HIV/AIDSINMINDNCT05131165
INcentives and ReMINDers to Improve Long-term Medication Adherence
A study testing Daily Text Messages and Incentivization based on timely ART adherence in people with HIV/AIDS, run by RAND at 1 site in Uganda.
Trial summary
The study will test the feasibility and acceptability of using text messages and behavioral economics-based incentives to support anchoring Anti-Retroviral Therapy (ART) adherence to an existing routine in order to improve long-term ART medication adherence. 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?
- Daily Text Messages and Incentivization based on timely ART adherence
- 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
- 166 participants
- Where
- 1 siteUganda
- Study dates
- 25 Oct 2021to 23 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male and female clients age 18 and older.
- Started ART at Mildmay or another clinic within the preceding three months but have since been receiving care at Mildmay.
- Able to speak and understand either English or Luganda.
- Have their own cell phone or have consistent access to someone else's phone.
- Willing to receive daily text messages for the 3 months of intervention duration.
- Willing and able to use the MEMS caps distributed for adherence verification for the duration of the study.
Who cannot join
- Not mentally fit to consent.
- 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
The study will test the feasibility and acceptability of using text messages and behavioral economics-based incentives to support anchoring Anti-Retroviral Therapy (ART) adherence to an existing routine in order to improve long-term ART medication adherence. The intervention phase of the three-phased study will constitute the pilot RCT. A sample of 150 clients who have initiated ART in the preceding three months will be randomized to either usual care (C = 50) or one of the two INMIND intervention groups (daily text message reminders with or without incentives) for three months (T1 = 50; T2=50). Subsequently, behavioral persistence will be evaluated for six months post-intervention. Assessments will be conducted at baseline, month 3, and month 9. The primary outcomes are 1) electronically measured mean medication adherence during the intervention and 2) six months post intervention, along with 3) timeliness of medication adherence during the intervention and 4) six months post-intervention.
Read the detailed description
Adherence of Anti-Retroviral Therapy (ART) among HIV-infected patients initiating treatment (treatment initiators) in Sub-Saharan Africa has remained low, even though the number of treatment initiators has increased in recent years. Lack of retention in care and low adherence in the first year of ART treatment are substantial barriers to virologic suppression. The current R34 study tests a novel approach for improving long-term ART adherence among treatment initiators by turning adherence into a behavioral routine. This is done in two ways: 1) anchoring ART adherence to an existing routine, and 2) providing more immediate rewards and increasing the salience through reminder messages. 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) and lack of salience (where over time, the choice of target behavior is overshadowed by more pressing needs of daily life) which have been found to be prevalent among people living with chronic medical conditions from past studies.
The intervention will be tested through a pilot RCT, wherein 150 adult clients will be randomly assigned to three groups. The first intervention group would receive daily text messages that reinforce routine formation information provided to all participants (across the three groups). The second intervention group will receive the text messages, and additionally be eligible for a prize drawing based on timely ART adherence, at each monthly clinic visit. The control group will receive care as usual, consisting of routine formation information as well as adherence counseling. The intervention will last three months, with a six-month post-intervention follow up period. All participants will receive MEMS caps to record adherence, and will complete assessments over nine months (baseline, post-intervention, and six months post-intervention).
The Specific Aim of the intervention phase of the study is to test the preliminary effectiveness of the intervention, including the relative effectiveness of the two different implementation approaches. This is preceded by the formative phase, with the Specific Aim of developing the intervention parameters. The intervention phase is succeeded by the adaptation phase, whose Specific Aim is to collect data in preparation for a subsequent R01 application.
- Conditions
- HIV/AIDS
- Being tested
- Daily Text Messages, Incentivization based on timely ART adherence
- Keywords
- ART Adherence, Reminders, Behavioral Economics, Viral Suppression, Long-term Adherence, Routines, Habit Formation
- 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.
Daily Text MessagesBehavioural
Participants will receive daily text message reminders to use their routine behavior to trigger medication adherence.
