Pharmacist-led Intervention for Injectable HIV Treatment for Women With Health-related Social Needs
- Conditions
- Hiv
- Interventions
- Behavioral: Collaborative drug therapy management modelDrug: 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
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pharmacist lead CDTM+ Collaborative drug therapy management model 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. Pharmacist lead CDTM+ Cabotegravir/Rilpivirine 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Barriers and facilitators to CAB/RPV LA initiation Baseline, 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 adherence Month 12 Percent of on-time injections
Uptake/adoption of the CDTM+ intervention Baseline, Month 12 Interaction time\*frequency
Evaluate the effectiveness of the CDTM+ intervention on intention to switch to CAB/RPV LA Baseline, 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 suppression Month 12 Percent of participants with HIV VL \<50
Reach/penetration of the CDTM+ intervention Baseline, 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