HIV/AIDSNCT03494777
Behavioral Economics Incentives to Support HIV Treatment Adherence in Sub-Saharan Africa
A study testing Incentivization based on high adherence, Incentivization based on timely clinic visit and Annual adherence prize drawing in people with HIV/AIDS, run by RAND at 1 site in Uganda.
Trial summary
This study will implement an intervention in a two-year randomized controlled trial (RCT) to establish efficacy on viral suppression as a biological endpoint, compare the effectiveness of two different modes of implementation (including one entirely based on readily available clinic data), and investigate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Incentivization based on high adherence, Incentivization based on timely clinic visit and Annual adherence prize drawing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 1 siteUganda
- Study dates
- 11 Apr 2018to 2 Oct 2023
- 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
- 18 years of age or older
- at Mildmay clinic on ART for at least two years
- adherence problems in the last six months
- Note: for the 70 treatment initiators to be recruited in addition to the main sample of 330 treatment-mature clients (on which the main analysis will focus), the inclusion criteria are:
- 18 years of age or older
- started on ART at Mildmay clinic within the last six months
Who cannot join
- not able to understand the consent form and study procedures
- language other than Luganda or English
- not willing to consistently use the MEMS caps device for adherence measurement
Trial locations and contacts
1 site in 1 country.
About this study
This study will implement an intervention in a two-year randomized controlled trial (RCT) to establish efficacy on viral suppression as a biological endpoint, compare the effectiveness of two different modes of implementation (including one entirely based on readily available clinic data), and investigate cost-effectiveness. Participants in the first intervention group (T1, n=110) will be eligible for small lottery prizes based on timely clinic visits, and qualify for an annual lottery conditional if demonstrating viral suppression; those in the second group (T2, n=110) will draw prizes conditional on electronically measured adherence at each clinic visit, and also participate in an annual lottery that is conditional on high adherence throughout the year. The control group (n=110) will receive the usual standard of care. Assessments will be conducted at baseline and then every six months. Primary outcomes are undetectable viral load and electronically measured adherence.
Read the detailed description
It is imperative to find ways to boost ART adherence in sub-Saharan Africa where adherence rates have been found to decline over time, and where treatment options such as second-line regimens are limited. A promising tool is the use of incentives based on insights from behavioral economics (BE) for healthy HIV-related behavior. The proposed R01 study is based on the results of the PI's R34 'Rewarding Adherence Program (RAP)' [R34 MH096609] that demonstrated feasibility and acceptability of incentives allocated by a drawing for HIV-related behaviors, and established preliminary efficacy. The current R01 study builds on these promising results with the aim to a) use viral loads as biological endpoints that were not included in the R34 for cost reasons; b) establish efficacy in a fully powered intervention as well as comparative efficacy of two different ways of implementing the incentives including one arm that has been adapted to changing clinical guidelines and can be implemented with readily available data from clinic records; and c) assess the cost effectiveness of these two implementation modes as a further input for policy-makers. The intervention is targeted at increasing the motivation of HIV clients who have been on ART for several years through the benefit and joy of prize drawings, thereby attempting to overcome the treatment 'fatigue' that can develop in the context of mundane, daily pill taking over the course of life-long treatment. Insights from behavioral economics suggest that such an intervention may be particularly effective for people with present bias (those who have a tendency to give in to short-term temptation at the cost of more long-term benefits) that was found to be prevalent among HIV clients in the R34 study. The intervention will be implemented among 330 adult clients in three groups: for the first intervention group, timely clinic attendance will constitute the eligibility criteria for participating in a prize drawing at each scheduled clinic visit; participants are also eligible for an annual prize drawing based on showing viral suppression. The second treatment group will be incentivized on demonstrated high ART adherence between clinic visits that also determine the winning chances at an annual prize drawing. The control group will receive the usual standard of care. All participants will receive MEMS caps to record adherence and assessments over 24 months (at baseline and every 6 months thereafter). The first Specific Aim will be to evaluate the effectiveness of the intervention; the second aim is to compare the relative effectiveness of the adherence-based arm and the arm directly incentivizing viral suppression that uses only data readily available in the clinic. The third Specific Aim is to perform a comparative cost-effectiveness analysis of the two intervention arms as a further policy input. If proven efficacious, the intervention as implemented in the newly adapted arm based on viral load suppression can be readily taken over by the clinic and scaled at low cost to other clinics.
In the study also 70 treatment initiating clients (in addition to the 330 treatment mature clients described above) will be recruited, but they will be excluded from the main analysis. [Note on 9/7/2019: due to funding, we will not recruit this additional sample of treatment initiating clients]
- Conditions
- HIV/AIDS
- Being tested
- Incentivization based on high adherence, Incentivization based on timely clinic visit, Annual adherence prize drawing, Annual viral suppression-based prize drawing, Year 2 booster
- Keywords
- ART adherence
- 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.
Incentivization based on high adherenceBehavioural
When a participant comes for a regular clinic visit, s/he will have the MEMS data extracted, and if adherence over the previous month >=90%, will participate in a prize drawing.
Incentivization based on timely clinic visitBehavioural
When a participant comes for a regular clinic visit on the day s/he is scheduled, s/he will participate in a prize drawing.
Annual adherence prize drawingBehavioural
Participants will have a chance to take part in an annual drawing where eligibility is based on the average adherence during that year.
Annual viral suppression-based prize drawingBehavioural
Participants will have a chance to take part in an annual drawing where eligibility is based on showing viral suppression.
Year 2 boosterBehavioural
Those participants not showing viral suppression at month 12 will be randomized in a 1:1 fashion to receive an additional intervention component or continue receiving the same intervention arm as in Year 1.
| Study group | Role | What they receive |
|---|---|---|
| Adherence-based incentivization | Experimental | Participants will be eligible for prize drawings at every regular clinic visit based on high adherence as measured by MEMS-caps. In addition there will be an annual prize drawing that is conditional on showing high adherence over the course of the year.
This arm will receive the intervention 'Incentivization based on high adherence' and the intervention 'Annual adherence prize drawing' and (if eligible) the intervention 'Year 2 booster'.
Note: the 70 treatment initiating clients will all be assigned to this arm to receive preliminary data as to whether incentives may work for this group. Receives: Behavioral: Incentivization based on high adherence; Behavioral: Annual adherence prize drawing; Behavioral: Year 2 booster |
| Viral suppression-based incentivization | Experimental | Participants will be able to participate in prize drawings at every clinic visit where eligibility will be based on timely drug refills (that coincide with the clinic visits). Participants will also have a chance to enter a prize drawing at the end of every year if they show viral suppression.
This arm will receive the intervention 'Incentivization based on timely clinic visit' and the intervention 'Annual viral suppression-based prize drawing', and (if eligible) the intervention 'Year 2 booster'. Receives: Behavioral: Incentivization based on timely clinic visit; Behavioral: Annual viral suppression-based prize drawing; Behavioral: Year 2 booster |
| Control | No intervention | This arm will receive care as usual, including the adherence support mechanisms that are part of usual care practices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electronically measured adherence
Number of ART doses taken / number of doses prescribed
Measured: 12 months
Electronically measured adherence
Number of ART doses taken / number of doses prescribed
Measured: 24 months
Viral suppression
Viral load <=200 copies/mL
Measured: At month 12
Viral suppression
Viral load <=200 copies/mL
Measured: At month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start11 Apr 2018
- Primary completion2 Oct 2023
- Study completion2 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Randomized controlled trial with two intervention arms and a control group will receive an intervention for twelve months; those not showing viral suppression at month 12 will be randomized to either continue receiving the year 1 intervention for another twelve months, or receive an additional intervention component for twelve months. The main analysis will be based on the sample of 330 treatment mature clients, from which the 70 treatment initiating clients will be excluded.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Mildmay Uganda Limited
- Responsible party
- Sponsor
- Investigators
- Sebastian Linnemayr, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494777
- Sponsor's protocol ID
- R01MH110350
- Other IDs
- 1R01MH110350-01A1
- Status last verified
- Mar 2024
- First submitted
- 4 Apr 2018
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wagner Z, Wang Z, Stecher C, Karamagi Y, Odiit M, Haberer JE, Linnemayr S. The association between adherence to antiretroviral therapy and viral suppression under dolutegravir-based regimens: an observational cohort study from Uganda. J Int AIDS Soc. 2024 Aug;27(8):e26350. doi: 10.1002/jia2.26350.
PubMed 39155425Linnemayr S, Wagner Z, Saya UY, Stecher C, Lunkuse L, Wabukala P, Odiit M, Mukasa B. Behavioral Economic Incentives to Support HIV Care: Results From a Randomized Controlled Trial in Uganda. J Acquir Immune Defic Syndr. 2024 Jul 1;96(3):250-258. doi: 10.1097/QAI.0000000000003420.
