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Improving Treatment and Retention Adherence in Nontraditional Settings

NCT04973254 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-01-15

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Mari-Lynn Drainoni, PhD · BU School of Medicine, Infectious Diseases and Boston Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-23
Primary Completion
2023-03-17
Completion
2023-03-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04973254 on ClinicalTrials.gov