Implementing Cabenuva in Arkansas HIV Programs

Study Overview
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Brief Summary
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This study seeks to address this gap by studying two Cabenuva delivery strategies conducted at six outpatient HIV clinics in Arkansas, a Southern state with a large population of rural, poor, and African-American residents. The two delivery strategies are clinic delivery and home delivery. In the clinic delivery study arm patients will receive Cabenuva injections at the clinic (50 patients), and in the home delivery study arm patients will receive the injections at home (50 patients). The study team will follow the patients in both study arms for 10 months. After 5 months, the patients will complete a treatment satisfaction survey, and after 10 months the study team will examine clinic records to assess their medication adherence. Secondary outcomes will include clinician perceptions of acceptability, feasibility, and appropriateness of Cabenuva delivery strategies. The study team will also collect qualitative data from patients and clinic employees to learn more in depth about their perceptions of Cabenuva, the delivery strategies, their implementation, and barriers and facilitators. Finally, the study team will estimate the costs associated with the two delivery strategies from the clinic and patient perspectives. The data from this study provide information on what delivery strategies for long acting HIV medications offer best results, how these strategies are perceived by patients and clinicians, and how costly and feasible the strategies are to implement in practice.

Detailed Description
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Good medication adherence in patients living with HIV (PLHIV) is one of the key determinants of their treatment success. Most current HIV medications are taken daily, which represents a big burden and leads to many challenges for maintaining medication adherence. These challenges are exacerbated by socio-economic factors, such as poverty, rurality, race/ethnicity, and stigma, leading to disparities in treatment and outcomes. Long acting injectable medications offer promise of reducing medication adherence burden and barriers, potentially improving the health and well-being of PLHIV, and helping limit the spread of HIV. In January 2021, FDA approved Cabenuva, the first long acting HIV medication, administered as monthly or every-2-month injections. Injectable treatment holds promise to improve treatment adherence and facilitate access to treatment for rural residents. However, it is currently not known what delivery strategies would optimize delivery of long acting HIV medications for best patient adherence and satisfaction. This study seeks to address this gap by studying two Cabenuva delivery strategies conducted at six outpatient HIV clinics in Arkansas, a Southern state with a large population of rural, poor, and African-American residents. The two delivery strategies are clinic delivery and home delivery. In the clinic delivery study arm patients will receive Cabenuva injections at the clinic (50 patients), and in the home delivery study arm patients will receive the injection at home (50 patients). The study team will follow the patients in both study arms for 10 months. After 5 months, the patients will complete a treatment satisfaction survey, and after 10 months the study team will examine clinic records to assess their medication adherence. Secondary outcomes will include clinician perceptions of acceptability, feasibility, and appropriateness of Cabenuva delivery strategies. The study team will also collect qualitative data from patients and clinic employees to learn more in depth about their perceptions of Cabenuva, the delivery strategies, their implementation, and barriers and facilitators. Finally, the study team will estimate the costs associated with the two delivery strategies from the clinic and patient perspectives. The data from this study provide information on what delivery strategies for long acting HIV medications offer best results, how these strategies are perceived by patients and clinicians, and how costly and feasible the strategies are to implement in practice.

Official Title
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Implementing Long-Acting Cabotegravir + Rilpivirine in Arkansas Programs Utilizing Out-patient Clinics Versus In-home Visits

Conditions
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HIV-1-infection, Medication Adherence, Satisfaction, Patient

Intervention / Treatment
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* Other: Home visit delivery strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persons, 18-years old and older Receiving Cabenuva injections (following registered USPI) at one of the six clinics in this study Ability to provide informed consent Patients who would receive Cabenuva at home: Living within 40-miles from the three clinics randomized to the at-home arm of the study Exclusion Criteria: Pregnant or breastfeeding women, or women who plan to become pregnant during the study period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster-randomized parallel design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Clinic visit arm<br>Patient will receive Cabenuva injection at the clinic | |
| Experimental: Home visit arm<br>Patient will receive Cabenuva injection at home | Other: Home visit delivery strategy<br>* A nurse will deliver and administer Cabenuva injection at patient's home<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence | Medication adherence will be quantified as a binary variable, based on whether the patient received all scheduled injections as planned or not. (As of January 2022, Cabenuva is approved for monthly and every-2-month injection schedule, and the study does not dictate which schedule the participants follow.) | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient treatment satisfaction | Modified version of the Satisfaction with HIV/AIDS Treatment Interview Scale (SATIS) instrument (Tran & Nguyen, 2012), with values ranging from 0 to 10 (higher scores are better). | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delivery, Implementation, Long acting medication