Passport to Wellness-Full Intervention Phase
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 4
- 主要终点
- Number self-reporting specific HIV/STD (sexually transmitted disease) Testing outcomes
研究概览
简要总结
The proposed research study will focus on Black men who have sex with men (BMSM) who
- are HIV- or unknown status AND
- have not received HIV testing in over a year or
- who test irregularly (on 9/21/2016, the protocol was changed to modify the last to criteria and focus on those who have not used PrEP in the prior six months).
and implement an innovative, culturally-informed, peer-based, and client-centered approach that is designed to increase their awareness of their HIV status and their timely entry into prevention (including PrEP), testing, care, and treatment services. The research design compares the effect of an incentives-only approach to one that uses incentives, along with the involvement of peer mentors to support timely entry into prevention, testing, care and treatment. This phase of the study is designed to assess peer-supported intervention group versus a passport/incentive-only control group over an 18-month period using a randomized trial approach.
详细描述
The proposed research study focuses on BMSM who have not received HIV testing in over a year, or who test irregularly, and implement an innovative, culturally-informed, peer-based, and client-centered approach that is designed to increase their awareness of their HIV status and their timely entry into prevention, care, and treatment services. On 9/21/2016, the protocol was changed to focus on those who have not used PrEP in the prior six months.
The research design compares the effect of an incentives-only approach to one that uses incentives, along with the involvement of peer mentors to support timely entry into prevention, testing, care and treatment. This phase of the study is designed to assess peer-supported intervention group versus a passport/incentive-only control group over an 18-month period using a randomized trial approach.
The Specific Aims of the full intervention phase are:
2 (Modified). To assess the effectiveness of a peer-supported, incentivized, and client-centered approach (PtW) compared to a non-peer supported, incentivized, and client-centered approach (Control) for linking at-risk BMSM to biomedical (PEP, STD testing), structural or behavioral services that support HIV prevention and care.
2a. Hypothesis: the peer-supported model (PtW) will lead to more frequent and earlier linkages to services than the non-peer supported model (Control).
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
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Control-Passport Only
Complete a needs assessment and develop a written "Passport to Wellness," an itemized set of health promoting behaviors and services aligned with lifestyle and goals. Participants are compensated based on the items they complete, services they attend.
干预措施: Control-Passport Only (Behavioral)
Intervention-Passport and Peer Mentor
In addition to the "Passport to Wellness" developed with project staff, study participants will select a peer mentor trained in motivational interviewing. The peer mentor will help guide the participant to complete passport items. Part of passport development will include compensation for meeting with peer mentors to form strategies for meeting goals and addressing barriers/challenges that arise.
干预措施: Intervention-Passport and Peer Mentor (Behavioral)
Intervention-Passport and Peer Mentor
In addition to the "Passport to Wellness" developed with project staff, study participants will select a peer mentor trained in motivational interviewing. The peer mentor will help guide the participant to complete passport items. Part of passport development will include compensation for meeting with peer mentors to form strategies for meeting goals and addressing barriers/challenges that arise.
干预措施: Control-Passport Only (Behavioral)
结局指标
主要结局
Number self-reporting specific HIV/STD (sexually transmitted disease) Testing outcomes
时间窗: 6 Months
--Number of participants 1) human immunodeficiency virus (HIV) tested within one and six months of their baseline; 2) newly diagnosed with HIV, and 3) obtaining testing for other STDs within six months of their baseline.
Number with specific PrEP outcomes
时间窗: 6 Months
--Number of participants who attend a PrEP information session, meet with a PrEP provider, or obtain a new PrEP prescription.
Number self-reporting specific Social and Behavioral Outcomes
时间窗: 6 Months
--Number of participants who obtain social and behavioral services that support HIV prevention and care.
Percentage with specific PrEP outcomes
时间窗: 6 Months
--Percentage of participants who attend a PrEP information session, meet with a PrEP provider, or obtain a new PrEP prescription. Summary items may include the percentage who report doing any of these three PrEP activities.
Percentage self-reporting specific HIV/STD (sexually transmitted disease) Testing outcomes
时间窗: 6 Months
--Percentage of participants 1) human immunodeficiency virus (HIV) tested within one and six months of their baseline; 2) newly diagnosed with HIV, and 3) obtaining testing for other STDs within six months of their baseline. Summary data may include the percentage who report HIV or STD testing.
Percentage of self-reporting specific Social and Behavioral Outcomes
时间窗: 6 Months
--Percentage of participants who obtain social and behavioral services that support HIV prevention and care.
次要结局
- Number of referrals HIV tested(6 Months)