Wellness, Intervention Strategies and HIV Care

NCT07069374 | Recruiting

• 1 other identifier: K01DA056306
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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. The intervention will address behavioral coping strategies, HIV care engagement behaviors, and substance use management.

Conditions

HIV; Substance Use Disorder (SUD)

Keywords

HIV; Substance Use; Risk Reduction; Behavioral Intervention; Public Health; Intervention Program

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  5 Weeks

Secondary Outcomes (3)

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

  6 Months

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

  Baseline, 3 months, and 6 months

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

  6 Months

Study Arms (2)

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.

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.

Behavioral: Movie Night Club - Attention and Time Matched Control

Interventions

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.

Intervention Arm

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.

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Oakland MWCCS Site Office

Oakland, California, 94612, United States

RECRUITING

SF MWCCS Site Office

San Francisco, California, 94115, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders; Risk Reduction Behavior

Interventions

Health; Methods

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Population Characteristics; Investigative Techniques

Study Officials

• Jennifer P Jain, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Freasier Project Director, MS

CONTACT

415-502-8800; heather.freasier@ucsf.edu

Julian Paredes-Gotamco Clinical Research Coordinator

CONTACT

415-502-3507; Julian.Paredes-Gotamco@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: September 1, 2025
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (2)