Acquired Immunodeficiency SyndromeNCT01455740
A Commitment Device for Medication Adherence Among HIV Patients
A study testing Provider Visit Incentive (PVI) and Incentive Choice (IC) in people with Acquired Immunodeficiency Syndrome and HIV, run by National Bureau of Economic Research, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Immunodeficiency Syndrome, HIV
- What is being tested?
- Provider Visit Incentive (PVI) and Incentive Choice (IC)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Using pillboxes
- Were planning to relocate
- Were enrolled in another trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Ponce Clinic
Atlanta, Georgia, 30308
About this study
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.
Read the 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.
- Conditions
- Acquired Immunodeficiency Syndrome, HIV
- Being tested
- Provider Visit Incentive (PVI), Incentive Choice (IC)
- Keywords
- Acquired Immunodeficiency Syndrome, HIV, Commitment, Financial Incentives
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider Visit Incentive (PVI)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Provider Visit Incentive (PVI) | Experimental | 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. Receives: Behavioral: Provider Visit Incentive (PVI) |
| Incentive Choice (IC) | Experimental | 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. Receives: Behavioral: Incentive Choice (IC) |
| Passive Control (PC) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virologic Suppression (pVL =< 200 copies/mL) at Fifth Study Visit
Measured: 12 months (median)
Secondary outcomes (1)
Virologic Suppression (pVL =< 200 copies/mL) at Unanticipated Sixth Study Visit
Measured: 15 months (median)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acquired Immunodeficiency SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Bureau of Economic Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University
- Responsible party
- Sponsor
- Investigators
- David I Laibson, Ph.D., Principal investigator, National Bureau of Economic Research, Harvard UniversityVincent Marconi, M.D., Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455740
- Sponsor's protocol ID
- 0005
- Status last verified
- Dec 2017
- First submitted
- 13 Oct 2011
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28514277
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Commitment Device for Medication Adherence Among HIV Patients
- ClinicalTrials.gov ID
- NCT01455740
- Acronym / sponsor ID
- 0005
- Conditions
- Acquired Immunodeficiency Syndrome, HIV
- Keywords
- Acquired Immunodeficiency Syndrome, HIV, Commitment, Financial Incentives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- National Bureau of Economic Research, Inc.University, hospital or other
- Collaborators
- Emory University
- Study start
- Oct 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Provider Visit Incentive (PVI) | Experimental | Behavioral: 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) | Experimental | Behavioral: 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. |
| Passive Control (PC) | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Using pillboxes
- Were planning to relocate
- Were enrolled in another trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Provider Visit Incentive (PVI) |
| 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. | Behavioural | Incentive Choice (IC) |
Primary outcome
Virologic Suppression (pVL =< 200 copies/mL) at Fifth Study Visit
Time frame: 12 months (median)
1 secondary outcome
Virologic Suppression (pVL =< 200 copies/mL) at Unanticipated Sixth Study Visit
Time frame: 15 months (median)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Results publication: PubMed 28514277Alsan 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David I Laibson, Ph.D. principal investigator
National Bureau of Economic Research, Harvard University
Vincent Marconi, M.D. principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provider Visit Incentive (PVI) and Incentive Choice (IC) in people with Acquired Immunodeficiency Syndrome and HIV, run by National Bureau of Economic Research, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virologic Suppression (pVL =< 200 copies/mL) at Fifth Study Visit (time frame: 12 months (median)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01455740, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2017.