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

Primary Purpose

HIV Infections, Sexually Transmitted Infections (Not HIV or Hepatitis)

Status
Not yet recruiting
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
HIV disclosure intervention
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Mbarara University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

HIV disclosure intervention

Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
HIV viral suppression
Participant HIV viral suppression measured by nucleic acid amplification testing.

Full Information

First Posted
March 6, 2023
Last Updated
March 15, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
National Institute of Mental Health (NIMH), Mbarara University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05771519
Brief Title
Developing an HIV Disclosure Intervention for Men in Uganda
Acronym
DASH
Official Title
Development and Assessment of an HIV Disclosure Intervention for Men in Uganda
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2025 (Anticipated)
Primary Completion Date
February 2027 (Anticipated)
Study Completion Date
July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Institute of Mental Health (NIMH), Mbarara University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Sexually Transmitted Infections (Not HIV or Hepatitis)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIV disclosure intervention
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
HIV disclosure intervention
Intervention Description
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 Outcome Measure Information:
Title
HIV disclosure intervention acceptability
Description
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.
Time Frame
6 months
Title
HIV disclosure intervention feasibility
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Index participant-reported disclosure
Description
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.
Time Frame
6 months
Title
Partner participant HIV study site/clinic testing and counseling
Description
The investigators will measure the percentage of partners that participants bring to clinic for HIV testing.
Time Frame
6 months
Title
HIV viral suppression
Description
Participant HIV viral suppression measured by nucleic acid amplification testing.
Time Frame
6 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
All index participants will self-identify as male. Partner participants who men disclose to and bring into the study can be either male or female.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pooja Chitneni, MD
Phone
563-650-2245
Email
pchitneni@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Haberer, MD
Phone
408-605-3500
Email
jhaberer@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pooja Chitneni, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mbarara University of Science and Technology
City
Mbarara
Country
Uganda
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Winnie Muyindike, MBChB, MMED

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Developing an HIV Disclosure Intervention for Men in Uganda

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