Improving Treatment and Retention Adherence in Nontraditional Settings (I-TRAINS)
HIV Infections
About this trial
This is an interventional health services research trial for HIV Infections focused on measuring HIV injectable medication, Cabotegravir-Rilpivirine Long Acting (CAB-RPV LA), Treatment adherence, Community-based delivery strategy, Patient-centeredness, Acceptability, Feasibility
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
Sites / Locations
- Boston Medical Center, Center for Infectious Disease
- Boston Medical Center, Project Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
Cohort 1- HIV injection at a community-based site
Cohort 2- HIV injection at a HIV clinic
Cohort 3- Standard of care for HIV
CAB-RPV LA administered to patients in an alternative community-based site
CAB-RPV LA administered to patients in the HIV clinic
Individuals who share characteristics of cohort 1 and are engaged in standard of care