Raw, Unadulterated African Honey for Ulcer Healing in Leprosy: Protocol for the Honey Experiment on Leprosy Ulcer (HELP) Randomized Controlled Trial.

Background: Leprosy leads to nerve damage and slow-healing ulcers, which are treatable with routine therapy. There has been a recent resurgence of interest in the use of honey for the treatment of different kinds of wounds. Objective: The aim of this study, Honey Experiment on Leprosy Ulcer (HELP), is to evaluate the healing properties of raw, unadulterated African honey in comparison with normal saline dressing for the treatment leprosy ulcers. Methods: This is a multicenter, comparative, prospective, single-blinded, parallel-group, and 1:1 individually randomized controlled trial to be conducted at The Leprosy Referral Hospital, Chanchaga in Minna, Niger State, North Central Nigeria, and St. Benedict Tuberculosis and Leprosy Rehabilitation Hospital in Ogoja, Cross River State, South-South Nigeria. Raw, unadulterated honey will be used in the ulcer dressing of eligible, consenting participants in the intervention group, whereas those in the control group will be treated by dressing with normal saline. The main outcomes will be the proportion of complete healing and the rate of healing up to 84 days after randomization. Follow-up will be conducted 6 months after randomization. We aim to enroll 90-130 participants into the study. Blinded observers will examine photographs of ulcers to determine the outcomes. Results: The recruitment of trial participants began on March 14, 2022, and has been continuing for approximately 24 months. Conclusions: Our study will provide an unbiased estimate of the effect of honey on the healing of neuropathic ulcers.

Participatory Development and Assessment of Audio-Delivered Interventions and Written Material and Their Impact on the Perception, Knowledge, and Attitudes Toward Leprosy in Nigeria: Protocol for a Cluster Randomized Controlled Trial.

BACKGROUND: In Nigeria, similar to many leprosy-endemic countries, leprosy is highly stigmatized. High levels of stigma among community members as well as internalized stigma among persons affected by leprosy often result in negative psychosocial consequences for those affected. To break this vicious cycle, it is important to conduct context-specific behavioral change activities. Although written material has been successful in improving knowledge and perception, it is not suitable for populations with low educational levels. Audio-delivered interventions are likely to be more suitable for people who are illiterate. This study proposes to assess the impact of an audio-delivered intervention on the perception (knowledge, attitudes, and beliefs) of community members with regard to leprosy in Nigeria. OBJECTIVE: This study aims to assess the impact of audio-delivered and written health education on the perception of leprosy. Specific objectives are to (1) investigate the perception (local beliefs, knowledge, and attitudes) of community members toward leprosy and persons affected by leprosy; (2) investigate whether there is a difference in impact on perception between participants who have received audio-delivered health education and those who have received written health education, with specific reference to gender differences and differences between rural and urban areas; and (3) assess the impact of the participatory development of the audio-delivered and written interventions on empowerment and internalized stigma of persons affected by leprosy who developed the interventions. Additionally, we will translate and cross-culturally validate 4 study instruments measuring outcomes in 2 major Nigerian languages. METHODS: We will use a mixed methods, cross-sectional study design for the intervention development and a 3-arm cluster randomized controlled trial for its implementation and evaluation, comprising (1) baseline assessments of knowledge, attitudes, perceptions, and fears of community members, to develop the audio-delivered content and written material, and the self-esteem and internalized stigma of persons affected by leprosy; and (2) participatory development of the audio-delivered content and written material by persons affected by leprosy and the pilot and implementation of the interventions. This will be done among different groups (selected using cluster randomization) that will be compared (control group, audio-intervention group, and written material group) to evaluate the intervention and the impact of developing the intervention on the persons affected. RESULTS: This study was funded in June 2022, and community member participant recruitment started in January 2023. Baseline data collection was completed by May 2023 (n=811). Participatory cocreation of the audio and written health education content began in July 2023, and the materials are currently under development. Study results are expected in September 2024. CONCLUSIONS: Study findings will contribute to developing evidence-based, context-specific behavioral change interventions, which are critical to addressing stigma in many leprosy-endemic communities where leprosy is highly stigmatized, and contribute toward global triple zero leprosy efforts. TRIAL REGISTRATION: Pan African Clinical Trial Registry PACTR202205543939385; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=23667. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/53130.

