Effect of Peer-led Educational Intervention on Treatment Outcomes Among Adults With Drug-susceptible Pulmonary Tuberculosis in South Omo and Ari Zone, Southern Ethiopia (DS-PTB)

February 17, 2026 updated by: Bahirdar University

Effect of Peer-led Educational Intervention on Treatment Outcomes Among Adults With Drug-susceptible Pulmonary Tuberculosis in South Omo and Ari Zone, Southern Ethiopia: A Protocol for a Cluster- Randomized Controlled Trial Study

The study might come up with valuable findings to address poor treatment outcome, poor quality of life, disability score and depressive symptoms. The findings may also be decreased health professional workload. The findings would be supportive evidences for policy makers, program managers, to clinician as well as the patients themselves and for other researchers. The study may help to promote and maintain good treatment outcome for the patients in the study area as well as the country. The findings will also be used for teaching & learning purposes in educational & training programs.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Peer-led education is an effective approach in improving knowledge and attitude. It is also helpful to reach specific marginalized populations, to reduce social stigma and to enhance adherence by improving behavioral outcomes since behaviour is socially influenced and behavioral norms are developed through social interaction. Peers are underused resources for strengthening TB control and prevention because they have a unique power to support socially excluded patients through sharing their personal experience, to affirm previous beliefs and intentions, and to inspire future opportunities. Peers are more preferred than TB focal persons because they act as a friend, as an educator, as an activist, as a role model and as a team member but TB focal persons act only as an educator. So, this manual is organized to improve knowledge and attitude towards tuberculosis, to reduce social stigma and to strengthen TB control and prevention strategies

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Moges Getie Workie, MPH in Epidemiology and PhD st
  • Phone Number: +251949998832/918059106
  • Email: getiemoges@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults with new drug-susceptible pulmonary TB who will be diagnosed in bacteriological diagnostic methods
  • not participating in similar study,
  • mentally capable to provide consent,
  • physically capable of following the intervention.

Exclusion Criteria:

  • Seriously ill patients at the time of screening or enrollment
  • Tuberculosis patients with a known plan to be transferred out of the study sites

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Peer-Led Educational Intervention plus Standard TB Treatment

Participants in this arm received a structured peer-led educational intervention in addition to standard anti-tuberculosis therapy for drug-susceptible pulmonary tuberculosis.

The intervention consisted of education and support sessions delivered by trained peer educators who were previously treated and successfully cured of drug-susceptible pulmonary TB. The sessions focused on improving treatment adherence, enhancing knowledge about tuberculosis and its transmission, managing medication side effects, reducing stigma, and promoting healthy behaviors during treatment.

The peer-led sessions were conducted [weekly/biweekly/monthly - specify] over the course of the standard TB treatment period (typically 6 months), using interactive methods such as group discussions, experience sharing, question-and-answer sessions, and motivational support. Educational materials were provided to reinforce key messages
Combination product: peer-led education
The Intervention is a structured, evidence-based program designed to promote positive and sustained behavioral changes among participants through education, counseling, and supportive follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
treatment success rate
Time Frame: the primary outcome will be measured at the end of 6 months i.e after July 24/2026
as defined by 7th edition of Ethiopian guidelines for clinical and programmatic management of TB, TB/HIV, DR-TB and Leprosy and by WHO. Data on the patients' status on the primary outcome variable will be extracted from TB register logbook.
the primary outcome will be measured at the end of 6 months i.e after July 24/2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bahirdar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Authors (full names or at least last name + initials, in order) Article title Journal name Publication date (year, and month if available) Volume number Page numbers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 24, 2026

Primary Completion (Estimated)

July 12, 2026

Study Completion (Estimated)

July 22, 2026

Study Registration Dates

First Submitted

January 28, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 4064/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The following individual participant data (IPD) will be shared: demographic information (age, sex, ethnicity), clinical measurements (blood pressure, weight, laboratory test results), questionnaire responses (PHQ-9 scores for depression, quality of life scores), and study outcomes (treatment response, adverse events). All data will be de-identified to protect participant privacy

IPD Sharing Time Frame

February 10/2026-July 24/2026

IPD Sharing Access Criteria

up on the request the correspondence author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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