Improving Drug Adherence Among Adolescents in Uganda Using SMS Reminders
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Human Immunodeficiency Virus
- Sponsor
- RAND
- Enrollment
- 330
- Locations
- 3
- Primary Endpoint
- Medication adherence rates using electronically monitored adherence (MEMS cap) data
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Sebastian Linnemayr
Economist
RAND
Eligibility Criteria
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
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Clinic Attendance(Continuous over 24 months)
- Self-reported adherence(At baseline, 6, 12, 18 and 24 months)
- Pharmacy Refill Adherence(Months 6, 12, 18 and 24)
- Fraction of clients displaying adherence of 90% or more(At 6, 12, 18 and 24 months)
- Viral load assays(At month 12)
- Cluster of differentiation 4 (CD4) count(Occasionally over 24 months)
- Indicator for treatment interruptions of more than 48 hours(At 6, 12, 18 and 24 months)