PubMed 38534162MacCarthy S, Wagner Z, Saya U, Ghai I, Karamagi Y, Odiit M, Mukasa B, Linnemayr S. Food Insecurity During the COVID-19 Pandemic: A Longitudinal Mixed-Methods Study from a Cohort of HIV Clients in Uganda. AIDS Behav. 2023 Jul;27(7):2216-2225. doi: 10.1007/s10461-022-03953-6. Epub 2023 Jan 11.
PubMed 36629972Saya U, MacCarthy S, Mukasa B, Wabukala P, Lunkuse L, Wagner Z, Linnemayr S. "The one who doesn't take ART medication has no wealth at all and no purpose on Earth" - a qualitative assessment of how HIV-positive adults in Uganda understand the health and wealth-related benefits of ART. BMC Public Health. 2022 May 27;22(1):1056. doi: 10.1186/s12889-022-13461-w.
PubMed 35619119MacCarthy S, Mendoza-Graf A, Jennings Mayo-Wilson L, Wagner Z, Saya U, Chemusto H, Mukasa B, Linnemayr S. A qualitative exploration of health-related present bias among HIV-positive adults in Uganda. AIDS Care. 2023 Jun;35(6):883-891. doi: 10.1080/09540121.2021.2004298. Epub 2021 Nov 21.
PubMed 34802344Wagner Z, Mukasa B, Nakakande J, Stecher C, Saya U, Linnemayr S. Impact of the COVID-19 Pandemic on Use of HIV Care, Antiretroviral Therapy Adherence, and Viral Suppression: An Observational Cohort Study From Uganda. J Acquir Immune Defic Syndr. 2021 Dec 15;88(5):448-456. doi: 10.1097/QAI.0000000000002811.
PubMed 34757973Jennings Mayo-Wilson L, Devoto B, Coleman J, Mukasa B, Shelton A, MacCarthy S, Saya U, Chemusto H, Linnemayr S. Habit formation in support of antiretroviral medication adherence in clinic-enrolled HIV-infected adults: a qualitative assessment using free-listing and unstructured interviewing in Kampala, Uganda. AIDS Res Ther. 2020 Jun 8;17(1):30. doi: 10.1186/s12981-020-00283-2.
PubMed 32513192Linnemayr S, Stecher C, Saya U, MacCarthy S, Wagner Z, Jennings L, Mukasa B. Behavioral Economics Incentives to Support HIV Treatment Adherence (BEST): Protocol for a randomized controlled trial in Uganda. Trials. 2020 Jan 3;21(1):9. doi: 10.1186/s13063-019-3795-4.
PubMed 31900193
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Economics Incentives to Support HIV Treatment Adherence in Sub-Saharan Africa
- ClinicalTrials.gov ID
- NCT03494777
- Acronym / sponsor ID
- R01MH110350
- Conditions
- HIV/AIDS
- Keywords
- ART adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Mildmay Uganda Limited
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 11 Apr 2018 (actual)
- 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.
This study will implement an intervention in a two-year randomized controlled trial (RCT) to establish efficacy on viral suppression as a biological endpoint, compare the effectiveness of two different modes of implementation (including one entirely based on readily available clinic data), and investigate cost-effectiveness. Participants in the first intervention group (T1, n=110) will be eligible for small lottery prizes based on timely clinic visits, and qualify for an annual lottery conditional if demonstrating viral suppression; those in the second group (T2, n=110) will draw prizes conditional on electronically measured adherence at each clinic visit, and also participate in an annual lottery that is conditional on high adherence throughout the year. The control group (n=110) will receive the usual standard of care. Assessments will be conducted at baseline and then every six months. Primary outcomes are undetectable viral load and electronically measured adherence.
