Clinical trial NCT04973254: Improving Treatment and Retention Adherence in Nontraditional Settings
Official title: Cabotegravir-Rilpivirine Long Acting (CAB-RPV LA) Implementation Strategies Among High-Risk Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV injectable medication
Cabotegravir-Rilpivirine Long Acting (CAB-RPV LA)
Treatment adherence
Community-based delivery strategy
Patient-centeredness
Acceptability
Feasibility
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: ViiV Healthcare
First posted: 2021-07-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three-arm cohort study comparing adherence to HIV treatment of monthly injections delivered outside of standard clinical settings to treatment adherence in the HIV clinic setting and to HIV standard care delivered in the HIV clinic
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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?

Eligibility criteria: Inclusion Criteria for Cohort 1:

* HIV-positive
* English or Spanish speaking
* Lab values that indicate the patient is a candidate for the medication and virally suppressed
* Willing to complete the locator form to receive appointment reminders prior to follow-up data collection

Inclusion Criteria for Cohort 2:

* HIV-positive
* English or Spanish speaking
* Enrolled in care and receiving CAB-RPV LA injection at Boston Medical Center Infectious Disease Clinic (HIV clinic)
* Willing to complete the locator form to receive appointment reminders prior to follow-up data collection

Inclusion Criteria for Cohort 3:

* HIV-positive
* English or Spanish speaking
* Enrolled in care but NOT receiving CAB-RPV LA injection at Boston Medical Center Infectious Disease Clinic (HIV clinic)
* Willing to complete the locator form to receive appointment reminders prior to follow-up data collection
* Matched to participants demographically and in terms of other characteristics in Cohort 1 at a 2:1 ratio

Exclusion Criteria (for all 3 cohorts unless stated):

* Not virally suppressed prior to beginning CAB-RPV LA (does not apply to cohort 3)
* A history of adhering fully to their antiretroviral therapy (ART)
* Not willing to take CAB-RPV LA after detailed discussion of what the use of CAB-RPV LA will entail (does not apply to cohort 3)
* Unable to undergo clinical eligibility testing to confirm eligibility (does not apply to cohort 3)
* A history of integrase inhibitor mutations suggesting resistance to Cabotegravir or Cabenuva
* A history or evidence of resistance to either integrase strand transfer inhibitor (INSTI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) HIV drugs
* Currently pregnant or breastfeeding
* Currently has HIV 1 with an HIV 2 co-infection or an HIV 2 infection
* Taking any drugs that have known interactions with Cabenuva, including but not limited to carbamazepine, oxcarbazepine, phenobarbital, phenytoin, St Johns Wort, systemic Dexamethasone, rifabutin, rifampin and rifapentine
* Chronic Hepatitis B infection

Primary outcomes:
measure: Adherence to Cabenuva Injections
timeFrame: 3 months, 6 months
measure: Adherence to Primary Care Appointments
timeFrame: 3 months, 6 months
measure: Adherence to Mental Health/Behavioral Appointments
timeFrame: 3 months, 6 months
measure: Adherence to Substance Abuse Appointments in Cohorts 1 and 2
timeFrame: 3 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center, Center for Infectious Disease
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center, Project Trust
state: Massachusetts
Study officials:
affiliation: BU School of Medicine, Infectious Diseases and Boston Medical Center
name: Mari-Lynn Drainoni, PhD
role: PRINCIPAL_INVESTIGATOR
References: