Reducing Co-occurring Substance Use and HIV Risk Among Stimulant-using Men at High Risk for HIV in the United States of America.
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 84
- 主要终点
- Rate of PrEP uptake
概览
简要总结
This intervention will focus on stimulant-using men at high risk for HIV who are in need of tailored behavioral interventions to mitigate co-occurring stimulant use and HIV risk in the era of pre-exposure prophylaxis (PrEP). The study is a pilot randomized controlled trial to evaluate the adaptation, feasibility, acceptability, and preliminary efficacy of a behavioral intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •be 18 years of age or older;
- •be sexually active cisgender men at high risk for HIV (foreign and US-born, residing in the US)-reporting any condomless anal sex (CAS) in the past three months with a man;
- •report use of stimulant (i.e., methamphetamine, powder cocaine, or crack-cocaine) at least one day in the past three or six month;
- •have HIV-negative serostatus;
- •be bilingual (Spanish and English), or Spanish or English monolingual;
- •meet CDC criteria for PrEP eligibility.
排除标准
- •display diminished capacity to consent (e.g., cognitive impairment); or
- •severe psychiatric symptoms (e.g., psychosis) that require more intensive treatment;
- •if they are HIV positive or living with HIV;
- •if they are already taking PrEP; and
- •if the participant can't consent to participate in English or Spanish.
研究组 & 干预措施
Attention-Control condition
Participants randomized to the control condition will have six 1-on-1 sessions with a facilitator engaging in writing exercises. The sessions will be comparable in length to the intervention sessions but will not include any skills practice. Each session will include a neutral writing exercises.
干预措施: Contingency Management (Behavioral)
Experimental condition
Participants randomized to the experimental condition (tailored behavioral intervention) will have a 1-on-1 session with a facilitator. The intervention consists of six individually delivered sessions (1-2 sessions per week, approximately 1.5 hours each). The intervention will be interactive and include rapport- and trust-building activities; didactic teaching; multimedia (e.g., videos) messages to facilitate modeling and discussion; role-playing and skills building, practice, and feedback. The intervention will be led by a CITI certified facilitator, who is also a member of the study team. The sessions are: (1) Positive affect skills; (2) Positive Conscious Networks broaden and building supportive personal networks; (3) Mindfulness; (4) Personal Strengths and Obtainable Goals; (5) Positive Reassessment; and (6) Compassion/solidarity to one-self as to others. Sessions/modules will be guided by Segmented Assimilation and Stress and Coping Theory.
干预措施: Tailored Positive Affect Intervention (Behavioral)
Experimental condition
Participants randomized to the experimental condition (tailored behavioral intervention) will have a 1-on-1 session with a facilitator. The intervention consists of six individually delivered sessions (1-2 sessions per week, approximately 1.5 hours each). The intervention will be interactive and include rapport- and trust-building activities; didactic teaching; multimedia (e.g., videos) messages to facilitate modeling and discussion; role-playing and skills building, practice, and feedback. The intervention will be led by a CITI certified facilitator, who is also a member of the study team. The sessions are: (1) Positive affect skills; (2) Positive Conscious Networks broaden and building supportive personal networks; (3) Mindfulness; (4) Personal Strengths and Obtainable Goals; (5) Positive Reassessment; and (6) Compassion/solidarity to one-self as to others. Sessions/modules will be guided by Segmented Assimilation and Stress and Coping Theory.
干预措施: Contingency Management (Behavioral)
结局指标
主要结局
Rate of PrEP uptake
时间窗: From enrollment to 6 months
Changes in number of participants obtaining prescription to begin PrEP. Measured through documented evidence of an active prescription for PrEP.
次要结局
- Stimulant use (self-report)(Enrollment to 6 months)
- Condomless Anal Sex (CAS)(From enrollment to 6 months)
- Social Network Composition(From enrollment to 6 months)