Wellness Program for HIV

(WISH Trial)

Recruiting at 1 trial location

Overseen By Julian Paredes-Gotamco Clinical Research Coordinator

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: Antiretrovirals

Disqualifiers: Severe cognitive impairment, active psychosis

Compensation: Varies

Number of Visits: 10

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new wellness program designed to help people with HIV adhere to their medication, manage stress, and stay engaged in their healthcare. The program, called Wellness, Intervention Strategies and HIV Care (WISH), includes group sessions that focus on coping strategies and reducing barriers to care. Participants who are HIV-positive and have used substances like cannabis, cocaine, or non-prescribed opioids in the last 90 days may be a good fit. The trial aims to determine if this program is practical and appealing for individuals managing both HIV and substance use. As an unphased trial, it offers participants the opportunity to contribute to innovative approaches in HIV care and substance use management.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on improving adherence to HIV treatment, so it's likely you can continue your current HIV medications.

What prior data suggests that this intervention is safe for individuals living with HIV?

Research has shown that the Wellness, Intervention Strategies and HIV Care (WISH) program aims to help people better adhere to their HIV treatment plans. The program uses group sessions to teach skills for managing stress and staying engaged in HIV care.

Regarding safety, detailed safety information is not yet available because this is an early study. However, programs like WISH are generally considered low-risk since they don't involve drugs or medical procedures. They are usually easy to manage, with few side effects. The main goal is to assess the program's ease of use and helpfulness for participants, rather than focusing on medical risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Wellness, Intervention Strategies and HIV Care (WISH) program because it takes a holistic approach to supporting people living with HIV who use substances. Unlike traditional treatments that often focus solely on medication adherence or medical management, WISH provides a structured, group-based behavioral support program. This program emphasizes stress management, reducing barriers to care, and enhancing engagement in HIV-related health services and overall wellness. This comprehensive strategy could lead to better health outcomes by addressing the broader lifestyle and psychological factors that impact individuals with HIV, offering a fresh perspective compared to standard medical treatments alone.

What evidence suggests that the WISH intervention is effective for improving HIV care engagement?

Research has shown that wellness programs like WISH, which participants in this trial may receive, can help people with HIV take their medication regularly and stay engaged in their healthcare. Studies have found that these programs improve how individuals reconnect with their healthcare, which is vital for managing HIV effectively. This program addresses stress and removes obstacles to care, common challenges for people living with HIV. By tackling these issues, WISH aims to help individuals achieve better health. Early findings suggest that such programs effectively improve treatment adherence and overall wellness. ^{6 7 8 9 10}

Who Is on the Research Team?

Jennifer P Jain, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for individuals with drug addiction or substance use disorder who are also living with HIV/AIDS. It aims to help them stick to their antiretroviral therapy, manage viral suppression, and stay engaged in HIV care. Participants should be interested in behavioral coping strategies and substance use management.

Inclusion Criteria

Participants must self-report biological characteristics consistent with the population under study

Participants must be HIV-positive

Participants must 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

Exclusion Criteria

I do not have severe cognitive issues or psychosis that would prevent me from understanding the consent form.

The research team is trained to recognize if I can't participate or consent due to mental health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants attend a structured, group-based behavioral support program consisting of five weekly sessions focusing on stress management, reducing barriers to care, and improving engagement in HIV-related health services.

5 weeks

5 visits (in-person)

Control

Participants attend five weekly group-based sessions where non-intervention-related movies are shown to control for time and group exposure.

5 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention, including assessments of ART adherence and viral suppression.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Wellness, Intervention Strategies and HIV Care (WISH)

Trial Overview The study is testing a program called WISH that includes activities like Movie Night Club as a control comparison. The goal of WISH is to see if it can improve how well patients follow their HIV treatment plans and handle their substance use.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

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.

Group II: Control Arm Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10167711/

Strategies to improve HIV care outcomes for people with ... Author manuscript; available in PMC: 2023 May 9. Published in final edited form as: AIDS. 2022 Jan 12;36(6):853–862. doi: 10.1097/QAD.0000000000003172.

2. trialx.com trialx.com/clinical-trials/listings/318744/wellness-intervention-strategies-and-hiv-care/

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 ...

3. stacks.cdc.gov stacks.cdc.gov/view/cdc/128318

Strategies to improve HIV care outcomes for people with ... Overall, intervention strategies are effective in improving re-engagement in care ... Acquired Immunodeficiency Syndrome Article Delivery Of Health Care HIV Care ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40668458/

Assessing the Effectiveness of Data-to-Care Strategies for ... AIDS Behav. 2025 Jul 16. doi: 10.1007/s10461-025-04768-x. Online ahead of print.

5. journals.plos.org journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003389

A cost-effectiveness analysis | PLOS Medicine The US National HIV/AIDS Strategy (NHAS) emphasizes the use of technology to facilitate coordination of comprehensive care for people with HIV.

6. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/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), ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8597894/

Design and Methods of a Randomized Trial Testing the ... [32] This trial will compare the effectiveness and reach of the Wellness Intervention for Smokers' living with HIV (WISH) against standard care services ...

8. htsyndication.com htsyndication.com/us-fed-news/article/clinical-trial%3A-wellness%2C-intervention-strategies-and-hiv-care/555742876

Clinical Trial: Wellness, Intervention Strategies and HIV Care Brief Summary: This is a pilot trial designed to assess the feasibility and acceptability of an intervention aimed at improving adherence to ...

9. californiaaidsresearch.org californiaaidsresearch.org/funded-research/implementation-science.html

Implementation Science - CHRP CHRP awarded approximately $2,000,000 to three investigators testing the impact of interventions that support economic security on HIV outcomes. The studies ...

10. sig.columbia.edu sig.columbia.edu/sites/sig.columbia.edu/files/content/PDFs/Leveraging%20Randomized%20Controlled%20Trial%20Design%20HIV%20and%20Wellness%20Interventions%20with%20Marginalized%20Populations.pdf

HIV and Wellness Interventions with Marginalized Populations We use the results from the CONNECT 2 RCT's wellness intervention control arm as a case example of active comparison conditions that can control for dosage or ...