Human Immunodeficiency VirusSITANCT02514356
SMS as an Incentive To Adhere (SITA) - An Intervention Communicating Social Norms by SMS to Improve ARV Adherence
A study testing Own adherence and Own and group level adherence in people with Human Immunodeficiency Virus, run by RAND at 1 site in Uganda.
Trial summary
The purpose of this study 'SMS as an Incentive To Adhere' (SITA) is to test two novel approaches of using SMS messages (provision of information about electronically measured own adherence, as well as in combination with group adherence level) to improve adherence to anitretroviral (ART) and pre-ART prophylaxis among… Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Own adherence and Own and group level 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
- 147 participants
- Where
- 1 siteUganda
- Study dates
- Aug 2015to 7 Mar 2017
- 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 15 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- have been in HIV care at the clinic for at least three months
- are currently taking HIV-related medication (ART or co-trimoxazole)
- either own a phone or have regular access to one
- intend to stay at the clinic for the study period
- are not in boarding school (where phones are forbidden)
Who cannot join
- does not speak or understand either English or Luganda
- does not have the cognitive capacity to consent and/or understand the study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Small Randomized Controlled Trial Providing Weekly Information by SMS About Own and Group-level ARV Adherence to Patients in Two Clinics in Uganda
The purpose of this study 'SMS as an Incentive To Adhere' (SITA) is to test two novel approaches of using SMS messages (provision of information about electronically measured own adherence, as well as in combination with group adherence level) to improve adherence to anitretroviral (ART) and pre-ART prophylaxis among youth age 15-24 at an HIV clinic in Uganda.
Read the detailed description
SITA addresses two behavioral biases observed in people living with HIV/AIDS (PLWHA). The growing field of behavioral economics (BE) suggests that people display behavioral biases (i.e. systematic decision making errors) that among patients can contribute to suboptimal adherence. Investigators observed two important such biases in our own work in Uganda: first, investigators found that patients to a large degree overestimate their own adherence, i.e. think that they adhere better than they actually do. Second, a patient's social environment matters: PLWHA clearly care about their peers and their peers' attitudes and behavior.
SITA is based on Social Cognitive Theory (SCT) and adapts two traditional interventions to mHealth. The first intervention is that of self-monitoring, i.e. providing participants with feedback about their adherence performance. Traditionally this involves clinic visits that take up provider and patient time and resources; SITA instead suggests providing objective, real-time information measured by electronic monitoring (Wisepill) devices sent to patients by weekly SMS. Such feedback builds self-efficacy, a key SCT concept and thereby may improve adherence. The second intervention is based on the SCT concept of social learning. Perceived group norms, and interventions that affect those perceptions, are a key influence on health behavior among youths, providing a substitute for direct learning. Investigators adapt this approach to a mHealth environment by providing PLWHA not only with their own adherence information but also that of a reference (peer) group.
SITA will use mixed methods research techniques and focus on knowledge transfer within a multidisciplinary team. In formative Phase 1 investigators will conduct qualitative focus groups with key stakeholders to elicit information about the use of wisepill devices, and acceptance, feasibility and locally appropriate adaptation of SITA. In Phase 2, investigators will implement a nine-months, three-arm (with 50-60 participants each) randomized controlled trial: youths in intervention group 1 will receive information about their wisepill-measured adherence level by weekly SMS. Intervention group 2 will in addition be sent the adherence level of a reference group that investigators hypothesize to exert normative influence. The control group will receive the usual standard of care. Throughout the study investigators will focus on capacity building and knowledge transfer to the Ugandan collaborators through workshops and mentoring.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Own adherence, Own and group level adherence
- Keywords
- behavioral economics, antiretroviral adherence, SMS, mobile health (mHealth), Adolescents, Uganda, HIV
- 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.
Own adherenceBehavioural
In this intervention group, participants receive weekly SMS messages informing them of their adherence that week as measured by the wise pill device used by the participant.
