Assessing Perceptions and Preferences Around Long-acting Injectables (APPLI)

Hiv Clinical Trial

— APPLI  

Official title:

Assessing Perceptions and Preferences Around Long-acting Injectables in the Ryan White HIV/AIDS Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05833542
• Other study ID #: R34MH126809
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: June 2023
• Source: City University of New York
• Contact: Mary Irvine, DrPH
• Phone: 347-396-7712
• Email: Mirvine[@]health.nyc.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Ryan White HIV/AIDS Program is an essential platform for reducing health disparities among people with HIV and scaling up evidence-based strategies to strengthen the HIV care continuum. The investigators propose an implementation-science study based in New York Ryan White Part A programs, to inform the delivery of long-acting injectable antiretroviral therapy and related supportive services to low-income, largely Black and Latino/a people with HIV who have struggled with daily oral antiretroviral therapy adherence. As a major biomedical advance de-necessitating adherence to daily dosing, long-acting injectable antiretroviral therapy could greatly increase opportunities for health, survival and transmission prevention, particularly in populations confronting complex barriers to viral load suppression. However, optimizing the public health impact of long-acting injectable antiretroviral therapy will require implementation science to assess perceptions and preferences around long-acting injectable versus daily oral regimens, identify support services and delivery mechanisms suited to promoting long-acting injectable uptake and engagement, and address the role of provider beliefs as to which patients should be offered long-acting injectable options. In the absence of this groundwork, long-acting injectable antiretroviral therapy may primarily reach those who are already relatively advantaged, and even exacerbate HIV disparities.

Description:

The proposed project aims to develop, select and pilot strategies to promote long-acting injectable antiretroviral therapy uptake, adherence and impact in real-world care settings. Timely formative work on patient and provider perceptions and preferences will be essential to a successful, equitable roll-out of long-acting injectable antiretroviral therapy. The proposed study will yield valuable insights into barriers and facilitators of long-acting injectable antiretroviral therapy engagement in Ryan White Part A medical case management programs designed for people with HIV with documented adherence barriers. Specifically, Aim 3 pilot testing will further inform long-acting injectable antiretroviral therapy delivery and scale-up, by measuring implementation outcomes of strategies emerging from earlier Aims of the proposed project. The approach of introducing long-acting injectable options through a patient decision aid has been selected for the pilot. During the pilot, the investigators plan to test two different versions (and three components) of the patient decision aid process, with three of the six partnering service sites testing each version. These will be tested simultaneously during the 9-month pilot, expected to begin in early May 2023. Through a partnership between the Institute for Implementation Science and Population Health at the City University of New York, the New York City Health Department and six Ryan White Part A service provider agencies, products from the proposed project will be translated to local HIV services planning and practice improvements, while being disseminated nationally and internationally.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients: Adults enrolled in Ryan White Part A medical case management services and able to understand materials provided or discussed in English or Spanish. Although minors may possibly receive enhanced services related to the pilot, their data will not be included in pilot analyses. Baseline data from the sites suggest that only 1-2 minors might be served at all in the partnering medical case management programs during the pilot period. Some patients may be able to utilize the decision aid and informational materials in a language other than their primary language, but it is expected that the providers will focus on pilot testing with clients whose primary language is used in the videos and written materials.

• Providers: Adults overseeing or delivering Ryan White Part A medical case management services or prescribing antiretroviral therapy for patients in Ryan White Part A medical case management programs (and able to read and speak English, in that provider data collection will only be conducted in English). It is expected that the 12 providers participating in Aim 3 implementation-focused surveys and interviews about the pilot will already have participated in APPLI in some form during Aim 1 focus groups or Aim 2 discreet choice experiment surveys, and thus will not add to the total number of study enrollees.

Exclusion Criteria:

N/A, aside from age minimum and language requirements already noted above

Related Conditions & MeSH terms

• Hiv

Intervention

Behavioral:
• Health education materials
Participants will receive informational material (designed to be self-guided), including a video and an information sheet about current HIV treatment options (i.e., long-acting injectable and daily oral antiretroviral therapy). These materials will provide a comparison of the risks and benefits of long-acting injectable and oral regimens, set expectations about clinic visits, present information about side effects, and provide additional resources for patients to assist them in preparing to discuss HIV treatment and support options with their medical case manager and clinical provider. Participants receiving this intervention will be offered/pointed to these materials by a medical case manager or patient navigator and will be encouraged to review the materials on their own, but may also go over the materials with staff during a medical case management visit.
• Patient-provider decision tool
Participants will receive a shared patient-provider assessment and decision-making tool, utilizing techniques from Motivational Interviewing and based on the Ottawa Patient Decision Aid framework, for weighing each patient's treatment options and their fit to patient interests, needs, assets, and constraints. The tool will facilitate and record patient-provider agreement on an antiretroviral treatment and support-services plan, to be integrated into the broader existing medical case management care plan signed by both patient and provider. The tool will be administered during a medical case management visit and completed by the participant and a patient navigator or medical case manager.

Locations

Country	Name	City	State
United States	La Casa De Salud	Bronx	New York
United States	State University of New York Downstate Health Sciences University	Brooklyn	New York
United States	Together Our Unity Can Heal	Congers	New York
United States	Open Door Family Medical Centers	Mamaroneck	New York
United States	Council on Adoptable Children	New York	New York
United States	Sun River Health	Yonkers	New York

Sponsors (2)

Lead Sponsor	Collaborator
City University of New York	New York City Department of Health and Mental Hygiene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Concordance between decision/intent documented and treatment plan pursued	The proportion of participants whose documented intent in the decision process is carried through in terms of the antiretroviral regimen they receive thereafter (use of daily oral regimens, receipt of directly observed therapy to achieve suppression before starting long-acting injectable antiretroviral therapy, or transition to long-acting injectable antiretroviral therapy).	Measured continuously from date of an individual's decision tool completion, for up to nine months (39 weeks).
Primary	Uptake	The proportion of participants who start long-acting injectable therapy - including any transition from a prior regimen and any transition from a period of non-antiretroviral use or as a first antiretroviral regimen. The denominator includes patients not already on a long-acting injectable regimen at the start of the study period; the numerator includes any of those in the denominator who begin a long-acting injectable antiretroviral regimen during the study period.	Measured continuously for up to nine months (39 weeks)
Secondary	Maintenance	Among trial participants who initiate long-acting injectable antiretroviral therapy, the time from first injection to first deviation from the injection schedule. A deviation includes any injection more than 1 week ahead of the treatment target date or any delay of more than 1 week after the treatment target date. (Injection target date depends on whether the prescribed regimen is monthly or bimonthly.)	From date of first injection to date of first deviation from the injection schedule or date of death from any cause, whichever comes first, assessed for up to 35 weeks from first injection.