A Commitment Device for Medication Adherence Among HIV Patients

Not Applicable

Completed

• Conditions: HIV; Acquired Immunodeficiency Syndrome
• Interventions: Behavioral: Provider Visit Incentive (PVI); Behavioral: Incentive Choice (IC)

• Registration Number: NCT01455740
• Lead Sponsor: National Bureau of Economic Research, Inc.

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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-13
• Study First Submitted QC: 2011-10-19
• Study First Posted: 2011-10-20
• Primary Completion: 2013-06
• Study Completion: 2014-10
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-14
• Last Update Posted: 2017-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Provider Visit Incentive (PVI)	Provider Visit Incentive (PVI)	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.
Incentive Choice (IC)	Incentive Choice (IC)	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.

Primary Outcome Measures

Name	Time	Method
Virologic Suppression (pVL =< 200 copies/mL) at Fifth Study Visit	12 months (median)

Secondary Outcome Measures

Name	Time	Method
Virologic Suppression (pVL =< 200 copies/mL) at Unanticipated Sixth Study Visit	15 months (median)

Trial Locations

Locations (1)

Emory University Ponce Clinic; 🇺🇸 Atlanta, Georgia, United States