Own and group level adherenceBehavioural
In this intervention group, participants receive weekly SMS messages informing them of their adherence that week as measured by the wise pill device used by the participant. In addition, in the same message they are informed of the adherence demonstrated by the other participants
| Study group | Role | What they receive |
|---|---|---|
| Own adherence | Active comparator | Participants in this group receive a weekly message by SMS. They receive the intervention 'Behavioral: Own Adherence'. Receives: Behavioral: Own adherence |
| Own and group level adherence | Active comparator | Participants in this group receive a weekly message by SMS. They receive the intervention 'Behavioral: Own and Group Adherence'. Receives: Behavioral: Own and group level adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence rates using electronically monitored adherence (wise pill) data
Wisepill data will be collected continuously over the course of the 9-month study period (preceded by about one month of adherence measurement only to allow for solution of any wisepill-related problems) allowing us to investigate daily adherence and its timing. Wisepill data indicating the date and time when the participant opened their pill container (either one of the ART medications or prophylaxis if not on ART yet) will be used to calculate the primary outcome variable of adherence (# of actual bottle openings / # of prescribed bottle openings).
Measured: 9 months after enrollment
Secondary outcomes (1)
Self-reported adherence
Survey will ask about self-reported adherence at baseline and month 9.
Measured: 9 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study startAug 2015
- Primary completion7 Mar 2017
- Study completion7 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies 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
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- The AIDS Support Organization
- Responsible party
- Sponsor
- Investigators
- Sebastian Linnemayr, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514356
- Sponsor's protocol ID
- 1R21MH107218-01
- Acronym
- SITA
- Status last verified
- Apr 2017
- First submitted
- 30 Jul 2015
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
MacCarthy S, Wagner Z, Mendoza-Graf A, Gutierrez CI, Samba C, Birungi J, Okoboi S, Linnemayr S. A randomized controlled trial study of the acceptability, feasibility, and preliminary impact of SITA (SMS as an Incentive To Adhere): a mobile technology-based intervention informed by behavioral economics to improve ART adherence among youth in Uganda. BMC Infect Dis. 2020 Feb 24;20(1):173. doi: 10.1186/s12879-020-4896-0.
PubMed 32093630MacCarthy S, Saya U, Samba C, Birungi J, Okoboi S, Linnemayr S. "How am I going to live?": exploring barriers to ART adherence among adolescents and young adults living with HIV in Uganda. BMC Public Health. 2018 Oct 4;18(1):1158. doi: 10.1186/s12889-018-6048-7.
PubMed 30286746
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Small Randomized Controlled Trial Providing Weekly Information by SMS About Own and Group-level ARV Adherence to Patients in Two Clinics in Uganda
- ClinicalTrials.gov ID
- NCT02514356
- Acronym / sponsor ID
- SITA / 1R21MH107218-01
- Conditions
- Human Immunodeficiency Virus
- Keywords
- behavioral economics, antiretroviral adherence, SMS, mobile health (mHealth), Adolescents, Uganda, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- The AIDS Support Organization
- Study start
- Aug 2015 (actual)
- Primary completion
- 7 Mar 2017 (actual)
- Study completion
- 7 Mar 2017 (actual)
- First posted
- 3 Aug 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 purpose of this study 'SMS as an Incentive To Adhere' (SITA) is to test two novel approaches of using SMS messages (provision of information about electronically measured own adherence, as well as in combination with group adherence level) to improve adherence to anitretroviral (ART) and pre-ART prophylaxis among youth age 15-24 at an HIV clinic in Uganda.
Detailed description
SITA addresses two behavioral biases observed in people living with HIV/AIDS (PLWHA). The growing field of behavioral economics (BE) suggests that people display behavioral biases (i.e. systematic decision making errors) that among patients can contribute to suboptimal adherence. Investigators observed two important such biases in our own work in Uganda: first, investigators found that patients to a large degree overestimate their own adherence, i.e. think that they adhere better than they actually do. Second, a patient's social environment matters: PLWHA clearly care about their peers and their peers' attitudes and behavior.
