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HIV/AIDSINMINDNCT06949774

INcentives and ReMINDers to Improve Long-term Medication Adherence (INMIND)

A study testing Daily Text Messages and Incentivization based on timely ART adherence in people with HIV/AIDS and Medication Adherence, run by RAND at 1 site in Uganda.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Low medication adherence when initiating antiretroviral treatment (ART) is a key barrier to HIV virologic suppression, resulting in avoidable cases of drug resistance, death, and viral transmission. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV/AIDS, Medication Adherence, Habits
What is being tested?
Daily Text Messages and Incentivization based on timely ART adherence
Could I receive a placebo?
No, everyone receives an active treatment
How many people
550 participants
Where
1 siteUganda
Study dates
2 Apr 2025to 31 Oct 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 2 months
  • 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 6 months of intervention duration.
  • Willing and able to use the WisePill device 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 Wisepill device for adherence measurement.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yvonne Karamagi Site Principal Investigator contact

+256312210200

yvonne.karamagi@mildmay.or.ug

Lillian Lukuse contact

lillianlunkuse@gmail.com

Uganda1 site, 1 recruiting
  • Mildmay Uganda

    Kampala, 24985

    Lillian Lukuse, +256703925522, lillianlunkuse@gmail.com

    Yvonne Karamagi, MB.Ch.B.

    Recruiting

Other trials in Uganda

About this study

Official title: INcentives and ReMINDers to Improve Long-term Medication Adherence

Low medication adherence when initiating antiretroviral treatment (ART) is a key barrier to HIV virologic suppression, resulting in avoidable cases of drug resistance, death, and viral transmission. Routinized pill-taking can lead to successful long-term ART adherence, and short-term behavioral economics-based supports are a novel way to overcome the limited success of existing routinization interventions. This study proposes to test this combined approach for promoting long-term ART adherence using a Stage III Sequential, Multiple Assignment, Randomized Trial (SMART) design in one of the largest HIV clinics in Uganda to identify the most cost-effective adaptive intervention that if found effective is generalizable to other settings and other chronic diseases.

Read the detailed description

Building on a previous R34 study, the investigators will adapt and deliver the INMIND approach to 550 ART initiators at Mildmay. Participants will initially be randomized to receive either usual care (Control, n=275) or daily text messages (Messages, n=275) to support adherence routines. At months 1 and 2, participants may revise their adherence plans. Those showing <80% adherence in month 3 will be re-randomized to receive either monthly or monthly escalated prize incentives for the next three months. Adherence will be monitored for an additional 12 months (total follow-up: 18 months) to assess long-term routine maintenance and recovery after interruptions. The SMART design will help identify the most cost-effective intervention sequencing. A cost-effectiveness analysis and stakeholder dissemination will support future scale-up. The investigators hypothesize that Messages will be more effective than Control as a first-stage treatment; that monthly escalated prizes will be more effective than monthly prizes as a second-stage treatment; and that the mechanisms of lack of Salience and Present Bias will mediate the effect of INMIND on our primary and secondary outcomes.

Being tested
Daily Text Messages, Incentivization based on timely ART adherence
Keywords
Behavioral: Daily Text Messages, Behavioral: Incentivization based on
Medical subject headings
Acquired Immunodeficiency Syndrome, Medication Adherence, Habits

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 in monthly prize group) or get a monthly prize (monthly escalated group) if they take their medication within +/-one hour of the stated existing routine to which pill-taking is anchored on at least 80% of days for 3-months.

