NCT07387601

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

February 19, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2026

Completed
Last Updated

July 6, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

January 28, 2026

Last Update Submit

July 2, 2026

Conditions

Keywords

Southern Ethiopia south omo

Outcome Measures

Primary Outcomes (1)

  • treatment success rate

    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

Study Arms (1)

Peer-Led Educational Intervention plus Standard TB Treatment

ACTIVE COMPARATOR

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

Interventions

peer-led educationCOMBINATION_PRODUCT

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

Peer-Led Educational Intervention plus Standard TB Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinka University

Jinka, Southern Ethiopia, Ethiopia

RECRUITING

Related Publications (1)

  • 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

    RESULT

Central Study Contacts

Moges Getie Workie, MPH in Epidemiology

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a cluster randomized controlled trial with a parallel assignment design to evaluate the effect of a peer-led educational intervention on treatment outcomes, quality of life, disability, and depression among adult tuberculosis patients
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 4, 2026

Study Start

February 19, 2026

Primary Completion

July 12, 2026

Study Completion

July 22, 2026

Last Updated

July 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL
Time Frame
February 10/2026-July 24/2026
Access Criteria
up on the request the correspondence author
More information

Locations