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Cell Phone Reminders Intervention

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01049568
First Posted: January 14, 2010
Last Update Posted: February 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
  Purpose

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.


Condition Intervention
HAART Non-Adherence HIV HIV Infections Behavioral: Cell Phone Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Using Cell Phone Interactions to Improve Medication Adherence in Adolescents Who Have Previously Failed Antiretroviral Therapy Due to Non-Adherence

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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. [ Time Frame: 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. [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • To examine the trends of self-reported and chart-documented service utilization among intervention versus control participants. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 1 year ]
  • To evaluate barriers to and promoters of implementation of cell phone support through qualitative interviews with intervention participants and Adherence Facilitators. [ Time Frame: 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. [ Time Frame: 1 year ]
Enrollment: 43
Study Start Date: October 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cell Phone Intervention Behavioral: Cell Phone Intervention

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.
No Intervention: Control

Control 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.

Detailed Description:

Forty participants, non-adherent to HAART at study start, will be randomly assigned to either a 1) "Cell Phone Adherence Facilitator" group (intervention group) or a 2) control group. In the intervention group, a Cell Phone Adherence Facilitator will initiate a short (typically five minutes or less) contact Monday through Friday (excluding major holidays) with each participant to enhance their adherence to HAART. Occasionally, calls may be longer if crises arise that can be addressed by the Adherence Facilitator. Calls from the Adherence Facilitator will occur once or twice a day (depending on dosing schedule) and go on for 24 weeks in the intervention group. Calls will occur at a time soon after the prescribed dose is supposed to be taken, but also one convenient to the participant and the Adherence Facilitator.

All participants regardless of condition will be followed for 48 weeks. This intervention will be examined as a tool to address participant-specific, healthcare systems and participant-provider relationship barriers to ARV adherence.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Evidence of cognitive impairment or other mental condition (including substance abuse) that limits his/her ability to complete intervention and assessments (per PI or designee discretion). Participants with stable and treated mental health/substance abuse disorders are acceptable for inclusion with protocol team approval.

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.

  Contacts and Locations
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): NCT01049568


Locations
United States, California
Childrens Hospital of Los Angeles
Los Angeles, California, United States, 90027
University of California San Francisco
San Francisco, California, United States, 94117
United States, District of Columbia
Childrens National Medical Center
Washington, District of Columbia, United States, 20010-2970
United States, Florida
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, United States, 33316
United States, Louisiana
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Investigators
Study Chair: Marvin Belzer, MD Adolescent Trials Network
  More Information

Additional Information:
ATN Website  This link exits the ClinicalTrials.gov site

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01049568     History of Changes
Other Study ID Numbers: ATN 078
First Submitted: January 13, 2010
First Posted: January 14, 2010
Last Update Posted: February 28, 2017
Last Verified: March 2016

Keywords provided by University of North Carolina, Chapel Hill:
HIV
Cell phone
HAART

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


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