to Assess Effect of Peer-led EducationDS-PTBNCT07387601
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 study testing peer-led education in people with to Assess Effect of Peer-led Education, run by Bahirdar University at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- to Assess Effect of Peer-led Education
- What is being tested?
- peer-led education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteEthiopia
- Study dates
- 19 Feb 2026to 22 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Seriously ill patients at the time of screening or enrollment
- Tuberculosis patients with a known plan to be transferred out of the study sites
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ethiopia1 site, 1 recruiting
- Recruiting
Jinka University
Jinka, Southern Ethiopia
Bahirdar University School of public health, PhD student, +251949998832/725059106, getiemoges@gmail.com
About this study
Official title: 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.
Read the 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
- Conditions
- to Assess Effect of Peer-led Education
- Being tested
- peer-led education
- Keywords
- Southern Ethiopia south omo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Combination Product: peer-led education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: the primary outcome will be measured at the end of 6 months i.e after July 24/2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start19 Feb 2026
- Primary completion12 Jul 2026 (estimated)
- Study completion22 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for to Assess Effect of Peer-led EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahirdar University
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387601
- Sponsor's protocol ID
- 4064/2024
- Acronym
- DS-PTB
- Status last verified
- Feb 2026
- First submitted
- 28 Jan 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
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 at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07387601
- Acronym / sponsor ID
- DS-PTB / 4064/2024
- Conditions
- to Assess Effect of Peer-led Education
- Keywords
- Southern Ethiopia south omo
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Bahirdar UniversityResearch network
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- 12 Jul 2026 (estimated)
- Study completion
- 22 Jul 2026 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Peer-Led Educational Intervention plus Standard TB Treatment | Active comparator | Combination Product: peer-led educationParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Seriously ill patients at the time of screening or enrollment
- Tuberculosis patients with a known plan to be transferred out of the study sites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peer-led educationThe Intervention is a structured, evidence-based program designed to promote positive and sustained behavioral changes among participants through education, counseling, and supportive follow-up | Combination product | Peer-Led Educational Intervention plus Standard TB Treatment |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Results publicationAuthors (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
- Individual participant dataSharing planned: Yes. 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
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peer-led education in people with to Assess Effect of Peer-led Education, run by Bahirdar University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moges Getie Workie, MPH in Epidemiology (+251949998832/918059106, getiemoges@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment success rate (time frame: the primary outcome will be measured at the end of 6 months i.e after July 24/2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07387601, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.