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

Yale University

Status and phase: Active, not recruiting; Phase 2

Conditions: Hiv

Treatments: Drug: Cabotegravir/Rilpivirine; Behavioral: Collaborative drug therapy management model

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06411223

2000036673

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Pharmacist lead CDTM+

Other group

Description:

Participants will meet with a clinic-based pharmacist via telehealth for an introductory visit to discuss CAB/RPV LA and possible switch from oral to injectable therapy. The tele-visit can occur by phone or video visit.

Treatment:

Behavioral: Collaborative drug therapy management model

Drug: Cabotegravir/Rilpivirine