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

Last updated: March 19, 2025
Sponsor: City University of New York
Overall Status: Completed

Phase

N/A

Condition

Hiv

Treatment

Patient-provider decision tool

Health education materials

Clinical Study ID

NCT05833542
R34MH126809
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients: Adults enrolled in Ryan White Part A medical case management services andable to understand materials provided or discussed in English or Spanish. Althoughminors may possibly receive enhanced services related to the pilot, their data willnot 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 programsduring the pilot period. Some patients may be able to utilize the decision aid andinformational materials in a language other than their primary language, but it isexpected that the providers will focus on pilot testing with clients whose primarylanguage is used in the videos and written materials.

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 243
Treatment Group(s): 2
Primary Treatment: Patient-provider decision tool
Phase:
Study Start date:
May 03, 2023
Estimated Completion Date:
September 30, 2024

Study 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.

Connect with a study center

  • La Casa De Salud

    Bronx, New York 10459
    United States

    Site Not Available

  • State University of New York Downstate Health Sciences University

    Brooklyn, New York 11203
    United States

    Site Not Available

  • Together Our Unity Can Heal

    Congers, New York 10920
    United States

    Site Not Available

  • Open Door Family Medical Centers

    Mamaroneck, New York 10543
    United States

    Site Not Available

  • Council on Adoptable Children

    New York, New York 10018
    United States

    Site Not Available

  • Sun River Health

    Yonkers, New York 10703
    United States

    Site Not Available

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