Incentivization based on timely ART adherenceBehavioural
Participants will be eligible to draw a prize if they take their medication within +/- one hour of the stated existing routine to which pill-taking is anchored on at least 70% of days between recruitment and the 3-month study visit.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This arm will receive care as usual, including the adherence support mechanisms that are part of usual care practices. At recruitment participant will be explained the importance of pill-taking. All participants (including in the control group) will receive a leaflet containing detailed information on how to establish healthy pill-taking routines. Finally, clinic staff will counsel participants on how to select an already regularly routine behavior that occurs at roughly the same time each day that forms the basis of their implementation plan. |
| Intervention group receiving messages (Messages Group) | Experimental | Participants will receive the same information as those in the Control Group, but in addition, receive the "Daily Text Message" Intervention. Receives: Behavioral: Daily Text Messages |
| Intervention group receiving messages and incentives (Incentives Group) | Experimental | Participants will receive the same information as the Control group. Additionally, they will receive the "Daily Text Message Intervention" and will be eligible for prize drawings. Receives: Behavioral: Daily Text Messages; Behavioral: Incentivization based on timely ART adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Pills Taken as Prescribed Over the Intervention Period (Baseline - Month 3)
MEMS-data was collected continuously over the course of the three-month intervention period allowing us to investigate mean adherence. Only one of the ART medications was used to calculate the primary adherence variable (# of actual bottle openings / # of prescribed bottle openings).
Measured: Three months
Proportion of Pills Taken as Prescribed Over the Post-intervention Period (Months 4-9)
MEMS-data was collected continuously over the course of the six-month post intervention period allowing for the investigation of post-intervention mean adherence. Only one of the ART medications was used to calculate the primary adherence variable (# of actual bottle openings / # of prescribed bottle openings).
Measured: Six months post-intervention
Proportion of Pills Taken Within +/- 1 Hour of the Anchor Time Over the Intervention Period (Baseline - Month 3)
A novel measure of routine adherence (that it is explicitly based on the temporal pattern of pill-taking), calculated as the fraction of scheduled pills taken within a one-hour window around the typical time that participants report completing their existing routine behavior that anchors their pill-taking, was calculated. This measure provides an objective way for determining behavioral automaticity of pill-taking.
Measured: Three months
Proportion of Pills Taken Within +/- 1 Hour of the Anchor Time Over the Post-Intervention Period (Months 4-9)
This measure would be calculated as a fraction of scheduled pills taken within a one-hour window around the typical time that participants report completing their existing routine behavior that anchors their pill-taking, for all visits made post-intervention.
Measured: Six months post-intervention
Secondary outcomes (2)
Retention in Care
Retention in care was measured as the fraction of participants recruited who are still active clients at the clinic at month 9.
Measured: Month 9
Change in Viral Suppression Status
HIV RNA (viral load) was the secondary outcome measure. For each participant, viral loads taken just prior to baseline and viral loads taken just after month-9 were compared; if participant was virally suppressed (with < 200 copies of HIV per millilitre (mL) of blood) at baseline, but had a viral load of >= 200 copies/mL after month-9, then the indicator was assigned "-1"; if there was no change in viral suppression status (i.e., if participant either had >= 200 copies of virus/mL at baseline and month-9 OR if participant had < 200 copies/mL at baseline and month-9), then the indicator was assigned "0". If, however, the participant's viral load went from >= 200 copies/mL at baseline to < 200 copies/mL after month-9, then the indicator was assigned "1".
Measured: Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start25 Oct 2021
- Primary completion23 Aug 2023
- Study completion23 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)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
- Parallel groups
- Model description
- A pilot randomized controlled trial with two intervention arms and a control group, that will receive intervention for three months with follow-on assessment for six months after the intervention period ends.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Mildmay Uganda Limited, Arizona State University
- Responsible party
- Sponsor
- Investigators
- Sebastian Linnemayr, Ph.D., Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131165
- Sponsor's protocol ID
- R34MH122331
- Other IDs
- R34MH122331
- Acronym
- INMIND
- Status last verified
- Sep 2024
- First submitted
- 12 Nov 2021
- Last updated
- 13 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected in the execution of the aims described in the application will be shared in the form of journal publications. Following publication of the main paper(s) for this study and the grant end-date, the RAND Human Subjects Protection Committee will be consulted about how to securely make data publicly available in the form of an electronic database for researchers who successfully complete a registration process (described below). Any shared data will be de-identified and will not contain any direct identifiers or indirect identifiers (that could identify participants by inference). No qualitative data will be shared, as such data would be difficult to de-identify given that participants will be telling their own experiences and thus could be identified by inference. Documentation of shared data will be provided in the form of a codebook in which each variable name and response options are defined.
