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Improving Drug Adherence Among Adolescents in Uganda Using SMS Reminders (RATA)

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ClinicalTrials.gov Identifier: NCT02128087
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
Sebastian Linnemayr, RAND

Tracking Information
First Submitted Date  ICMJE April 15, 2014
First Posted Date  ICMJE May 1, 2014
Last Update Posted Date April 14, 2017
Study Start Date  ICMJE February 2013
Actual Primary Completion Date January 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2014)
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02128087 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2014)
  • Fraction of clients displaying adherence of 90% or more [ Time Frame: At 6, 12, 18 and 24 months ]
    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.
  • Indicator for treatment interruptions of more than 48 hours [ Time Frame: At 6, 12, 18 and 24 months ]
    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.
  • Viral load assays [ Time Frame: At month 12 ]
    A randomized subset of 30 clients from each intervention arm (90 total) will measure viral load assays at month 12.
  • Self-reported adherence [ Time Frame: At baseline, 6, 12, 18 and 24 months ]
    We will ask about number of missed doses over the past 7 days. Adherence is calculated as a proportion of prescribed doses taken.
  • Pharmacy Refill Adherence [ Time Frame: Months 6, 12, 18 and 24 ]
    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.
  • Clinic Attendance [ Time Frame: Continuous over 24 months ]
    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.
  • Cluster of differentiation 4 (CD4) count [ Time Frame: Occasionally over 24 months ]
    CD4 counts will be chart abstracted from the clinic data; they are typically taken about every six months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Drug Adherence Among Adolescents in Uganda Using SMS Reminders
Official Title  ICMJE Improving Drug Adherence Among Adolescents in Uganda Using SMS Reminders
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Human Immunodeficiency Virus
Intervention  ICMJE
  • Behavioral: Two-way SMS intervention
    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.
  • Behavioral: One-way SMS intervention group
    Clients will receive a weekly one-way SMS message. There will be no prompt for any response.
Study Arms  ICMJE
  • No Intervention: Control group
    This study arm will receive care as usual.
  • Experimental: Two-way SMS intervention group
    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.
    Intervention: Behavioral: Two-way SMS intervention
  • Experimental: One-way SMS intervention group
    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.
    Intervention: Behavioral: One-way SMS intervention group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 29, 2014)
330
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 31, 2017
Actual Primary Completion Date January 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • does not speak or understand either English or Luganda
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 24 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Uganda,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02128087
Other Study ID Numbers  ICMJE 1R01HD074925-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sebastian Linnemayr, RAND
Study Sponsor  ICMJE RAND
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sebastian Linnemayr, PhD RAND
PRS Account RAND
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP