Adherence Connection for Counseling, Education, and Support (ACCESS) II
NCT ID: NCT04499781
Last Updated: 2025-09-24
Study Results
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View full resultsBasic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2022-02-14
2024-07-25
Brief Summary
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Detailed Description
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Study participants will access the intervention and control conditions outside of the clinical setting using study funded smart phones. Self-reported adherence and viral load (extracted from the medical records) of study participants will be measured, and uploaded to RedCAP. ART knowledge, adherence self-efficacy, HIV stigma, social support, psychological distress, and substance use will be measured using survey measures. Statistical analyses will be computed to assess the potential impact of ACCESS on adherence and HIV viral suppression, and will also be computed to assess changes in ART knowledge, adherence self-efficacy, HIV stigma, social support, psychological distress, and substance use among participants in both the intervention and control conditions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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HIV-infected youth: Intervention
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years).
Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation.
ACCESS II mHealth Intervention
Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
HIV-infected youth: control
Sample population of perinatally and behaviorally, HIV-infected youth (ages 18-29 years).
Characteristics of the target study population include ethnic minority, Black and Hispanic HIV+AYA; both males and females are eligible for participation.
ACCESS II control condition
Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Interventions
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ACCESS II mHealth Intervention
Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
ACCESS II control condition
Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
Eligibility Criteria
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Inclusion Criteria
* Ages 18-29 years
* English speaking
* Currently being prescribed an antiretroviral treatment regimen
* Evidence of virologic failure or (detectable quantitative HIV serum viral load\>200 copies/ml)
* No neuro-cognitive deficits which would impede participation in videoconferencing sessions or completion of study measures
18 Years
29 Years
ALL
No
Sponsors
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Jacobi Medical Center
OTHER
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Ann-Margaret Navarra, PhD, CPNP-PC
Role: PRINCIPAL_INVESTIGATOR
NYU Meyers College of Nursing
Locations
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Jacobi Medical Center
The Bronx, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20-01135
Identifier Type: -
Identifier Source: org_study_id
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