CTRI Number |
CTRI/2017/01/007704 [Registered on: 16/01/2017] Trial Registered Prospectively |
Last Modified On: |
30/12/2022 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Process of Care Changes |
Study Design |
Cluster Randomized Trial |
Public Title of Study
|
Reducing Scabies in tribal area of Gadchiroli |
Scientific Title of Study
|
Field trial of community-based intervention to control scabies in the tribal communities of Gadchiroli, Maharshtra |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Priyamadhaba Behera |
Designation |
In Charge Tribal Health, SEARCH |
Affiliation |
SEARCH |
Address |
SEARCH
Shodhgram
PO and District Gadchiroli
Maharashtra, India 442605
Gadchiroli MAHARASHTRA 442605 India |
Phone |
9404821908 |
Fax |
07138-255411 |
Email |
priya.madhaba@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Priyamadhaba Behera |
Designation |
In Charge Tribal Health, SEARCH |
Affiliation |
SEARCH |
Address |
SEARCH
Shodhgram
PO and District Gadchiroli
Maharashtra, India 442605
Gadchiroli MAHARASHTRA 442605 India |
Phone |
9404821908 |
Fax |
07138-255411 |
Email |
priya.madhaba@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Abhay Bang |
Designation |
Director |
Affiliation |
SEARCH |
Address |
SEARCH, Shodhgram, Post & district Gadchiroli 442605
Maharashtra, India
Gadchiroli MAHARASHTRA 442605 India |
Phone |
07138255407 |
Fax |
|
Email |
search.gad@gmail.com |
|
Source of Monetary or Material Support
|
Navajbai Ratan Tata Trust Bombay House Homi Mody street Fort Mumbai 400001 |
|
Primary Sponsor
|
Name |
Society for Education Action and Research in Community Health |
Address |
Shodhgram PO and District Gadchiroli,Maharashtra, India 442605 |
Type of Sponsor |
Other [Non-Governmental Organisation] |
|
Details of Secondary Sponsor
|
Name |
Address |
Not applicable |
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Priyamadhaba Behera |
SEARCH |
Room no-3 Shrish building Tribal Health Gadchiroli MAHARASHTRA |
9404821908 07138-255411 priya.madhaba@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee, SEARCH |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Scabies, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Community-based intervention to control scabies |
The community-based intervention package will target all people of the intervention villages. A community survey will be conducted by trained community health workers to address the prevalence of scabies. If the prevalence is found to be less than 10%, then the intervention will include i) Treatment of cases of scabies with two doses of ivermectin (200 microgram per kg) with a gap of 14 days, along with single dose ivermectin (200 microgram per kg) administration to household members unless contraindicated (weight less than 15 kg, pregnant and breastfeeding women, individual with neurologic disease such as parkinson’s disease or cerebral palsy and individual taking medication that is metabolized by the cytochrome p450 pathway eg. warfarin, anticonvulsants). ii) Ivermectin will be replaced by topical permethrin 5% lotion in the above “ivermectin contra-indication†groups. iii) In addition to scabies treatment, the identified infected scabies or impetigo cases will be treated with 0.5% gentian violet paint by health workers. The severe infected scabies and impetigo cases (fever over 101°F, toxic and delirious, severe protein energy malnutrition children with infected scabies or impetigo, patients with more than 40 lesions, no response to health worker treatment) will be referred to the tribal friendly hospital of SEARCH for further management. iv) If the prevalence of scabies is more than 10% in the community, then all the villagers in place of household members of scabies patient in the intervention villages will be treated with a single dose of ivermectin (200 microgram per kg) unless contraindicated |
Comparator Agent |
Control arm |
The identified cases (scabies, impetigo & infected scabies) will be referred to Mobile Medical Unit (National Rural Health Mission) or Primary Health Care (PHC) for the management according standard guideline. Permethrin 5% will be made available in Mobile Medical Unit (National Rural Health Mission). |
|
Inclusion Criteria
|
Age From |
1.00 Day(s) |
Age To |
99.00 Year(s) |
Gender |
Both |
Details |
Inclusion criteria:
Cluster/Village level:
1) Tribal village in the field practice area of SEARCH in Gadchiroli district of Maharashtra state of India
2) The village should provide community consent through Gram Sabha for participation in the study.
Individual:
1) Should provide verbal consent for participation in the study.
|
|
ExclusionCriteria |
Details |
Exclusion Criteria:
Cluster level:
1) Village with population less than 100
Individual level:
1) Currently on, or has taken ivermectin in the
previous 7 days
2) Has had topical 5% permethrin applied within previous 7 days
3) Seriously ill patients
4) Allergy to any of the components of the allocated drug regimen
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Centralized |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Reduction in the prevalence of scabies in the intervention villages as compared to the control villages at the end community-based intervention |
2 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Reduction in the prevalence of impetigo in the intervention villages as compared to the control villages at the end community-based intervention |
2 months
|
Reduction in the prevalence of scabies in the intervention villages as compared to the control villages after community-based intervention |
12 months |
Reduction in the prevalence of impetigo in the intervention villages as compared to the control villages after community-based intervention |
12 months |
|
Target Sample Size
|
Total Sample Size="3000" Sample Size from India="3000"
Final Enrollment numbers achieved (Total)= "3109"
Final Enrollment numbers achieved (India)="3109" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
16/01/2017 |
Date of Study Completion (India) |
30/01/2018 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published in Plos NTD dated 16th April 2021 |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
This study is a cluster randomized, parallel group, two arm controlled trial to assess the effectiveness of community-based intervention to control scabies in the tribal communities of Gadchiroli, Maharashtra. The study will be conducted in the selected 12 villages of Dhanora block of Gadchiroli district. The community-based intervention package will target all people of the intervention villages. During community survey if the prevalence of scabies is found to be less than 10%, then the intervention will include i) Treatment of cases of scabies with two doses of ivermectin (200 microgram per kg) with a gap of 14 days, along with single dose ivermectin (200 microgram per kg) administration to household members unless contraindicated (weight less than 15 kg, pregnant and breastfeeding women, individual with neurologic disease such as parkinson’s disease or cerebral palsy and individual taking medication that is metabolised by the cytochrome p450 pathway eg. warfarin, anticonvulsants). ii) Ivermectin will be replaced by topical permethrin 5% lotion in the above “ivermectin contra-indication†groups. iii) In addition to scabies treatment, the identified infected scabies or impetigo cases will be treated with 0.5% gentian violet paint by health workers. The severe infected scabies and impetigo cases (fever above 101 0F, toxic and delirious, severe protein energy malnutrition children with infected scabies or impetigo, patients with more than 40 lesions, no response to health worker treatment) will be referred to the tribal friendly hospital of SEARCH for further management. iv) If the prevalence of scabies is more than 10% in the community, then all the villagers in place of household members of scabies patient in the intervention villages will be treated with a single dose of Ivermectin (200 microgram per kg) unless contraindicated. The primary outcome will be reduction of prevalence of scabies among people of intervention villages as compared to the control villages at the end of 2 months of community-based intervention. The secondary outcome will be reduction of prevalence of impetigo among people of intervention villages as compared to the control villages after 2 months of community-based intervention. Other secondary outcomes will be reduction of prevalence of scabies and impetigo among people of intervention villages as compared to the control villages after 12 months of community-based intervention. |