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临床试验/NCT07387601
NCT07387601招募中不适用

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

Bahirdar University1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2026年2月19日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
250
试验地点
1
主要终点
treatment success rate

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

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

干预措施: peer-led education (Combination Product)

结局指标

主要结局

treatment success rate

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Bahirdar University
申办方类型
Network
责任方
Sponsor

研究点 (1)

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