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

NCT02744521 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-04-20

No results posted yet for this study

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

Interventions

OTHER

Symptom-based screening intervention

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.

Sponsors & Collaborators

  • Mekelle University

    collaborator OTHER

  • Maastricht University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-04-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02744521 on ClinicalTrials.gov