A Commitment Device for Medication Adherence Among HIV Patients
1 other identifier
interventional
110
1 country
1
Brief Summary
We used a randomized trial design combined with a comparison to a non-randomized control group to study patients on appropriate antiretroviral therapy (ART) having virologic failure within a publicly-funded HIV clinic serving Atlanta, GA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 13, 2011
CompletedFirst Posted
Study publicly available on registry
October 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedDecember 18, 2017
December 1, 2017
1.7 years
October 13, 2011
December 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Virologic Suppression (pVL =< 200 copies/mL) at Fifth Study Visit
12 months (median)
Secondary Outcomes (1)
Virologic Suppression (pVL =< 200 copies/mL) at Unanticipated Sixth Study Visit
15 months (median)
Study Arms (3)
Provider Visit Incentive (PVI)
EXPERIMENTALParticipants were told that they would receive $30 after attending each scheduled provider visit (a CCT). A block randomization scheme, stratified on whether or not the majority of the participant's three previous viral load measurements were suppressed, assigned 21 individuals to the PVI arm.
Incentive Choice (IC)
EXPERIMENTALParticipants were given a choice between the CCT described in the PVI arm and a commitment contract, which made the $30 payment conditional on the patient attending the provider visit AND meeting an ART adherence threshold. A block randomization scheme, stratified on whether or not the majority of the participant's three previous viral load measurements were suppressed, assigned 19 individuals to the IC arm.
Passive Control (PC)
NO INTERVENTIONThe study also included 70 individuals in a PC arm, who did not receive financial incentives. Individuals in the PC arm were not enrolled in the randomized trial but met basic study eligibility criteria during the same time period.
Interventions
All participants received the standard of care (SOC), which included not only medical care but also a wide range of social services. In addition, participants in the PVI arm received financial incentives designed to motivate health-improving behaviors. After the initial study enrollment visit, participants in the PVI arm received a $30 payment each time they showed up as scheduled for one of their next four HIV primary care visits. Participants in the PVI arm were also asked to return for a sixth, unanticipated study visit approximately three months after the last of the four study visits to which the incentive scheme applied. To reduce attrition, participants were offered $100 for showing up to the fifth and sixth study visits.
All participants received the SOC. In addition, participants in the IC arm received financial incentives designed to motivate health-improving behaviors. At the initial study enrollment visit, participants in the IC arm chose between either the incentive scheme assigned to the PVI arm or an incentive scheme that tied payments to clinic attendance and ART medication adherence. Participants who selected the 2nd option received a $30 payment at each of their next 4 HIV primary care visits if the (i) showed up as scheduled and (ii) presented a dose-recording pill bottle cap indicating that they correctly took at least 90% of doses of a sentinal medication since the previous study visit. Participants in the IC arm were also asked to return for a 6th, unanticipated study visit approximately three months after the last of the 4 study visits to which the incentive scheme applied. To reduce attrition, participants were offered $100 for showing up to the 5th and 6th study visits.
Eligibility Criteria
You may qualify if:
- Attended the Grady Health System Infectious Disease Program (IDP)
- Most recent HIV-1 plasma RNA viral load (pVL) \> 200 copies/mL; this value must have been measured within the prior 18 months and at least 6 months after starting the current ART regimen
- English-speaking
You may not qualify if:
- Using pillboxes
- Were planning to relocate
- Were enrolled in another trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Bureau of Economic Research, Inc.lead
- Emory Universitycollaborator
Study Sites (1)
Emory University Ponce Clinic
Atlanta, Georgia, 30308, United States
Related Publications (1)
Alsan M, Beshears J, Armstrong WS, Choi JJ, Madrian BC, Nguyen MLT, Del Rio C, Laibson D, Marconi VC. A commitment contract to achieve virologic suppression in poorly adherent patients with HIV/AIDS. AIDS. 2017 Jul 31;31(12):1765-1769. doi: 10.1097/QAD.0000000000001543.
PMID: 28514277RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David I Laibson, Ph.D.
National Bureau of Economic Research, Harvard University
- PRINCIPAL INVESTIGATOR
Vincent Marconi, M.D.
Emory University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2011
First Posted
October 20, 2011
Study Start
October 1, 2011
Primary Completion
June 1, 2013
Study Completion
October 1, 2014
Last Updated
December 18, 2017
Record last verified: 2017-12