Study groups in NCT06949774
Study groupRoleWhat they receive
Phase B Stage 1: ControlNo interventionThis 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 existing routine behavior that occurs at roughly the same time each day that forms the basis of their implementation plan.
Phase B Stage 1: Intervention group receiving messages (Messages group)ExperimentalThe Messages group will receive the same brief information session as the Control group but also receive daily text messages reinforcing the information provided at the recruitment visit and reminders of their personalized routinization strategy.
Receives: Behavioral: Daily Text Messages
Phase B Stage 2: Intervention group receiving messages and incentives (Monthly prize draws)ExperimentalFirst-stage non-responders will be re-randomized to the monthly prize draw group, where they may become eligible for a small prize each month for three months of the intervention if they take their ART pills within one hour of the time, they carry out their existing routine as stated in their anchoring plan for at least 80% of the days in that month. The prizes at each monthly drawing will be worth 1,000; 5,000; or 10,000 Uganda Shillings. Participants who were receiving messages will continue to receive messages as before.
Receives: Behavioral: Daily Text Messages; Behavioral: Incentivization based on timely ART adherence
Phase B Stage 2: Intervention group receiving messages and incentives (Monthly escalated Prizes)ExperimentalFirst-stage non-responders will be re-randomized to the monthly escalating prizes group, where they may become eligible for a small prize each month for three months of the intervention if they take their ART pills for at least 80% of the days in that month. In the first month, the prize will be worth 1,000 Uganda Shillings. If they are consistent, the prize amount will increase to 5,000 Uganda Shillings in the second month and 10,000 Uganda Shillings in the third month. However, if they do not achieve the 80% adherence level, they will be reset to only receive 1,000 Uganda Shillings in that month. Participants in this group who have been receiving messages will continue to receive messages as before.
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.

  1. Electronically measured mean medication adherence

    We will collect Wisepill data continuously over the 24-month study period to calculate the primary outcome variable of mean adherence (# of actual bottle openings /# of prescribed bottle openings)

    Measured: 24 months

Secondary outcomes (3)
  1. Retention in Care.

    Retention in care will be measured as the fraction of participants recruited who are still active clients at the clinic at month 24.

    Measured: 24 months

  2. Viral Suppression

    HIV RNA (viral load) is the secondary outcome measure, and we will also examine intervention effects on mean change in log-transformed viral load. Viral loads are now part of routine clinical care in Uganda and will be chart abstracted.

    Measured: 24 months

  3. Routinization of ART adherence

    We will calculate 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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2025
  2. Study start2 Apr 2025
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Oct 2029 (estimated)

Resources

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
At recruitment, participants will be randomized to one of two low-intensity components (Control or Messages). Those not showing progress towards routinization (defined as pill-taking in line with their anchoring plan on fewer than 80% of days during study month three) will be re-randomized to one of two higher-intensity components (monthly or monthly escalated prizes), ensuring that even participants who do not show routinization progress at month three will have a full three months in the second stage to form a strong ART adherence routine. The second-stage incentives will be given out as prize drawings, as BE shows that they leverage the bias of overestimation of small probabilities and take advantage of the motivational power and joy of games of chance.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
550 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06949774
Sponsor's protocol ID
R01MH135751
Other IDs
R01MH135751
Acronym
INMIND
Status last verified
Jul 2026
First submitted
22 Apr 2025
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: This study will produce longitudinal data on a sample of 550 adult (≥18 years old) clients of Mildmay Uganda who started receiving antiretroviral (ART) medications for their HIV infection within the past month. The data will include continuous ART adherence measures over the 24-month study and questionnaires responses. All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier for the NIMH Data Archive (NDA) will be collected for each subject. Documentation to be made publicly available to the research community will include a codebook with univariate statistics for each variable and study-level metadata following the Data Documentation Initiative specifications. Each variable in the codebook will include a brief description of the item along with the question number and question text from the questionnaire, variable name, variable label, value labels, and standard codes for missing values.

Publications

  • Linnemayr 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 29048966
  • Linnemayr 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 25987190
  • Linnemayr 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
  • Jennings 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 32513192
  • Stecher 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 33306553
  • 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 33831632
  • Lally 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 21749245
  • Ruppar TM, Russell CL. Medication adherence in successful kidney transplant recipients. Prog Transplant. 2009 Jun;19(2):167-72. doi: 10.1177/152692480901900211.

    PubMed 19588667

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 and Medication Adherence, 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: looking for participants now, as of the sponsor's last update on 14 Jul 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yvonne Karamagi Site Principal Investigator (+256312210200, yvonne.karamagi@mildmay.or.ug), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Electronically measured mean medication adherence (time frame: 24 months). 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 NCT06949774, 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 14 Jul 2026.

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