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Evaluating Rewards-Based Adherence and Electronic Medication Monitoring in HIV-Positive Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01849393
First received: May 6, 2013
Last updated: December 12, 2013
Last verified: December 2013

May 6, 2013
December 12, 2013
June 2013
December 2013   (final data collection date for primary outcome measure)
Reported perceptions about incentive-based adherence programs and electronic medication monitoring [ Time Frame: Once, at enrollment ] [ Designated as safety issue: No ]
Participants will complete a survey/questionnaire on the computer describing their disease state, the frequency and amount of medication taken daily, and how well they comply with taking their medications and attending their clinic appointments. They will also note their perceptions about how incentive-based adherence programs and electronic medication monitoring. Descriptive statistics will be prepared from survey results.
Same as current
Complete list of historical versions of study NCT01849393 on ClinicalTrials.gov Archive Site
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Evaluating Rewards-Based Adherence and Electronic Medication Monitoring in HIV-Positive Adolescents
Incentives and Technology Survey 2013: Evaluation of Acceptance of Incentive-Based Adherence Programs and Electronic Medication Monitoring Among HIV-Positive Adolescents

The primary objective of this project is to assess the study population's acceptance of two medication adherence support strategies: incentive-based programs and electronic medication monitoring. The study population is adolescents (ages 16 - 24) positive for human immunodeficiency virus (HIV) currently undergoing treatment with antiretrovirals at St. Jude's HIV clinic. Participation in the study will involve completion of a survey: an Audio Computer Assisted Self Interview (ACASI). The duration of the survey is anticipated to be 10-20 minutes. Patient identifiers will not be attached the survey.

Whether or not patients take their medications is one of the most noticeable and important predictors of treatment success or failure for HIV infection. Ways to improve compliance, specifically rewards-based programs and electronic medication monitoring, have shown some success in limited clinical research studies focused on adult subjects. Because the social and developmental factors in adolescents are different from adults, adolescents may not respond to these interventions in the same way as adults. This study will investigate adolescent acceptance and the effectiveness of these programs.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

HIV-positive adolescents between the ages of 16 and 24 years who are currently undergoing treatment with antiretrovirals at St. Jude's HIV clinic.

  • Human Immunodeficiency Virus (HIV)
  • Acquired Immunodeficiency Syndrome (AIDS)
Other: Questionnaire
Participants who consent to participate in this study will complete a short questionnaire. The survey will be completely anonymous (not matched with the participant's name). Estimated time to complete the survey is 10-20 minutes.
Other Name: Survey
Study Population
Participants must meet the eligibility requirements will complete a questionnaire on the computer.
Intervention: Other: Questionnaire
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV positive
  • Ages 16-24 years.
  • Participants must understand written or spoken English, because the ACASI used in the study can only be administered in English.

Exclusion Criteria:

  • Adolescents with a documented diagnosis of mental retardation or a significant motor or sensory impairment that would preclude participation in the study survey.
Both
16 Years to 24 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01849393
INTECH
No
St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
Not Provided
Principal Investigator: Mary Westfall, MD St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP