Diseases Hepatitis Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Infections (Not HIV or Hepatitis) Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Mbarara University of Science and Technology

Mbarara, Uganda

Location contact

Winnie Muyindike, MBChB, MMED

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

  1. Index participant-reported disclosure

    Time frame: 6 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.

  2. Partner participant HIV study site/clinic testing and counseling

    Time frame: 6 months

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

  3. HIV viral suppression

    Time frame: 6 months

    Participant HIV viral suppression measured by nucleic acid amplification testing.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Haberer, MD

CONTACT

[email protected]

408-605-3500

Pooja Chitneni, MD

CONTACT

[email protected]

563-650-2245

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Mbarara University of Science and Technology
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: DASH

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 16, 2023
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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