Publications
Ruppar TM, Russell CL. Medication adherence in successful kidney transplant recipients. Prog Transplant. 2009 Jun;19(2):167-72. doi: 10.1177/152692480901900211.
PubMed 19588667Phillips LA, Gardner B. Habitual exercise instigation (vs. execution) predicts healthy adults' exercise frequency. Health Psychol. 2016 Jan;35(1):69-77. doi: 10.1037/hea0000249. Epub 2015 Jul 6.
PubMed 26148187Lally P, Wardle J, Gardner B. Experiences of habit formation: a qualitative study. Psychol Health Med. 2011 Aug;16(4):484-9. doi: 10.1080/13548506.2011.555774.
PubMed 21749245Stecher 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 33831632Stecher C, Linnemayr S. Promoting antiretroviral therapy adherence habits: a synthesis of economic and psychological theories of habit formation. AIDS. 2021 Apr 1;35(5):711-716. doi: 10.1097/QAD.0000000000002792. No abstract available.
PubMed 33306553Jennings 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. Behavioral Economics Matters for HIV Research: The Impact of Behavioral Biases on Adherence to Antiretrovirals (ARVs). AIDS Behav. 2015 Nov;19(11):2069-75. doi: 10.1007/s10461-015-1076-0.
PubMed 25987190Linnemayr 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 28225450Linnemayr S, Huang H, Luoto J, Kambugu A, Thirumurthy H, Haberer JE, Wagner G, Mukasa B. Text Messaging for Improving Antiretroviral Therapy Adherence: No Effects After 1 Year in a Randomized Controlled Trial Among Adolescents and Young Adults. Am J Public Health. 2017 Dec;107(12):1944-1950. doi: 10.2105/AJPH.2017.304089. Epub 2017 Oct 19.
PubMed 29048966Linnemayr S, Odiit M, Mukasa B, Ghai I, Stecher C. INcentives and ReMINDers to Improve Long-Term Medication Adherence (INMIND): impact of a pilot randomized controlled trial in a large HIV clinic in Uganda. J Int AIDS Soc. 2024 Jun;27(6):e26306. doi: 10.1002/jia2.26306.
PubMed 38923298Stecher C, Ghai I, Lunkuse L, Wabukala P, Odiit M, Nakanwagi A, Linnemayr S. Incentives and Reminders to Improve Long-term Medication Adherence (INMIND): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2022 Oct 31;11(10):e42216. doi: 10.2196/42216.
PubMed 36315224
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INcentives and ReMINDers to Improve Long-term Medication Adherence
- ClinicalTrials.gov ID
- NCT05131165
- Acronym / sponsor ID
- INMIND / R34MH122331
- Conditions
- HIV/AIDS
- Keywords
- ART Adherence, Reminders, Behavioral Economics, Viral Suppression, Long-term Adherence, Routines, Habit Formation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Mildmay Uganda Limited, Arizona State University
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 23 Nov 2021 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will test the feasibility and acceptability of using text messages and behavioral economics-based incentives to support anchoring Anti-Retroviral Therapy (ART) adherence to an existing routine in order to improve long-term ART medication adherence. The intervention phase of the three-phased study will constitute the pilot RCT. A sample of 150 clients who have initiated ART in the preceding three months will be randomized to either usual care (C = 50) or one of the two INMIND intervention groups (daily text message reminders with or without incentives) for three months (T1 = 50; T2=50). Subsequently, behavioral persistence will be evaluated for six months post-intervention. Assessments will be conducted at baseline, month 3, and month 9. The primary outcomes are 1) electronically measured mean medication adherence during the intervention and 2) six months post intervention, along with 3) timeliness of medication adherence during the intervention and 4) six months post-intervention.
