Improving Drug Adherence Among Adolescents in Uganda Using SMS Reminders
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

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.
    

Intervention name(s): Two-way SMS intervention; One-way SMS intervention group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: HIV; Antiretroviral (ARV); co-trimoxazole; SMS; mobile Health (mHealth); Adolescents; Uganda; Adherence