Wellness, Intervention Strategies and HIV Care

Not Applicable

Recruiting

• Conditions: HIV; Substance Use Disorder (SUD)

• Registration Number: NCT07069374
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-07
• Study First Submitted QC: 2025-07-07
• Last Update Submitted: 2025-07-07
• Study Start: 2025-07-14
• Study First Posted: 2025-07-16
• Last Update Posted: 2025-07-16
• Primary Completion: 2026-03-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Client Satisfaction Questionnaire (CSQ-8)	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)	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	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	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	6 Months	Total number of staff members involved in intervention delivery and data collection, documented throughout the pilot period.
Feasibility of Intervention Measure (FIM)	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.

Secondary Outcome Measures

Name	Time	Method
Binary Measure of Optimal Adherence to ART (≥85%)	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.
Cumulative Adherence to TDF/TAF as Measured by Drug Concentration in Hair Samples	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.
Binary Measure of HIV Viral Suppression (<200 copies/mL)	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.

Trial Locations

Locations (2)

Oakland MWCCS Site Office; 🇺🇸 Oakland, California, United States

SF MWCCS Site Office; 🇺🇸 San Francisco, California, United States