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A Commitment Device for Medication Adherence Among HIV Patients

Primary Purpose

Acquired Immunodeficiency Syndrome, HIV

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Provider Visit Incentive (PVI)
Incentive Choice (IC)
Sponsored by
National Bureau of Economic Research, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acquired Immunodeficiency Syndrome focused on measuring Acquired Immunodeficiency Syndrome, HIV, Commitment, Financial Incentives

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Using pillboxes
  • Were planning to relocate
  • Were enrolled in another trial

Sites / Locations

  • Emory University Ponce Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Provider Visit Incentive (PVI)

Incentive Choice (IC)

Passive Control (PC)

Arm Description

Participants 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.

Participants 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.

The 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.

Outcomes

Primary Outcome Measures

Virologic Suppression (pVL =< 200 copies/mL) at Fifth Study Visit

Secondary Outcome Measures

Virologic Suppression (pVL =< 200 copies/mL) at Unanticipated Sixth Study Visit

Full Information

First Posted
October 13, 2011
Last Updated
December 14, 2017
Sponsor
National Bureau of Economic Research, Inc.
Collaborators
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT01455740
Brief Title
A Commitment Device for Medication Adherence Among HIV Patients
Official Title
A Commitment Device for Medication Adherence Among HIV Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Bureau of Economic Research, Inc.
Collaborators
Emory University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This study demonstrated the feasibility of using commitment contracts in HIV care. Many previous interventions have produced statistically significant effects on ART adherence that do not persist after the intervention ends. A notable feature of our study is that after the incentives for ART adherence and provider visits were removed, participants who had been offered a commitment contract for ART adherence were more likely to achieve virologic suppression relative to individuals who had been assigned a conditional cash transfer for provider visits and relative to individuals who had been assigned the standard of care, although the difference was only statistically significant in the latter comparison. There were differences in the prevalence of missing outcomes across groups, but these differences were not statistically significant for the unanticipated post-incentive visit and therefore were unlikely to be the explanation for the results. Thus, financial rewards coupled with individual choice can increase engagement in healthy behaviors after incentives are removed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Immunodeficiency Syndrome, HIV
Keywords
Acquired Immunodeficiency Syndrome, HIV, Commitment, Financial Incentives

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study used a randomized trial design for two treatment arms: (i) Participants in the provider visit incentive (PVI) arm were told that they would receive $30 after attending each scheduled provider visit (a CCT). (ii) Participants in the incentive choice (IC) were given a choice between the above CCT 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 no the majority of the participant's three previous viral load measurements were suppressed, assigned 21 individuals to the PVI arm and 19 to the IC arm.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Provider Visit Incentive (PVI)
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Incentive Choice (IC)
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Passive Control (PC)
Arm Type
No Intervention
Arm Description
The 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.
Intervention Type
Behavioral
Intervention Name(s)
Provider Visit Incentive (PVI)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Incentive Choice (IC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Virologic Suppression (pVL =< 200 copies/mL) at Fifth Study Visit
Time Frame
12 months (median)
Secondary Outcome Measure Information:
Title
Virologic Suppression (pVL =< 200 copies/mL) at Unanticipated Sixth Study Visit
Time Frame
15 months (median)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Using pillboxes Were planning to relocate Were enrolled in another trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David I Laibson, Ph.D.
Organizational Affiliation
National Bureau of Economic Research, Harvard University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vincent Marconi, M.D.
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Ponce Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28514277
Citation
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.
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A Commitment Device for Medication Adherence Among HIV Patients

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