Optimizing Bio-behavioral HIV Prevention Approaches for People Who Inject Drugs
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- PrEP uptake by self-report
研究概览
简要总结
People who inject drugs (PWID) experience high risk of HIV acquisition. Antiretroviral pre-exposure prophylaxis (PrEP) is an efficacious biomedical HIV prevention strategy for high risk HIV-uninfected individuals including PWID, yet uptake has been low in this population and uptake and adherence interventions have not been developed or tested. Drawing from formative qualitative research, the overall goal of this project is to develop an intervention to promote PrEP uptake and adherence among PWID in the U.S. Northeast. The investigators will:
- Analyze existing literature and data to identify specific barriers and facilitators to PrEP uptake and adherence among PWID to inform the initial adaptation of existing theory-based interventions;
- Conduct qualitative interviews with ~30 PWID and ~10 key informants (PrEP and other clinical and social service providers) to identify intervention targets;
- Develop and iteratively refine and finalize an intervention manual based on feedback from qualitative exit-interviews with an interventionist and ~10 PWID; and
- Conduct a pilot randomized clinical trial (RCT) in ~50 HIV-uninfected PWID to compare PrEP uptake and adherence outcomes and assess intervention feasibility and acceptability.
详细描述
This mixed methods phased research will use qualitative and quantitative techniques to improve PrEP uptake and adherence among PWID through the following three phases:
- Phase 1 will identify the modifiable determinants of PrEP uptake and adherence among HIV-uninfected PWID using in-depth qualitative interviews with PWID and key informants (KIs). Qualitative interviews will explore perceived acceptability and identify barriers and facilitators to PrEP uptake and adherence among ~30 HIV-uninfected PWID and explore perspectives on optimal PrEP delivery methods with ~15 KIs (e.g., PrEP physicians, community-based organization staff members with experience working with PWID).
- Phase 2 will involve identifying intervention targets and adapting existing intervention strategies to improve PrEP uptake and adherence among PWID. This will involve reviewing the literature to identify and select components of existing, evidence-based medication adherence interventions to adapt for the unique determinants of PrEP uptake and adherence among PWID. Investigators will then develop and iteratively refine and finalize an intervention manual by conducting an open-pilot of the intervention in a community-based setting. Refinements will be based on feedback from qualitative exit-interviews with the interventionist and ~10 PWID.
- Phase 3 will involve pilot testing the resulting PrEP uptake and adherence intervention in a selected community-based setting to obtain preliminary data on PrEP uptake and adherence outcomes (primary outcomes) and intervention feasibility and acceptability (secondary outcomes). Investigators will use a pilot RCT design with a mixed methods process evaluation in which 50 HIV-uninfected PWID will be randomized to the PrEP intervention or a control condition (SEP standard of care; n=25 per arm). Investigators will assess changes in PrEP outcomes (primary outcomes of uptake and adherence) and key implementation measures (e.g., secondary outcomes of acceptability, feasibility, adoption by the interventionist).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For all phases:
- •Inclusion Criteria:
- •An adult PWID
- •Self report of any high risk behaviors for HIV (past-month receptive syringe sharing, transactional sex, condomless sex with an HIV-infected or unknown status partner)
排除标准
- •Unable or unwilling to provide informed consent
- •For Phase 3 (the RCT pilot):
- •Inclusion Criteria:
- •Clinically eligible for PrEP (confirmed HIV-uninfected status, adequate renal function [estimated creatinine clearance ≥60 ml/min], and documented hepatitis B virus [HBV] status)
研究组 & 干预措施
PrEP uptake/adherence intervention
A trained interventionist will deliver the manualized, single session PrEP uptake/adherence intervention in private counseling rooms at a community-based setting.
干预措施: PrEP uptake/adherence intervention (Behavioral)
Harm reduction standard of care
Participants will be provided harm reduction supplies and health information and counseling according to routine practice at the community-based setting.
干预措施: Harm reduction standard of care (Behavioral)
结局指标
主要结局
PrEP uptake by self-report
时间窗: 3 months
measured using 1 item in a structured questionnaire
PrEP uptake by pharmacy records
时间窗: 3 months
measured by accessing pharmacy records
PrEP adherence by self-report
时间窗: 3 months
measured using 1 item in a structured questionnaire to determine the proportion of doses taken as prescribed
PrEP adherence by dried blood spot
时间窗: 3 months
measured via detection of tenofovir and emtricitabine in dried blood spots (DBS)
PrEP uptake by self-report
时间窗: 1 month
measured using 1 item in a structured questionnaire
PrEP uptake by pharmacy records
时间窗: 1 month
measured by accessing pharmacy records
PrEP adherence by self-report
时间窗: 1 month
measured using 1 item in a structured questionnaire to determine the proportion of doses taken as prescribed
PrEP adherence by dried blood spot
时间窗: 1 month
measured via detection of tenofovir and emtricitabine in dried blood spots (DBS)
次要结局
- Interventionist satisfaction with training materials(1 month)
- Interventionist satisfaction with intervention content(1 month)
- Interventionist satisfaction with intervention delivery methods(1 month)
- Interventionist satisfaction with intervention manual(1 month)
- Participant satisfaction with intervention content(1 month)
- Participant satisfaction with intervention delivery methods(1 month)