Optimizing Pre-exposure Prophylaxis (PrEP) Uptake & Adherence Among MSW Using a 2-stage Randomization Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- Number of Participants With Verified Attendance at Initial Appointment at PrEP Clinic
研究概览
简要总结
"PrEPare for Work" is a two-stage randomized controlled pilot trial which utilizes a behavioral intervention to optimize the uptake and adherence of Pre-exposure Prophylaxis (PrEP) in Male Sex Workers (MSW).
详细描述
The "PrEPare for Work" package includes two behavioral intervention components:
- Strengths-based case management for PrEP initiation, and
- Counseling and problem-solving PrEP adherence intervention that addresses individualized barriers to optimal use.
Stage 1: MSW will be equally randomized to receive either the strengths-based case management or standard of care referral to PrEP clinic.
Stage 2: Those from stage 1 who initiate PrEP , regardless of stage 1 randomization condition, will then be equally randomized to either the "PrEPare for Work" adherence intervention or standard of care comparison condition.
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
- Single (Outcomes Assessor)
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
- •18 years of age or older
- •Biological male at birth and current male gender identity
- •Exchanged sex for money or drugs with another man in the past 3 months
- •Report behavioral risk for HIV infection, consistent with Centers for Disease Control and Prevention guidelines for prescribing PrEP: condomless anal intercourse with at least one HIV-infected or unknown serostatus partner in the past three months
- •HIV uninfected by antibody test* Stage 2
- •Able to understand and speak English (for consent and counseling)
- •Mental competency to provide voluntary informed consent
- •Lives in the New England area
- •Willing to initiate PrEP
排除标准
- •Unable to provide informed consent, including as a result of severe mental illness requiring immediate treatment or mental illness limiting the ability to participate
- •HIV Positive at baseline
- •Infected with Hepatitis B or diagnosed with renal insufficiency (glomerular filtration rate < 50) *Stage 2
- •History of or current medical conditions that would preclude taking Truvada for PrEP *Stage 2
- •Currently taking Truvada for PrEP
研究组 & 干预措施
Strength Based Case Management
Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.
干预措施: PrEPare for Work: Strength Based Case Management (Stage 1) (Behavioral)
PrEP adherence training and counseling
Stage 2: Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist.
干预措施: PrEPare for Work: Adherence Training and Counseling (Stage 2) (Behavioral)
Standard of Care:Stage 1
Stage 1: Referral to The Miriam Hospital PrEP Clinic.
Standard of Care: Stage 2
Stage 2: Doctor visit every three months to assess for side effects and receive a HIV test.
结局指标
主要结局
Number of Participants With Verified Attendance at Initial Appointment at PrEP Clinic
时间窗: 2-month post Stage 1 randomization
Number of participants with attendance at initial appointment at PrEP Clinic verified using medical records
Number of Participants Who Initiated PrEP
时间窗: 2-month post Stage 1 randomization
Initial prescription from provider filled and shown to study staff
Number of Participants Reporting Optimal PrEP Adherence
时间窗: 6-months post Stage 2 randomization
Self-reporting missing 0 PrEP pills in the past week
次要结局
未报告次要终点