Detailed description
Adherence of Anti-Retroviral Therapy (ART) among HIV-infected patients initiating treatment (treatment initiators) in Sub-Saharan Africa has remained low, even though the number of treatment initiators has increased in recent years. Lack of retention in care and low adherence in the first year of ART treatment are substantial barriers to virologic suppression. The current R34 study tests a novel approach for improving long-term ART adherence among treatment initiators by turning adherence into a behavioral routine. This is done in two ways: 1) anchoring ART adherence to an existing routine, and 2) providing more immediate rewards and increasing the salience through reminder messages. 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) and lack of salience (where over time, the choice of target behavior is overshadowed by more pressing needs of daily life) which have been found to be prevalent among people living with chronic medical conditions from past studies.
The intervention will be tested through a pilot RCT, wherein 150 adult clients will be randomly assigned to three groups. The first intervention group would receive daily text messages that reinforce routine formation information provided to all participants (across the three groups). The second intervention group will receive the text messages, and additionally be eligible for a prize drawing based on timely ART adherence, at each monthly clinic visit. The control group will receive care as usual, consisting of routine formation information as well as adherence counseling. The intervention will last three months, with a six-month post-intervention follow up period. All participants will receive MEMS caps to record adherence, and will complete assessments over nine months (baseline, post-intervention, and six months post-intervention).
The Specific Aim of the intervention phase of the study is to test the preliminary effectiveness of the intervention, including the relative effectiveness of the two different implementation approaches. This is preceded by the formative phase, with the Specific Aim of developing the intervention parameters. The intervention phase is succeeded by the adaptation phase, whose Specific Aim is to collect data in preparation for a subsequent R01 application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A pilot randomized controlled trial with two intervention arms and a control group, that will receive intervention for three months with follow-on assessment for six months after the intervention period ends.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This arm will receive care as usual, including the adherence support mechanisms that are part of usual care practices. At recruitment participant will be explained the importance of pill-taking. All participants (including in the control group) will receive a leaflet containing detailed information on how to establish healthy pill-taking routines. Finally, clinic staff will counsel participants on how to select an already regularly routine behavior that occurs at roughly the same time each day that forms the basis of their implementation plan. |
| Intervention group receiving messages (Messages Group) | Experimental | Behavioral: Daily Text MessagesParticipants will receive the same information as those in the Control Group, but in addition, receive the "Daily Text Message" Intervention. |
| Intervention group receiving messages and incentives (Incentives Group) | Experimental | Behavioral: Daily Text Messages, Behavioral: Incentivization based on timely ART adherenceParticipants will receive the same information as the Control group. Additionally, they will receive the "Daily Text Message Intervention" and will be eligible for prize drawings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female clients age 18 and older.
- Started ART at Mildmay or another clinic within the preceding three months but have since been receiving care at Mildmay.
- Able to speak and understand either English or Luganda.
- Have their own cell phone or have consistent access to someone else's phone.
- Willing to receive daily text messages for the 3 months of intervention duration.
Key exclusion criteria (3 listed)
- Not mentally fit to consent.
- 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 |
|---|---|---|
| Daily Text MessagesParticipants will receive daily text message reminders to use their routine behavior to trigger medication adherence. | Behavioural | Intervention group receiving messages (Messages Group), Intervention group receiving messages and incentives (Incentives Group) |
| Incentivization based on timely ART adherenceParticipants will be eligible to draw a prize if they take their medication within +/- one hour of the stated existing routine to which pill-taking is anchored on at least 70% of days between recruitment and the 3-month study visit. | Behavioural | Intervention group receiving messages and incentives (Incentives Group) |
Primary outcome
Proportion of Pills Taken as Prescribed Over the Intervention Period (Baseline - Month 3)
Time frame: Three months
MEMS-data was collected continuously over the course of the three-month intervention period allowing us to investigate mean adherence. Only one of the ART medications was used to calculate the primary adherence variable (# of actual bottle openings / # of prescribed bottle openings).
Proportion of Pills Taken as Prescribed Over the Post-intervention Period (Months 4-9)
Time frame: Six months post-intervention
MEMS-data was collected continuously over the course of the six-month post intervention period allowing for the investigation of post-intervention mean adherence. Only one of the ART medications was used to calculate the primary adherence variable (# of actual bottle openings / # of prescribed bottle openings).
