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

Phase 2
Recruiting
Conditions
Hiv
Interventions
Behavioral: Collaborative drug therapy management model
Drug: Cabotegravir/Rilpivirine
Registration Number
NCT06411223
Lead Sponsor
Yale University
Brief 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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
50
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
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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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Pharmacist lead CDTM+Collaborative drug therapy management modelParticipants 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.
Pharmacist lead CDTM+Cabotegravir/RilpivirineParticipants 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.
Primary Outcome Measures
NameTimeMethod
Feasibility of CDTM+Baseline, Month 12

Feasibility of CDTM+ assessed using the Intervention Measure: 4-item Likert scale, each item scored 1 (completely disagree) to 5 (completely agree) and averaged. Score range 4-20, higher scores reflect higher feasibility.

Evaluate the adoption of CAB/RPV LA in the population receiving CDTM+Month 12

Assessed by the percentage of patients who have a documented 1st injection visit

Acceptability of CDTM+Baseline, Month 12

Assessed using the Theoretical Framework of Acceptability Questionnaire: 7-items, each scored on Likert scale 1 to 5 and averaged. Score range 7-35, higher scores reflect higher acceptability.

Secondary Outcome Measures
NameTimeMethod
Barriers and facilitators to CAB/RPV LA initiationBaseline, Month 6, Month 12

Qualitative patient interview will be conducted to assess Barriers and facilitators to CAB/RPV LA initiation

Among those who initiate CAB/RPV LA, evaluate the effectiveness of CDTM+ on CAB/RPV LA adherenceMonth 12

Percent of on-time injections

Uptake/adoption of the CDTM+ interventionBaseline, Month 12

Interaction time\*frequency

Evaluate the effectiveness of the CDTM+ intervention on intention to switch to CAB/RPV LABaseline, immediately following CDTM+

How likely are you to switch from your current medication to CAB/RPV LA? 5-item Likert scale (1=not at all likely to 5=very likely; score range 1-5)

Among those who initiate CAB/RPV LA, evaluate the effectiveness of CDTM+ on CAB/RPV LA maintenance of virologic suppressionMonth 12

Percent of participants with HIV VL \<50

Reach/penetration of the CDTM+ interventionBaseline, Month 12

Enrollment rate (# of people enrolled/# of people screened for eligibility)

Trial Locations

Locations (1)

Yale Clinical and Community Research

🇺🇸

New Haven, Connecticut, United States

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