Implementing Cabenuva in Arkansas HIV Programs

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

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.

Study Overview

• Status: Terminated
• Conditions: Satisfaction, Patient; Medication Adherence; HIV-1-infection
• Intervention / Treatment: Other: Home visit delivery strategy

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician perceptions of acceptability	Modified version of Acceptability of Intervention Measure (AIM; Weiner et al., 2017), with values ranging from 1 to 5 (higher scores are better).	3 months
Clinician perceptions of appropriateness	Modified version of Intervention Appropriateness Measure (IAM; Weiner et al., 2017), with values ranging from 1 to 5 (higher scores are better).	3 months
Clinician perceptions of feasibility	Modified version of Feasibility of Intervention Measure (FIM; Weiner et al., 2017), with values ranging from 1 to 5 (higher scores are better).	3 months

Collaborators and Investigators

• Sponsor: University of Arkansas
• Collaborators: ViiV Healthcare
• Investigators: Principal Investigator: Jure Baloh, PhD, University of Arkansas

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: October 18, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Implementation; Delivery; Long acting medication
• Other Study ID Numbers: 261250

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After publication, anonymized patient level data from the study may be shared with other researchers on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes