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

NCT05833542 | Completed

• 1 other identifier: R34MH126809
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Hiv

Keywords

Medical Case Management; Viral Load Suppression; Long-Acting Injectable Antiretroviral Therapy; Decision Support

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Maintenance

  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.

Other Outcomes (1)

• Concordance between decision/intent documented and treatment plan pursued

  Measured continuously from date of an individual's decision tool completion, for up to nine months (39 weeks).

Study Arms (2)

Health education materials only

EXPERIMENTAL

Participants will receive informational materials on their HIV treatment options and related support-service options. These will include a brief "Frequently Asked Questions" document with answers and a video comparing long-acting injectable with daily oral antiretroviral therapy, and explaining considerations for patients who may be interested in long-acting injectable treatment options. Both components are designed for patient self-guided use, but can also be presented or discussed in a session with medical case management program staff.

Behavioral: Health education materials

Health education materials and shared patient-provider decision tool

EXPERIMENTAL

Prior to or during a medical case management visit, participants will receive informational materials (described above) on their HIV treatment options and related support-service options. During their medical case management visit, the participant and their medical case management provider will review a shared decision tool to facilitate patient-provider agreement on an HIV treatment plan.

Behavioral: Patient-provider decision tool

Interventions

Health education materials BEHAVIORAL

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.

Health education materials only

Patient-provider decision tool BEHAVIORAL

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.

Health education materials and shared patient-provider decision tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• City University of New York: lead
• New York City Department of Health and Mental Hygiene: collaborator

Study Sites (6)

State University of New York Downstate Health Sciences University

Brooklyn, New York, 11203, United States

Location

Together Our Unity Can Heal

Congers, New York, 10920, United States

Location

Open Door Family Medical Centers

Mamaroneck, New York, 10543, United States

Location

Council on Adoptable Children

New York, New York, 10018, United States

Location

La Casa De Salud

The Bronx, New York, 10459, United States

Location

Sun River Health

Yonkers, New York, 10703, United States

Location

Related Publications (1)

• Irvine MK, Zimba R, Avoundjian T, Peterson M, Emmert C, Kulkarni SG, Philbin MM, Kelvin EA, Nash D. Patient Education and Decision Support for Long-Acting Injectable HIV Antiretroviral Therapy: Protocol for Tool Development and Pilot Testing with Ryan White HIV/AIDS Program Medical Case Management Programs in New York. JMIR Res Protoc. 2024 Mar 27;13:e56892. doi: 10.2196/56892.

  PMID: 38536227 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Denis Nash, PhD

  City University of New York, Institute for Implementation Science in Population Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research and Evaluation

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: April 27, 2023
• Study Start: May 3, 2023
• Primary Completion: February 2, 2024
• Study Completion: September 30, 2024
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)