A Social Network Approach to Improve HIV Prevention and Substance Use Treatment For People Who Use Drugs
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 398
- 试验地点
- 3
- 主要终点
- Percentage of Participants with PrEP Uptake
概览
简要总结
This study includes finalization of the LINKED social network intervention to improve PrEP and MOUD uptake among people who inject drugs (PWID) in collaboration with an Expert Advisory Board and staff (N=16) at The Sidewalk Project (TSP), followed by a Hybrid Type II cluster randomized trial of the LINKED intervention (versus an equal-attention control) among N=372 people who inject drugs, with 6- and 12-month follow-up assessment of PrEP and MOUD uptake. The investigators will also evaluate implementation outcomes to inform future sustainable implementation of LINKED in harm reduction organizations.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Aim 1 - Virtual Focus Group
- •Is 18 years or older
- •Is a current TSP staff
- •Is capable and willing to provide consent
- •Aim 2 - Intervention
- •18 years or older
- •Spend majority of their time in the Los Angeles, CA area where recruited
- •Able to complete surveys and group sessions in English
- •Self-report to have injected drugs in the past 3 months
- •Self-reported HIV negative serostatus
排除标准
- •Aims 1 and 3:
- •Individuals who are not current TSP staff members will be excluded from participation.
- •Under age 18;
- •Does not spend majority of time in the Los Angeles, CA area where recruited;
- •Unable to complete surveys and groups sessions in English;
- •Does not self-report injecting drugs in past 3 months;
- •Self-reported HIV positive serostatus
- •Currently on PrEP or MOUD
- •Currently pregnant
- •If a network recruit: does not present a valid recruitment coupon
研究组 & 干预措施
LINKED Intervention
Participants randomized to the LINKED arm will receive a peer change agent intervention consisting of a 3-hour workshop divided into four learning and practice modules.
干预措施: LINKED (Behavioral)
Equal-Attention Control
Participants randomized to the equal attention control group will receive a group intervention facilitated by trained study staff.
干预措施: Group Intervention (Behavioral)
结局指标
主要结局
Percentage of Participants with PrEP Uptake
时间窗: Month 6
Measured via filled PrEP prescription.
Percentage of Participants with PrEP Uptake
时间窗: Month 12
Measured via filled PrEP prescription.
Percentage of Participants with MOUD Uptake
时间窗: Month 6
Measured via filled MOUD prescription or buprenorphine, methadone, or naltrexone enrollment.
Percentage of Participants with MOUD Uptake
时间窗: Month 12
Measured via filled MOUD prescription or buprenorphine, methadone, or naltrexone enrollment.
Percentage of Participants with PrEP Adherence
时间窗: Month 6
Measured via urine immunoassays to test for oral PrEP.
Percentage of Participants with PrEP Adherence
时间窗: Month 12
Measured via urine immunoassays to test for oral PrEP.
Percentage of Participants with MOUD Adherence
时间窗: Month 6
Measured via urinalysis to test for metabolites for MOUD.
Percentage of Participants with MOUD Adherence
时间窗: Month 12
Measured via urinalysis to test for metabolites for MOUD.
次要结局
未报告次要终点