Developing an HIV Disclosure Intervention for Men in Uganda

NCT ID: NCT05771519

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-05-31
• Study Completion Date: 2027-07-31

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

HIV disclosure intervention

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Mbarara University of Science and Technology

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Pooja R. Chitneni.,MD

Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pooja Chitneni, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Mbarara University of Science and Technology

Mbarara, , Uganda

Countries

Uganda

Central Contacts

Pooja Chitneni, MD

Role: CONTACT

pchitneni@mgh.harvard.edu

563-650-2245

Jessica Haberer, MD

Role: CONTACT

jhaberer@partners.org

408-605-3500

Facility Contacts

Winnie Muyindike, MBChB, MMED

Role: primary

Other Identifiers

K23MH126771

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2022P003409

Identifier Type: -

Identifier Source: org_study_id