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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
A structured behavioral group program consisting of five weekly sessions, each approximately 60-90 minutes in length. The intervention is designed for individuals living with HIV who use substances and focuses on: managing stress, addressing barriers to care, and enhancing engagement with HIV-related health services. Sessions are delivered in a small-group format and facilitated by trained staff using a manualized curriculum.
Weekly 90-minute group sessions over 5 weeks in which participants watch non-therapeutic, neutral-content movies in a group setting. Sessions are facilitated to control for social interaction and time spent in a structured group environment but do not include any therapeutic content.
Oakland MWCCS Site Office
Oakland, California, United States
RECRUITINGSF MWCCS Site Office
San Francisco, California, United States
RECRUITINGThe Client Satisfaction Questionnaire (CSQ-8)
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.
Time frame: 6 Months
Acceptability of Intervention Measure (AIM)
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.
Time frame: 5 Weeks
Participant Retention Rate
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.
Time frame: 5 Weeks
Participant Enrollment Rate
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.
Time frame: 6 Months
Number of Staff Members Required for Study Implementation
Total number of staff members involved in intervention delivery and data collection, documented throughout the pilot period.
Time frame: 6 Months
Feasibility of Intervention Measure (FIM)
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.
Time frame: 5 Weeks
Julian Paredes-Gotamco Clinical Research Coordinator
CONTACT
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Binary Measure of Optimal Adherence to ART (≥85%)
Adherence will be assessed using participant self-report over the prior three months. A binary outcome will be calculated: participants with an adherence rate of 85% or higher will be classified as "optimal adherence," and those below 85% as "non-optimal adherence." This measure reflects adherence to the assigned intervention.
Time frame: 6 Months
Binary Measure of HIV Viral Suppression (<200 copies/mL)
HIV viral load will be measured using plasma HIV RNA nucleic acid tests. Viral suppression is defined as \<200 copies/mL, and non-suppression as \>200 copies/mL, in accordance with Department of Health and Human Services and AIDS Clinical Trials Group guidelines.
Time frame: Baseline, 3 months, and 6 months
Cumulative Adherence to TDF/TAF as Measured by Drug Concentration in Hair Samples
Cumulative adherence will be assessed by quantifying levels of tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) in hair samples. Drug concentrations will be measured using validated LC-MS/MS assays. Higher drug levels indicate greater cumulative adherence.
Time frame: 6 Months