Proportion of Pills Taken Within +/- 1 Hour of the Anchor Time Over the Intervention Period (Baseline - Month 3)
Time frame: Three months
A novel measure of routine adherence (that it is explicitly based on the temporal pattern of pill-taking), calculated as the fraction of scheduled pills taken within a one-hour window around the typical time that participants report completing their existing routine behavior that anchors their pill-taking, was calculated. This measure provides an objective way for determining behavioral automaticity of pill-taking.
Proportion of Pills Taken Within +/- 1 Hour of the Anchor Time Over the Post-Intervention Period (Months 4-9)
Time frame: Six months post-intervention
This measure would be calculated as a fraction of scheduled pills taken within a one-hour window around the typical time that participants report completing their existing routine behavior that anchors their pill-taking, for all visits made post-intervention.
2 secondary outcomes
Retention in Care
Time frame: Month 9
Change in Viral Suppression Status
Time frame: Month 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19588667Ruppar TM, Russell CL. Medication adherence in successful kidney transplant recipients. Prog Transplant. 2009 Jun;19(2):167-72. doi: 10.1177/152692480901900211.
- Background: PubMed 26148187Phillips LA, Gardner B. Habitual exercise instigation (vs. execution) predicts healthy adults' exercise frequency. Health Psychol. 2016 Jan;35(1):69-77. doi: 10.1037/hea0000249. Epub 2015 Jul 6.
- Background: PubMed 21749245Lally P, Wardle J, Gardner B. Experiences of habit formation: a qualitative study. Psychol Health Med. 2011 Aug;16(4):484-9. doi: 10.1080/13548506.2011.555774.
- Background: 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.
- Background: PubMed 33306553Stecher C, Linnemayr S. Promoting antiretroviral therapy adherence habits: a synthesis of economic and psychological theories of habit formation. AIDS. 2021 Apr 1;35(5):711-716. doi: 10.1097/QAD.0000000000002792. No abstract available.
- Background: 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.
- Background: PubMed 25987190Linnemayr S, Stecher C. Behavioral Economics Matters for HIV Research: The Impact of Behavioral Biases on Adherence to Antiretrovirals (ARVs). AIDS Behav. 2015 Nov;19(11):2069-75. doi: 10.1007/s10461-015-1076-0.
- Background: 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.
- Background: PubMed 29048966Linnemayr S, Huang H, Luoto J, Kambugu A, Thirumurthy H, Haberer JE, Wagner G, Mukasa B. Text Messaging for Improving Antiretroviral Therapy Adherence: No Effects After 1 Year in a Randomized Controlled Trial Among Adolescents and Young Adults. Am J Public Health. 2017 Dec;107(12):1944-1950. doi: 10.2105/AJPH.2017.304089. Epub 2017 Oct 19.
- Derived from this study: PubMed 38923298Linnemayr S, Odiit M, Mukasa B, Ghai I, Stecher C. INcentives and ReMINDers to Improve Long-Term Medication Adherence (INMIND): impact of a pilot randomized controlled trial in a large HIV clinic in Uganda. J Int AIDS Soc. 2024 Jun;27(6):e26306. doi: 10.1002/jia2.26306.
- Derived from this study: PubMed 36315224Stecher C, Ghai I, Lunkuse L, Wabukala P, Odiit M, Nakanwagi A, Linnemayr S. Incentives and Reminders to Improve Long-term Medication Adherence (INMIND): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2022 Oct 31;11(10):e42216. doi: 10.2196/42216.
- Individual participant dataSharing planned: Yes. Data collected in the execution of the aims described in the application will be shared in the form of journal publications. Following publication of the main paper(s) for this study and the grant end-date, the RAND Human Subjects Protection Committee will be consulted about how to securely make data publicly available in the form of an electronic database for researchers who successfully complete a registration process (described below). Any shared data will be de-identified and will not contain any direct identifiers or indirect identifiers (that could identify participants by inference). No qualitative data will be shared, as such data would be difficult to de-identify given that participants will be telling their own experiences and thus could be identified by inference. Documentation of shared data will be provided in the form of a codebook in which each variable name and response options are defined.
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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, Ph.D. 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 Daily Text Messages and Incentivization based on timely ART adherence 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 13 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Pills Taken as Prescribed Over the Intervention Period (Baseline - Month 3) (time frame: Three 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 NCT05131165, which also lists 11 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 13 Apr 2025.