Wellness, Intervention Strategies and HIV Care (NCT07069374) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Wellness, Intervention Strategies and HIV Care
United States50 participantsStarted 2025-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Client Satisfaction Questionnaire (CSQ-8)
Timeframe: 6 Months
2
Acceptability of Intervention Measure (AIM)
Timeframe: 5 Weeks
3
Participant Retention Rate
Timeframe: 5 Weeks
4
Participant Enrollment Rate
Timeframe: 6 Months
5
Number of Staff Members Required for Study Implementation