The PEP++ is a multi-country, multi-partners collaborative research program, which is being implemented in three leprosy high burden countries namely India, Brazil and Indonesia. It is a five years study, funded by National Post Code Lottery (NPL), Netherlands through Netherlands Leprosy Relief, Netherlands and implemented by NLR country offices in partnership with Erasmus Medical Center (EurMC), Rotterdam, and universities in each country. Two districts/municipalities were selected for the study in each country and In India, the study is implemented by NLR India in collaboration with Central Leprosy Division, NLEP, Government of India (GoI) and Vardhman Mahavir Medical College (VMMC) & Safdarjung Hospital (SHJ), Ministry of Health & Family Welfare (MoHFW), New Delhi, in Fatehpur and Chandauli districts in Uttar Pradesh, which has higher Annual Case Detection Rate (ACDR) of >10 per 10,000 and prevalence rate of >
Key program components: Some of the key program components are a) perception or baseline study to assess the perceptions on leprosy; b) development of training materials, IEC & BCC interventions’ including pilot test of draft IEC materials and methods c) GIS mapping of index cases reported from April 2014 till March 2022; d) cluster analysis of index cases and block randomization for selection of intervention and control areas; e) development of open data kit (ODK) server and data collection system; f) contact listings of index cases; g) advocacy, training of general health care workers including ASHA and project staff; including sensitization of key stakeholders (block, district, state/national); h) time-motion study to define /facilitate operational planning; i) implementation of EC interventions ; j) systematic screening and examination; k) administration of drug regimen to eligible contacts; l) referral of suspected cases to PHC ; m) use of lab based (ELISA) test for confirmation of cases among sample of close contacts; n) follow up of contacts for screening and detection o) management of adverse reactions etc.; p) data analysis and publications.
Key Progress Update as in April 2019:
a)Offices and HR:fully functional district offices and well-placed 34 staff at all levels (national, districts) including 1 PhD student (sponsored by NLR);
- b) Approval Status:VMMC & SJH’s Institutional Ethic Committee (IEC) and Indian Council of Medical Research (ICMR)’s approval through High Ministerial Steering Committee (HMSC) on original /amended PEP++ proposal in Dec’2017 and in Aug/Sep’2018;
c)Establishment of committees: Several national level committees and working groups were established in 2018-2019 such as Task Force/Advisory Committee; Data Management Committee; Drug Procurement Committee; IEC working groups; Adverse Reactions Committee (national/district) etc. for taking key decisions on PEP++ on various aspects of program. The committee meet regularly (quarterly/monthly) or as need arises from time to time.
- c) Grant of import license by Drug Controller General of India (DCGI) for ML flow test kits in Jan 2019 d) perception studies: Studies wereconducted in Dec 2017 till April 2018 in 2 districts, of which the study findings were disseminated in IEC strategic planning workshop held on 10th&11th April 2018 in Delhi, among stakeholders; followed by communication needs assessment carried out in 2 districts to assess the most suitable media for dissemination of information on leprosy/PEP++.
- e) Development of IEC materials including piloting of draft prototypes in 2 districts were carried out in August 2018 and continued till April 2019 for testing of draft posters, stickers, flipbooks and FAQ.
- f) Mapping survey of index cases reported from April 2014 till March 2019 carried out in 3 phases (1st phase: Jan-Feb 2018; 2nd phase: April 2018 and 3rd phase: April 2019) in 2 districts. Total 3188 index cases in 2 districts (till Dec 2018) got mapped, which is 98% of reported cases.
- g) Contact listing: Enlisting of contacts of total 2463 index cases were completed through household visits in 2 districts as on 16th April 2019. Total 43,490 contacts have been listed until April 2019. The average number of contacts per index patient is 20.3 in Chandauli and 17.8 in Fatehpur
- h) Cluster Analysis: Cluster analysis was carried out in March 2019, and 406 clusters and 300 clusters in Fatehpur and Chandauli were prepared and analysed, with each cluster ranging from 2.3 to 4.4, and distance considered was 400meters. Total 7 clusters falling outside district boundaries (as per shapefiles)
- i) Registration at Clinical Trial Registry of India (CTRI): The proposal was submitted online at CTRI and enrolment date for 1st subject is 1st October 2019.
- j) Scientific Steering Committee (SSC)/International Meeting: The 3rd SSC/International meeting was organized by NLR India, at Varanasi (UP) from 26th Feb to 28th Feb 2019, under chairmanship of Dr Paul Saunderson (chair), and participated by 7 SSC members and PIs , Co-PIs, PCs, CD and NLR International staff. Some of the key decisions made was regarding change of drug regimen and use of screening test- ML flow etc.