Human Immunodeficiency VirusRATANCT02128087
Improving Drug Adherence Among Adolescents in Uganda Using SMS Reminders
A study testing Two-way SMS intervention and One-way SMS intervention group in people with Human Immunodeficiency Virus, run by RAND at 3 sites in 2 countries.
Trial summary
In this project the investigators develop and test a short message service (SMS) intervention based on the Information Motivation and Behavior skills (IMB) model. Reminding Adolescents To Adhere (RATA) prompts youths at two clinics in Uganda to take their medications and offers social support via weekly text messages. 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?
- Two-way SMS intervention and One-way SMS intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Feb 2013to 31 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
- age 15-24
- have been in HIV care at the clinic for at least three months
- are currently taking HIV-related medication (ART or co-trimoxazole)
- have demonstrated adherence problems (defined as having missed at least one medication dose per week on average)
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
In this project the investigators develop and test a short message service (SMS) intervention based on the Information Motivation and Behavior skills (IMB) model. Reminding Adolescents To Adhere (RATA) prompts youths at two clinics in Uganda to take their medications and offers social support via weekly text messages. The investigators propose to adapt their previous successful SMS-intervention to the specific needs of youths and to evaluate the relative effectiveness of one-way versus two-way text messages (where two-way messages allow youths to respond to messages and we hypothesize that this may increase perceived social support that may be important for youth populations). We will also test the effectiveness of SMS messages over the longer-term (2 years), for which currently no information is available.
Read the detailed description
The primary goal of the proposed study is to develop and test SMS-based text messages for improving medication adherence among HIV-positive youths in a resource-limited setting. The study will be conducted in three phases: Phase 1 will consist of qualitative interviews with patients, clinic providers and directors, and community leaders and will elicit information on barriers to treatment and adherence patterns and cognitive obstacles to adherence that may be addressed by RATA. A second focus of this phase will be to investigate the familiarity with and attitude towards SMS messages among adolescents, and their attitudes towards different aspects of these messages. Parameters of the messages that will be probed include their frequency, content, and form using Figure 1 as a guiding principle for this exploratory phase. Phase 2 will use the findings from Phase 1 to develop and implement RATA in a randomized controlled trial (RCT). A sample of 330 clients aged 15-24 who are in HIV care and show signs of problems with adherence will be recruited and randomized into one of three equal-sized intervention arms: a control group that will receive usual care, or one of two treatment groups in which participants will receive usual care and additionally will receive either two-way SMS messages or one-way SMS messages. All RATA participants will be followed for two years. Assessments will be conducted at baseline and every 6 months over the course of 24 months. Medication event monitoring system (MEMS)-caps measured medication adherence will be the primary outcome measure, while viral load (for a subset of clients) CD4 count, self-reported adherence and pharmacy refill data as well as retention in care constitute secondary outcomes. Phase 3 will be used to analyze the collected data, conduct qualitative interviews with providers, clinic administrators, and study participants to learn about implementation difficulties and areas of improvement, and to share preliminary results and project implementation insights with these key players. This stage allows evaluating the feasibility and sustainability of the intervention for potential scale-up, for which we will also conduct a relative cost-effectiveness analysis of two- versus one-way messages. RATA will be extended to the control group in Year 5 if findings from phase 2 suggest its success at improving outcomes.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Two-way SMS intervention, One-way SMS intervention group
- Keywords
- HIV, Antiretroviral (ARV), co-trimoxazole, SMS, mobile Health (mHealth), Adolescents, Uganda, 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.
Two-way SMS interventionBehavioural
Clients will receive a weekly two-way SMS, meaning that the clients in this group will receive the same message as in the one-way SMS study arm, but in addition will be asked how they feel. Clients are required to either press 1 or respond "well" or press 2 or write 'Unwell" in response in the language of their choice within 48 hours. A missing response after 48 hours triggers a second SMS to remind the client to respond. If after 24 more hours the participant still does not respond or if at any point s/he responds "unwell" then the study coordinator will follow up with a call within 24 hours.
