Ecological Momentary Assessment and Intervention Clinical Trial
Official title:
Mobile Behavioral Ecological Momentary Assessment and Intervention in Rakai, Uganda: A Pilot Study
Ecological Momentary Assessment and Intervention (EMAI) is an emerging technique for
gathering richer and more relevant data through repeated, longitudinal sampling of
participants in their natural setting in order to deliver real-time interventions. The main
study objective is to conduct a pilot EMAI study in Rakai, Uganda. Secondary objectives are
to assess processes, facilitators, and barriers to EMAI. The study will compare behaviors
between participants randomized to receive intervention messages and those not receiving
messages. To assess EMAI validity and relevance, EMAI-collected behavioral data will be
compared with traditional questionnaire-collected data.
After recruitment, participants will be given a smartphone with an application that will
collect geospatial coordinates and ask behavioral assessment questions on topics including
diet/alcohol, smoking, and sexual behaviors. Participants will have training on the phone and
application, demonstrating proficiency with the EMAI interface prior to study start.
Days 1-30, Baseline Behaviors: Participants will complete assessment questions to establish
baseline behaviors. This will include twice-daily and weekly behavioral report prompts and
participant-initiated event-contingent behavioral reports. After the initial 30 day period,
participants will return to the study office to complete a short questionnaire and to be
randomized to the second phase of follow-up.
Days 31-90, Randomized Evaluation: Participants will be randomized in a 1:1 ratio to either
continue assessment questions only (control arm) or to also begin receiving intervention
messages (intervention arm) in response to reported behaviors. Messages will encourage
positive behaviors and suggest alternatives to negative behaviors (e.g. "Eating a mixed diet
(meats and vegetables) is a healthy way to go."). At 90 days of follow-up, participants will
return to the study office to complete a brief questionnaire on behaviors and smartphone
experiences.
Study hypotheses are as follows: EMAI can be successfully implemented in Uganda, and
participants receiving intervention messaging will have improved self-reported health
behaviors compared to controls; EMAI will be feasible and acceptable by this population; and,
EMAI-collected data will correlate with traditional questionnaire-collected data.
Outcomes will be assessed using descriptive statistics, multivariate regression and analysis
of themes in patient EMAI experience and acceptability.
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