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Education & Decision Tools for Long-Acting Injectables in HIV (APPLI Trial)

N/A

Recruiting

Led By Denis Nash, PhD

Research Sponsored by City University of New York

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured continuously for up to nine months (39 weeks)

Awards & highlights

APPLI Trial Summary

This trial will study how to provide long-acting injectable HIV/AIDS treatment to low-income, largely Black/Latino people who have struggled with daily oral treatment. This could reduce disparities & improve health, survival & prevention.

Who is the study for?

This trial is for adults with HIV who are enrolled in Ryan White Part A medical case management services and can understand English or Spanish. It's also for providers managing or prescribing antiretroviral therapy within these programs. There are no specific exclusions, except participants must meet the age minimum and language requirements.Check my eligibility

What is being tested?

The study is exploring how to deliver long-acting injectable antiretroviral therapy (LA-ART) effectively to low-income individuals, particularly Black and Latino/a communities that have issues with daily oral medication adherence. It involves health education materials and a patient-provider decision tool.See study design

What are the potential side effects?

Since this trial focuses on perceptions and preferences rather than direct medical interventions, it does not directly involve side effects from medications. However, LA-ART may have its own set of side effects not detailed in this particular study.

APPLI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured continuously for up to nine months (39 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured continuously for up to nine months (39 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured continuously for up to nine months (39 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Uptake

Secondary outcome measures

Maintenance

Other outcome measures

Concordance between decision/intent documented and treatment plan pursued

APPLI Trial Design

2Treatment groups

Experimental Treatment

Group I: Health education materials onlyExperimental Treatment1 Intervention

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.

Group II: Health education materials and shared patient-provider decision toolExperimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

City University of New YorkLead Sponsor

17 Previous Clinical Trials

5,533 Total Patients Enrolled

New York City Department of Health and Mental HygieneOTHER_GOV

18 Previous Clinical Trials

18,413 Total Patients Enrolled

Denis Nash, PhDPrincipal InvestigatorCity University of New York, Institute for Implementation Science in Population Health

4 Previous Clinical Trials

4,189 Total Patients Enrolled

Media Library

Health education materials and shared patient-provider decision tool Clinical Trial Eligibility Overview. Trial Name: NCT05833542 — N/A

HIV (Human Immunodeficiency Virus) Research Study Groups: Health education materials and shared patient-provider decision tool, Health education materials only

HIV (Human Immunodeficiency Virus) Clinical Trial 2023: Health education materials and shared patient-provider decision tool Highlights & Side Effects. Trial Name: NCT05833542 — N/A

Health education materials and shared patient-provider decision tool 2023 Treatment Timeline for Medical Study. Trial Name: NCT05833542 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for individuals to become involved in this experiment?

"As communicated through clinicaltrials.gov, this trial is now closed for enrollment; its initial posting date was April 25th 2023 and the last update to the page occurred on April 17th of that same year. Although no longer looking for participants, 95 other medical studies are currently seeking volunteers."

Answered by AI

How widespread is the implementation of this research endeavor?

"Currently, this medical trial is offered at 6 different sites. These locations are located in Brooklyn, Congers and Mamaroneck as well as 3 additional cities. For the convenience of patients wishing to partake, it would be beneficial for them to choose a site closest to their residence."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Mary Irvine 2023. "Assessing Perceptions and Preferences Around Long-acting Injectables (APPLI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05833542.