HIV-infection/AIDSACCESSNCT02753049
Adherence Connection for Counseling, Education, and Support
A study testing Peer led mHelath behavioral intervention in people with HIV-infection/AIDS, run by New York University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 29 years
- Conditions the study is for
- HIV-infection/AIDS
- What is being tested?
- Peer led mHelath behavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2016to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
- HIV seropositive status (perinatally and behaviorally infected youth)
- Ages 16-29 years
- English speaking
- Current ART with a prescribed 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. [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.]
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Bellevue Hospital Center
New York, New York, 10016
Aditya Kaul, MD, aditya.kaul@nyumc.org
About this study
Official title: Adherence Connection for Counseling, Education, and Support (ACCESS): A Proof of Concept Study
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
- Being tested
- Peer led mHelath behavioral intervention
- Keywords
- HIV, AIDS, Adolescent, Adherence, Retention, mHealth
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer led mHelath behavioral interventionBehavioural
Also called ACCESS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Peer led mHelath behavioral intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Serum HIV RNA quantitative viral load will be measured at baseline and at 8 weeks, 16 weeks, and 24 weeks post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study start23 Nov 2016
- Primary completionJan 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-infection/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- NYU Langone Health
- Responsible party
- Principal investigator, Ann-Margaret Dunn Navarra, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753049
- Sponsor's protocol ID
- 1K23NR015970-02
- Acronym
- ACCESS
- Status last verified
- Apr 2017
- First submitted
- 8 Apr 2016
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence Connection for Counseling, Education, and Support (ACCESS): A Proof of Concept Study
- ClinicalTrials.gov ID
- NCT02753049
- Acronym / sponsor ID
- ACCESS / 1K23NR015970-02
- Conditions
- HIV-infection/AIDS
- Keywords
- HIV, AIDS, Adolescent, Adherence, Retention, mHealth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- NYU Langone Health
- Study start
- 23 Nov 2016 (actual)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peer led mHealth adherence intervention | Experimental | Behavioral: Peer led mHelath behavioral interventionEligible 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. |
Who may qualify
- Ages
- 16 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer led mHelath behavioral interventionAlso: ACCESSA 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. | Behavioural | Peer led mHealth adherence intervention |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer led mHelath behavioral intervention in people with HIV-infection/AIDS, run by New York University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ann-Margaret Navarra, PhD (212-998-9009, amd363@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.