Adherence Connection for Counseling, Education, and Support

NCT02753049 | Unknown DMC

• 1 other identifier: 1K23NR015970-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

HIV; AIDS; Adolescent; Adherence; Retention; mHealth

Outcome Measures

Primary Outcomes (1)

• Change in Serum HIV RNA quantitative viral load

  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.

  Serum HIV RNA quantitative viral load will be measured at baseline and at 8 weeks, 16 weeks, and 24 weeks post-intervention.

Other Outcomes (5)

• Change in Beliefs about antiretroviral treatment

  Beliefs about antiretroviral treatment will be measured at baseline and 24 weeks.

• Change in Knowledge about antiretroviral treatment

  Knowledge about antiretroviral therapy will be measured at baseline and 24 weeks.

• Change in Adherence Self-Efficacy

  Adherence self-efficacy will be measured at baseline and 24 weeks.

Study Arms (1)

Peer led mHealth adherence intervention

EXPERIMENTAL

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

Interventions

Peer led mHelath behavioral intervention BEHAVIORAL

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.

Also known as: ACCESS

Peer led mHealth adherence intervention

Eligibility Criteria

• Age: 16 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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. \[Screening with the Folstein Mini-Mental State Exam (MMSE) will be performed to assess for the presence of neurocognitive deficits. Participants with a score of 24 or greater will be eligible for study participation.\]

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• New York University: lead
• NYU Langone Health: collaborator

Study Sites (1)

Bellevue Hospital Center

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Ann-Margaret Navarra, PhD

CONTACT

212-998-9009; amd363@nyu.edu

Gail Melkus, EdD

CONTACT

212-998-5356; gdm3@nyu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: April 27, 2016
• Study Start: November 23, 2016
• Primary Completion: January 1, 2018
• Study Completion: August 1, 2018
• Last Updated: April 12, 2017

Record last verified: 2017-04

Locations

US (1)