Positive Connections: COPA2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- HIV viral Load (VL)
研究概览
简要总结
This study proposes to assess the impact of a provider-based intervention to enhance re-engagement and improve retention, adherence, persistence and viral load among challenging patients in Argentina
详细描述
Motivational Interviewing (MI) has primarily been utilized as a counseling strategy by therapists to counter addiction and improve lifestyle behaviors.
This application proposes to train physicians to utilize MI to promote re-engagement in HIV care and to sustain retention and adherence. The study will increase the reach of the original pilot study and increase its generalizability, expanding the patient population to a wide variety of public and private clinic and hospital patients, including transgender women, drug users, men who have sex with men (MSM), and heterosexual men and women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •HIV seropositive
- •At least 18 years of age (there will be no upper age range)
- •"Challenging" HIV-infected patients, defined as 1) diagnosed for > 6 months and having detectable viral load > 500 copies/mL at last assessment following 6 months of ART prescription, AND 2) not retained in care, i.e., 3 missed pharmacy pick-ups in the last 6 consecutive months, or not attending a physician visit in the last 12 months or more
排除标准
- •Participants with delirium and/or psychosis will be excluded.
- •There are no exclusions based on literacy as all materials will be administered using an audio computer assisted self-interview system (ACASI) supervised by assessors.
结局指标
主要结局
HIV viral Load (VL)
时间窗: Less than 6 months detectable VL
VL will be assessed by blood sampling. Viral suppression (HIV VL \<200 copies/mL) will be the primary dichotomous outcome; a secondary dichotomization will be made among detectable patients with VL \<1000 and those with VL \>1000.
Retention in care
时间窗: 2 years
Defined as the number of missed clinic appointments (i.e., "no shows" not cancelled in advance by patients or clinic staff) in the 6 months preceding assessment.
Medication persistence
时间窗: 2 years
Medication persistence is the time to treatment discontinuation, with a permissible gap of \< 30 days, participants will be considered to have discontinued the regimen if a therapy gap = \> 30 days occurs.
Medication adherence: Self-report
时间窗: 2 years
Proportion of self-reported adherent participants over time
Medication adherence: Hair sample
时间窗: 2 years
Adherence by hair sample to estimate an average concentration of ARV medication exposure
次要结局
未报告次要终点
研究者
DEBORAH JONES
Professor of Psychiatry & Behavioral Sciences
University of Miami