Clinical trial NCT01455740: A Commitment Device for Medication Adherence Among HIV Patients
Official title: A Commitment Device for Medication Adherence Among HIV Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Immunodeficiency Syndrome
HIV
Keywords: Acquired Immunodeficiency Syndrome
HIV
Commitment
Financial Incentives
Lead sponsor: National Bureau of Economic Research, Inc.
Sponsor class: OTHER
Collaborators: name: Emory University
First posted: 2011-10-20
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Virologic Suppression (pVL =< 200 copies/mL) at Fifth Study Visit
timeFrame: 12 months (median)
Secondary outcomes:
measure: Virologic Suppression (pVL =< 200 copies/mL) at Unanticipated Sixth Study Visit
timeFrame: 15 months (median)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Ponce Clinic
state: Georgia
Study officials:
affiliation: National Bureau of Economic Research, Harvard University
name: David I Laibson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Vincent Marconi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.