Investigating the sustainability of self-help programmes in the context of leprosy and the work of leprosy missions in Nigeria, Nepal and India: a qualitative study protocol.

INTRODUCTION: Leprosy occurs among very poor people who may be stigmatised and pushed further to the margins of society. Programmes to improve social integration and stimulate economic development have been implemented to help break the vicious cycle of poverty, reduced quality of life and ulcer recurrence. These involve forming groups of people, with a common concern, to provide mutual support and form saving syndicates-hence the term 'self-help groups' (SHGs). While there is literature on the existence and effectiveness of SHGs during the funded periods, little is known about their sustainability. We aim to explore the extent to which SHG programme activities have continued beyond the funding period and record evidence of sustained benefits. METHODS AND ANALYSIS: In India, Nepal and Nigeria, we identified programmes funded by international non-governmental organisations, primarily aimed at people affected by leprosy. In each case, financial and technical support was allocated for a predetermined period (up to 5 years).We will review documents, including project reports and meeting minutes, and conduct semistructured interviews with people involved in delivery of the SHG programme, potential beneficiaries and people in the wider environment who may have been familiar with the programme. These interviews will gauge participant and community perceptions of the programmes and barriers and facilitators to sustainability. Data will be analysed thematically and compared across four study sites. ETHICS AND DISSEMINATION: Approval was obtained from the University of Birmingham Biomedical and Scientific Research Ethics Committee. Local approval was obtained from: The Leprosy Mission Trust India Ethics Committee; Federal Capital Territory Health Research Ethics Committee in Nigeria and the Health Research Ethics Committee of Niger State Ministry of Health; University of Nigeria Teaching Hospital and the Nepal Health and Research Council. Results will be disseminated via peer-reviewed journals, conference presentations and community engagement events through the leprosy missions.

A cluster randomized trial for improving mental health and well-being of persons affected by leprosy or buruli ulcer in Nigeria: A study protocol.

This protocol describes a study in which we would assess the effect of using community lay counselors, self-help groups (SHGs), and trained frontline health workers to reduce mental disorders and improve quality of life (QOL) of persons affected by leprosy or Buruli ulcer (BU). A cluster randomized controlled study design will be employed. The study will involve persons affected by leprosy or BU. Ten local government areas (clusters) with the highest number of notified leprosy or BU cases between 2014 and 2018 in Southern Nigeria will be purposively selected. The clusters will be randomized into intervention and control groups using a computer-generated list of random numbers. At baseline, data were collected using the following validated questionnaires, Patient Health Questionnaire, Generalized Anxiety Disorder questionnaire, Stigma Assessment and Reduction of Impact Scale, World Health Organization QOL BREF and Warwick-Edinburgh Mental Well-being scale among persons affected by leprosy or BU. The intervention will last for 2 years and will involve use of community lay counselors, SHGs, and appropriately trained frontline health workers in reducing mental disorders and improving QOL of persons affected by leprosy or BU. This project postulates that the reduction of burden of mental health problems and improved QOL among persons affected by leprosy or BU could be achieved through a holistic approach involving SHGs, appropriately trained community opinion leaders, and general health-care workers as well as a functional referral system. If successful, the model will be integrated into the activities of the National Tuberculosis and Leprosy Control Programme and scaled up nationwide. Trial registration: ISRCTN Registry: ISRCTN 83649248. https://trialsearch. who.int/Trial2.aspx? TrialID % ISRCTN83649248 Prospectively registered.

Effectiveness of self-care interventions for integrated morbidity management of skin neglected tropical diseases in Anambra State, Nigeria.