Detailed description
It is imperative to find ways to boost ART adherence in sub-Saharan Africa where adherence rates have been found to decline over time, and where treatment options such as second-line regimens are limited. A promising tool is the use of incentives based on insights from behavioral economics (BE) for healthy HIV-related behavior. The proposed R01 study is based on the results of the PI's R34 'Rewarding Adherence Program (RAP)' [R34 MH096609] that demonstrated feasibility and acceptability of incentives allocated by a drawing for HIV-related behaviors, and established preliminary efficacy. The current R01 study builds on these promising results with the aim to a) use viral loads as biological endpoints that were not included in the R34 for cost reasons; b) establish efficacy in a fully powered intervention as well as comparative efficacy of two different ways of implementing the incentives including one arm that has been adapted to changing clinical guidelines and can be implemented with readily available data from clinic records; and c) assess the cost effectiveness of these two implementation modes as a further input for policy-makers. The intervention is targeted at increasing the motivation of HIV clients who have been on ART for several years through the benefit and joy of prize drawings, thereby attempting to overcome the treatment 'fatigue' that can develop in the context of mundane, daily pill taking over the course of life-long treatment. Insights from behavioral economics suggest that such an intervention may be particularly effective for people with present bias (those who have a tendency to give in to short-term temptation at the cost of more long-term benefits) that was found to be prevalent among HIV clients in the R34 study. The intervention will be implemented among 330 adult clients in three groups: for the first intervention group, timely clinic attendance will constitute the eligibility criteria for participating in a prize drawing at each scheduled clinic visit; participants are also eligible for an annual prize drawing based on showing viral suppression. The second treatment group will be incentivized on demonstrated high ART adherence between clinic visits that also determine the winning chances at an annual prize drawing. The control group will receive the usual standard of care. All participants will receive MEMS caps to record adherence and assessments over 24 months (at baseline and every 6 months thereafter). The first Specific Aim will be to evaluate the effectiveness of the intervention; the second aim is to compare the relative effectiveness of the adherence-based arm and the arm directly incentivizing viral suppression that uses only data readily available in the clinic. The third Specific Aim is to perform a comparative cost-effectiveness analysis of the two intervention arms as a further policy input. If proven efficacious, the intervention as implemented in the newly adapted arm based on viral load suppression can be readily taken over by the clinic and scaled at low cost to other clinics.
In the study also 70 treatment initiating clients (in addition to the 330 treatment mature clients described above) will be recruited, but they will be excluded from the main analysis. [Note on 9/7/2019: due to funding, we will not recruit this additional sample of treatment initiating clients]
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled trial with two intervention arms and a control group will receive an intervention for twelve months; those not showing viral suppression at month 12 will be randomized to either continue receiving the year 1 intervention for another twelve months, or receive an additional intervention component for twelve months. The main analysis will be based on the sample of 330 treatment mature clients, from which the 70 treatment initiating clients will be excluded.
| Arm | Type | Receives |
|---|---|---|
| Adherence-based incentivization | Experimental | Behavioral: Incentivization based on high adherence, Behavioral: Annual adherence prize drawing, Behavioral: Year 2 boosterParticipants will be eligible for prize drawings at every regular clinic visit based on high adherence as measured by MEMS-caps. In addition there will be an annual prize drawing that is conditional on showing high adherence over the course of the year. This arm will receive the intervention 'Incentivization based on high adherence' and the intervention 'Annual adherence prize drawing' and (if eligible) the intervention 'Year 2 booster'. Note: the 70 treatment initiating clients will all be assigned to this arm to receive preliminary data as to whether incentives may work for this group. |
| Viral suppression-based incentivization | Experimental | Behavioral: Incentivization based on timely clinic visit, Behavioral: Annual viral suppression-based prize drawing, Behavioral: Year 2 boosterParticipants will be able to participate in prize drawings at every clinic visit where eligibility will be based on timely drug refills (that coincide with the clinic visits). Participants will also have a chance to enter a prize drawing at the end of every year if they show viral suppression. This arm will receive the intervention 'Incentivization based on timely clinic visit' and the intervention 'Annual viral suppression-based prize drawing', and (if eligible) the intervention 'Year 2 booster'. |
| Control | No intervention | –This arm will receive care as usual, including the adherence support mechanisms that are part of usual care practices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- at Mildmay clinic on ART for at least two years
- adherence problems in the last six months
- Note: for the 70 treatment initiators to be recruited in addition to the main sample of 330 treatment-mature clients (on which the main analysis will focus), the inclusion criteria are:
- 18 years of age or older
Key exclusion criteria (3 listed)
- not able to understand the consent form and study procedures
- language other than Luganda or English
- not willing to consistently use the MEMS caps device for adherence measurement
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 |
|---|---|---|
| Incentivization based on high adherenceWhen a participant comes for a regular clinic visit, s/he will have the MEMS data extracted, and if adherence over the previous month >=90%, will participate in a prize drawing. | Behavioural | Adherence-based incentivization |
| Incentivization based on timely clinic visitWhen a participant comes for a regular clinic visit on the day s/he is scheduled, s/he will participate in a prize drawing. | Behavioural | Viral suppression-based incentivization |
| Annual adherence prize drawingParticipants will have a chance to take part in an annual drawing where eligibility is based on the average adherence during that year. | Behavioural | Adherence-based incentivization |
| Annual viral suppression-based prize drawingParticipants will have a chance to take part in an annual drawing where eligibility is based on showing viral suppression. | Behavioural | Viral suppression-based incentivization |
| Year 2 boosterThose participants not showing viral suppression at month 12 will be randomized in a 1:1 fashion to receive an additional intervention component or continue receiving the same intervention arm as in Year 1. | Behavioural | Adherence-based incentivization, Viral suppression-based incentivization |
Primary outcome
Electronically measured adherence
Time frame: 12 months
Number of ART doses taken / number of doses prescribed
Electronically measured adherence
Time frame: 24 months
Number of ART doses taken / number of doses prescribed
Viral suppression
Time frame: At month 12
Viral load <=200 copies/mL
Viral suppression
Time frame: At month 24
Viral load <=200 copies/mL
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 15 Mar 2024.
