Cell Phone Reminders Intervention
A Pilot Study Using Cell Phone Interactions to Improve Medication Adherence in Adolescents Who Have Previously Failed Antiretroviral Therapy Due to Non-Adherence
1 other identifier
interventional
43
1 country
5
Brief Summary
This study will use a longitudinal, experimental design. Participants will be randomized to either the intervention or the control group. The intervention will involve cell phone support, including reminders, assessment of barriers to adherence, problem solving and referrals conducted by an Adherence Facilitator. Control group participants will participate in all on-study evaluations, except the intervention exit interviews.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2009
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 13, 2010
CompletedFirst Posted
Study publicly available on registry
January 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFebruary 28, 2017
March 1, 2016
1.1 years
January 13, 2010
February 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To examine the content of the Adherence Facilitator's conversation; including reported stressful life circumstances, what solutions were offered, and acceptability of the intervention among intervention participants.
1 year
To examine the trends of therapeutic success at 6 and 12 months, as measured by lowered viral load, and self-reported adherence among intervention versus control group participants.
1 year
Secondary Outcomes (5)
To examine the trends of self-reported and chart-documented service utilization among intervention versus control participants.
1 year
To identify the characteristics of youth who may require longer-term adherence support with cell phone conversations based on their self-reported scores of depression, life stressors, substance use, and their utilization of services.
1 year
To track the costs of implementation of cell phone contacts with Adherence Facilitators in the adolescent clinical setting by collecting the monthly cost of youths' cell phones.
1 year
To evaluate barriers to and promoters of implementation of cell phone support through qualitative interviews with intervention participants and Adherence Facilitators.
1 year
To examine the trends for self-reported adherence self-efficacy, perceived stress, and problem-solving orientation towards medication among intervention versus control group participants.
1 year
Study Arms (2)
Cell Phone Intervention
EXPERIMENTALControl
NO INTERVENTIONControl group participants will participate in all on-study evaluations, except the intervention exit interviews. Data will be collected using the ACASI and CRFs at entry, weeks 6, 12, 24, 36, 48 and the premature discontinuation visits. Measures will assess social support, coping, self-efficacy, substance use, adherence, life stressors, perceived stress, psychological symptoms and health service utilization.
Interventions
Cell phone support, including reminders, assessment of barriers to adherence, problem solving and referrals conducted by an Adherence Facilitator. Data will be collected using the ACASI and CRFs at entry, weeks 6, 12, 24, 36, 48 and the premature discontinuation visits. Measures will assess social support, coping, self-efficacy, substance use, adherence, life stressors, perceived stress, psychological symptoms and health service utilization.
Eligibility Criteria
You may qualify if:
- Documented HIV-positive infected either behaviorally or perinatally as determined by medical record review or verbal verification from referring professional.
- Age 15 and 0 days to 24 years and 364 days. Enrolled in care at an AMTU or affiliated site.
- History of non-adherence to one or more components of antiretroviral therapy, defined as meeting one of the following criteria:
- Currently prescribed HAART and reports to care provider less than 90% adherence in previous month and has viral load greater than 1000 copies/ml when last evaluated (within the last four weeks);
- Discontinued HAART in the past while documented to be less than 90% adherent during the most recent antiretroviral treatment; and
- Agreed to initiate antiretroviral treatment in the past, but never initiated. Able to speak and understand English. Willing to provide informed consent or assent.
You may not qualify if:
- Any condition, including active substance abuse that is expected to limit the likelihood that the participant may maintain involvement for the entire year on-study (per PI or designee discretion with protocol team approval).
- No participant consent, parental permission or youth assent (as appropriate). Minors unable to acquire parental/guardian consent, even if not living at home, will not be able to participate as a change in housing status during the study might require premature discontinuation.
- Current participation in another behavioral interventional trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Childrens Hospital of Los Angeles
Los Angeles, California, 90027, United States
University of California San Francisco
San Francisco, California, 94117, United States
Childrens National Medical Center
Washington D.C., District of Columbia, 20010-2970, United States
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, 33316, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marvin Belzer, MD
Adolescent Trials Network
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2010
First Posted
January 14, 2010
Study Start
October 1, 2009
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
February 28, 2017
Record last verified: 2016-03