Improving Drug Adherence Among Adolescents in Uganda Using SMS Reminders
RATA
1 other identifier
interventional
330
2 countries
3
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2013
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 15, 2014
CompletedFirst Posted
Study publicly available on registry
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2017
CompletedApril 14, 2017
April 1, 2017
3 years
April 15, 2014
April 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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).
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).
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).
24 months after enrollment
Secondary Outcomes (7)
Fraction of clients displaying adherence of 90% or more
At 6, 12, 18 and 24 months
Indicator for treatment interruptions of more than 48 hours
At 6, 12, 18 and 24 months
Viral load assays
At month 12
Self-reported adherence
At baseline, 6, 12, 18 and 24 months
Pharmacy Refill Adherence
Months 6, 12, 18 and 24
- +2 more secondary outcomes
Study Arms (3)
Control group
NO INTERVENTIONThis study arm will receive care as usual.
Two-way SMS intervention group
EXPERIMENTALTwo-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
EXPERIMENTALClients will receive a weekly one-way SMS with the message "We hope you are feeling well today." There will be no prompt for response.
Interventions
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.
Clients will receive a weekly one-way SMS message. There will be no prompt for any response.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- does not speak or understand either English or Luganda
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RANDlead
Study Sites (3)
RAND
Santa Monica, California, 90407, United States
Infectious Diseases Institute
Kampala, Uganda
Mildmay Uganda
Kampala, Uganda
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sebastian Linnemayr, PhD
RAND
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Economist
Study Record Dates
First Submitted
April 15, 2014
First Posted
May 1, 2014
Study Start
February 1, 2013
Primary Completion
January 31, 2016
Study Completion
March 31, 2017
Last Updated
April 14, 2017
Record last verified: 2017-04