Intervention to Reduce Drug Use and HIV Incidence Among High PrEP Priority Partnered YMSM
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 196
- 试验地点
- 2
- 主要终点
- Illicit Drug Use Days
研究概览
简要总结
This research examines the efficacy of an individually-delivered intervention tailored for YMSM in relationships. The intervention - termed PARTNER - utilizes a brief (4 session) motivational interviewing format to target Pre-Exposure Prophylaxis (PrEP) uptake/adherence, HIV transmission risk behavior, and associated drug use.
详细描述
This study aims to evaluate a individual-focused intervention with an integrated focus on drug use and HIV prevention, including uptake of and adherence to PrEP. The investigators will recruit a sample of 240 partnered individuals.
Recruitment occurs using a mix of in-person and Internet recruitment. Outreach workers will visit bars and events in the New York City area to recruit participants. Also,information on our project will be posted on social media sites (e.g.,Facebook, Grindr, Scruff). Interested individuals will complete a brief online screener to assess eligibility. A telephone screener will be conducted with participants who are preliminarily eligible based upon online screener responses. Participants who are eligible based upon telephone screening responses will be sent an email. The email contains a link for them to access the baseline online survey. It provides information which introduces the study to the recruited partner and a link to the baseline survey online. If participants indicate intimate partner violence (IPV) on the online baseline survey, participants will be rendered ineligible. Only the participant that indicated experiencing IPV will be given a list of local referrals to access IPV-related services.
An in-person baseline assessment appointment will be scheduled after both participants have completed the online survey.
The in-person baseline assessment appointment consists of four components; written consent, a computer-assisted self interview (CASI), a timeline follow back interview, and biological testing.
Written consent is obtained prior to the start of any in-person baseline activity. Participants additionally complete a computer-assisted self interview (CASI). After this, participants will independently complete a TFLB. TLFB is a semi-structured interview to collect retrospective event-level data on drug use, sexual behavior and PrEP adherence (for those on PrEP) in the past 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18 to 29 years of age (inclusive);
- •Main partner must be aged 18 or older.
- •Must be in a main partner relationship with another male (duration ≥ 1 months);
- •HIV-negative serostatus (confirmed by rapid test);
- •Recent (past 30 day) use of at least one of the substances identified as most commonly used by YMSM (marijuana, cocaine, methamphetamine, heroin or other opiates, MDMA, psychedelics, GHB, and/or ketamine);
- •Sexual behavior meeting CDC criteria for PrEP candidacy (TRB with a casual partner in the past 30 days or TRB with a non-monogamous or serodiscordant main partner).
- •Participants must reside in the NYC metro area
- •Ability to communicate in English
排除标准
- •Unstable, serious psychiatric symptoms (assessed by the Psychotic Disorder subsection of the Structured Clinical Interview for DSM-IV);
- •Current suicidal/homicidal ideation;
- •Evidence of gross cognitive impairment (a score of <24 on the mini-mental state examination)
- •A history of severe physical or sexual Intimate Partner Violence (IPV) victimization in the current relationship in which participants report not currently feeling "safe" in their relationship and/or coerced to participate in the study.
结局指标
主要结局
Illicit Drug Use Days
时间窗: Baseline, 3-Month, 6-Month, 9-Month, 12-Month
The self-reported number of illicit drug use days (not including marijuana) in the past 30 days
Cannabis Use Days
时间窗: Baseline, 3-Month, 6-Month, 9-Month, 12-Month
The self-reported number of cannabis drug use days in the past 30 days
Number (Proportion) of Participants Who Report Sexual HIV Transmission Risk With Casual Partners
时间窗: Baseline, 3-Month, 6-Month, 9-Month, 12-Month
The percentage of participants in each condition reporting sexual HIV transmission risk with a casual partner (any condomless sex with a casual partner in the absence of PrEP).
The Number (Proportion) of Participants Reporting Pre-Exposure Prophylaxis (PrEP) Uptake
时间窗: Baseline, 3-Month, 6-Month, 9-Month, 12-Month,
The percentage participants in each condition who report having a current PrEP prescription at the time of follow-up.
次要结局
未报告次要终点
研究者
Tyrel Starks
Professor of Psychology
Hunter College of City University of New York