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

March 19, 2025 updated by: Mary Irvine, City University of New York

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
243

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10459
        • La Casa De Salud
      • Brooklyn, New York, United States, 11203
        • State University of New York Downstate Health Sciences University
      • Congers, New York, United States, 10920
        • Together Our Unity Can Heal
      • Mamaroneck, New York, United States, 10543
        • Open Door Family Medical Centers
      • New York, New York, United States, 10018
        • Council on Adoptable Children
      • Yonkers, New York, United States, 10703
        • Sun River Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Health education materials only
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
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.
Experimental: Health education materials and shared patient-provider decision tool
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Uptake
Time Frame: Measured continuously for up to nine months (39 weeks)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maintenance
Time Frame: 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.
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.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Concordance between decision/intent documented and treatment plan pursued
Time Frame: Measured continuously from date of an individual's decision tool completion, for up to nine months (39 weeks).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
City University of New York

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
New York City Department of Health and Mental Hygiene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Denis Nash, PhD, City University of New York, Institute for Implementation Science in Population Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 2, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R34MH126809 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to the legal restrictions (New York Public Health Law Article 21, Title III) and the confidential nature of HIV health-related data in New York, public health authorities in New York City cannot release individual-level data on reported HIV cases for purposes other than ensuring appropriate HIV care. The New York City Department of Health and Mental Hygiene staff are available to assist external researchers who may have further specific data questions or uses. Please send an email to the study contact persons with questions or requests for additional information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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