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

Mass General Brigham

Status: Not yet enrolling

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

Treatments: Behavioral: HIV disclosure intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05771519

K23MH126771 (U.S. NIH Grant/Contract)

2022P003409

Details and patient eligibility

About

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

Enrollment: 70 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

HIV disclosure intervention

Experimental group

Description:

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.

Treatment:

Behavioral: HIV disclosure intervention

Control

No Intervention group

Description:

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.