One-way SMS intervention groupBehavioural
Clients will receive a weekly one-way SMS message. There will be no prompt for any response.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | This study arm will receive care as usual. |
| Two-way SMS intervention group | Experimental | Two-way messages allow the recipient of the SMS message (the patient) to respond to the messages ("We hope you are feeling well today. Reply 1 if well, 2 if unwell") to request a follow-up call from the clinic. Receives: Behavioral: Two-way SMS intervention |
| One-way SMS intervention group | Experimental | Clients will receive a weekly one-way SMS with the message "We hope you are feeling well today." There will be no prompt for response. Receives: Behavioral: One-way SMS intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence rates using electronically monitored adherence (MEMS cap) data
Medication Event Monitoring System (MEMS)-cap data will be collected continuously over the course of the 24-month study period allowing us to investigate daily adherence and its timing. MEMS caps data indicating the date and time when the participant opened their pill bottle (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: 6 months after enrollment
Medication adherence rates using electronically monitored adherence (MEMS cap) data
Medication Event Monitoring System (MEMS)-cap data will be collected continuously over the course of the 24-month study period allowing us to investigate daily adherence and its timing. MEMS caps data indicating the date and time when the participant opened their pill bottle (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: 12 months after enrollment
Medication adherence rates using electronically monitored adherence (MEMS cap) data
Medication Event Monitoring System (MEMS)-cap data will be collected continuously over the course of the 24-month study period allowing us to investigate daily adherence and its timing. MEMS caps data indicating the date and time when the participant opened their pill bottle (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: 24 months after enrollment
Secondary outcomes (7)
Fraction of clients displaying adherence of 90% or more
MEMS caps data indicating the date and time when the participant opened their pill bottle (either one of the ART medications or prophylaxis if not on ART yet) will be used to calculate the secondary outcome measures of fraction of clients displaying adherence of 90% or more.
Measured: At 6, 12, 18 and 24 months
Indicator for treatment interruptions of more than 48 hours
MEMS caps data indicating the date and time when the participant opened their pill bottle (either one of the ART medications or prophylaxis if not on ART yet) will be used to calculate the secondary outcome measures of an indicator for treatment interruptions of more than 48 hours.
Measured: At 6, 12, 18 and 24 months
Viral load assays
A randomized subset of 30 clients from each intervention arm (90 total) will measure viral load assays at month 12.
Measured: At month 12
Self-reported adherence
We will ask about number of missed doses over the past 7 days. Adherence is calculated as a proportion of prescribed doses taken.
Measured: At baseline, 6, 12, 18 and 24 months
Pharmacy Refill Adherence
All patients on ART receive their medications in 30-day supplies from the Infectious Disease Institute (IDI) and Mildmay clinic pharmacies. For clients on co-trimoxazole, the drugs are typically dispensed in units of 90 count. We will adjust the measure according to the refill period specific to each client. A composite continuous multiple interval measure of medication availability or refill rate will be calculated (# of pills dispensed/ # pills prescribed per day)/ days between refills.
Measured: Months 6, 12, 18 and 24
Clinic Attendance
Attendance at regularly scheduled clinic visits as part of usual care will be tracked for all participants from the electronic client database and will be available in real-time to the study coordinator.
Measured: Continuous over 24 months
Cluster of differentiation 4 (CD4) count
CD4 counts will be chart abstracted from the clinic data; they are typically taken about every six months
Measured: Occasionally over 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startFeb 2013
- Primary completion31 Jan 2016
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Linnemayr, RAND
- Investigators
- Sebastian Linnemayr, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128087
- Sponsor's protocol ID
- 1R01HD074925-01
- Acronym
- RATA
- Status last verified
- Apr 2017
- First submitted
- 15 Apr 2014
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
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
- Improving Drug Adherence Among Adolescents in Uganda Using SMS Reminders
- ClinicalTrials.gov ID
- NCT02128087
- Acronym / sponsor ID
- RATA / 1R01HD074925-01
- Conditions
- Human Immunodeficiency Virus
- Keywords
- HIV, Antiretroviral (ARV), co-trimoxazole, SMS, mobile Health (mHealth), Adolescents, Uganda, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- RANDUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- 31 Jan 2016 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 1 May 2014 (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.
In this project the investigators develop and test a short message service (SMS) intervention based on the Information Motivation and Behavior skills (IMB) model. Reminding Adolescents To Adhere (RATA) prompts youths at two clinics in Uganda to take their medications and offers social support via weekly text messages. The investigators propose to adapt their previous successful SMS-intervention to the specific needs of youths and to evaluate the relative effectiveness of one-way versus two-way text messages (where two-way messages allow youths to respond to messages and we hypothesize that this may increase perceived social support that may be important for youth populations). We will also test the effectiveness of SMS messages over the longer-term (2 years), for which currently no information is available.
