A Commitment Device for Medication Adherence Among HIV Patients - Full Text View

Purpose

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.

Condition	Intervention
Acquired Immunodeficiency Syndrome HIV	Other: Medication Adherence among HIV/AIDS Patients

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	A Commitment Device for Medication Adherence Among HIV Patients

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by National Bureau of Economic Research, Inc.:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

CD4 Counts [ Time Frame: Up to three years ] [ Designated as safety issue: No ]
The investigators will measure the patients' CD4 counts to see if they have changed due to a change in health behavior.
Provider Check-up Attendance [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
The investigators will track attendance at provider check-ups to measure patients' adherence to the health plan set out by their physician.
Adherence to Medical Regimen [ Time Frame: Up to three years ] [ Designated as safety issue: No ]
The investigators will measure patients' adherence to their medical regimen.
Attitude and Motivation [ Time Frame: Up to two years ] [ Designated as safety issue: No ]
The investigators will measure patients' attitude and motivation through the use of surveys.
Demographic Considerations [ Time Frame: Up to two years ] [ Designated as safety issue: No ]
The investigators will examine demographic characteristics to see if there are correlates to other outcomes.

Estimated Enrollment:	40
Study Start Date:	October 2011
Estimated Study Completion Date:	October 2014
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Incentive Choice Arm In the Incentive Choice arm, patients will first be presented with a brief explanation of the differences between the Attend-Check-up-Get-Paid arm and the Take-Meds-Get-Paid arm. The RC has a paper diagram that he will use in the explanation. Only after patients make a decision are they given a full walk-through of what they need to do to receive their incentive payment, as in the above Attendance Incentive arm. There is the question of how much detail we might want to shift from the walk-through to the initial brief explanation of the Attend-Check-up-Get-Paid arm and the Take-Meds-Get-Paid arm.	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.
Experimental: Attendance Incentive Arm In the Attendance Incentive arm, patients will be given a walk-through of what they need to do to receive their incentive payment, which would include attending their provider check-up, seeing the RC and remembering to bring their MEMs bottle.	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.

Arms

Assigned Interventions

Experimental: Incentive Choice Arm

In the Incentive Choice arm, patients will first be presented with a brief explanation of the differences between the Attend-Check-up-Get-Paid arm and the Take-Meds-Get-Paid arm. The RC has a paper diagram that he will use in the explanation. Only after patients make a decision are they given a full walk-through of what they need to do to receive their incentive payment, as in the above Attendance Incentive arm. There is the question of how much detail we might want to shift from the walk-through to the initial brief explanation of the Attend-Check-up-Get-Paid arm and the Take-Meds-Get-Paid arm.

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.

Experimental: Attendance Incentive Arm

In the Attendance Incentive arm, patients will be given a walk-through of what they need to do to receive their incentive payment, which would include attending their provider check-up, seeing the RC and remembering to bring their MEMs bottle.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The patient's most recent ART regimen has been in place for at least 24 weeks, counting back from the patient's most recently scheduled provider check-up.
Of viral load assays taken at least 24 weeks after the start of the patient's most recent ART regimen, the latest assay is higher than 400 copies/mL.
Patient is at least 18 years of age.
Patient collects his/her HIV medication only from the Ponce clinic.
Patient is not involved in another study.
Patient is not currently using a pill box or organizer.
Patient is not moving out of the area within the next 18 months.
Patient is not on the do-not-contact list.

Exclusion Criteria:

Patient is involved in another study.
Patient uses a pill box or organizer.
Patient is moving out of the area in the next 18 months.
Patient is on the do-not-contact list.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455740

Locations

United States, Georgia
Emory University Ponce Clinic
Atlanta, Georgia, United States, 30308

Sponsors and Collaborators

National Bureau of Economic Research, Inc.

Emory University

Investigators

Principal Investigator:	David I Laibson, Ph.D.	National Bureau of Economic Research, Harvard University
Principal Investigator:	Vincent Marconi, M.D.	Emory University

More Information

No publications provided

Responsible Party:	National Bureau of Economic Research, Inc.
ClinicalTrials.gov Identifier:	NCT01455740 History of Changes
Other Study ID Numbers:	0005
Study First Received:	October 13, 2011
Last Updated:	May 16, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by National Bureau of Economic Research, Inc.:

Acquired Immunodeficiency Syndrome
HIV
Commitment
Financial Incentives

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections

Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013