Clinical trial NCT04375423: Mobile Behavioral Ecological Momentary Assessment and Intervention in Rakai, Uganda
Official title: Mobile Behavioral Ecological Momentary Assessment and Intervention in Rakai, Uganda: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ecological Momentary Assessment and Intervention
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Rakai Health Sciences Program
First posted: 2020-05-05
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* literate
* current Rakai Community Cohort Study participant

We will purposely recruit a sample that has a broad range of participant characteristics in our study to optimize diversity of responses and increase study generalizability. Specific variables for which we will target sampling include: gender (\~50% female), age (at least 20% among age groups 18-25, 26-35, \>50), and occupation (at least 20% traders and farmers).

Exclusion Criteria:

* Participants without a listed phone number in the Rakai Community Cohort Study

Primary outcomes:
measure: Change in health behavior according to EMAI self-report
timeFrame: Daily, comparing baseline (days 1-30) to follow up (days 31-90), up to a total 90 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Larry Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beres LK, Mbabali I, Anok A, Katabalwa C, Mulamba J, Thomas AG, Bugos E, Nakigozi G, Grabowski MK, Chang LW. Mobile Ecological Momentary Assessment and Intervention and Health Behavior Change Among Adults in Rakai, Uganda: Pilot Randomized Controlled Trial. JMIR Form Res. 2021 Jul 20;5(7):e22693. doi: 10.2196/22693.