Recruiting

Observational Study

Sponsor:

New York University

Code:

NCT02753049

Conditions

HIV-infection/AIDS

Eligibility Criteria

Sex: All

Age: 16 - 29

Healthy Volunteers: Not accepted

Interventions

Peer led mHelath behavioral intervention

Study Details

Brief summary:

This Mentored Patient-Oriented Research Career Development Award - (K23) seeks to provide the advanced knowledge, skills, and experience for the candidate's career transition to an independent nurse scientist. Her long term goal is to become a leading nurse scientist in designing, implementing, and evaluating technology supported behavioral interventions targeted for improved disease self-management (i.e. medication adherence, retention in care) among human immunodeficiency virus (HIV)-infected, ethnic minority adolescents and young adults. With an extensive background in pediatric HIV nursing and completed NIH funded pre and post-doctoral interdisciplinary research traineeships, the candidate has begun to develop the knowledge-base and skills necessary for this goal.

This award details a 3-year scope of mentored career development through which she will gain the foundation for future research endeavors. Specifically, the goals of this proposal are to: 1) conduct a novel research project under the mentorship of an interdisciplinary team of expert researchers; 2) acquire expertise in health informatics for implementation of technology supported behavioral interventions, health disparities, and advanced qualitative and mixed methods design and analysis through firsthand experience, didactic interactions with mentors, and graduate level coursework; 3) build a network of colleagues and collaborators within New York University and elsewhere through this research and participation at national and international meetings; and 4) prepare and submit a federal research grant (R-21) based upon the skills and findings from this award period.

The specific research project through which she will accomplish these goals is a proof of concept study, Adherence Connection for Counseling, Education, and Support (ACCESS), and addresses the challenge of adherence to antiretroviral treatment among HIV-infected adolescents and young adults. A mixed method design is proposed and the specific aims are to: 1) Characterize the feasibility and acceptability of a peer led, mHealth cognitive behavioral intervention delivered via remote videoconferencing using smartphones; 2) Obtain initial estimates of the biobehavioral impact of ACCESS on HIV virologic outcomes and self-reported ART adherence, beliefs and knowledge about antiretroviral treatment, adherence self-efficacy, and healthcare utilization (retention in HIV care). In summary, the ACCESS adherence intervention is consistent with the National Institute of Nursing Research (NINR) call for the development of novel interventions to deliver personalized care and real-time health information for patients.

Conditions

HIV-infection/AIDS

Study ID

NCT02753049

Start date

Nov 23, 2016

Status verified date

Apr, 2017

Completion date

Aug, 2018

Anticipated

Primary completion date

Jan, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 29

Healthy Volunteers: Not accepted

1. HIV seropositive status (perinatally and behaviorally infected youth)
2. Ages 16-29 years
3. English speaking
4. Current ART with a prescribed regimen
5. Evidence of virologic failure or (detectable quantitative HIV serum viral load>200 copies/ml)
6. No neuro-cognitive deficits which would impede participation in videoconferencing sessions or completion of study measures. \[Screening with the Folstein Mini-Mental State Exam (MMSE) will be performed to assess for the presence of neurocognitive deficits. Participants with a score of 24 or greater will be eligible for study participation.\]

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Peer led mHealth adherence intervention

Eligible participants enrolled will receive five, weekly-60 minute, 'ACCESS' sessions, delivered by a peer adherence coach via remote videoconferencing, using smartphones. Cognitive behavioral strategies will be employed to target beliefs about antiretroviral treatment (ART), knowledge of ART, and adherence self-efficacy.

Interventions

Peer led mHelath behavioral intervention

A trained peer adherence coach will schedule five, weekly-60 minute, 'ACCESS' sessions, delivered to participants via remote videoconferencing, using smartphones. Cognitive behavioral strategies will be employed to target beliefs about antiretroviral treatment (ART), knowledge of ART, and adherence self-efficacy.

Primary outcome measure

  • Change in Serum HIV RNA quantitative viral load [ Time Frame: Serum HIV RNA quantitative viral load will be measured at baseline and at 8 weeks, 16 weeks, and 24 weeks post-intervention. ]

Central Contacts and Locations

Central contacts

Ann-Margaret Navarra, PhD

212-998-9009amd363@nyu.edu

Locations

Bellevue Hospital Center

Recruiting

New York, New York, United States, 10016

Contacts

Aditya Kaul, MD

aditya.kaul@nyumc.org

More Information

Sponsor

New York University

Last update posted

Apr 12, 2017

Last verified

Apr, 2017

Keywords

  • HIV
  • AIDS
  • Adolescent
  • Adherence
  • Retention
  • mHealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York University on 2017-04-12.