A Commitment Device for Medication Adherence Among HIV Patients
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| First Received Date ICMJE | October 13, 2011 | ||||||||
| Last Updated Date | May 16, 2012 | ||||||||
| Start Date ICMJE | October 2011 | ||||||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Viral Loads [ Time Frame: Up to three years ] [ Designated as safety issue: No ] The investigators will measure the patients' viral loads to see if their health behaviors have changed. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01455740 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Commitment Device for Medication Adherence Among HIV Patients | ||||||||
| Official Title ICMJE | A Commitment Device for Medication Adherence Among HIV Patients | ||||||||
| Brief Summary | The goal is to improve HIV patients' adherence to medication regimens. The investigators are planning an intervention in which the patient is given financial incentives to take clinic attendance seriously, and then given the option to make these incentives contingent on taking medications as prescribed—that is, to require better behavior from themselves to earn the same reward. Past studies have shown that conditional payments improve adherence to HIV treatment, but only while payments are being made. The investigators expect that patients will be willing to give up some payments to commit themselves to better adherence. The investigators also hope to see some patients maintaining good adherence after financial incentives are removed, among those who are given the opportunity to choose this commitment. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Medication Adherence among HIV/AIDS Patients
If patients are interested and available, they will be scheduled for a first study visit ("study visit 1") involving enrollment and baseline data collection. The second ("study visit 2"), third ("3"), fourth ("4"), and fifth ("5") study visits will be used to implement the intervention with financial incentives and will involve data collection. The sixth ("6") will involve only data collection; there should be time during the sixth to complete chart extraction—for hospital, pharmacy, and clinical records. Subjects will be told that study visit 5 is "the end of the study", although we "may follow up later". Study visit 6 will be an unanticipated meeting. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | October 2014 | ||||||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01455740 | ||||||||
| Other Study ID Numbers ICMJE | 0005 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | National Bureau of Economic Research, Inc. | ||||||||
| Study Sponsor ICMJE | National Bureau of Economic Research, Inc. | ||||||||
| Collaborators ICMJE | Emory University | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Bureau of Economic Research, Inc. | ||||||||
| Verification Date | May 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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