Clinical trial NCT02753049: Adherence Connection for Counseling, Education, and Support
Official title: Adherence Connection for Counseling, Education, and Support (ACCESS): A Proof of Concept Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV-infection/AIDS
Keywords: HIV
AIDS
Adolescent
Adherence
Retention
mHealth
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: NYU Langone Health
First posted: 2016-04-27
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Change in Serum HIV RNA quantitative viral load
timeFrame: Serum HIV RNA quantitative viral load will be measured at baseline and at 8 weeks, 16 weeks, and 24 weeks post-intervention.
Secondary outcomes:
Other outcomes:
measure: Change in Beliefs about antiretroviral treatment
timeFrame: Beliefs about antiretroviral treatment will be measured at baseline and 24 weeks.
measure: Change in Knowledge about antiretroviral treatment
timeFrame: Knowledge about antiretroviral therapy will be measured at baseline and 24 weeks.
measure: Change in Adherence Self-Efficacy
timeFrame: Adherence self-efficacy will be measured at baseline and 24 weeks.
measure: Change in 3-day adherence estimate
timeFrame: 3-day adherence estimates will be measured at baseline, and 8 weeks, 16 weeks, and 24 weeks
measure: Change in health care utilization (retention in care)
timeFrame: Retention in care will be measured at baseline and 24 weeks
Locations:
city: New York
country: United States
facility: Bellevue Hospital Center
state: New York
Study officials:
References: