title: Operational research in Malawi: making a difference with cotrimoxazole preventive therapy in patients with tuberculosis and HIV.
abstract: BACKGROUND
  In Malawi, high case fatality rates in patients with tuberculosis, who were also co-infected with HIV, and high early death rates in people living with HIV during the initiation of antiretroviral treatment (ART) adversely impacted on treatment outcomes for the national tuberculosis and ART programmes respectively. This article i) discusses the operational research that was conducted in the country on cotrimoxazole preventive therapy, ii) outlines the steps that were taken to translate these findings into national policy and practice, iii) shows how the implementation of cotrimoxazole preventive therapy for both TB patients and HIV-infected patients starting ART was associated with reduced death rates, and iv) highlights lessons that can be learnt for other settings and interventions.
  
  
  CONCLUSIONS
  District and facility-based operational research was undertaken between 1999 and 2005 to assess the effectiveness of cotrimoxazole preventive therapy in reducing death rates in TB patients and subsequently in patients starting ART under routine programme conditions. Studies demonstrated significant reductions in case fatality in HIV-infected TB patients receiving cotrimoxazole and in HIV-infected patients about to start ART. Following the completion of research, the findings were rapidly disseminated nationally at stakeholder meetings convened by the Ministry of Health and internationally through conferences and peer-reviewed scientific publications. The Ministry of Health made policy changes based on the available evidence, following which there was countrywide distribution of the updated policy and guidelines. Policy was rapidly moved to practice with the development of monitoring tools, drug procurement and training packages. National programme performance improved which showed a significant decrease in case fatality rates in TB patients as well as a reduction in early death in people with HIV starting ART.
  
  
  CONCLUSIONS
  Key lessons for moving this research endeavour through to policy and practice were the importance of placing operational research within the programme, defining relevant questions, obtaining "buy-in" from national programme staff at the beginning of projects and having key actors or "policy entrepreneurs" to push forward the policy-making process. Ultimately, any change in policy and practice has to benefit patients, and the ultimate judge of success is whether treatment outcomes improve or not.
authors.affiliation: International Union against Tuberculosis and Lung Disease, Paris, France. adharries@theunion.org
authors.forename: Anthony D
authors.initials: AD
authors.lastname: Harries
authors.forename: Rony
authors.initials: R
authors.lastname: Zachariah
authors.forename: Rhehab
authors.initials: R
authors.lastname: Chimzizi
authors.forename: Felix
authors.initials: F
authors.lastname: Salaniponi
authors.forename: Francis
authors.initials: F
authors.lastname: Gausi
authors.forename: Henry
authors.initials: H
authors.lastname: Kanyerere
authors.forename: Erik J
authors.initials: EJ
authors.lastname: Schouten
authors.forename: Andreas
authors.initials: A
authors.lastname: Jahn
authors.forename: Simon D
authors.initials: SD
authors.lastname: Makombe
authors.forename: Frank M
authors.initials: FM
authors.lastname: Chimbwandira
authors.forename: James
authors.initials: J
authors.lastname: Mpunga
mesh_terms: D000890:Anti-Infective Agents / Q000627:therapeutic use*; D044966:Anti-Retroviral Agents / Q000627:therapeutic use; D015897:Comorbidity; D015658:HIV Infections / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D008295:Malawi / Q000453:epidemiology; D017063:Outcome Assessment, Health Care; D011322:Primary Prevention; D016896:Treatment Outcome; D015662:Trimethoprim, Sulfamethoxazole Drug Combination / Q000627:therapeutic use*; D014376:Tuberculosis / Q000188:drug therapy* / Q000401:mortality
chemical_list: D000890:Anti-Infective Agents; D044966:Anti-Retroviral Agents; D015662:Trimethoprim, Sulfamethoxazole Drug Combination