Wellness, Intervention Strategies and HIV Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- The Client Satisfaction Questionnaire (CSQ-8)
研究概览
简要总结
This is a pilot trial designed to assess the feasibility and acceptability of an intervention aimed at improving adherence to antiretroviral therapy (ART), viral suppression, and engagement in HIV care. The intervention will address behavioral coping strategies, HIV care engagement behaviors, and substance use management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants must:
- •Be at least 18 years of age
- •Self-report biological characteristics consistent with the population under study
- •Be HIV-positive
- •Report use of at least one of the following substances in the last 90 days:
- •Methamphetamine
- •Cocaine/crack
- •Non-prescribed opioids (e.g., fentanyl, morphine)
- •Phencyclidine (PCP)
- •Psychedelics (e.g., Lysergic acid diethylamide, mescaline, ketamine)
- •Poppers (alkyl nitrites)
- •Non-prescribed benzodiazepines (e.g., Valium, Xanax, Klonopin, Librium)
- •Barbiturates
- •Be English-speaking
- •Be able and willing to provide informed consent
排除标准
- •Evidence of severe cognitive impairment or active psychosis that may impede ability to provide fully informed consent, determined by the research assistants and clinical supervisor(s)
- •The research staff are trained on guidelines for identifying participants who exhibit signs of inability to meaningfully participate or provide consent due to mental illness or impairment
研究组 & 干预措施
Control Arm
Participants in this arm will attend five weekly group-based sessions where non-intervention-related movies are shown. This condition is intended to control for time and group exposure without delivering active behavioral content related to the study outcomes.
干预措施: Movie Night Club - Attention and Time Matched Control (Behavioral)
Intervention Arm
Participants in this arm will attend a structured, group-based behavioral support program consisting of five weekly sessions. The intervention is designed for individuals living with HIV who use substances. It focuses on strategies for managing stress, reducing barriers to care, and improving engagement in HIV-related health services and overall wellness.
干预措施: Wellness, Intervention Strategies and HIV Care (WISH) (Behavioral)
结局指标
主要结局
The Client Satisfaction Questionnaire (CSQ-8)
时间窗: 6 Months
The Client Satisfaction Questionnaire-8 (CSQ-8) consists of eight items, each rated on a 4-point Likert scale. Total scores range from 8 to 32, with higher scores indicating greater satisfaction with the services received.
Acceptability of Intervention Measure (AIM)
时间窗: 5 Weeks
The AIM consists of 4 items rated on a 5-point Likert scale, ranging from 1 (completely disagree) to 5 (completely agree). Total scores range from 4 to 20, with higher scores indicating greater acceptability of the intervention.
Participant Retention Rate
时间窗: 5 Weeks
The percentage of participants who complete the intervention protocol. Calculated as (number of participants completing the study ÷ number enrolled) × 100%. A retention rate of ≥70% will indicate protocol adherence feasibility.
Participant Enrollment Rate
时间窗: 6 Months
The proportion of participants enrolled out of those screened for eligibility. This will be calculated as (number enrolled ÷ number screened) × 100%. An enrollment rate of ≥70% will be considered feasible, based on clinical standards in the literature.
Number of Staff Members Required for Study Implementation
时间窗: 6 Months
Total number of staff members involved in intervention delivery and data collection, documented throughout the pilot period.
Feasibility of Intervention Measure (FIM)
时间窗: 5 Weeks
The FIM includes 4 items rated on a 5-point Likert scale, from 1 (completely disagree) to 5 (completely agree). Total scores range from 4 to 20, with higher scores indicating greater perceived feasibility of the intervention.
次要结局
- Binary Measure of Optimal Adherence to ART (≥85%)(6 Months)
- Cumulative Adherence to TDF/TAF as Measured by Drug Concentration in Hair Samples(6 Months)
- Binary Measure of HIV Viral Suppression (<200 copies/mL)(Baseline, 3 months, and 6 months)