HIVWISHNCT07069374
Wellness, Intervention Strategies and HIV Care
A study testing Wellness, Intervention Strategies and HIV Care (WISH) in people with HIV and Substance Use Disorder (SUD), run by University of California, San Francisco at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV, Substance Use Disorder (SUD)
- What is being tested?
- Wellness, Intervention Strategies and HIV Care (WISH)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2025to 21 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Oakland MWCCS Site Office
Oakland, California, 94612
SF MWCCS Site Office
San Francisco, California, 94115
About this study
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.
- Conditions
- HIV, Substance Use Disorder (SUD)
- Being tested
- Wellness, Intervention Strategies and HIV Care (WISH), Movie Night Club - Attention and Time Matched Control
- Keywords
- HIV, Substance Use, Risk Reduction, Behavioral Intervention, Public Health, Intervention Program
- Medical subject headings
- Substance-Related Disorders, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness, Intervention Strategies and HIV Care (WISH)Behavioural
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 ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | 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. Receives: Behavioral: Wellness, Intervention Strategies and HIV Care (WISH) |
| Control Arm | Placebo comparator | 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. Receives: Behavioral: Movie Night Club - Attention and Time Matched Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 Weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Sep 2025
- Primary completion21 Jul 2026
- Study completion21 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Jennifer P Jain, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069374
- Sponsor's protocol ID
- K01DA056306
- Other IDs
- K01DA056306
- Acronym
- WISH
- Status last verified
- Sep 2026
- First submitted
- 7 Jul 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wellness, Intervention Strategies and HIV Care
- ClinicalTrials.gov ID
- NCT07069374
- Acronym / sponsor ID
- WISH / K01DA056306
- Conditions
- HIV, Substance Use Disorder (SUD)
- Keywords
- HIV, Substance Use, Risk Reduction, Behavioral Intervention, Public Health, Intervention Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 21 Jul 2026 (actual)
- Study completion
- 21 Jul 2026 (actual)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Wellness, Intervention Strategies and HIV Care (WISH)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. |
| Control Arm | Placebo comparator | Behavioral: Movie Night Club - Attention and Time Matched ControlParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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:
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention Arm |
| Movie Night Club - Attention and Time Matched ControlWeekly 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. | Behavioural | Control Arm |
Primary outcome
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.
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.
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.
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.
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.
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.
3 secondary outcomes
Binary Measure of Optimal Adherence to ART (≥85%)
Time frame: 6 Months
Binary Measure of HIV Viral Suppression (<200 copies/mL)
Time frame: Baseline, 3 months, and 6 months
Cumulative Adherence to TDF/TAF as Measured by Drug Concentration in Hair Samples
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer P Jain, PhD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellness, Intervention Strategies and HIV Care (WISH) in people with HIV and Substance Use Disorder (SUD), run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Client Satisfaction Questionnaire (CSQ-8) (time frame: 6 Months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.