Stakeholders' Perceptions of Benefits of and Barriers to Using Video-Observed Treatment for Monitoring Patients With Tuberculosis in Uganda: Exploratory Qualitative Study.

BACKGROUND: Nonadherence to treatment remains a barrier to tuberculosis (TB) control. Directly observed therapy (DOT) is the standard for monitoring adherence to TB treatment worldwide, but its implementation is challenging, especially in resource-limited settings. DOT is labor-intensive and inconvenient to both patients and health care workers. Video DOT (VDOT) is a novel patient-centered alternative that uses mobile technology to observe patients taking medication remotely. However, the perceptions and acceptability of potential end users have not been evaluated in Africa. OBJECTIVE: This study explores stakeholders' acceptability of, as well as perceptions of potential benefits of and barriers to, using VDOT to inform a pilot study for monitoring patients with TB in urban Uganda. METHODS: An exploratory, qualitative, cross-sectional study with an exit survey was conducted in Kampala, Uganda, from April to May 2018. We conducted 5 focus group discussions, each comprising 6 participants. Groups included patients with TB (n=2 groups; male and female), health care providers (n=1), caregivers (n=1), and community DOT volunteer workers (n=1). The questions that captured perceived benefits and barriers were guided by domains adopted from the Technology Acceptance Model. These included perceived usefulness, ease of use, and intent to use technology. Eligible participants were aged ≥18 years and provided written informed consent. For patients with TB, we included only those who had completed at least 2 months of treatment to minimize the likelihood of infection. A purposive sample of patients, caregivers, health care providers, and community DOT workers was recruited at 4 TB clinics in Kampala. Trained interviewers conducted unstructured interviews that were audio-recorded, transcribed, and analyzed using inductive content analysis to generate emerging themes. RESULTS: The average age of participants was 34.5 (SD 10.7) years. VDOT was acceptable to most participants on a scale of 1 to 10. Of the participants, 70% (21/30) perceived it as highly acceptable, with scores ≥8, whereas 30% (9/30) scored between 5 and 7. Emergent themes on perceived benefits of VDOT were facilitation of easy adherence monitoring, timely follow-up on missed doses, patient-provider communication, and saving time and money because of minimal travel to meet in person. Perceived barriers included limited technology usability skills, inadequate cellular connectivity, internet access, availability of electricity, cost of the smartphone, and use of the internet. Some female patients raised concerns about the disruption of their domestic work routines to record videos. The impact of VDOT on privacy and confidentiality emerged as both a perceived benefit and barrier. CONCLUSIONS: VDOT was acceptable and perceived as beneficial by most study participants, despite potential technical and cost barriers. Mixed perceptions emerged about the impact of VDOT on privacy and confidentiality. Future efforts should focus on training users, ensuring adequate technical infrastructure, assuring privacy, and performing comparative cost analyses in the local context.

Using a Mobile Health Intervention (DOT Selfie) With Transfer of Social Bundle Incentives to Increase Treatment Adherence in Tuberculosis Patients in Uganda: Protocol for a Randomized Controlled Trial.

BACKGROUND: The World Health Organization's End TB Strategy envisions a world free of tuberculosis (TB)-free of deaths, disease, and suffering due to TB-by 2035. Nonadherence reduces cure rates, prolongs infectiousness, and contributes to the emergence of multidrug-resistant TB (MDR-TB). Moreover, MDR-TB is a growing, complex, and costly problem that presents a major obstacle to TB control. Directly observed therapy (DOT) for treatment adherence monitoring is the recommended standard; however, it is challenging to implement at scale because it is labor-intensive. Mobile health interventions can facilitate remote adherence monitoring and minimize the costs and inconveniences associated with standard DOT. OBJECTIVE: The study aims to evaluate the effectiveness of using video directly observed therapy (VDOT) plus incentives to improve medication adherence in TB treatment versus usual-care DOT in an African context. METHODS: The DOT Selfie study is an open-label, randomized controlled trial (RCT) with 2 parallel groups, in which 144 adult patients with TB aged 18-65 years will be randomly assigned to receive the usual-care DOT monitoring or VDOT as the intervention. The intervention will consist of a smartphone app, a weekly internet subscription, translated text message reminders, and incentives for those who adhere. The participant will use a smartphone to record and send time-stamped encrypted videos showing their daily medication ingestion. This video component will directly substitute the need for daily face-to-face meetings between the health provider and patients. We hypothesize that the VDOT intervention will be more effective because it allows patients to swallow their pills anywhere, anytime. Moreover, patients will receive mobile-phone-based "social bundle" incentives to motivate adherence to continued daily submission of videos to the health system. The health providers will log into a secured computer system to verify treatment adherence, document missed doses, investigate the reasons for missed doses, and follow prespecified protocol measures to re-establish medication adherence. The primary endpoint is the adherence level as measured by the fraction of expected doses observed over the treatment period. The main secondary outcome will be time-to-treatment completion in both groups. RESULTS: This study was funded in 2019. Enrollment began in July and is expected to be completed by November 2020. Data collection and follow-up are expected to be completed by June 2021. Results from the analyses based on the primary endpoint are expected to be submitted for publication by December 2021. CONCLUSIONS: This random control trial will be among the first to evaluate the effectiveness of VDOT within an African setting. The results will provide robust scientific evidence on the implementation and adoption of mobile health (mHealth) tools, coupled with incentives to motivate TB medication adherence. If successful, VDOT will apply to other low-income settings and a range of chronic diseases with lifelong treatment, such as HIV/AIDs. TRIAL REGISTRATION: ClinicalTrials.gov NCT04134689; http://clinicaltrials.gov/ct2/show/NCT04134689. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18029.