PROJECT ABSTRACT
In 2018, approximately 10 million people developed TB disease globally, of which men aged =15 years
accounted for over 50% of the cases. South African national TB prevalence studies have reported that men had
a higher burden of TB, a lower case detection and larger reporting gaps compared to women. An analysis of
South Africa's TB care cascade revealed that only 53% of TB patients completed treatment. Most strikingly, TB
in South Africa is responsible for a large proportion of the difference in life expectancy between men and women.
For South Africa to contribute to the End TB Strategy target of halving TB incidence by 2025, it is imperative to
implement effective interventions to support engagement and retention in TB care, especially among men.
This study will develop a method to gather factors and resources influencing TB treatment in real-time, by
integrating modified ecological momentary assessments (mEMA) with medication event-monitoring system
(MEMS) and assessing its feasibility. This study will be conducted over two aims.
In Aim 1, we will integrate EMA and MEMS and then determine functionality and usability. This aim will be
conducted over two phases. In Phase 1, the research study team will integrate the Wisepill technology (MEMS)
with REDCap and conduct a functionality simulation with study staff. In Phase 2, a usability assessment of the
mEMA-MEMS platform will be conducted with 20 participants, 10 men and 10 women. This phase will involve a
think-aloud method and 30-day test using the mEMA-MEMS platform with a study mobile phone. Findings will
inform the final mEMA-MEMS platform for Aim 2.
In Aim 2, we will conduct an observational cohort study with 60 participants (30 men and 30 women) initiating
TB treatment. All participants will be trained on how to use the mEMA-MEMS platform and provided a study
mobile phone. Every 28 days, they will return to the clinic study site to refill their Wisepill with medication. During
the study, each participant will receive random and event mEMAs based on their dosing behaviors. Participants
will be interviewed at enrollment, during continuation and post-continuation stages of treatment, to assess
feasibility, acceptability, willingness and safety using interviews and surveys. We will also collect preliminary data
to understand psychosocial and contextual factors influential in TB treatment across the continuum, results will
be used to inform subsequent study design.
The results of this study will inform a larger R01 observational study that will determine what resources are
needed at particular times during treatment to support adherence, and determine what resources are
generalizable to all and distinctive for men such that an intervention may be developed and tested to support
their adherence and TB treatment outcomes.
