An interventional study of Wellness, Intervention Strategies and HIV Care (WISH) and Movie Night Club - Attention and Time Matched Control in HIV and Substance Use Disorder (SUD), sponsored by University of California, San Francisco. Completed at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
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.
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's enrollment of 33 is below the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Report use of at least one of the following substances in the last 90 days:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Wellness, Intervention Strategies and HIV Care (WISH)
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.
Behavioral: Movie Night Club - Attention and Time Matched Control
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.
The 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
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
Plan to share: Yes — De-identified data will be made available beginning 12 months after the completion of data collection through a secure, NIH-approved data repository. Access will be granted to qualified researchers who provide a data use request and comply with data sharing agreements. Shared data will not include direct identifiers and will be limited to information consistent with participant consent.
Time frame: IPD will be available beginning 12 months after the primary completion date of the study. IPD will be available for up to 5 years after the initial release date, or longer if the repository's policies permit extended access.
Access criteria: De-identified individual participant data (IPD) and supporting documentation (such as the data dictionary) will be made available to qualified researchers whose proposed use of the data has been approved by the study PI. Approved users will be granted access through a secure NIH-designated repository, contingent upon completion of a data use agreement. Shared data will include baseline characteristics, outcome measures, and other variables as outlined in the data management and sharing plan, excluding any direct identifiers.
No publications or documents are linked to this record.
Ran from Sep 2025 to primary completion in Jul 2026, 10 months.
Of 814 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's 10 months is below that.
Counting every sponsor, half of 854 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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