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Active, Not Recruiting

NCT Number: NCT07069374

Wellness, Intervention Strategies and HIV Care

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

HIV Behavior Chemically-Induced Disorders Mental Disorders Risk Reduction Behavior Substance Use Disorder (SUD) Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oakland MWCCS Site Office, Oakland, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. The Client Satisfaction Questionnaire (CSQ-8)

    Time frame: 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.

  2. Acceptability of Intervention Measure (AIM)

    Time frame: 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.

  3. Participant Retention Rate

    Time frame: 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.

  4. Participant Enrollment Rate

    Time frame: 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.

  5. Number of Staff Members Required for Study Implementation

    Time frame: 6 Months

    Total number of staff members involved in intervention delivery and data collection, documented throughout the pilot period.

  6. Feasibility of Intervention Measure (FIM)

    Time frame: 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

  1. Binary Measure of Optimal Adherence to ART (≥85%)

    Time frame: 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.

  2. Binary Measure of HIV Viral Suppression (<200 copies/mL)

    Time frame: 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.

  3. Cumulative Adherence to TDF/TAF as Measured by Drug Concentration in Hair Samples

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: WISH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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