Pepped on Pre-exposure Prophylaxis (PrEP): Pilot-randomized Controlled Trial (RCT) to Assess the Feasibility/Acceptability of the Pepped-for-PrEP Package (Counseling and Problem-solving PrEP Adherence Intervention With Behavioral Activation (BA) Approach) Among Stimulant Abusing MSM.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- PrEP Uptake
研究概览
简要总结
Pepped on PrEP is an innovative pilot RCT designed by an interdisciplinary team to develop a counseling and problem-solving PrEP adherence intervention with a Behavioral Activation (BA) approach that aims to re-engage participants in safe but pleasurable activities in life and addresses stimulant-abuse as well as associated factors including depression, as barriers to optimal PrEP adherence.
详细描述
Enrolled participants will receive a referral to the Miriam Hospital for standard of care PrEP treatment. Once prescribed PrEP through the Miriam Hospital, the study participants will be randomly assigned to one of two treatment conditions. In the intervention condition, participants will receive a two-stepped intervention which could include up to 10 free BA and risk reduction (RR) counseling sessions. Participants assigned to the comparison condition will receive the standard of care for PrEP treatment at the Miriam Hospital, which includes information about PrEP and how to obtain it, assistance from medical staff in obtaining health insurance for study participants, and information regarding local community resources.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessor will be blind to the participant's assigned intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age: 18 years or older
- •Sex: assigned male sex at birth
- •Self-reports having sex with another man in the past month while using stimulants
- •Self-reports behavioral risk for HIV infection (consistent with the Center for Disease Control guidelines) for prescribing PrEP: condomless anal intercourse with at least one HIV-infected or unknown serostatus partner in the preceding six months)
- •Not currently prescribed PrEP at initial visit
- •Able to speak and understand English (for consenting and counseling)
- •Lives in New England
排除标准
- •1.) Potential participants unable to provide informed consent, including people with severe mental illness requiring immediate treatment or with mental illness limiting their ability to participate.
研究组 & 干预措施
Pepped on PrEP
Using an efficient stepped care ("adaptive") model, all participants will receive three sessions of PrEP-STEPS counseling for PrEP adherence delivered by a Masters-level or above therapist. Some individuals may require a more intensive approach. These participants will receive an additional seven counseling sessions of behavioral activation with integrated cognitive behavioral therapy (CBT) designed to reduce stimulant use and promote positive behaviors.
干预措施: Pepped on PrEP Package (Behavioral)
Standard of Care
PrEP adherence counseling from the Miriam Hospital PrEP Clinic.
结局指标
主要结局
PrEP Uptake
时间窗: Baseline Stage 2
\>80% of participants who complete Stage 1 baseline and report PrEP initiation (verified by prescription) will progress to Stage 2 Baseline.
Improve rate of PrEP adherence
时间窗: Baseline Stage 2 and four month assessment
Self report adherence to assess for change in adherence.
次要结局
- Reduce Unsafe Sex(Baseline Stage 1,Baseline Stage 2 and four month assessment)
- Reduce Stimulant Use(Baseline Stage 1,Baseline Stage 2 and four month assessment)
研究者
Matthew Mimiaga
Professor, Departments of Behavioral & Social Health Sciences and Epidemiology, School of Public Health Professor, Department of Psychiatry & Human Behavior, Alpert Medical School Director, Center for Health Equity Research (CHER)
Brown University