Reassessing the Significance of Mycobacterium in Neglected Tropical Diseases: A Study Protocol in Nigeria.

Background: Neglected tropical diseases (NTDs) significantly impact the physical and mental well-being of affected individuals, particularly in Nigeria. This study aims to evaluate the effectiveness of integrating mental health services with self-care practices for individuals suffering from leprosy, Buruli ulcer (BU), and lymphatic filariasis (LF). The role of trained Healthcare Workers (HCWs) and NTD champions (NTD-Cs) will be explored to enhance health outcomes in this population.

Methods: A cluster-randomized controlled trial was conducted in four local government areas (clusters) with the highest incidence of leprosy, BU, or LF. Clusters were purposively selected and randomized into intervention and control groups: three clusters received interventions, while one served as a control. The intervention arms include (a) Mental health and self-care interventions by NTD-Cs. (b) Mental health and self-care interventions by HCWs. (c) Self-care interventions only by HCWs. d) Control group receiving standard care. Data were collected at baseline and postintervention using validated questionnaires, including the Patient Health Questionnaire and World Health Organization Quality of Life (QOL-BREF), among others. The intervention will last for 8 months, with monthly self-help group meetings providing support and resources.

Results: The study aims to provide evidence on the effectiveness of integrated mental health and self-care interventions for NTD patients by evaluating outcomes such as mental health status, quality of life (QOL), and socioeconomic factors.

Conclusion: This trial aims to inform policy and practice by demonstrating the potential benefits of integrating mental health services within the care framework for individuals affected by NTDs in Nigeria. If successful, the findings will contribute to the enhancement of healthcare delivery and may be incorporated into the National Tuberculosis and Leprosy Control Program for broader implementation across the country.Trial registration: PACTR Registration number: PACTR202404852537141.https://pactr.samrc.ac.za/Default.aspx?Logout=TrueRetrospectively registered.