Wellness, Intervention Strategies and HIV Care

• Wellness, Intervention Strategies and HIV Care (WISH) (Behavioral): 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.
• Movie Night Club - Attention and Time Matched Control (Behavioral): 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.

Primary outcomes

• 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 outcomes

• 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.

Sex: Female, ages: 18 Years to any

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

• Jennifer P Jain, PhD, Principal investigator, University of California, San Francisco

NIH grants: K01DA056306