Training Inmate Peer Educators in Detecting Tuberculosis in a Developing Country Prison: A Cluster Randomized Trial

NCT02744521 | Unknown

• 1 other identifier: MaastrichtU
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction: Finding and successfully treating all tuberculosis (TB) patients is the cornerstone of the Global Strategy to Stop TB. However, many patients in resource-limited countries remain undiagnosed. Prisons are a well-known source of undetected TB. Thus, there is a need to find feasible interventions to find and treat TB patients in these settings. Objective: The objective of this study is to evaluate whether empowering and involving inmate peer educators in TB control has an impact on increasing TB case detection rate and improving treatment success in resource-limited prison settings. Methodology: This is a matched cluster randomized control trial where randomization to the intervention and treatment groups will be carried out within pairs. Eight matched prison pairs will be randomly selected for this study in which eight prisons from each pair will be randomly assigned to the intervention and the remaining to the control group. Trained prison peer educators at the intervention sites will organize and provide education about TB every two weeks on a regular basis for one year. Peer educators will also perform routine TB screening, using a screening protocol to identify presumptive TB cases for a referral. Identified presumptive TB cases will then be linked to the prison health personnel for a referral to nearby hospitals. The TB diagnosis will be carried out at the referral sites using the routine direct smear microscopy and/or chest X-ray (Radiography). Tuberculosis case finding in the control sites will follow the existing referral system (self-referral to nearby hospitals) and the diagnosis will be undertaken using direct sputum microscopy and/or chest X-ray as in the intervention sites. The data will be entered using Epi Data entry version 3.1 software and analyzed using SPSS version 20.0. Considering prisons as a unit of analysis, the mean Case Detection Rate (CDR), Treatment Success Rate (TSR) and the percentage of patients symptomatic for \> =3 months will be compared within pairs using the paired t-test or sign test as appropriate.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Tuberculosis case detection rate (CDR)

  Calculated as notifications of new and relapse cases divided by the estimated incidence per year. The mean CDR will be compared within each pair at the end of the intervention (after 12 months).

  One year

Secondary Outcomes (2)

• Pre-treatment symptom duration

  One year

• Treatment success rate (TSR)

  One year

Other Outcomes (1)

• Improvement of the knowledge, attitude and practices (KAP) of the prisoners measured by a closed and open-ended standardized KAP questionnaire.

  After one year

Study Arms (2)

Symptom based screening intervention

EXPERIMENTAL

Other: Symptom-based screening intervention

control

NO INTERVENTION

Interventions

Symptom-based screening intervention OTHER

The objective of this study is to evaluate whether empowering and involving inmate peer educators in TB control has an impact on increasing TB case detection rate and improving treatment success in resource-limited prison settings. In this interventional study, inmate peer educators will be trained about TB, its prevention, and control. Once tested for their capability, peer educators will then provide education about TB, its prevention and control for their fellows every two weeks on a regular basis for one year. They will also undertake routine TB screening using a standardized TB screening protocol to identify presumptive TB cases for a referral.

Symptom based screening intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 years or more.

Sponsors & Collaborators

• Maastricht University: lead
• Mekelle University: collaborator

Related Publications (2)

• 1. World Health Organization. Global tuberculosis report. Geneva, Switzerland 2014. 2. World Health Organization. Global tuberculosis report Geneva, Switzerland 2013. 3. 20202297 4. 17439681 5. 15971390 6. Reyes H. Pitfalls of TB management in prisons, revisited. International Journal of Prisoner Health. 2007;3(1):43-67. 7. 21251881 8. 9032218 9. 11419576 11. 17958984 12. 24498059 13. World Health Organization WH. Global tuberculosis report. 2013. 14. Ministry of Health of Ethiopia. Tuberculosis, Leprosy and TB/HIV Prevention and Control Programme Manual. Addis Ababa 2008. 15. 20003219 16. 23241368 17. Tuberculosis Coalition for Technical Assistance and International Committee of the Red Cross. Guidelines for the control of tuberculosis in prisons. 2009. 18. 23241368 19. 25203007 20. 26914770 21. 9755959 22. Walmsley R, Britain G. World prison population list. Home Office London, England; 2003. 23. The Ethiopian Human Rights Commission. Human Rights Protection Monitoring in Ethiopian Prisons: Primary Report. Addis Ababa 2012. 24. The Federal Democratic Republic of Ethiopia. Guidelines for clinical and programmatic management of TB, TB/HIV and leprosy in Ethiopia. Addis Ababa, Ethiopia 2013. 25. World Health Organization. TB Case Definitions Revision 2011. 26. 10342698

  BACKGROUND

• Adane K, Spigt M, Winkens B, Dinant GJ. Tuberculosis case detection by trained inmate peer educators in a resource-limited prison setting in Ethiopia: a cluster-randomised trial. Lancet Glob Health. 2019 Apr;7(4):e482-e491. doi: 10.1016/S2214-109X(18)30477-7. Epub 2019 Feb 26.

  PMID: 30824364 DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr

Study Record Dates

• First Submitted: March 20, 2016
• First Posted: April 20, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2017
• Last Updated: April 20, 2016

Record last verified: 2016-04