HIV, Substance Use Disorder (SUD)
Conditions
Keywords
HIV, Substance Use, Risk Reduction, Behavioral Intervention, Public Health, Intervention Program
Brief summary
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.
Interventions
BEHAVIORALWellness, Intervention Strategies and HIV Care (WISH)
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.
BEHAVIORALMovie Night Club - Attention and Time Matched Control
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.
Sponsors
University of California, San Francisco
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• 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: * Cannabis * Methamphetamine * Cocaine/crack * Cocaine * Heroin * Non-prescribed opioids (e.g., fentanyl, morphine) * Ecstasy * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Client Satisfaction Questionnaire (CSQ-8) | 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) | 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 | 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 | 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 | 6 Months | Total number of staff members involved in intervention delivery and data collection, documented throughout the pilot period. |
| Feasibility of Intervention Measure (FIM) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binary Measure of Optimal Adherence to ART (≥85%) | 6 Months | 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. |
| Binary Measure of HIV Viral Suppression (<200 copies/mL) | Baseline, 3 months, and 6 months | 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. |
| Cumulative Adherence to TDF/TAF as Measured by Drug Concentration in Hair Samples | 6 Months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJennifer P Jain, PhD
University of California, San Francisco
Outcome results
None listed