- Derived from this study: PubMed 39155425Wagner Z, Wang Z, Stecher C, Karamagi Y, Odiit M, Haberer JE, Linnemayr S. The association between adherence to antiretroviral therapy and viral suppression under dolutegravir-based regimens: an observational cohort study from Uganda. J Int AIDS Soc. 2024 Aug;27(8):e26350. doi: 10.1002/jia2.26350.
- Derived from this study: PubMed 38534162Linnemayr S, Wagner Z, Saya UY, Stecher C, Lunkuse L, Wabukala P, Odiit M, Mukasa B. Behavioral Economic Incentives to Support HIV Care: Results From a Randomized Controlled Trial in Uganda. J Acquir Immune Defic Syndr. 2024 Jul 1;96(3):250-258. doi: 10.1097/QAI.0000000000003420.
- Derived from this study: PubMed 36629972MacCarthy S, Wagner Z, Saya U, Ghai I, Karamagi Y, Odiit M, Mukasa B, Linnemayr S. Food Insecurity During the COVID-19 Pandemic: A Longitudinal Mixed-Methods Study from a Cohort of HIV Clients in Uganda. AIDS Behav. 2023 Jul;27(7):2216-2225. doi: 10.1007/s10461-022-03953-6. Epub 2023 Jan 11.
- Derived from this study: PubMed 35619119Saya U, MacCarthy S, Mukasa B, Wabukala P, Lunkuse L, Wagner Z, Linnemayr S. "The one who doesn't take ART medication has no wealth at all and no purpose on Earth" - a qualitative assessment of how HIV-positive adults in Uganda understand the health and wealth-related benefits of ART. BMC Public Health. 2022 May 27;22(1):1056. doi: 10.1186/s12889-022-13461-w.
- Derived from this study: PubMed 34802344MacCarthy S, Mendoza-Graf A, Jennings Mayo-Wilson L, Wagner Z, Saya U, Chemusto H, Mukasa B, Linnemayr S. A qualitative exploration of health-related present bias among HIV-positive adults in Uganda. AIDS Care. 2023 Jun;35(6):883-891. doi: 10.1080/09540121.2021.2004298. Epub 2021 Nov 21.
- Derived from this study: PubMed 34757973Wagner Z, Mukasa B, Nakakande J, Stecher C, Saya U, Linnemayr S. Impact of the COVID-19 Pandemic on Use of HIV Care, Antiretroviral Therapy Adherence, and Viral Suppression: An Observational Cohort Study From Uganda. J Acquir Immune Defic Syndr. 2021 Dec 15;88(5):448-456. doi: 10.1097/QAI.0000000000002811.
- Derived from this study: PubMed 32513192Jennings Mayo-Wilson L, Devoto B, Coleman J, Mukasa B, Shelton A, MacCarthy S, Saya U, Chemusto H, Linnemayr S. Habit formation in support of antiretroviral medication adherence in clinic-enrolled HIV-infected adults: a qualitative assessment using free-listing and unstructured interviewing in Kampala, Uganda. AIDS Res Ther. 2020 Jun 8;17(1):30. doi: 10.1186/s12981-020-00283-2.
- Derived from this study: PubMed 31900193Linnemayr S, Stecher C, Saya U, MacCarthy S, Wagner Z, Jennings L, Mukasa B. Behavioral Economics Incentives to Support HIV Treatment Adherence (BEST): Protocol for a randomized controlled trial in Uganda. Trials. 2020 Jan 3;21(1):9. doi: 10.1186/s13063-019-3795-4.
- Individual participant dataSharing planned: Undecided
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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 Incentivization based on high adherence, Incentivization based on timely clinic visit and Annual adherence prize drawing in people with HIV/AIDS, 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 6 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 15 Mar 2024. 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?
Electronically measured adherence (time frame: 12 months). The study lists 4 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 NCT03494777, which also lists 8 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 15 Mar 2024.