Pharmacist-led Intervention for Injectable HIV Treatment for Women With Health-related Social Needs

Launched by YALE UNIVERSITY · May 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way for women living with HIV to receive treatment using long-acting injectable medications called cabotegravir and rilpivirine (CAB/RPV). The focus is on a pharmacist-led program that aims to help women who have specific social needs, such as housing instability or food insecurity, access these injections through telehealth services. The goal is to see how well this approach works in real-life situations and to improve the overall care for women with HIV.

To participate in the trial, you need to be diagnosed with HIV, receiving care from Yale New Haven Health, and currently on oral HIV medications while maintaining a low level of the virus for at least six months. You should also have faced at least one social challenge in the last six months, like homelessness or difficulties with food. If you join the study, you can expect to work closely with pharmacists who will help manage your treatment and provide support through virtual appointments. Please note that pregnant or breastfeeding women, and those who have specific health concerns related to the medications, are not eligible to participate.

Gender

ALL

Eligibility 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 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