Improving Drug Adherence Among Adolescents in Uganda Using SMS Reminders
| Status: | Active, not recruiting |
|---|---|
| Conditions: | HIV / AIDS, HIV / AIDS, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 15 - 24 |
| Updated: | 4/21/2016 |
| Start Date: | February 2013 |
| End Date: | January 2018 |
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.
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.
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.
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.
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
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