Pharmacist-led program for injectable HIV treatment in women with social needs
Project Tara: Pharmacist-led Intervention for Injectable HIV Treatment for Women With Health-related Social Needs
This study is testing a new program where pharmacists help women with HIV, especially those facing social challenges, to access a long-acting injectable treatment through telehealth to see if it improves their health and well-being.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT06411223 on ClinicalTrials.gov |
What this trial studies
This study evaluates a pharmacist-led collaborative drug therapy management model (CDTM+) for delivering long-acting injectable cabotegravir/rilpivirine (CAB/RPV LA) to women living with HIV who face health-related social needs. The approach aims to enhance accessibility through telehealth outreach, targeting women who are often under-represented in clinical trials. The study will assess the feasibility and acceptability of this model, as well as its impact on clinical outcomes and patient engagement in broader health care. Key metrics include the initiation of CAB/RPV LA and improvements in psychological, sexual, and social well-being.
Who should consider this trial
Good fit: Ideal candidates are women living with HIV who are receiving care from Yale New Haven Health and have experienced health-related social needs.
Not a fit: Patients who are not living with HIV or those who have contraindications to CAB/RPV LA will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve access to effective HIV treatment for women facing social challenges.
How similar studies have performed: Other studies have shown promise in using pharmacist-led interventions for medication management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 6 months (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
Where this trial is running
New Haven, Connecticut
- Yale Clinical and Community Research — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Jaimie Meyer, MD, MS, FACP — Yale University
- Study coordinator: Carolina Price, MPA
- Email: carolina.price@yale.edu
- Phone: 2034998075
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.