Enhancing adherence and completion of the three-month isoniazid with rifapentine (3HP) tuberculosis preventive therapy regimen through biomarker-guided adherence counselling - PROJECT SUMMARY/ABSTRACT The overall goal of this Emerging Global Leader Award (K43) project is to support Dr. Dickens Onyango’s research and enable him to acquire additional skills to transition to an independent scientist focused on tuberculosis (TB) prevention among people with HIV through innovative approaches. The proposed study intends to develop and evaluate a urine dipstick-guided counseling intervention to support adherence and completion of the three-month isoniazid with rifapentine (3HP) tuberculosis preventive therapy (TPT) regimen. This award will allow Dr. Onyango to achieve his training goals to: 1) Acquire expertise in qualitative research and mixed-methods analysis; 2) Gain advanced knowledge and hands-on experience in randomized controlled trials; 3) Develop proficiency in assessing implementation outcomes using the Proctor Implementation Outcomes framework. Building on his expertise in TB and HIV epidemiology and implementation science, Dr. Onyango will receive mentorship from a multidisciplinary team of mentors and collaborators with expertise in HIV/TB clinical research, human-centered design, qualitative methods, randomized controlled trials (RCTs), and implementation science. This award will enable him to develop into a leading investigator in clinical and implementation research at the intersection of TB and HIV. Despite the availability of effective TB preventive therapy regimens, adherence remains suboptimal, hindering the impact of these interventions. Although the need to improve adherence to TPT regimens has been identified by the World Health Organization and the Kenya Ministry of Health, effective strategies to enhance adherence remain limited. Biomarker-guided counseling has shown promise in improving adherence to HIV pre- exposure therapy but has not been explored in improving adherence to TPT. Robust evidence is needed evidence on the effectiveness of such strategies in routine settings. Additionally, policymakers need data on the real-world impact of these approaches, including their acceptability, feasibility, fidelity, and cost, to inform scale-up. The overall goal of the proposed study is to develop a dipstick-guided adherence counseling intervention, evaluate its effectiveness in improving adherence and completion of 3HP, and assess its implementation outcomes. Using a phased implementation approach, the specific aims are to: 1) develop the intervention using human-centered design 2)Assess the effectiveness of dipstick-guided adherence counseling in improving adherence and treatment completion of 3HP among PLHIV in a randomized controlled trial; 2) Explore the acceptability, feasibility, fidelity, and cost of this approach using mixed-methods evaluations. This work will generate critical pilot data for a subsequent R01 application to assess the impact of the proposed intervention in improving adherence and completion of 3HP using a cluster randomized design. The findings will advance evidence-based strategies for improving adherence to TPT and improving outcomes among PLHIV, contributing to global TB elimination goals.
