Clinical trial NCT05096949: Implementing Cabenuva in Arkansas HIV Programs
Official title: Implementing Long-Acting Cabotegravir + Rilpivirine in Arkansas Programs Utilizing Out-patient Clinics Versus In-home Visits
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: HIV-1-infection
Medication Adherence
Satisfaction, Patient
Keywords: Delivery
Implementation
Long acting medication
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: ViiV Healthcare
First posted: 2021-10-27
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized parallel design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Medication adherence
timeFrame: 10 months
Secondary outcomes:
measure: Patient treatment satisfaction
timeFrame: 5 months
Other outcomes:
measure: Clinician perceptions of acceptability
timeFrame: 3 months
measure: Clinician perceptions of appropriateness
timeFrame: 3 months
measure: Clinician perceptions of feasibility
timeFrame: 3 months
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Jure Baloh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tran BX, Nguyen NP. Patient satisfaction with HIV/AIDS care and treatment in the decentralization of services delivery in Vietnam. PLoS One. 2012;7(10):e46680. doi: 10.1371/journal.pone.0046680. Epub 2012 Oct 5.
citation: Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.