Hybrid Type 2 Effectiveness-Implementation Trial of Status Neutral, Integrated Behavioral Activation and Risk Reduction Intervention for Stimulant Use Among Sexually Active Adolescents and Young Adults (Project IMPACT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Distinct acts of condomless sex without the protection of PrEP or viral suppression.
研究概览
简要总结
The use of behavioral intervention to reduce stimulant use and concurrent HIV sexual transmission risk.
详细描述
IMPACT is a Human Immunodeficiency Virus (HIV) status-neutral, behavioral intervention to reduce stimulant use and concurrent HIV sexual transmission risk. This study will evaluate the effectiveness of IMPACT and determine feasibility of implementing IMPACT for translation into real-world practice using a hybrid effectiveness-implementation design.
The IMPACT intervention includes 10 sessions: 2 sessions of HIV sexual risk reduction (RR) counseling, 1 session focused on orienting and rationale of behavioral activation (BA), 6 sessions integrating BA and sexual RR counseling-including pre-exposure prophylaxis (PrEP) or antiretroviral therapy (ART) and HIV care-and 1 final session on strategies for slip-ups and recurrence management.
The enhanced Standard of Care (eSOC) group includes two HIV sexual RR sessions.
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
- 16 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 16-24 years, inclusive, at enrollment
- •Male or female
- •Self-reports condomless anal or vaginal sex while using stimulants (5 hour prior to, or during sex) within the last 4 months; stimulants is defined as crystal methamphetamine, cocaine, and MDMA (e.g., ecstasy, molly)
- •Willing and able to provide written informed consent for study participation
- •Access to a computer/smartphone/tablet that can use video chat (e.g., Zoom or Google Meet)
- •Provide a mailing address where they can receive a package
- •Access to stable internet that they can use for more than 2 hours at a time
- •Have a private place (where no one else can see or hear) where they can complete visits online
- •Reside within the continental U.S.
排除标准
- •Unable to provide informed consent due to severe mental or physical illness
- •Concurrent enrollment in another HIV prevention or treatment study (enrollment in a substance treatment program is acceptable)
- •Randomized to IMPACT arm prior to March 2025 study stop
- •Non-English-speaking
- •Is currently incarcerated or pending incarceration
- •Is currently pregnant or planning to become pregnant
- •Any other medical condition, medical/behavioral intervention, or other condition that, in the opinion of the Project Lead or designee, could interfere with the safety of participants or staff, adherence to study procedures, or compromise interpretation of study results
研究组 & 干预措施
IMPACT Group
Participants who report stimulant use in the context of condomless sex will be randomized using a 2:1 allocation ratio with two-thirds being allocated to the IMPACT intervention.
干预措施: IMPACT (Behavioral)
Enhanced Standard of Care (eSOC) Group
Participants who report stimulant use in the context of condomless sex will be randomized using a 2:1 allocation ratio with one-third being allocated to the eSOC intervention.
干预措施: eSOC (Behavioral)
结局指标
主要结局
Distinct acts of condomless sex without the protection of PrEP or viral suppression.
时间窗: Participants will recall and report acts of condomless sex and medication adherence for the 30 days prior to each of 4 visits: Baseline, Month 4, Month 8 and Month 12.
The number of times participants report engaging in condomless sex without the protection of PrEP (for those not living with HIV) or viral suppression (for those living with HIV).
次要结局
- Days of stimulant use(Participants will recall and report the number of days they used stimulants out of the 30 days prior to each of 4 visits and will also have urine drug testing done. The visits are at: Baseline, Month 4, Month 8 and Month 12.)