Developing an HIV Disclosure Intervention for Men in Uganda

HIV Infections Clinical Trial

— DASH  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05771519
• Other study ID #: 2022P003409
• Secondary ID: K23MH126771
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2025
• Est. completion date: July 2027

Study information

• Verified date: March 2023
• Source: Brigham and Women's Hospital
• Contact: Pooja Chitneni, MD
• Phone: 563-650-2245
• Email: pchitneni[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: July 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• Infections
• Sexually Transmitted Diseases
• Sexually Transmitted Infections (Not HIV or Hepatitis)

Intervention

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.

Locations

Country	Name	City	State
Uganda	Mbarara University of Science and Technology	Mbarara

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Mbarara University of Science and Technology, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	HIV viral suppression	Participant HIV viral suppression measured by nucleic acid amplification testing.	6 months