Pharmacist-led Intervention for Injectable HIV Treatment for Women With Health-related Social Needs (NCT06411223) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Pharmacist-led Intervention for Injectable HIV Treatment for Women With Health-related Social Needs
United States50 participantsStarted 2024-08-01
Plain-language summary
This study addresses real-world use of long-acting injectable cabotegravir/rilpivirine (CAB/RPV LA) by evaluating implementation and clinical outcomes of a pharmacist-led collaborative drug therapy management model (CDTM+) that will be expanded for telehealth outreach to women with health-related social needs (HRSN).
Who can participate
Age range
18 Years
Sex
ALL
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:
* Living with diagnosed HIV
* Receiving HIV care-related services from Yale New Haven Health (YNHH)
* Currently on oral ART and virally suppressed for at least 6 months (from electronic health review).
* Have experienced at least one HRSN: a) homelessness or housing insecurity; b) food insecurity; c) criminal legal system involvement; OR d) substance use in the past 3 years (from self-report at screening).
* Able to converse comfortably in English or Spanish
Exclusion Criteria:
* Unable or unwilling to complete informed consent (e.g., have a conservator of person)
* Have initiated CAB/RPV oral lead-in prior to enrollment.
* Have a contraindication to CAB/RPV LA per label.
* Have known or suspected resistance to CAB/RPV
* Pregnant or breast-feeding
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
Feasibility of CDTM+
Timeframe: Baseline, Month 12
2
Acceptability of CDTM+
Timeframe: Baseline, Month 12
3
Evaluate the adoption of CAB/RPV LA in the population receiving CDTM+