Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05979714

The Cheeky Study: A Novel Delivery System for CAB-RPV LA

This is a single-arm implementation study of a novel integrated delivery model of CAB-RPV LA for transwomen living with HIV.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Bridge HIV, San Francisco Department of Public Health

San Francisco, California, 94134, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • Male sex at birth and gender identity other than male
  • Willing and able to provide written informed consent
  • HIV-infected, confirmed by laboratory testing (can be via medical record)
  • Eligible to receive CAB-RPV LA per FDA-approved label
  • Virologically suppressed at the last visit within the last 6 months (HIV RNA <50 copies/ml)
  • Interested in initiating CAB-RPV LA for HIV treatment and willing to receive injections at Bridge HIV
  • Currently receiving HIV care by a care provider at one of the collaborating primary care clinics.
  • Has a cell phone and active service
  • Able to understand, read, and speak English

Exclusion criteria

  • Unable to receive gluteal injections
  • Plans to move away from the site area within the next 9 months.
  • History of known or suspected drug resistance that would compromise the CAB-RPV regimen
  • Rilpivirine: L100I; K101E; V106I and A; V108I; E138K and A, G, Q, R; V179F and I; Y181C and I; V189I; G190E; H221Y and H/L; F227C; and M230I and L; K103N+K238T, K103N+E138G+K238T; Y188L
  • Cabotegravir: Q146L; S153Y; I162M; T124A; Q148H, K; C56S; V72I; L74M; V75A; T122N; E138K; G140S; G149A; M154I; and N155H
  • Prior hypersensitivity to cabotegravir or rilpivirine
  • Current or expected use of any of the following medications:
  • Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin
  • Antimycobacterials: rifabutin, rifampin, rifapentine
  • Systemic glucocorticoids: more than a single dose of dexamethasone
  • Herbal: St John's Wort
  • Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Treatment and study plan

Patient-centered injection site

Other

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.

Patient-centered adherence support

Behavioral

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.

Provider education

Other

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.

Improved clinic communication strategies

Behavioral

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.

Primary outcomes

  1. Feasibility of delivering CAB-RPV LA

    Time frame: 0, 9,18 Months

    Assess the feasibility of delivering CAB-RPV LA to trans women living with HIV via a trans-tailored, integrated delivery model

  2. Acceptability of delivering CAB-RPV LA

    Time frame: 0, 9,18 Months

    Assess the acceptability of delivering CAB-RPV LA to trans women living with HIV via a trans-tailored, integrated delivery model

  3. Client Satisfaction

    Time frame: 0, 3, 6, 9 Months

    Assess client satisfaction with treatment when CAB-RPV LA is delivered through a trans-tailored integrated model

Secondary outcomes

  1. Assess tolerability

    Time frame: 3, 6, 9 Months

    Assess tolerability of CAB-RPV LA among trans women receiving CAB-LA injections

  2. Assess adherence to injections

    Time frame: 3, 6, 9 Months

    Assess adherence to monthly or bimonthly injections among trans women receiving CAB-RPV LA in this delivery model

  3. Assess viral suppression

    Time frame: 3, 6, 9 Months

    Assess viral suppression rates among trans women receiving CAB-RPV LA

  4. Describe development of resistance mutations

    Time frame: 3, 6, 9 Months

    Describe development of resistance mutations in cases of virologic failure among trans women receiving CAB-RPV LA

Sponsors and collaborators

Lead sponsor

Public Health Foundation Enterprises, Inc.

Other

Collaborators

  • Lyon-Martin Community Health Services
  • San Francisco Department of Public Health
  • ViiV Healthcare

Registry information

Official study title

Developing a Novel Delivery System for CAB-RPV LA in Transgender Women Living With HIV in Public Health Settings

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 7, 2023
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.