Meet me Where I am: A Multilevel Strategy to Increase PrEP Uptake and Persistence in Rural NC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Proportion of Participants Reporting PrEP Initiation by 3 Months
研究概览
简要总结
This project consists of two phases to be completed over five years. Phase 1 (Aims 1 and 2) will be completed during Years 1-3 (R61). The Phase 1 study is a randomized trial of a multilevel HIV Pre-Exposure Prophylaxis (PrEP) intervention strategy in rural and peri-urban North Carolina sexually transmitted infection (STI) clinics, with primary outcome of PrEP uptake within 3 months of an index STI clinic visit.
详细描述
Participants will be randomized 1:1 to an intervention or control condition. Participants enrolled in the intervention arm will receive a multilevel intervention with three components: a PrEP Navigator to facilitate linkage to PrEP services and completion of applications for health insurance/drug assistance; a Digital Health Intervention (DHI) platform (HealthMpowerment) - a HIPAA-compliant evidence-based DHI that provides interactive educational resources, social support, and tools for developing PrEP behavioral skills and self-efficacy; and referral to Telehealth PrEP services as an option for linking to PrEP care.
Control arm participants will receive the standard PrEP referral services available at the STI clinic setting where they were recruited. They will also receive linkage to a limited version of the DHI, with basic PrEP resources and information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Report sexual activity with a male in the past 12 months
- •Received HIV testing within 90 days pre-enrollment and not known to be HIV-positive at screening/enrollment by self-report
- •Age 18-39 years
- •Have daily smartphone access
- •Be English speaking
- •Deny current PrEP use
排除标准
- •Confirmed prior HIV-positive diagnosis
- •Prior PrEP use (oral PrEP or injectable PrEP) within the last 3 months.
结局指标
主要结局
Proportion of Participants Reporting PrEP Initiation by 3 Months
时间窗: 3 months
Proportion of participants with verified self-reported pre-exposure prophylaxis (PrEP) use (first dose, oral or injectable PrEP)1 at or before 3 months, defined as the number verified to start PrEP divided by the total number of participants in each arm
次要结局
- Proportion of Participants Reporting PrEP Initiation by 6 Months(6 months)
- Proportion of PrEP Initiators Adhering to Chosen PrEP Strategy Over First 6 Months(6 months)
- Proportion of PrEP Initiators Adhering to Chosen PrEP Strategy Over First 3 Months(3 months)
- Average Number of Consecutive Months PrEP Used Over First 3 Months(3 months)
- Average Number of Consecutive Months PrEP Used Over First 6 Months(6 months)
- Average Number of Days PrEP Used Among Persons Initiating Daily Oral PrEP in the 30 Days Prior to the 3-month Visit.(3 months)
- Average Number of Condomless Anal Sex Acts Protected by PrEP Among Persons Initiating Event-driven Oral PrEP in the 30 Days Prior to the 3-month Visit.(3-months)
- Proportion of Injectable PrEP Initiators Reporting PrEP Use in the 90 Days Prior to the 3-month Visit(3 months)
- Average Number of Days PrEP Used Among Persons Initiating Daily Oral PrEP in the 30 Days Prior to the 6-month Visit.(6 months)
- Average Number of Condomless Anal Sex Acts Protected by PrEP Among Persons Initiating Event-driven Oral PrEP in the 30 Days Prior to the 6-month Visit.(6 months)
- Proportion of Injectable PrEP Initiators Reporting PrEP Use in the 90 Days Prior to the 6-month Visit(6 months)
- Proportion of Oral PrEP Initiators With Detected PrEP Concentrations in Blood at 3 Months(3 months)
- Proportion of Oral PrEP Initiators With Detected PrEP Concentrations in Blood at 6 Months(6 months)
- Proportion of Injectable PrEP Initiators Receiving All Prescribed Injections Through 3 Months(3 months)
- Proportion of Injectable PrEP Initiators Receiving All Prescribed Injections Through 6 Months(6 months)
- Proportion of Participants Who Test Positive for HIV Among Those Tested at or Prior to the 3-month Visit(3 months)
- Proportion of Participants Who Test Positive for HIV Among Those Tested at or Prior to the 6-month Visit(6 months)
- Proportion of Participants Who Test Positive for an STI Other Than HIV Among Those Tested at or Prior to the 3-month Visit(3 months)
- Proportion of Participants Who Test Positive for an STI Other Than HIV Among Those Tested at or Prior to the 6-month Visit(6 months)
- Average Self-reported Score on the PrEP Stigma Scale at 3 Months(3 months)
- Average Self-reported Score on the PrEP Stigma Scale at 6 Months(6 months)