NCT06411223

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Hiv

Interventions

Type	Name	Description
BEHAVIORAL	Collaborative drug therapy management model	CDTM+ is an interdisciplinary approach to patient care in which clinicians collaborate with pharmacists to provide and manage patient drug therapy.
DRUG	Cabotegravir/Rilpivirine	Long-acting injectable treatment prescribed to treat HIV-1 infection in people 12 years and older and who weigh at least 77 lbs (35kg), to replace their current HIV-1 medicines when their healthcare provider determines they meet certain requirements.

Timeline

• Start date: 2024-08-01
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2024-05-13
• Last updated: 2026-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study