Developing and Pilot Testing an Adaptive Intervention to Facilitate PrEP Uptake and Maximize PrEP Adherence Among At-Risk Transgender Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Verified medical visit and PrEP prescription
研究概览
简要总结
"PrEP N' Shine" 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 Transgender women (TGW).
详细描述
The "PrEP N' Shine" package includes two behavioral intervention components:
- Peer-led, strengths-based case management (SBCM) for PrEP linkage and uptake, and
- A resource-efficient, adaptive "stepped-care" technology and counseling intervention that addresses individualized barriers to optimal use.
Stage 1: TGW 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 "PrEP N' Shine" 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
- Treatment
- 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
- •Age: 18 years or older
- •Male sex at birth
- •Self-identify as a woman, a transgender woman, or another identity along the male-to-female gender spectrum
- •PrEP naïve
- •PrEP indicated per CDC guidelines (incl. HIV negative)
- •Owns a cell phone or willing to use one in the study
- •Able to understand and speak English or Spanish
排除标准
- •Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at time of visit
- •Has lived in RI for less than three months (as a means to enhance participant retention)
- •Discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of interview (these patients will be referred immediately for treatment, but may join the study when this is resolved)
- •Laboratory or clinical findings that would preclude PrEP initiation (e.g. Hepatitis B infection, decreased creatinine clearance)
研究组 & 干预措施
Strength Based Case Management (SBCM) & PrEP adherence training and counseling
Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.
Stage 2: Stepped Intervention:
- Initially TGW in this arm will receive daily 2-way gender-affirming text message reminders, and
- Then those continuing to have poor adherence will receive the 4 (once per week for 3 to 4 weeks) more intensive counseling session with a clinical interventionist.
干预措施: PrEP N' Shine: Strength Based Case Management (Stage 1) (Behavioral)
Strength Based Case Management (SBCM) & PrEP adherence training and counseling
Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.
Stage 2: Stepped Intervention:
- Initially TGW in this arm will receive daily 2-way gender-affirming text message reminders, and
- Then those continuing to have poor adherence will receive the 4 (once per week for 3 to 4 weeks) more intensive counseling session with a clinical interventionist.
干预措施: PrEP N' Shine: Stepped Adherence Training and Counseling (Stage 2) (Behavioral)
Standard of Care:Stage 1 and Stage 2
Stage 1: Referral to local PrEP clinic Stage 2: Standard clinical PrEP care: Doctor visit every three months to assess for side effects, do blood work, and receive a HIV test.
结局指标
主要结局
Verified medical visit and PrEP prescription
时间窗: Stage 1: one month post-baseline
Linkage to care and PrEP Initiation measured through verified medical appointment at PrEP Clinic and pharmacy through medical release.
Concentrations of TFV-DP in Dried Blood Spots at 6 months
时间窗: Stage 2: 6 months post-baseline
Dried Blood Spots (DBS) to be sent to the laboratory to test for tenofovir-diphosphate (700+ fmol/punch - corresponding to levels that are consistent with taking 4+ pills per week), which will serve as a biological measure of PrEP adherence
Concentrations of TFV-DP in Dried Blood Spots at 3 months
时间窗: Stage 2: 3 months post-baseline
Dried Blood Spots (DBS) to be sent to the laboratory to test for tenofovir-diphosphate (700+ fmol/punch - corresponding to levels that are consistent with taking 4+ pills per week), which will serve as a biological measure of PrEP adherence.
次要结局
- Change in sexual risk behavior based on self report(Stage 2: Change from baseline sexual risk behavior at 6 months)
研究者
Matthew Mimiaga, ScD, MPH, MA
Principal Investigator
University of California, Los Angeles