MyPEEPS Mobile Plus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- PrEP Initiation:
研究概览
简要总结
MyPEEPS Mobile Plus, a multi-level intervention for improving HIV prevention outcomes in YMSM, is a novel and evidence-driven approach using mobile technology to deliver HIV prevention information specifically developed for YMSM. Building on strong preliminary work, the proposed research is the next logical step in a body of work designed to assess whether refinement of this mobile intervention used in combination with virtual PrEP Peer Navigation will result in improvements in PrEP uptake and a reduction in HIV-related behavior. This is key to advancing HIV prevention among HIV-negative US persons at extremely high-risk for HIV seroconversion.
详细描述
This study expands MyPEEPS Mobile to develop MyPEEPS Mobile Plus, a multi-level intervention comprised of MyPEEPS Mobile with added PrEP content (based upon expert advisory and youth feedback) + PrEP E-Peer Navigation to overcome the challenges of PrEP initiation, adherence, and persistence among YMSM. Peer navigation is an evidence-based, widely recommended intervention for reaching youth and MSM for HIV-related care outcomes, with evidence of acceptability among racial/ethnic minority YMSM for PrEP. Peer navigation addresses common reasons for failing to begin or maintain PrEP use, including low perceived risk, structural or logistic barriers to care engagement, and anticipated side effects. Relative to in-person and group-based HIV prevention programs, behavioral interventions with digital and virtual components can have vast reach and present unique potential to rapidly scale delivery to very large and hidden groups. Therefore, the investigators propose to conduct a randomized controlled trial to test the efficacy of MyPEEPS Mobile Plus (a multi-level intervention comprised of MyPEEPS Mobile + PrEP E-Peer Navigation) for promoting initiation, adherence, and persistence of PrEP and decreased HIV risk behavior in YMSM. Building upon the team's demonstrated ability to enroll large numbers of young racially and ethnically diverse YMSM and extensive experience developing mobile health interventions, the proposed study will test the efficacy of this expanded, multi-level mobile HIV prevention intervention emphasizing PrEP. If efficacious, it will increase PrEP initiation, adherence, and persistence and decrease overall HIV risk in diverse YMSM in the US.
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 (Participant)
入排标准
- 年龄范围
- 16 Years 至 25 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •16-25 years of age
- •identify as male or non-binary
- •male sex assigned at birth
- •understand and read English
- •own a smartphone
- •report condomless anal sex with a male in the past year
- •HIV-negative (OraQuick verified)
排除标准
- •HIV Positive
- •If study staff determine participant unable to consent due to obvious and severe cognitive impairment or under the influence of drugs or alcohol
- •currently report consistent use of PrEP
- •currently enrolled in another HIV prevention study
研究组 & 干预措施
Intervention
Participants randomized to the intervention arm will have access to the MyPEEPS mobile application and Electronic peer PrEP navigation for the entire 12-month study period.
干预措施: MyPEEPS Mobile (Behavioral)
Control
Participants randomized to the control arm will receive standard of care information regarding sexual and other behaviors that potentiate one's risk for HIV infection, receipt of a fact sheet about PrEP and PEP, referrals to the local PrEP clinic, and referrals for local sexually transmitted disease testing, and will have access to the MyPEEPS Mobile App during the study.
干预措施: MyPEEPS Mobile (Behavioral)
Intervention
Participants randomized to the intervention arm will have access to the MyPEEPS mobile application and Electronic peer PrEP navigation for the entire 12-month study period.
干预措施: Electronic PrEP peer navigation (Behavioral)
结局指标
主要结局
PrEP Initiation:
时间窗: Baseline, 6-month follow-up, 12-month follow-up
Participants will self-report attending at least one PrEP-related care visit to asess medical eligibility for PrEP initiation.
次要结局
- PrEP Adherence(Baseline, 6-month follow-up, 12-month follow-up)
- PrEP Persistence(Baseline, 6-month follow-up, 12-month follow-up)
研究者
Rebecca Schnall, RN, MPH, PhD
Mary Dickey Lindsay Professor of Disease Prevention and Health Promotion
Columbia University