Wellness, Intervention Strategies and HIV Care (WISH)

January 23, 2026 updated by: University of California, San Francisco
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94612
        • Recruiting
        • Oakland MWCCS Site Office
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jennifer P Jain, PhD
      • San Francisco, California, United States, 94115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Arm
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)
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.
Placebo Comparator: Control Arm
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 Months
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.
5 Weeks
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.
5 Weeks
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.
6 Months
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 Months
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.
5 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
6 Months
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.
Baseline, 3 months, and 6 months
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.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer P Jain, PhD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K01DA056306 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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