Clinical trial NCT05833542: Assessing Perceptions and Preferences Around Long-acting Injectables (APPLI)
Official title: Assessing Perceptions and Preferences Around Long-acting Injectables in the Ryan White HIV/AIDS Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Keywords: Medical Case Management
Viral Load Suppression
Long-Acting Injectable Antiretroviral Therapy
Decision Support
Lead sponsor: City University of New York
Sponsor class: OTHER
Collaborators: name: New York City Department of Health and Mental Hygiene
First posted: 2023-04-27
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Uptake
timeFrame: Measured continuously for up to nine months (39 weeks)
Secondary outcomes:
measure: Maintenance
timeFrame: 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:
measure: Concordance between decision/intent documented and treatment plan pursued
timeFrame: Measured continuously from date of an individual's decision tool completion, for up to nine months (39 weeks).
Locations:
city: Bronx
country: United States
facility: La Casa De Salud
state: New York
city: Brooklyn
country: United States
facility: State University of New York Downstate Health Sciences University
state: New York
city: Congers
country: United States
facility: Together Our Unity Can Heal
state: New York
city: Mamaroneck
country: United States
facility: Open Door Family Medical Centers
state: New York
city: New York
country: United States
facility: Council on Adoptable Children
state: New York
city: Yonkers
country: United States
facility: Sun River Health
state: New York
Study officials:
affiliation: City University of New York, Institute for Implementation Science in Population Health
name: Denis Nash, PhD
role: PRINCIPAL_INVESTIGATOR
References: