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.

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.

Measuring endemicity and burden of leprosy across countries and regions: A systematic review and Delphi survey.

BACKGROUND: Leprosy is a chronic infectious disease caused by Mycobacterium leprae, the annual new case detection in 2019 was 202,189 globally. Measuring endemicity levels and burden in leprosy lacks a uniform approach. As a result, the assessment of leprosy endemicity or burden are not comparable over time and across countries and regions. This can make program planning and evaluation difficult. This study aims to identify relevant metrics and methods for measuring and classifying leprosy endemicity and burden at (sub)national level. METHODS: We used a mixed-method approach combining findings from a systematic literature review and a Delphi survey. The literature search was conducted in seven databases, searching for endemicity, burden and leprosy. We reviewed the available evidence on the usage of indicators, classification levels, and scoring methods to measure and classify endemicity and burden. A two round Delphi survey was conducted to ask experts to rank and weigh indicators, classification levels, and scoring methods. RESULTS: The literature review showed variation of indicators, levels, and cut-off values to measure leprosy endemicity and/or burden. The most used indicators for endemicity include new case detection rate (NCDR), new cases among children and new cases with grade 2 disability. For burden these include NCDR, MB cases, and prevalence. The classification levels 'high' and 'low' were most important. It was considered most relevant to use separate scoring methods for endemicity and burden. The scores would be derived by use of multiple indicators. CONCLUSION: There is great variation in the existing method for measuring endemicity and burden across countries and regions. Our findings contribute to establishing a standardized uniform approach to measure and classify leprosy endemicity and burden at (sub)national level, which would allow effective communication and planning of intervention strategies.

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.

Investigating barriers and challenges to the integrated management of neglected tropical skin diseases in an endemic setting in Nigeria.

BACKGROUND: There is a dearth of experience in and evidence for cost-effective integrated community-based management of skin neglected tropical diseases (NTDs). The objective of this study was to assess the knowledge, attitude and care-seeking practices including self-care with a view to introducing appropriate community-based interventions for skin NTDs in an endemic setting in Southern Nigeria. METHODS/PRINCIPAL FINDINGS: This exploratory study adopted a mixed-methods design consisting of cross-sectional surveys of community members and health workers using interviewer-administered questionnaires; and focus group discussions (FGDs) with community members, health care workers and patients with NTDs in Anambra State, Nigeria. The survey was completed by 353 community members (61.8% female) and 15 health care workers (100.0% female). A total of 52 individuals participated in six FGDs. Of the community members, 236 (66.9%) had heard or seen a case of leprosy; 324 (91.8%) and 131 (37.5%) had heard or seen a case of Buruli ulcer and lymphatic filariasis, respectively. Again, 213 (60.3%) of the respondents reported that the diseases were caused by witchcraft or curse. As regards prevention, 241 (68.3%) suggested avoiding handshake with affected persons. Up to 223 (63.2%) of respondents strongly agreed to the seriousness of skin NTDs in their community. Meanwhile, 272 (77.1%) of the respondents believed that the transmission of these skin NTDs can be prevented. Furthermore, 324 (91.7%) desired active community engagement for control of skin NTDs. Regarding community care seeking practices, 197 (55.8%) would first visit the health centre/hospital, followed by 91 (25.8%) traditional healer/herbalist and 35 (9.9%) pharmacy/patent medicine vendor if they develop a skin NTD. Overall, 332 (94.1%) of respondents expressed interest in being taught self-care practices for skin NTDs. Out of 15 healthcare workers, 13 (86.7%) were able to correctly diagnose two of these skin NTDs and 10 (66.7%) would encourage patients to practice self-care. Prominent themes in the FGDs were belief in witchcraft and herbal remedies; as well as the occurrence of physical, social and economic distress. CONCLUSIONS: Our study helped quantify the information gaps that need to be addressed in order to create demand for integrated skin NTDs services in an endemic setting in Nigeria. Individual, structural and socioeconomic challenges to access and delivery of services were identified. Community and health care workers' empowerment and engagement through outreach and regular training, respectively may alleviate these challenges.

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.

Establishing the reliability and construct validity of the Igbo version of Screening Activity Limitation and Safety Awareness scale in persons with Hansen disease.

OBJECTIVE: Leprosy or Hansen's disease is an infectious disease affecting skin and peripheral nerves. The World Health Organization (WHO) Recent Report reveals Africa as having 20,599 new cases, America 36, 178, Eastern Asia 166,445, Western pacific 5,400; totally up to 232,875 new cases. Nigeria as at 2012 had 3,805 new cases. Nerve dysfunction can lead to severe impairments, such as wounds, clawing and shortening of digits, and visual impairments that are often indicated as WHO Grade 2 disabilities. The Screening Activity Limitation Safety Awareness (SALSA) scale however, was developed to-measure self-reported activity limitation in people affected by peripheral neuropathy, and has been translated into several languages world-wide, including two of the three major indigenous languages in Nigeria (i.e. Yoruba and Hausa), leaving the Igbo language yet to be translated. This resulted in the present study, in which the scale was translated into Igbo and the psychometric properties also established to help in data collection and to promote research among the Igbo speaking people living with disabilities from Hansen's disease. DESIGN: The research design was a cross-sectional survey, facility based with 70% RFT and 30% on MDT. Data were analysed using Cronbach's alpha and factor analyses. RESULT: A quantitative exploration of participants' characteristics revealed that of the 40 respondents that participated in the study; 87.5% of them were predominantly from a rural population; 42.5% were males and 57.5% females. Their ages ranged between 15 and 64 years; 55% were uneducated; while 45% were educated. The SALSA Scale was interviewer-administered to the participants. Reliability analysis conducted on the data revealed high Cronbach's alpha co-efficient of 0.93 - 0.94 for the entire items on the scale. Firstly, most of the scale items correlated at least 0.3 with at least one other item on the scale, Secondly, the Kaiser-Meyer-Olkin measure of sampling adequacy was 0.71, Bartlett's test of sphericity was significant (Χ2 (190) = 482.63, P < 0.001). Finally, the communalities were all above 0.3. The principal factor analysis of the scale revealed a five factor scale, having fulfilled all the necessary conditions. CONCLUSION: It can be concluded that the Igbo version of SALSA is reliable and valid for use among the Igbo speaking group 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.

Leprosy situation in Nigeria.

With an annual new case detection of 4000 people, a Grade 2 disability rate of 12%, and nearly 10% child ratio among new cases, leprosy remains a disease of public health importance in Nigeria. Faced with the reality of low endemicity; a declining budgetary allocation to leprosy control; and a pervasive loss of expertise; it is necessary for Nigeria to re-organise its leprosy control services to further reduce the burden of the disease and ensure quality care to people affected by leprosy.