Detailed description
The primary goal of the proposed study is to develop and test SMS-based text messages for improving medication adherence among HIV-positive youths in a resource-limited setting. The study will be conducted in three phases: Phase 1 will consist of qualitative interviews with patients, clinic providers and directors, and community leaders and will elicit information on barriers to treatment and adherence patterns and cognitive obstacles to adherence that may be addressed by RATA. A second focus of this phase will be to investigate the familiarity with and attitude towards SMS messages among adolescents, and their attitudes towards different aspects of these messages. Parameters of the messages that will be probed include their frequency, content, and form using Figure 1 as a guiding principle for this exploratory phase. Phase 2 will use the findings from Phase 1 to develop and implement RATA in a randomized controlled trial (RCT). A sample of 330 clients aged 15-24 who are in HIV care and show signs of problems with adherence will be recruited and randomized into one of three equal-sized intervention arms: a control group that will receive usual care, or one of two treatment groups in which participants will receive usual care and additionally will receive either two-way SMS messages or one-way SMS messages. All RATA participants will be followed for two years. Assessments will be conducted at baseline and every 6 months over the course of 24 months. Medication event monitoring system (MEMS)-caps measured medication adherence will be the primary outcome measure, while viral load (for a subset of clients) CD4 count, self-reported adherence and pharmacy refill data as well as retention in care constitute secondary outcomes. Phase 3 will be used to analyze the collected data, conduct qualitative interviews with providers, clinic administrators, and study participants to learn about implementation difficulties and areas of improvement, and to share preliminary results and project implementation insights with these key players. This stage allows evaluating the feasibility and sustainability of the intervention for potential scale-up, for which we will also conduct a relative cost-effectiveness analysis of two- versus one-way messages. RATA will be extended to the control group in Year 5 if findings from phase 2 suggest its success at improving outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –This study arm will receive care as usual. |
| Two-way SMS intervention group | Experimental | Behavioral: Two-way SMS interventionTwo-way messages allow the recipient of the SMS message (the patient) to respond to the messages ("We hope you are feeling well today. Reply 1 if well, 2 if unwell") to request a follow-up call from the clinic. |
| One-way SMS intervention group | Experimental | Behavioral: One-way SMS intervention groupClients will receive a weekly one-way SMS with the message "We hope you are feeling well today." There will be no prompt for response. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- age 15-24
- have been in HIV care at the clinic for at least three months
- are currently taking HIV-related medication (ART or co-trimoxazole)
- have demonstrated adherence problems (defined as having missed at least one medication dose per week on average)
- either own a phone or have regular access to one
Key exclusion criteria (1 listed)
- does not speak or understand either English or Luganda
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 |
|---|---|---|
| Two-way SMS interventionClients will receive a weekly two-way SMS, meaning that the clients in this group will receive the same message as in the one-way SMS study arm, but in addition will be asked how they feel. Clients are required to either press 1 or respond "well" or press 2 or write 'Unwell" in response in the language of their choice within 48 hours. A missing response after 48 hours triggers a second SMS to remind the client to respond. If after 24 more hours the participant still does not respond or if at any point s/he responds "unwell" then the study coordinator will follow up with a call within 24 hours. | Behavioural | Two-way SMS intervention group |
| One-way SMS intervention groupClients will receive a weekly one-way SMS message. There will be no prompt for any response. | Behavioural | One-way SMS intervention group |
Primary outcome
Medication adherence rates using electronically monitored adherence (MEMS cap) data
Time frame: 6 months after enrollment
Medication Event Monitoring System (MEMS)-cap data will be collected continuously over the course of the 24-month study period allowing us to investigate daily adherence and its timing. MEMS caps data indicating the date and time when the participant opened their pill bottle (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).
Medication adherence rates using electronically monitored adherence (MEMS cap) data
Time frame: 12 months after enrollment
Medication Event Monitoring System (MEMS)-cap data will be collected continuously over the course of the 24-month study period allowing us to investigate daily adherence and its timing. MEMS caps data indicating the date and time when the participant opened their pill bottle (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).
Medication adherence rates using electronically monitored adherence (MEMS cap) data
Time frame: 24 months after enrollment
Medication Event Monitoring System (MEMS)-cap data will be collected continuously over the course of the 24-month study period allowing us to investigate daily adherence and its timing. MEMS caps data indicating the date and time when the participant opened their pill bottle (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).
7 secondary outcomes
Fraction of clients displaying adherence of 90% or more
Time frame: At 6, 12, 18 and 24 months
Indicator for treatment interruptions of more than 48 hours
Time frame: At 6, 12, 18 and 24 months
Viral load assays
Time frame: At month 12
Self-reported adherence
Time frame: At baseline, 6, 12, 18 and 24 months
Pharmacy Refill Adherence
Time frame: Months 6, 12, 18 and 24
Clinic Attendance
Time frame: Continuous over 24 months
Cluster of differentiation 4 (CD4) count
Time frame: Occasionally over 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
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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
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two-way SMS intervention and One-way SMS intervention group in people with Human Immunodeficiency Virus, run by RAND at 3 sites in 2 countries.
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 7 inclusion and 1 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 3 sites in Uganda, United States. 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 (MEMS cap) data (time frame: 6 months after enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.