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Adherence Connection for Counseling, Education, and Support (ACCESS)

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ClinicalTrials.gov Identifier: NCT02753049
Recruitment Status : Recruiting
First Posted : April 27, 2016
Last Update Posted : April 12, 2017
Sponsor:
Collaborator:
New York University School of Medicine
Information provided by (Responsible Party):
Ann-Margaret Dunn Navarra, New York University

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.


Condition or disease Intervention/treatment Phase
HIV-infection/AIDS Behavioral: Peer led mHelath behavioral intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Adherence Connection for Counseling, Education, and Support (ACCESS): A Proof of Concept Study
Actual Study Start Date : November 23, 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.
Behavioral: 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.
Other Name: ACCESS




Primary Outcome Measures :
  1. 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. ]
    Serum HIV RNA quantitative viral load results will be available for medical record data extraction at four time points, baseline (pre-intervention), and weeks 8, 16 & 24 post-intervention. The primary outcome variable of adherence as measured with serum HIV-RNA will be dichotomized as a binary variable (< 48 copies/ml; > 48 copies/ml), indicating viral suppression. An interval estimate of the odds ratio will indicate the potential impact of ACCESS on viral suppression, with Chi-Square or Fisher's Exact Test for statistical significance.


Other Outcome Measures:
  1. Change in Beliefs about antiretroviral treatment [ Time Frame: Beliefs about antiretroviral treatment will be measured at baseline and 24 weeks. ]
    Beliefs about ART will be assessed with the Beliefs about Medication Scale (BAMS)- a 59 item health beliefs questionnaire using a 7-point Likert scale to assess perceived threat, positive outcome expectancy, negative outcome expectancy, and intent regarding oral medication adherence [Riekert K. et al. 2002; J Clinical Psychol Med Settings]. Changes in scores of beliefs about medications will be compared pre and post the ACCESS intervention using Chi-Square or Fisher's Exact Test for discrete variables, and paired t-tests for continuous variables.

  2. Change in Knowledge about antiretroviral treatment [ Time Frame: Knowledge about antiretroviral therapy will be measured at baseline and 24 weeks. ]
    Knowledge about antiretroviral treatment will be measured with the HIV Treatment Knowledge Scale. This 21 item instrument uses true and false questions to assess knowledge of adherence, side effects and antiretroviral resistance [Balfour L. et al. 2007; AIDS Care]. Changes in scores of knowledge about ART will be compared pre and post the ACCESS intervention using Chi-Square or Fisher's Exact Test for discrete variables, and paired t-tests for continuous variables.

  3. Change in Adherence Self-Efficacy [ Time Frame: Adherence self-efficacy will be measured at baseline and 24 weeks. ]

    Adherence self-efficacy will be measured with the Adherence Self-Efficacy Scale - a 12 item survey measure that uses a 10 point scale (0=cannot do it all;10=completely certain can do it) to assess confidence in ability to carry out important treatment related behaviors [Johnson M. et al. 2007; J Behav Med].

    Changes in scores of self-efficacy will be compared pre and post the ACCESS intervention using Chi-Square or Fisher's Exact Test for discrete variables, and paired t-tests for continuous variables.


  4. Change in 3-day adherence estimate [ Time Frame: 3-day adherence estimates will be measured at baseline, and 8 weeks, 16 weeks, and 24 weeks ]
    An average missed dose calculation will be computed and operationalized as: # of doses missed per medication multiplied by dosing schedule during the past 3 days/ divided by total number of prescribed doses over past 3 days. This percentage will be subtracted from 100% to obtain the 3-day adherence estimate [Garvie P. et al. 2010; J Adol Health]

  5. Change in health care utilization (retention in care) [ Time Frame: Retention in care will be measured at baseline and 24 weeks ]
    For the purposes of this proof of concept study, retention in HIV care will be calculated as a proportion of kept to scheduled visits (range 0-100%). Changes in scores of healthcare utilization (retention) will be compared pre and post the ACCESS intervention using Chi-Square or Fisher's Exact Test for discrete variables, and paired t-tests for continuous variables.



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Ages Eligible for Study:   16 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  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.]

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02753049


Contacts
Contact: Ann-Margaret Navarra, PhD 212-998-9009 amd363@nyu.edu
Contact: Gail Melkus, EdD 212-998-5356 gdm3@nyu.edu

Locations
United States, New York
Bellevue Hospital Center Recruiting
New York, New York, United States, 10016
Contact: Aditya Kaul, MD       aditya.kaul@nyumc.org   
Sponsors and Collaborators
New York University
New York University School of Medicine

Responsible Party: Ann-Margaret Dunn Navarra, Assistant Professor, New York University
ClinicalTrials.gov Identifier: NCT02753049     History of Changes
Other Study ID Numbers: 1K23NR015970-02 ( U.S. NIH Grant/Contract )
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ann-Margaret Dunn Navarra, New York University:
HIV
AIDS
Adolescent
Adherence
Retention
mHealth

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases