Health Extension Workers Improve Tuberculosis Case Detection and Treatment Success in Southern Ethiopia: A Community Randomized Trial Daniel G. Datiko1,2*, Bernt Lindtj��rn1 1 Centre for International Health, University of Bergen, Bergen, Norway, 2 Southern Nations, Nationalities, and Peoples��� Regional Health Bureau, Awassa, Ethiopia Abstract Background: One of the main strategies to control tuberculosis (TB) is to find and treat people with active disease. Unfortunately, the case detection rates remain low in many countries. Thus, we need interventions to find and treat sufficient number of patients to control TB. We investigated whether involving health extension workers (HEWs: trained community health workers) in TB control improved smear-positive case detection and treatment success rates in southern Ethiopia. Methodology/Principal Finding: We carried out a community-randomized trial in southern Ethiopia from September 2006 to April 2008. Fifty-one kebeles (with a total population of 296, 811) were randomly allocated to intervention and control groups. We trained HEWs in the intervention kebeles on how to identify suspects, collect sputum, and provide directly observed treatment. The HEWs in the intervention kebeles advised people with productive cough of 2 weeks or more duration to attend the health posts. Two hundred and thirty smear-positive patients were identified from the intervention and 88 patients from the control kebeles. The mean case detection rate was higher in the intervention than in the control kebeles (122.2% vs 69.4%, p,0.001). In addition, more females patients were identified in the intervention kebeles (149.0 vs 91.6, p,0.001). The mean treatment success rate was higher in the intervention than in the control kebeles (89.3% vs 83.1%, p = 0.012) and more for females patients (89.8% vs 81.3%, p = 0.05). Conclusions/Significance: The involvement of HEWs in sputum collection and treatment improved smear-positive case detection and treatment success rate, possibly because of an improved service access. This could be applied in settings with low health service coverage and a shortage of health workers. Trial Registration: ClinicalTrials.gov NCT00803322 Citation: Datiko DG, Lindtj��rn B (2009) Health Extension Workers Improve Tuberculosis Case Detection and Treatment Success in Southern Ethiopia: A Community Randomized Trial. PLoS ONE 4(5): e5443. doi:10.1371/journal.pone.0005443 Editor: Delia Goletti, National Institute for Infectious Diseases (INMI) L. Spallanzani, Italy Received November 25, 2008 Accepted March 21, 2009 Published May 8, 2009 Copyright: �� 2009 Datiko, Lindtj��rn. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Funding: The University of Bergen funded this study. The university had no role in the design, data collection, analysis and interpretation or writing of the report. Competing Interests: The authors have declared that no competing interests exist. * E-mail: danieljohn42@yahoo.com Introduction Each year, more than nine million new cases of tuberculosis (TB) occur and about two million people die of TB. As a result of the interaction between TB and human immunodeficiency virus (HIV) infection, TB incidence is rising in sub-Saharan Africa. It has also led to an increase in drug resistance and poor treatment outcomes [1]. Information from South India shows that directly observed treatment, short-course (DOTS) reduces TB incidence [2]. However, in many other countries, the case detection rates are too low to reduce the incidence of TB. The main obstacles are low health service coverage, shortage of health workers and poor programme performance [3]. Epidemiological models show that active case finding might reduce TB incidence and avoid TB deaths. Although active case finding is effective in contact tracing on a small scale, high cost and poor treatment adherence limit its use [4,5]. We therefore need alternative methods to improve TB case finding. In Ethiopia, the National TB and Leprosy Control Programme (NTLCP) started to implement DOTS in 1992. NTLCP is responsible for policy formulation, resource mobilisation, moni- toring and evaluation. Under the NTLCP, three levels of function exist in the regions, zones and districts for coordinating TB control activities. TB control is also integrated into the general service at health facilities. The district TB programme coordinator is responsible for supervision of the general health workers involved in patient care in hospitals and health centres. However, community DOTS was not started. Ethiopia has the seventh highest TB burden in the world. In 2006, the estimated number of new smear-positive cases was 168 per 105 for Ethiopia. Unfortunately, the case detection rate was 27%, far below the target [6]. In 2004, the government of Ethiopia launched a community-based initiative to provide essential health services to the community under a health extension programme PLoS ONE | www.plosone.org 1 May 2009 | Volume 4 | Issue 5 | e5443

(HEP) to ensure equitable access to health services. The aim of the HEP is to prevent major communicable diseases and pro- mote health in the community. A new cadre of community level health workers, health extension workers (HEWs), was trained for 1 year at an undergraduate level. With the aim of preventing major communicable diseases, HEWs are trained on how to identify and refer TB suspects, trace defaulters, and provide treatment and health education [6,7]. However, their role in TB control has not been evaluated. The aim of the present study was to establish whether involving HEWs in TB control improved smear-positive case detection and treatment success rates in southern Ethiopia. Methods The protocol for this trial and supporting CONSORT checklist are available as supporting information see Checklist S1 and Protocol S1. Study area and population This study was conducted in Dale and Wonsho, rural districts of Sidama zone in southern Ethiopia from September 2006 to April 2008. There were 51 kebeles (lowest administrative units) in the two districts. Fifty-five per cent of the population live within two- hour walking distance of health facilities. There were 21 health posts (operational unit for HEWs), two health stations, two nucleus health centres (health stations upgrading to health centres) and one health centre. Three health facilities (one health centre and two health stations) conducted sputum microscopy, and DOT was provided in the health centre, nucleus health centres and health stations. None of the health posts provide DOT. Health service and HEP The Government of Ethiopia has a four-tier health service, and the lowest level is a primary health care unit (a health centre and five satellite health posts). On average, a health post serves a kebele with 5000 people. The health policy focuses on provision of preventive and promotive health care to the population under the HEP, which involves prevention and control of diseases, including TB. The local health authorities in consultation with kebele leaders select two female residents, who have completed tenth grade, from each kebele. The women receive training for 1 year and are placed as HEWs in their respective kebele. They receive a salary from the government and they are accountable to the health centre [7]. Participants TB case finding and treatment outcome Case finding. TB suspects, who had cough for two weeks or more, were referred for further investigations. A smear-positive pulmonary TB case was defined by two positive sputum smears or one positive smear and x-ray findings consistent with active TB. Treatment regimen and duration. The treatment regimen for new smear-positive cases consisted of two months intensive phase treatment with ethambutol, rifampicin, isoniazid and pyrazinamide followed by continuation phase treatment for 6 months with ethambutol and isoniazid. For children, in the continuation phase, ethambutol/isoniazid was replaced by rifampcin/isoniazid for 4 months. Follow-up sputum smear examination was done at the end of 2, 5 and 7 months treatment. Treatment outcome. A patient with at least two negative smears including that at 7 months was reported as cured. A patient who finished the treatment but did not have the 7-month smear result was reported as treatment completed. If a patient remained or became smear-positive at the end of 5 months or later, he/she was reported as treatment failure. A patient who missed treatment for eight consecutive weeks after receiving treatment for at least 4 weeks was reported as a defaulter. A patient who was transferred to another district after receiving treatment for at least 4 weeks and whose treatment outcome was not reported to the referring district was reported as transferred out. A patient who died while on treatment was reported as dead irrespective of the cause of death [8]. Ethics. We obtained ethical clearance from the Ethical Review Committee of the Regional Health Bureau in southern Ethiopia. We obtained permission from TB programme managers and kebele leaders after discussing with them community-based TB care. TB patients were enrolled after giving informed consent after explaining the aim of the study and the right to refuse or to withdraw from the study. HIV testing was not offered to TB patients because of the unavailability of HIV testing and treatment in the study area at the time the study was conducted. The intervention Training on how to identify TB suspects and administer DOT. We trained health workers, laboratory technicians and HEWs for 2 days. The training focused on symptoms and transmission of TB, how to identify TB suspects, how to collect, label, store and transport sputum specimens, administer DOT, and follow patients during treatment. The messages and the content of our training were similar to the curriculum of training HEWs. HEWs, in the in the intervention kebeles, received on job training about how to collect sputum samples and support patients to adhere to treatment. HEWs collected sputum specimens once a month. An ice box was used to keep the sputum specimens in the health post and during their transportation on foot to diagnostic units. The intervention included sputum collection and providing DOT. During health education sessions at health posts, HEWs informed people living in the kebele about TB and advised them to come to a health post if they had productive cough of 2 weeks or more duration. TB suspects who came to the health posts were told about community-based TB care. HEWs collected spot-morning-spot sputum specimens, and labelled and transported them to the diagnostic units every month for examination for acid-fast bacilli by direct microscopy. Smear- positive patients in the intervention kebeles received standard DOTS under the direct observation of HEWs. TB patients visited health posts daily during the intensive phase and once a month in the continuation phase. Control kebeles Identifying TB suspects and DOT administration. HEWs in the in the control kebeles did not received on job training about how to collect sputum samples and how to support patients to adhere to treatment. However, they provided health services, including health education about TB, to the people living in their kebeles. TB suspects presented themselves to diagnostic units. However, the health workers from health facilities were trained as they provided the service to intervention and control kebeles. Smear-positive patients in the control kebeles received standard DOTS were treated under the direct observation of general health workers at health centres. TB patients visited health centres and health stations daily during the intensive phase and once a month in the continuation phase. Community TB Care in Ethiopia PLoS ONE | www.plosone.org 2 May 2009 | Volume 4 | Issue 5 | e5443