The Collaborative Care PrTNER (Prevention, Treatment, Navigation, Engagement, Resource) Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 275
- 试验地点
- 4
- 主要终点
- PrEP uptake at 12 months
研究概览
简要总结
A randomized controlled trial to assess the ability of a Collaborative Care Prevention, Treatment, Navigation, Engagement, Resource (PrTNER) intervention to increase initiation of preexposure prophylaxis (PrEP) (for those at-risk for HIV) and decrease viral load (for those living with HIV) among young aged 15 to 29 through engagement in SU treatment.
详细描述
The Collaborative Care (CC) PrTNER is a multi-component intervention developed by members of the research team specifically for young men aged 15 to 29 who are at-risk for or living with HIV. This model moves beyond the individual to consider the broader context in which, substance use (SU), and HIV risk are (re)produced.
Enhanced models that integrate SU treatment into HIV and PrEP primary care services (using a collaborative care approach that incorporates feedback from a psychiatrist and support from a peer coach) are needed to address the nuance of substance use in this population. We, therefore, are proposing to conduct a randomized trial to evaluate an integrated collaborative care model (CC PrTNER).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 29 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •15-24 years old;
- •Cisgender male;
- •History of condomless sex;
- •Moderate-to-high risk SU behaviors based upon a Car, Relax, Alone, Forget, Friends, Trouble (CRAFFT) score ≥2,
- •Living in Philadelphia, PA or Baltimore, MD, and surrounding areas;
- •Able to read and write in English
- •15-29 years old;
- •Cisgender male;
- •Living with a diagnosis of HIV;
- •CRAFFT score ≥2,
- •Living in Philadelphia, PA or Baltimore, MD, and surrounding areas;
- •Able to read and write in English
- •All randomized study participants will be included in Aim 3.
排除标准
- •Participants will be excluded if they are:
- •Assigned female sex at birth
- •Identify as transgender
- •Outside the age criteria (<15 or >29 years old)
- •Cognitively unable to complete study requirements
- •Living outside of the two geographic areas
- •Do not screen positive for SU
- •No prior substance use history
- •No prior condomless sex;
- •Unable to read or write in English,
- •Plan to move in the next 12 months.
研究组 & 干预措施
Standard of Care
The participant's provider will receive an electronic alert in real time of the participant's positive screen for SU and a list of area substance treatment resources. The provider at their discretion will provide counseling or initiate a referral to in-clinic or community-based resources for SU assessment and treatment. Each of our clinical sites has case management resources for counseling and support for linkage to co-located SU treatment or community-based resources for inpatient or outpatient SU treatment as indicated at the discretion of the HIV/PrEP provider. SOC arm participants will not be assigned a coach. Study visit surveys and sample collection at baseline, 3, 6, 9, and 12 months are identical for intervention and SOC arm participants. Research personnel will make no attempts to provide brief intervention, motivational interviewing (MI), or case management.
Intervention
Participants randomized to CC PrTNER will be assigned a peer coach, complete interviewer-administered behavioral surveys, receive psychoeducation, identify health goals.
干预措施: CC PrTNER (Behavioral)
结局指标
主要结局
PrEP uptake at 12 months
时间窗: 12 months
PrEP uptake from baseline to 12 month survey. Biomedical assessment of PrEP use at 12 months, Intraerythrocytic Tenofovir-Diphosphate (TVF-DP) from dried blood spot (DBS) \>700 fmol/punch (oral PrEP), 2+ on-time injections of Long-acting injectable cabotegravir (CAB-LA)
HIV virologic suppression at 12 months
时间窗: 12 months
Viral load \< 20 copies/mL from baseline to 12 months
Number of days of past-28-day non-tobacco drug/alcohol use
时间窗: 12 months
Number of days of past-28-day non-tobacco drug/alcohol use, assessed via Timeline Followback Method Assessment (TLFB) from baseline to 12 months
次要结局
- PrEP persistence(12 months)
- Sustained viral suppression(12 months)
- Uptake of HIV Antiretroviral therapy (ART) treatment(12 months)
- Mean number of negative urine drug screens (UDS)(12 months)
- Substance-related problems(12 months)