Real-time Tuberculosis Medication Adherence Intervention in Rural Southwestern Uganda (MAT K43)

This study has three major aims (Aims 1, 2 and 3)

Aim 1: Carry out a formative qualitative study to assess barriers and facilitators to TB medication adherence, and identify optimal SMS reminders, notifications, and initial feasibility of real time adherence monitoring. 35 TB patients will be recruited from the TB clinic in Mbarara Regional Referral Hospital (MRRH), and up to 15 social supporters specified by the TB patients (one per TB patient). Drawing from technology adoption and behavioral change models, the investigator will use semi-structured interviews to assess the initial feasibility and acceptability of the intervention, as well the barriers and facilitators to TB medication adherence, and how they can be addressed using the proposed intervention. The purpose will be to inform the development the technology necessary to conduct a real-time intervention involving a wireless monitor and SMS reminders and notifications (Aim 2 and 3).

Aim 2: Develop a TB medication adherence intervention based on SMS reminders (fixed and/or linked to real-time detection of missed doses) and assess its acceptability, feasibility and preliminary impact on adherence.

The Investigators will use real-time electronic adherence monitoring (i.e., Wisepill) to follow 60 TB-infected individuals initiating TB treatment in Mbarara Regional Referral Hospital (MRRH) for six months. Using a 1:1:1 manner, participants will be randomized to one of the following three study arms (details of each intervention will be informed by the data collected in Aim 1):

1. Intervention Arm A: SMS reminders on a fixed schedule
2. Intervention Arm B: SMS reminders linked to missed doses
3. Control: No SMS reminders.

Qualitative interviews to understand the patients experiences with Wisepill adherence monitoring and the SMS reminders will be carried out, depending on the study arm to which they are assigned. The first set of interviews for Arms A and B will be conducted at the end of Month 3 of the study. The second set of interviews is planned to be conducted within two weeks after the first 24+ hour lapse in Wisepill signal for the participants in the intervention arms (A and B). If there is no 24+ hour lapse, the interview will take place at the end of the study. The control participants in Arm C's interview will occur at a convenient time during Months 3-6. The effect sizes will be estimated by comparing adherence at the end of six months between each intervention group and the control group. The primary outcome will be percent adherence.

Treatment outcomes will be defined according to WHO definitions, where cure and completed treatment are defined as successful treatment outcomes (WHO 2014). Unsuccessful treatment outcomes for active TB treatment will include death ascertained from hospital death registry, treatment failure (sputum smear positive at 6 months) and loss to follow-up. Treatment outcomes will be compared for both intervention and control arms.

Aim 3: Develop a social support intervention linked to real-time adherence monitoring and assess its acceptability, feasibility and preliminary impact on adherence. Members of pre-existing social support networks for the same 40 TB-infected individuals in the two intervention arms described in Aim 2 above will be recruited to receive real-time SMS notification of sustained non-adherence (i.e., gaps of >24 hours) over the latter four months of follow-up. The investigators will continue to follow the 20 TB-infected individuals in the control group (i.e., electronic monitoring alone) to estimate the effect size of the intervention on adherence at the end of the six-month period. Qualitative interviews to understand the experiences of participants in each study arm and the social supporters with special emphasis on understanding mechanisms of effects of the SMS reminders, forms and dynamics of support, experiences with the SMS reminders/notifications, and technical problems encountered will be conducted. The results of Aim 3 will be used to determine the types of SMS (fixed versus linked SMS), and the nature of social support that shows the most promise for real time intervention on anti-TB medication adherence and cure.