NCT04973254

Improving Treatment and Retention Adherence in Nontraditional Settings

Cabotegravir-Rilpivirine Long Acting (CAB-RPV LA) Implementation Strategies Among High-Risk Populations

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a hybrid implementation-effectiveness study using both qualitative and quantitative methods. The research aims to examine whether providing a new, but approved, HIV once a month injection treatment \[Cabotegravir-Rilpivirine Long Acting (CAB-RPV LA)\] to individuals who are living with HIV outside of the standard doctors office or clinic increases adherence to treatment. This HIV monthly injections treatment which is already being delivered within the clinic setting, will be administered to participants in community partner spaces, reducing the barriers that having to present to a traditional clinic for treatment creates. Individuals who will receive the injection need to have a history of being unable to take their HIV oral medication, as well as other barriers to care that make it difficult to engage in a traditional clinic setting. These barriers may include, but are not limited to, homelessness, substance use, mental illness, and stigma around their diagnosis. Data will be collected on whether it was easier for the participants to receive care in a non-traditional setting, as well as whether the injection made it easier for them to remain adherent to their HIV medication in comparison to standard oral HIV medication.

Detailed description

The proposed implementation research is designed to evaluate a novel approach to engage individuals with HIV who are at the highest risk for not accessing care or adhering to treatment. The investigators are not testing CAB-RPV LA; this is an approved drug. The investigators are also not studying the drug nor studying it for a new population, new dosage or new route of administration. Rather, the investigators are conducting an implementation three-arm cohort study that uses quantitative methods and propose to test implementation of CAB-RPV LA in community-based settings. The three cohorts/groups will be: * cohort 1- individuals who receive CAB-RPV LA at an alternative community-based site * cohort 2- individuals who receive CAB-RPV LA in the HIV clinic * cohort 3- individuals who share characteristics of cohort 1 and are engaged in standard of care The research is designed to answer the following implementation and clinical questions. A. Implementation Questions 1. Will community-based delivery of CAB-RPV LA be an acceptable and feasible delivery method to high-risk people living with HIV (PLWH) from the patient, provider and community organization perspectives? (acceptability/feasibility) 2. Can a community-based delivery strategy lead to initiation and completion of injections for six months for at least 80% of individuals who are enrolled into cohort 1 for an initial visit in an outreach setting? (reach) See Section 11 for information on the details of the sample size calculations and Section 7.2 for how study staff will stay in contact with participants to maximize potential for longer term engagement. 3. What are the characteristics of patients who are most likely to have an initial injection and do these characteristics differ for individuals who receive CAB-RPV LA in and outside of the HIV clinic? (equity) 4. Are patients who are seen for CAB-RPV LA in community-based settings satisfied with their HIV care? (patient-centeredness) 5. Will consistent delivery of CAB-RPV LA be possible in community-based (non-HIV clinic) settings? (feasibility) 6. Will the providers at a drop-in center or community-based organization be willing to implement CAB-RPV LA within their non-traditional setting? (adoption) B. Clinical Questions 1. Can individuals targeted for intervention at community-based delivery site achieve viral suppression and receive initial injection? 2. Can a community-based delivery strategy ensure engagement in services and receipt of CAB-RPV LA visits among high-risk populations? (effectiveness) 3. Is a community-based delivery strategy using CAB-RPV LA superior to the current standard of care in ensuring treatment adherence for individuals at highest risk? (effectiveness) Can high-risk individuals who receive community-based CAB-RPV LA be adherent to care, defined as undetectable viral load, for six months?

Conditions

• HIV Infections

Interventions

Type	Name	Description
OTHER	CAB-RPV LA	Monthly administration of injectable HIV medication
OTHER	Standard treatment within an HIV clinic	Standard of care for HIV positive patients will be provided in the HIV clinic that may include HIV medication or may include oral medications.

Timeline

• Start date: 2022-02-23
• Primary completion: 2023-03-17
• Completion: 2023-03-28
• First posted: 2021-07-22
• Last updated: 2025-01-15
• Results posted: 2025-01-15

Locations

2 sites across 1 country: United States