Developing an HIV Disclosure Intervention for Men in Uganda

Study Overview
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Brief Summary
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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

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

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

Intervention / Treatment
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* Behavioral: HIV disclosure intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIV disclosure intervention<br>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. | Behavioral: HIV disclosure intervention<br>* 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.<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| HIV viral suppression | Participant HIV viral suppression measured by nucleic acid amplification testing. | 6 months |