An interventional study of Patient-centered injection site and Patient-centered adherence support in HIV Infections, sponsored by Public Health Foundation Enterprises, Inc.. Active, not recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-05.
Sponsored by Public Health Foundation Enterprises, Inc. · Not applicable, Interventional, and Health services research
This is a single-arm implementation study of a novel integrated delivery model of CAB-RPV LA for transwomen living with HIV.
CAB-RPV LA as a monthly injectable could address disparities in viral suppression among trans women living with HIV. This study is designed to enroll a diverse population of trans women living with HIV who receive HIV care within collaborating primary care clinics. This study proposes using mixed methods to tailor and evaluate implementation and client outcomes when CAB-RPV LA is delivered through this integrated delivery model.
This will be a 9-month pilot study among 40 participants who will be provided CAB-RPV LA through an integrated trans-friendly delivery model using 4 implementation strategies to improve the adoption and integration of CAB-RPV LA delivery to trans women. These strategies are aimed at all levels of implementation - system, clinic, provider, and patient to maximize impact. The 4 strategies are a patient-centered injection site (Bridge HIV, SFDPH), patient-centered adherence support (peer health navigation and SMS platform with reminders and communication with staff), provider education, and improved clinic communication strategies.. CAB-RPV LA is being provided as standard of care and is not paid for by the study.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's planned enrollment of 50 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Public Health Foundation Enterprises, Inc. is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
History of known or suspected drug resistance that would compromise the CAB-RPV regimen
Current or expected use of any of the following medications:
This study represents a hybrid design type 3 focusing primarily on implementation outcomes and secondarily on clinical effectiveness among trans women living with HIV receiving care within primary care clinics in San Francisco. A type 3 design was chosen, as the clinical efficacy of CAB- RPV LA has been established in clinical trials, and the focus of this study is on initial implementation of CAB-RPV LA within these clinics.
Other: Patient-centered injection site · Behavioral: Patient-centered adherence support · Other: Provider education · Behavioral: Improved clinic communication strategies
CAB-RPV LA will be delivered in a trans-friendly injection clinic at Bridge HIV, which is centrally located in SF. The clinic is staffed by physicians, nurses, and peer navigators who are experienced working with the trans community and are experts in delivery of injectable formulations. For patients unable to attend follow-up clinic visits, arrangements will be made for a clinical provider and peer navigator to conduct a home visit for injection delivery. This implementation strategy will overcome structural barriers where it is difficult to get a visit appointment, and when appointments are missed, even harder to re-schedule. The central location in a quiet, safe and trans-affirming clinical site will make injections easy-to-access. Because the Bridge HIV clinic is not a primary care site, injections can be delivered with minimal wait times due to low patient load relative to clinical capacity.
A Trans peer navigator will support trans women living with HIV receiving long-acting injectable treatment through our delivery model. Peer navigators will reach out to trans women using our highly effective mobile SMS platform to provide additional support before and between visits. This platform provides automated weekly check-ins for streamlined support and bi-directional asynchronous texting with a peer navigator. Peer navigators will use this SMS platform to send appointment reminders, assess needs for re-scheduling, answer questions and triage concerns regarding CAB-RPV LA, and offer support for transportation or scheduling a home visit. This approach has demonstrated efficacy in improving ART adherence and viral suppression in people living with HIV as well as retention in care and adherence to PrEP.
To support effective outreach to and education of providers on novel evidence-based practices, SFDPH has utilized public health detailing (brief educational visits via a nurse practitioner) to ensure providers are prepared to implement new interventions. This strategy has been effective in expanding the implementation of PrEP, RAPID ART initiation, and comprehensive STI screening across clinics in SF. For this study, we will develop educational materials on the CAB-RPV LA regimen, including a summary of results from Phase 3 trials (ATLAS20, FLAIR21), the FDA labeling indication, and details about SFDPH's implementation of CAB-RPV LA within our safety-net system and our new delivery model. These materials will include information on which patients will be eligible for this treatment modality and eligible for referral to our new delivery model, and how to make these referrals.
For SFDPH clinics, Bridge HIV providers will communicate with primary care providers through EPIC, SFDPH's electronic health record (EHR), and one of the most common EHR systems used across clinic systems in the US. For this study, secure email and/or telephone encounters within EPIC will be used to facilitate efficient referrals of TGW living with HIV from their primary providers to the Bridge HIV injection clinic and ongoing secure communication between Bridge HIV clinicians and the primary care team. For non-SFDPH clinics, communication will be via secure email or other secure communication strategies.
Feasibility of delivering CAB-RPV LA
Assess the feasibility of delivering CAB-RPV LA to trans women living with HIV via a trans-tailored, integrated delivery model
Time frame: 0, 9,18 Months
Acceptability of delivering CAB-RPV LA
Assess the acceptability of delivering CAB-RPV LA to trans women living with HIV via a trans-tailored, integrated delivery model
Time frame: 0, 9,18 Months
Client Satisfaction
Assess client satisfaction with treatment when CAB-RPV LA is delivered through a trans-tailored integrated model
Time frame: 0, 3, 6, 9 Months
Assess tolerability
Assess tolerability of CAB-RPV LA among trans women receiving CAB-LA injections
Time frame: 3, 6, 9 Months
Assess adherence to injections
Assess adherence to monthly or bimonthly injections among trans women receiving CAB-RPV LA in this delivery model
Time frame: 3, 6, 9 Months
Assess viral suppression
Assess viral suppression rates among trans women receiving CAB-RPV LA
Time frame: 3, 6, 9 Months
Describe development of resistance mutations
Describe development of resistance mutations in cases of virologic failure among trans women receiving CAB-RPV LA
Time frame: 3, 6, 9 Months
This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Public Health Foundation Enterprises, Inc.