Improving Treatment and Retention Adherence in Nontraditional Settings

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

I-TRAINS aims to integrate an injectable treatment that is approved for HIV to individuals outside of the standard doctors office or clinic. The treatment, a once a month injection, 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 may 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Medical Center
• Collaborator: ViiV Healthcare
• Treatments: Cabotegravir

Criteria

Inclusion Criteria:

• HIV-positive

• A person who frequents Women Connecting Affecting Change (WCAC) or Project Trust (PT)

• English or Spanish speaking

• Lab values that indicate the patient is a candidate for the medication

• willingness to receive care in community settings

Exclusion Criteria:

• Currently fully adherent to ART

• A history of adhering fully to their ART

• Not willing to take CAB-RPV LA after detailed discussion of what the use of CAB-RPV LA will entail

• A history of integrase inhibitor mutations suggesting resistance to Cabotegravir or Cabenuva

• Currently pregnant or breastfeeding

• Currently have HIV 1 with an HIV 2 co-infection or an HIV 2 infection

• Unable to undergo clinical eligibility testing to confirm eligibility

• Clinically ineligible based on viral load and/or genotype

• 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

• Has chronic Hepatitis B infection