HIV Infections Clinical Trial
— I-TRAINSOfficial title:
Cabotegravir-Rilpivirine Long Acting (CAB-RPV LA) Implementation Strategies Among High-Risk Populations
Verified date | September 2023 |
Source | Boston Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | March 28, 2023 |
Est. primary completion date | March 17, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Boston Medical Center, Center for Infectious Disease | Boston | Massachusetts |
United States | Boston Medical Center, Project Trust | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Medical Center | ViiV Healthcare |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Engagement in care | The percent of CAB-RPV LA injections received within the treatment window | 6 months | |
Primary | Percent of scheduled appointments kept | The percent of scheduled appointments kept in the standard of care arm | 6 months | |
Primary | Percent of participants with adherence to HIV care | Defined as undetectable HIV viral load status | 6 months |
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