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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
50
CDTM+ is an interdisciplinary approach to patient care in which clinicians collaborate with pharmacists to provide and manage patient drug therapy.
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.
Yale Clinical and Community Research
New Haven, Connecticut, United States
Feasibility of CDTM+
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.
Time frame: Baseline, Month 12
Acceptability of CDTM+
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.
Time frame: Baseline, Month 12
Evaluate the adoption of CAB/RPV LA in the population receiving CDTM+
Assessed by the percentage of patients who have a documented 1st injection visit
Time frame: Month 12
Evaluate the effectiveness of the CDTM+ intervention on intention to switch to CAB/RPV LA
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)
Time frame: Baseline, immediately following CDTM+
Among those who initiate CAB/RPV LA, evaluate the effectiveness of CDTM+ on CAB/RPV LA adherence
Percent of on-time injections
Time frame: Month 12
Among those who initiate CAB/RPV LA, evaluate the effectiveness of CDTM+ on CAB/RPV LA maintenance of virologic suppression
Percent of participants with HIV VL \<50
Time frame: Month 12
Reach/penetration of the CDTM+ intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Enrollment rate (# of people enrolled/# of people screened for eligibility)
Time frame: Baseline, Month 12
Uptake/adoption of the CDTM+ intervention
Interaction time\*frequency
Time frame: Baseline, Month 12
Barriers and facilitators to CAB/RPV LA initiation
Qualitative patient interview will be conducted to assess Barriers and facilitators to CAB/RPV LA initiation
Time frame: Baseline, Month 6, Month 12