HIVRAPNCT02503072
Rewarding Adherence Program - an Intervention Using Small Prizes Allocated by a Prize Drawing to Increase ARV Adherence
A study testing Small lottery prizes based on adherence and Small lottery prizes based on timely clinic visits in people with HIV, run by RAND at 1 site in Uganda.
Trial summary
The goal of this study is to identify ways for implementing small prizes allocated by a drawing to improve adherence to antiretroviral medication in an HIV clinic in Kampala, Uganda. The study is called Rewarding Adherence Program (RAP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Small lottery prizes based on adherence and Small lottery prizes based on timely clinic visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteUganda
- Study dates
- Mar 2013to Mar 2016
- 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
- patient at Mildmay Kampala clinic
- on antiretroviral medication (ARV) for at least two years
- shows recent adherence problems (missing a clinic visit or pharmacy refill in the last six months)
Who cannot join
- not able to understand study procedures and/or provide informed consent
- not fluent in either English or Luganda (the two main languages spoken around Kampala)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Variable Rewards Incentives for ART Adherence in Uganda
The goal of this study is to identify ways for implementing small prizes allocated by a drawing to improve adherence to antiretroviral medication in an HIV clinic in Kampala, Uganda. The study is called Rewarding Adherence Program (RAP).
Read the detailed description
The proposed 3-year study will develop and test RAP for incentivizing ART clients to remain engaged in care and highly adherent to their medication. Phase 1 of the project will consist of focus groups with patients, clinic providers and directors, and community leaders and will elicit information on barriers and facilitators of long-term retention and adherence maintenance, how to best implement the intervention to ensure acceptability and feasibility, and perceptions of the transportability of the planned intervention. Parameters of the intervention that will be probed include the frequency, type, and value of the prizes, and award presentation. Phase 2 will build on Phase 1 to develop and pilot test the RAP in a 20 months long randomized controlled trial (RCT) among clients who have been on ART for at least 2 years and have problems with missed clinic appointments or ART doses. Primary assessments will be administered at screening and months 4, 8, 14 and 20. In Phase 3 some adjustments to the intervention will be made after reviewing Phase 2 data, if needed, and then the intervention will be administered to the control group for 6 months to assess effects on adherence in this group (the original intervention group will not participate in this phase). Finally, the investigators will conduct focus groups with providers, implementers, and study participants to learn about implementation difficulties and areas for future improvement. Study findings will directly inform the design parameters of a larger, more rigorous evaluation in an R01 application that will focus on the cost-effectiveness and sustainability of the intervention.
- Conditions
- HIV
- Being tested
- Small lottery prizes based on adherence, Small lottery prizes based on timely clinic visits
- Keywords
- ARV adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small lottery prizes based on adherenceBehavioural
Clients coming for clinic visits have their MEMS data extracted, and if they show 95% adherence or higher are eligible to draw a number (1-6) out of a closed bag without looking; if they draw a '6' they win a small prize.
Small lottery prizes based on timely clinic visitsBehavioural
Clients coming for clinic visits have their patient booklet checked to confirm that they came on their scheduled day; if so, they are eligible to draw a number (1-6) out of a closed bag without looking; if they draw a '6' they win a small prize.
| Study group | Role | What they receive |
|---|---|---|
| Prizes conditional on adherence | Active comparator | Participants in this group are eligible for a prize drawing if they come on their scheduled clinic day. They receive the intervention 'Behavioral: Small lottery prizes based on adherence'. Receives: Behavioral: Small lottery prizes based on adherence |
| Prizes conditional on clinic visits | Active comparator | Participants in this group are eligible for a prize drawing if they show 95% adherence or higher based on their MEMS-cap measured adherence. They receive the intervention 'Behavioral: Small lottery prizes based on timely clinic visits'. Receives: Behavioral: Small lottery prizes based on timely clinic visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Event Monitoring System (MEMS) cap measured adherence
Change in adherence over the course of the study
Measured: 20 months
Medication Event Monitoring System (MEMS) cap measured adherence
Change in adherence over the first nine months of the study as an interim outcome
Measured: 9 months
Secondary outcomes (2)
Timely clinic visits
Number of timely clinic visits as a fraction of all scheduled clinic visits over the course of the study
Measured: 20 months
Self-reported adherence
Adherence level as reported by the patient at month 20
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startMar 2013
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- Mildmay Uganda Limited
- Responsible party
- Sponsor
- Investigators
- Sebastian Linnemayr, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503072
- Sponsor's protocol ID
- 1R34MH096609-01A1
- Acronym
- RAP
- Status last verified
- Sep 2016
- First submitted
- 14 Jul 2015
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Stecher C, Mukasa B, Linnemayr S. Uncovering a behavioral strategy for establishing new habits: Evidence from incentives for medication adherence in Uganda. J Health Econ. 2021 May;77:102443. doi: 10.1016/j.jhealeco.2021.102443. Epub 2021 Mar 16.
PubMed 33831632Wagner GJ, Ghosh-Dastidar B, Mukasa B, Linnemayr S. Changes in ART Adherence Relate to Changes in depression as Well! Evidence for the Bi-directional Longitudinal Relationship Between Depression and ART Adherence from a Prospective Study of HIV Clients in Uganda. AIDS Behav. 2020 Jun;24(6):1816-1824. doi: 10.1007/s10461-019-02754-8.
