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Evaluating Rewards-Based Adherence and Electronic Medication Monitoring in HIV-Positive Adolescents
This study has been completed.
Sponsor:
St. Jude Children's Research Hospital
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
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Purpose
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.
| Condition | Intervention |
|---|---|
| Human Immunodeficiency Virus (HIV) Acquired Immunodeficiency Syndrome (AIDS) | Other: Questionnaire |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Incentives and Technology Survey 2013: Evaluation of Acceptance of Incentive-Based Adherence Programs and Electronic Medication Monitoring Among HIV-Positive Adolescents |
Resource links provided by NLM:
Further study details as provided by St. Jude Children's Research Hospital:
Primary Outcome Measures:
- Reported perceptions about incentive-based adherence programs and electronic medication monitoring [ Time Frame: Once, at enrollment ]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.
| Enrollment: | 100 |
| Study Start Date: | June 2013 |
| Study Completion Date: | December 2013 |
| Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Study Population
Participants must meet the eligibility requirements will complete a questionnaire on the computer.
|
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 16 Years to 24 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
HIV-positive adolescents between the ages of 16 and 24 years who are currently undergoing treatment with antiretrovirals at St. Jude's HIV clinic.
Criteria
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01849393
Please refer to this study by its ClinicalTrials.gov identifier: NCT01849393
Locations
| United States, Tennessee | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
| Principal Investigator: | Mary Westfall, MD | St. Jude Children's Research Hospital |
More Information
Additional Information:
| Responsible Party: | St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT01849393 History of Changes |
| Other Study ID Numbers: |
INTECH |
| Study First Received: | May 6, 2013 |
| Last Updated: | December 12, 2013 |
Keywords provided by St. Jude Children's Research Hospital:
|
Adolescents Medication Compliance Rewards-Based Incentive Programs |
Additional relevant MeSH terms:
|
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections |
RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on August 16, 2017