Overview

This trial is active, not recruiting.

Condition human immunodeficiency virus
Treatments two-way sms intervention, one-way sms intervention group
Sponsor RAND
Start date February 2013
End date December 2016
Trial size 330 participants
Trial identifier NCT02128087, 1R01HD074925-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose health services research
Arm
(No Intervention)
This study arm will receive care as usual.
(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.
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.
(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.
one-way sms intervention group
Clients will receive a weekly one-way SMS message. There will be no prompt for any response.

Primary Outcomes

Measure
Medication adherence rates using electronically monitored adherence (MEMS cap) data
time frame: 6 months after enrollment
Medication adherence rates using electronically monitored adherence (MEMS cap) data
time frame: 12 months after enrollment
Medication adherence rates using electronically monitored adherence (MEMS cap) data
time frame: 24 months after enrollment

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 15 years up to 24 years old.

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

Additional Information

Official title Improving Drug Adherence Among Adolescents in Uganda Using SMS Reminders
Principal investigator Sebastian Linnemayr, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by RAND.