Development and Assessment of an HIV Disclosure Intervention for Men in Uganda
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- HIV disclosure intervention acceptability
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •an inability to speak the local language (Runyankole) or English
- •an inability to provide informed consent
研究组 & 干预措施
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.
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.
干预措施: HIV disclosure intervention (Behavioral)
结局指标
主要结局
HIV disclosure intervention acceptability
时间窗: 6 months
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
时间窗: 6 months
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.
次要结局
- Partner participant HIV study site/clinic testing and counseling(6 months)
- HIV viral suppression(6 months)
- Index participant-reported disclosure(6 months)
研究者
Pooja R. Chitneni.,MD
Instructor
Brigham and Women's Hospital