BACKGROUND: Lymphatic filariasis (LF), Buruli ulcer (BU) and leprosy are neglected tropical diseases (NTDs) of the skin co-endemic in some communities in Nigeria. Not enough is known about the effectiveness of integrated morbidity management and disability prevention in people with these conditions. An integrated self-care intervention was carried out for people with these skin NTDs in two endemic communities of Anambra state, Nigeria. The objective of the study was to assess the effectiveness of self-care practices on costs of care, disability status and health-related quality of life. METHODS: This study utilised a quasi-experimental pre-test/post-test design to assess the effectiveness of the self-care interventions for people affected by NTDs to care for these impairments at home. Data were collected using questionnaires administered at the beginning and at the end of the intervention on monthly cost of morbidity care, and on participants' disability status and their quality of life (QoL). Focus group discussions (FGDs) were held with both the participants and healthcare workers at follow-up. RESULTS: Forty-eight participants were recruited. Thirty participants (62.5%) continued the self-care interventions until the end of the project. Of those, 25 (83%) demonstrated improvement from their baseline impairment status. The mean household costs of morbidity care per participant decreased by 66% after the intervention, falling from US$157.50 at baseline to US$53.24 after 6 months of self-care (p = 0.004). The mean disability score at baseline was 22.3; this decreased to 12.5 after 6 months of self-care (p < 0.001). Among the 30 participants who continued the interventions until the end of the project, 26 (86.7%) had severe disability score (i.e. a score of 10-46) at baseline, and the number with severe disability fell to 18 (60%) of the 30 after the intervention. The mean QoL score increased from 45.7 at baseline to 57.5 at the end of the intervention (p = 0.004). CONCLUSIONS: The 6-month self-care intervention for participants affected by BU, leprosy, or LF led to lower costs of care (including out-of-pocket costs and lost earnings due to morbidity), improved QoL scores, and reduced disability status. TRIAL REGISTRATION: ISRCTN Registry: ISRCTN20317241 ; 27/08/2021, Retrospectively registered.

Worsening of the disability grade during leprosy treatment: prevalence and its determinants in Southern Nigeria.

Background: In Nigeria, little is known about the development of new or additional physical disability during leprosy treatment. The objective of this study was to determine the prevalence and evaluate factors associated with worsening of physical disability during leprosy treatment in Nigeria. Methods: This was a retrospective cohort study conducted among leprosy patients treated in six referral facilities in six States in Nigeria between January 2011 and December 2015. Multivariable logistic regression analysis was used to identify predictors of worsening disability after treatment. Results: Of 984 leprosy patients who completed treatment, the mean age of the patients was 39.8±17.6 years and 57.4% (565/984) of them were male. Also, 51.6% (508/984) of the patients had either grade 1 or 2 disability at diagnosis, but this declined to 30.8% (303/984) following treatment (p<0.001). Overall, 4.7% (46/984) of the cases developed new or additional disability (or worsening disability) during treatment. The cases with the greatest odds for developing worsening physical disability were patients from the southwest (adjusted odds ratio [aOR] 15.9; 95% CI 3.8-67.4) and southeast zones (aOR 4.7; 95% CI 1.1-19.2), and patients who had a leprosy reaction requiring additional corticosteroid therapy (aOR 11.7; 95% CI 4.4-31.2). Conclusion: Sustained capacity building for health professionals on better monitoring and management of leprosy and its complications is strongly recommended in Nigeria.

Children and leprosy in southern Nigeria: burden, challenges and prospects.

OBJECTIVES: To describe the trend of leprosy case notification among children from 2002 to 2012 in Southern Nigeria. 2. To identify the challenges faced by the children suffering from leprosy. DESIGN: A retrospective descriptive desk analysis of leprosy case notification data for children from 0 to 14 years in 14 states in Southern Nigeria. Secondly, a cross sectional study of all children currently undergoing leprosy treatment in three selected clusters (referral centres) in Southern Nigeria. A questionnaire-based interview was used to identify the challenges faced by the children with leprosy. RESULTS: Notified cases of leprosy among children in southern Nigeria decreased from 110 cases in 2002 to 64 cases in 2012. The median child proportion and MB proportion were 7.0% and 80.5% respectively. Two children (with WHO Grade 2 Disability) interviewed had great difficulty with their education and social life. Others were able to cope well in school and suffered no discrimination probably because their disease remained undisclosed to and unrecognised by the teachers. The school teachers were reportedly unable to recognise the symptoms/signs of leprosy in seven out of the 10 cases. Eight of the child leprosy cases were initially misdiagnosed at peripheral hospitals. The diagnostic delay ranged from 5 to 48 (with a median of 36) months. Notably, five out of the 10 children interviewed reported a positive household contact history. CONCLUSION: Notwithstanding the decline in leprosy case-notification in southern Nigeria over the past decade, transmission of the infection appears to be on-going as evidenced by the considerable number of child cases. Innovative approaches in case-finding including school-based activities and robust 'family-contact' management are recommended to address long diagnostic delays and lingering stigma.