Scaling up HIV Prevention Trials Network (HPTN) 074: a Cluster Randomized Implementation Trial of an Evidence-based Intervention for Antiretroviral Therapy for PWID in Vietnam
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Percent of PWID Who Initiated ART
研究概览
简要总结
The purpose of this study is to compare two implementation approaches [Standard Approach (SA) vs. Tailored Approach (TA)] for scaling-up the evidence-based systems navigation and psychosocial counseling integrated intervention (SNaP) in HIV test sites in Vietnam.
详细描述
This is a cluster randomized, controlled implementation trial to compare two implementation approaches (standard and tailored) for scaling-up the SNaP intervention in 42 HIV test sites in Vietnam. The SNaP intervention combines systems navigation and psychosocial counseling for people who inject drugs (PWID), and it is designed to facilitate PWID's engagement in HIV and substance use care.
The two implementation approaches being compared are:
- Standard Approach (SA); vs.
- Tailored Approach (TA)
SNaP is an evidence-based intervention (EBI) that combines systems navigation and psychosocial counseling to facilitate the engagement of HIV-infected people who inject drugs (PWID) into HIV and substance use care.
The 42 HIV test sites will be randomized in a 1:1 ratio to either the standard approach (SA) procedure or a tailored approach (TA), stratified by engagement of site leadership.
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
- Single (Outcomes Assessor)
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
- •PWID participants:
- •HIV infection:
- •Newly diagnosed HIV infection, based on confirmatory test, and not currently on ART at the time of study enrollment; or
- •If previously diagnosed with HIV infection, then must not currently be on ART at the time of study enrollment (self-reported)
- •Age 18 years or older
- •Injection drug use within the past 6 months (self-reported at time of screening)
- •Willing to provide informed consent for the study
- •Test site director boards and staff:
- •All test site director boards and staff, including the navigators and counselors, at the selected HIV test sites
- •Willing to provide informed consent for the study
排除标准
- •PWID participants:
- •Residence outside of the catchment area of local antiretroviral therapy (ART) and medication-assisted treatment (MAT, e.g. methadone) clinics
- •Currently on ART at time of study enrollment (self-reported)
- •Planning to move out of the catchment area within the next 24 months.
结局指标
主要结局
Percent of PWID Who Initiated ART
时间窗: Medical record reviews conducted within 6 months after enrollment; self-report: 6-12 months after enrollment among those who initiated SNaP
Percent of PWID who initiated antiretroviral therapy (ART) among the PWID who initiated SNaP, measured through ART clinic records of consenting PWID and/or self-report. This measures ART uptake among PWID who initiated the SNaP intervention.
Fidelity to SNaP Intervention Procedures
时间窗: Measured over 26 months after SNaP implementation in a clinic
Fidelity measures whether the SNaP intervention was delivered as intended. Fidelity score = (% Systems navigation sessions completed x Average navigation session quality score) + (% Counseling sessions completed x Average counseling session quality score) Session completion will be assessed by reviewing the navigator and counselor logs, while session quality will be assessed by central implementation team review and scoring of a random 10% of all forms (navigation) and audio-recordings (psychosocial counseling). Test site fidelity score range: 0-200 (Higher score indicates higher fidelity.)
次要结局
- Percent of PWID Who Were Contacted and Participated in SNaP(Up to 24 months after implementation of SNaP in a clinic)
- Percent of PWID Who Are Virally Suppressed(Up to 24 months after implementation of SNaP in a clinic)
- Percent of PWID on Medication-Assisted Treatment (MAT)(Up to 24 months after SNaP implementation in a clinic)
- Mean Acceptability Score of SNaP by PWID (AIM)(Up to 24 months after SNap implementation in a clinic)
- Mean Acceptability Score of SNaP by Test Site Staff (OADRI)(24 months after implementation of SNaP in a clinic)
- Incremental Cost-Effectiveness Ratio of SA Compared to TA for SNaP Implementation(Up to 24 months after SNaP implementation in a clinic.)
- Percent of PWID Alive and Remaining on ART(Up to 24 months after SNaP implementation in a clinic)
- Percent of Clinics Continuing to Offer SNaP After Completion of Study Activities(Up to 37 months after SNaP implementation in a clinic)