Clinical trial NCT02128087: Improving Drug Adherence Among Adolescents in Uganda Using SMS Reminders
Official title: Improving Drug Adherence Among Adolescents in Uganda Using SMS Reminders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: HIV
Antiretroviral (ARV)
co-trimoxazole
SMS
mobile Health (mHealth)
Adolescents
Uganda
Adherence
Lead sponsor: RAND
Sponsor class: OTHER
First posted: 2014-05-01
Enrollment: 330
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Medication adherence rates using electronically monitored adherence (MEMS cap) data
timeFrame: 6 months after enrollment
measure: Medication adherence rates using electronically monitored adherence (MEMS cap) data
timeFrame: 12 months after enrollment
measure: Medication adherence rates using electronically monitored adherence (MEMS cap) data
timeFrame: 24 months after enrollment
Secondary outcomes:
measure: Fraction of clients displaying adherence of 90% or more
timeFrame: At 6, 12, 18 and 24 months
measure: Indicator for treatment interruptions of more than 48 hours
timeFrame: At 6, 12, 18 and 24 months
measure: Viral load assays
timeFrame: At month 12
measure: Self-reported adherence
timeFrame: At baseline, 6, 12, 18 and 24 months
measure: Pharmacy Refill Adherence
timeFrame: Months 6, 12, 18 and 24
measure: Clinic Attendance
timeFrame: Continuous over 24 months
measure: Cluster of differentiation 4 (CD4) count
timeFrame: Occasionally over 24 months
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: RAND
state: California
city: Kampala
country: Uganda
facility: Infectious Diseases Institute
city: Kampala
country: Uganda
facility: Mildmay Uganda
Study officials:
affiliation: RAND
name: Sebastian Linnemayr, PhD
role: PRINCIPAL_INVESTIGATOR
References: