Improving Treatment and Retention Adherence in Nontraditional Settings

NCT04973254 | Completed Results

• 2 other identifiers: H-417244300844001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Infections

Keywords

HIV injectable medication; Cabotegravir-Rilpivirine Long Acting (CAB-RPV LA); Treatment adherence; Community-based delivery strategy; Patient-centeredness; Acceptability; Feasibility

Outcome Measures

Primary Outcomes (4)

• Adherence to Cabenuva Injections

  The number of participants who received CAB-RPV LA injections within the treatment window.

  3 months, 6 months

• Adherence to Primary Care Appointments

  The number participants who had a primary care appointment in the previous 3 months.

  3 months, 6 months

• Adherence to Mental Health/Behavioral Appointments

  The number participants who had a mental health/behavioral appointment in the previous 3 months.

  3 months, 6 months

• Adherence to Substance Abuse Appointments in Cohorts 1 and 2

  The number participants who had a substance abuse appointment in the previous 3 months.

  3 months, 6 months

Study Arms (3)

Cohort 1- HIV injection at a community-based site

EXPERIMENTAL

CAB-RPV LA administered to patients in an alternative community-based site

Other: CAB-RPV LA

Cohort 2- HIV injection at a HIV clinic

ACTIVE COMPARATOR

CAB-RPV LA administered to patients in the HIV clinic

Other: CAB-RPV LA

Cohort 3- Standard of care for HIV

ACTIVE COMPARATOR

Individuals who share characteristics of cohort 1 and are engaged in standard of care

Other: Standard treatment within an HIV clinic

Interventions

CAB-RPV LA OTHER

Monthly administration of injectable HIV medication

Also known as: Cabotegravir-Rilpivirine Long Acting

Cohort 1- HIV injection at a community-based site; Cohort 2- HIV injection at a HIV clinic

Standard treatment within an HIV clinic OTHER

Standard of care for HIV positive patients will be provided in the HIV clinic that may include HIV medication or may include oral medications.

Cohort 3- Standard of care for HIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead
• ViiV Healthcare: collaborator

Study Sites (2)

Boston Medical Center, Center for Infectious Disease

Boston, Massachusetts, 02118, United States

Location

Boston Medical Center, Project Trust

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

HIV Infections; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Health Behavior; Behavior

Limitations and Caveats

There were challenges enrolling participants resulting in only 25 actual participants from the anticipated enrollment of 100, with only 2 participants in Cohort 3. However, after the 2 participants in Cohort 3 were enrolled they did not participate in the study and no data were collected on them which is why there are no results for Cohort 3. Results for the outcome measures are provided for Cohort 1 (n=5) and Cohort 2 (n=18).

Results Point of Contact

• Title: Laura Fletcher, LCSW MSW MPH
• Organization: Boston Medical Center

laura.fletcher@bmc.org

857-225-5183

Study Officials

• Mari-Lynn Drainoni, PhD

  BU School of Medicine, Infectious Diseases and Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 22, 2021
• Study Start: February 23, 2022
• Primary Completion: March 17, 2023
• Study Completion: March 28, 2023
• Last Updated: January 15, 2025
• Results First Posted: January 15, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)