SITA is based on Social Cognitive Theory (SCT) and adapts two traditional interventions to mHealth. The first intervention is that of self-monitoring, i.e. providing participants with feedback about their adherence performance. Traditionally this involves clinic visits that take up provider and patient time and resources; SITA instead suggests providing objective, real-time information measured by electronic monitoring (Wisepill) devices sent to patients by weekly SMS. Such feedback builds self-efficacy, a key SCT concept and thereby may improve adherence. The second intervention is based on the SCT concept of social learning. Perceived group norms, and interventions that affect those perceptions, are a key influence on health behavior among youths, providing a substitute for direct learning. Investigators adapt this approach to a mHealth environment by providing PLWHA not only with their own adherence information but also that of a reference (peer) group.
SITA will use mixed methods research techniques and focus on knowledge transfer within a multidisciplinary team. In formative Phase 1 investigators will conduct qualitative focus groups with key stakeholders to elicit information about the use of wisepill devices, and acceptance, feasibility and locally appropriate adaptation of SITA. In Phase 2, investigators will implement a nine-months, three-arm (with 50-60 participants each) randomized controlled trial: youths in intervention group 1 will receive information about their wisepill-measured adherence level by weekly SMS. Intervention group 2 will in addition be sent the adherence level of a reference group that investigators hypothesize to exert normative influence. The control group will receive the usual standard of care. Throughout the study investigators will focus on capacity building and knowledge transfer to the Ugandan collaborators through workshops and mentoring.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Own adherence | Active comparator | Behavioral: Own adherenceParticipants in this group receive a weekly message by SMS. They receive the intervention 'Behavioral: Own Adherence'. |
| Own and group level adherence | Active comparator | Behavioral: Own and group level adherenceParticipants in this group receive a weekly message by SMS. They receive the intervention 'Behavioral: Own and Group Adherence'. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- have been in HIV care at the clinic for at least three months
- are currently taking HIV-related medication (ART or co-trimoxazole)
- either own a phone or have regular access to one
- intend to stay at the clinic for the study period
- are not in boarding school (where phones are forbidden)
Key exclusion criteria (2 listed)
- does not speak or understand either English or Luganda
- does not have the cognitive capacity to consent and/or understand the study procedures
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 |
|---|---|---|
| Own adherenceIn this intervention group, participants receive weekly SMS messages informing them of their adherence that week as measured by the wise pill device used by the participant. | Behavioural | Own adherence |
| Own and group level adherenceIn this intervention group, participants receive weekly SMS messages informing them of their adherence that week as measured by the wise pill device used by the participant. In addition, in the same message they are informed of the adherence demonstrated by the other participants | Behavioural | Own and group level adherence |
Primary outcome
Medication adherence rates using electronically monitored adherence (wise pill) data
Time frame: 9 months after enrollment
Wisepill data will be collected continuously over the course of the 9-month study period (preceded by about one month of adherence measurement only to allow for solution of any wisepill-related problems) allowing us to investigate daily adherence and its timing. Wisepill data indicating the date and time when the participant opened their pill container (either one of the ART medications or prophylaxis if not on ART yet) will be used to calculate the primary outcome variable of adherence (# of actual bottle openings / # of prescribed bottle openings).
1 secondary outcome
Self-reported adherence
Time frame: 9 months after enrollment
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 14 Apr 2017.
- Derived from this study: PubMed 32093630MacCarthy S, Wagner Z, Mendoza-Graf A, Gutierrez CI, Samba C, Birungi J, Okoboi S, Linnemayr S. A randomized controlled trial study of the acceptability, feasibility, and preliminary impact of SITA (SMS as an Incentive To Adhere): a mobile technology-based intervention informed by behavioral economics to improve ART adherence among youth in Uganda. BMC Infect Dis. 2020 Feb 24;20(1):173. doi: 10.1186/s12879-020-4896-0.
- Derived from this study: PubMed 30286746MacCarthy S, Saya U, Samba C, Birungi J, Okoboi S, Linnemayr S. "How am I going to live?": exploring barriers to ART adherence among adolescents and young adults living with HIV in Uganda. BMC Public Health. 2018 Oct 4;18(1):1158. doi: 10.1186/s12889-018-6048-7.
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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 Own adherence and Own and group level adherence in people with Human Immunodeficiency Virus, 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 5 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 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 adherence rates using electronically monitored adherence (wise pill) data (time frame: 9 months after enrollment). 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 NCT02514356, which also lists 2 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 Apr 2017.