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
Authors: Murphy-Okpala Ngozi , Dahiru Tahir , van ’t Noordende Anna T , Gunesch Carolin , Chukwu Joseph , Nwafor Charles , Abdullahi Suleiman Hudu , Anyaike Chukwuma , Okereke Ugochinyere Angelic , Meka Anthony , Eze Chinwe , Ezeakile Okechukwu , Ekeke Ngozi 
Published: January 2024

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