PubMed 31813077Linnemayr S, Stecher C, Mukasa B. Behavioral economic incentives to improve adherence to antiretroviral medication. AIDS. 2017 Mar 13;31(5):719-726. doi: 10.1097/QAD.0000000000001387.
PubMed 28225450
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variable Rewards Incentives for ART Adherence in Uganda
- ClinicalTrials.gov ID
- NCT02503072
- Acronym / sponsor ID
- RAP / 1R34MH096609-01A1
- Conditions
- HIV
- Keywords
- ARV adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- Mildmay Uganda Limited
- Study start
- Mar 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 20 Jul 2015 (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.
The goal of this study is to identify ways for implementing small prizes allocated by a drawing to improve adherence to antiretroviral medication in an HIV clinic in Kampala, Uganda. The study is called Rewarding Adherence Program (RAP).
Detailed description
The proposed 3-year study will develop and test RAP for incentivizing ART clients to remain engaged in care and highly adherent to their medication. Phase 1 of the project will consist of focus groups with patients, clinic providers and directors, and community leaders and will elicit information on barriers and facilitators of long-term retention and adherence maintenance, how to best implement the intervention to ensure acceptability and feasibility, and perceptions of the transportability of the planned intervention. Parameters of the intervention that will be probed include the frequency, type, and value of the prizes, and award presentation. Phase 2 will build on Phase 1 to develop and pilot test the RAP in a 20 months long randomized controlled trial (RCT) among clients who have been on ART for at least 2 years and have problems with missed clinic appointments or ART doses. Primary assessments will be administered at screening and months 4, 8, 14 and 20. In Phase 3 some adjustments to the intervention will be made after reviewing Phase 2 data, if needed, and then the intervention will be administered to the control group for 6 months to assess effects on adherence in this group (the original intervention group will not participate in this phase). Finally, the investigators will conduct focus groups with providers, implementers, and study participants to learn about implementation difficulties and areas for future improvement. Study findings will directly inform the design parameters of a larger, more rigorous evaluation in an R01 application that will focus on the cost-effectiveness and sustainability of the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prizes conditional on adherence | Active comparator | Behavioral: Small lottery prizes based on adherenceParticipants in this group are eligible for a prize drawing if they come on their scheduled clinic day. They receive the intervention 'Behavioral: Small lottery prizes based on adherence'. |
| Prizes conditional on clinic visits | Active comparator | Behavioral: Small lottery prizes based on timely clinic visitsParticipants in this group are eligible for a prize drawing if they show 95% adherence or higher based on their MEMS-cap measured adherence. They receive the intervention 'Behavioral: Small lottery prizes based on timely clinic visits'. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient at Mildmay Kampala clinic
- on antiretroviral medication (ARV) for at least two years
- shows recent adherence problems (missing a clinic visit or pharmacy refill in the last six months)
Key exclusion criteria (2 listed)
- not able to understand study procedures and/or provide informed consent
- not fluent in either English or Luganda (the two main languages spoken around Kampala)
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 |
|---|---|---|
| Small lottery prizes based on adherenceClients coming for clinic visits have their MEMS data extracted, and if they show 95% adherence or higher are eligible to draw a number (1-6) out of a closed bag without looking; if they draw a '6' they win a small prize. | Behavioural | Prizes conditional on adherence |
| Small lottery prizes based on timely clinic visitsClients coming for clinic visits have their patient booklet checked to confirm that they came on their scheduled day; if so, they are eligible to draw a number (1-6) out of a closed bag without looking; if they draw a '6' they win a small prize. | Behavioural | Prizes conditional on clinic visits |
Primary outcome
Medication Event Monitoring System (MEMS) cap measured adherence
Time frame: 20 months
Change in adherence over the course of the study
Medication Event Monitoring System (MEMS) cap measured adherence
Time frame: 9 months
Change in adherence over the first nine months of the study as an interim outcome
2 secondary outcomes
Timely clinic visits
Time frame: 20 months
Self-reported adherence
Time frame: 20 months
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 29 Sep 2016.
- Derived from this study: PubMed 33831632Stecher C, Mukasa B, Linnemayr S. Uncovering a behavioral strategy for establishing new habits: Evidence from incentives for medication adherence in Uganda. J Health Econ. 2021 May;77:102443. doi: 10.1016/j.jhealeco.2021.102443. Epub 2021 Mar 16.
- Derived from this study: PubMed 31813077Wagner GJ, Ghosh-Dastidar B, Mukasa B, Linnemayr S. Changes in ART Adherence Relate to Changes in depression as Well! Evidence for the Bi-directional Longitudinal Relationship Between Depression and ART Adherence from a Prospective Study of HIV Clients in Uganda. AIDS Behav. 2020 Jun;24(6):1816-1824. doi: 10.1007/s10461-019-02754-8.
- Derived from this study: PubMed 28225450Linnemayr S, Stecher C, Mukasa B. Behavioral economic incentives to improve adherence to antiretroviral medication. AIDS. 2017 Mar 13;31(5):719-726. doi: 10.1097/QAD.0000000000001387.
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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.
Sebastian Linnemayr, PhD principal investigator
RAND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small lottery prizes based on adherence and Small lottery prizes based on timely clinic visits in people with HIV, run by RAND at 1 site in Uganda.
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 2 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 29 Sep 2016. 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 Uganda. 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?
Medication Event Monitoring System (MEMS) cap measured adherence (time frame: 20 months). The study lists 2 primary outcomes in all. 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 NCT02503072, which also lists 3 linked publications.
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 29 Sep 2016.