Improving Treatment and Retention Adherence in Nontraditional Settings (I-TRAINS)

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Other: CAB-RPV LA; Other: Standard treatment within an HIV clinic

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?

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center, Center for Infectious Disease
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center, Project Trust

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1- HIV injection at a community-based site; CAB-RPV LA administered to patients in an alternative community-based site	Other: CAB-RPV LA; Monthly administration of injectable HIV medication; Other Names: Cabotegravir-Rilpivirine Long Acting
Active Comparator: Cohort 2- HIV injection at a HIV clinic; CAB-RPV LA administered to patients in the HIV clinic	Other: CAB-RPV LA; Monthly administration of injectable HIV medication; Other Names: Cabotegravir-Rilpivirine Long Acting
Active Comparator: Cohort 3- Standard of care for HIV; Individuals who share characteristics of cohort 1 and are engaged in standard of care	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement in care	The percent of CAB-RPV LA injections received within the treatment window	6 months
Percent of scheduled appointments kept	The percent of scheduled appointments kept in the standard of care arm	6 months
Percent of participants with adherence to HIV care	Defined as undetectable HIV viral load status	6 months

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: ViiV Healthcare
• Investigators: Principal Investigator: Mari-Lynn Drainoni, PhD, BU School of Medicine, Infectious Diseases and Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Actual): March 17, 2023
• Study Completion (Actual): March 28, 2023

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Feasibility; Acceptability; Treatment adherence; HIV injectable medication; Cabotegravir-Rilpivirine Long Acting (CAB-RPV LA); Community-based delivery strategy; Patient-centeredness
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; HIV Integrase Inhibitors; Integrase Inhibitors; Rilpivirine; Cabotegravir
• Other Study ID Numbers: H-41724; 4300844001 (Other Grant/Funding Number: ViiV Healthcare)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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