Overview
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).
Description
The purpose of this study is to evaluate the implementation and delivery of CAB/RPV LA to women with HRSN by adopting a pharmacist-led CDTM. The project primarily addresses the real-world use of CAB + RPV LA among women who are under-represented in clinical trials and assesses the feasibility and acceptability of CDTM+, and adoption of CAB/RPV LA among participants receiving the CDTM+ model.
Investigators will enhance the existing CDTM to reduce important social and structural barriers to CAB/RPV LA for women with HRSN, by increasing accessibility- using telehealth to deliver CDTM outreach to clinical and community sites without a clinician referral (CDTM+), which is highly scalable. In addition to assessing engagement with the CDTM+ intervention and impact on key implementation (reach, feasibility, acceptability, uptake) and clinical outcomes (CAB/RPV LA initiation), investigators will also assess impact on patient engagement in non-HIV related care and psychological, sexual, and social well-being.
Eligibility
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