A Commitment Device for Medication Adherence Among HIV Patients

HIV Clinical Trial

Official title:

A Commitment Device for Medication Adherence Among HIV Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01455740
• Other study ID #: 0005
• Status: Completed
• Phase: N/A
• First received: October 13, 2011
• Last updated: December 14, 2017
• Start date: October 2011
• Est. completion date: October 2014

Study information

• Verified date: December 2017
• Source: National Bureau of Economic Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Behavioral:
• Provider Visit Incentive (PVI)
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.
• Incentive Choice (IC)
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.

Locations

Country	Name	City	State
United States	Emory University Ponce Clinic	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
National Bureau of Economic Research, Inc.	Emory University

Country where clinical trial is conducted

United States, 

References & 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.00 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virologic Suppression (pVL =< 200 copies/mL) at Fifth Study Visit		12 months (median)
Secondary	Virologic Suppression (pVL =< 200 copies/mL) at Unanticipated Sixth Study Visit		15 months (median)