• Evaluation of Second Line Antiretroviral Treatment Outcomes and Determinants in Epworth, MSF-OCA HIV Cohort, Zimbabwe

      Zizhou, Simukai; Gashu, Tadele; Ahmad, Bilal; Dhliwayo, Rumbidzai; Aluma, Theresa; Gonzalez, Lucia; Sang, Sibylle; Mesic, Anita; Otiato, Alice Ayuma; Belaye, Abi Kebra; et al. (2018-07)
      Summary Epworth poly-clinic is found in Epworth district, Harare. It is a clinic jointly run by Epworth local board (on behalf of the Ministry of Health and Child Care) and Médecins sans Frontiers (MSF). One of the major MSF activities in the clinic is early detection and management of patients who fail first line ART. Patients with elevated viral load (VL), HIV RNA greater than 1000 copies/ml, undergo five to six sessions of two weekly enhanced adherence counseling (EAC) support. After enhanced adherence counseling sessions, those with elevated repeat VL test result are then switched to second line ART. Since the number of patients on second line ART is growing, there is an increased need to know the outcomes of second line ART and predictors of treatment failure. The main objective of this study is to evaluate the prognosis and determinants of second line ART regimen for cohort of HIV patients in Epworth MoH/MSF poly-clinic, Zimbabwe. The study will also identify cumulative incidence of SL ART treatment failure through clinical, immunological or virological criteria at 6, 12, 24 and 36 months of second line ART initiation for a cohort of patients enrolled from March 2009 to January 2016 in Epworth poly-clinic. This is a retrospective cohort study of patients on second line ART in Epworth poly-clinic enrolled since 2009. We describe baseline characteristics and outcomes of treatment using descriptive analysis. Multivariate cox proportional hazard modeling is used to model predictors of time to treatment failure. Kaplan–Meier curve is used to calculate cumulative incidence of treatment failure at 6, 12, 24 and 36 months of second line ART initiation. The study is expected to be finished and communicated to relevant stakeholders in December 2016. The report will be published on peer reviewed journals in January 2017. All the costs needed for this study will be covered by MSF OCA.
    • The Impact of a Tick-Sheet in Improving Interpretation Accuracy of Chest Radiographs by Non-Specialists in an HIV positive cohort

      Kosack, Cara; Mesic, Anita; Spijker, Saskia; Bonnet, Maryline; Joekes, Elizabeth; MSF-OCA (2018-07)
      Study objective 3.1 Primary objective To determine if the application of a tick-sheet after four hour training on its use and on CXR interpretation, improves the interpretation accuracy of CXRs for active TB, by nonspecialists, in an HIV-positive cohort. 3.2 Secondary objective To determine whether the application of a tick-sheet reduces the inter-reader variability of CXR interpretation in a group of non-specialists by comparing the inter-reader agreement before and after intervention.
    • Longitudinal cohort to evaluate Hepatitis C treatment effectiveness in HIV co-infected patients: Manipur, India

      Himanshu, M; Singh, Karam Romeo; Shougrakpam, Jeetesh; MSF-OCA (2018-07)
      4. OBJECTIVES Primary objective The primary objective of this study is to assess the effectiveness of HCV curative treatments in patients with chronic hepatitis C (CHC), co-infected with HIV in Manipur, India. Secondary objectives a. To describe the demographic, clinical and biological characteristics of patients with chronic hepatitis C and HIV co-infection b. To assess the effectiveness of HCV curative strategies in patients with chronic HCV, co-infected with HIV stratified by regimen and by site c. To identify risk factors associated with differing virological responses d. To assess the safety of HCV treatment e. To monitor the safety of HCV treatment in HIV co-infected patients f. To document the clinical and biological tolerance of the HCV treatment g. To assess the feasibility of HCV treatment h. To assess comparative performance of elastography (Fibroscan®) and APRI (AST to Platelet Ration Index), to evaluate liver fibrosis among HIV/HCV co-infected individuals i. To describe causes of non-eligibility for treatment j. To describe the clinical and biological evolution of co-infected patients, not eligible for HCV treatment k. To assess treatment adherence
    • Multi-site evaluation of HIV testing algorithms

      Kosack, Cara; Page, Anne-Laure; Shanks, Leslie; Chaillet, Pascale; Beelaert, Greet; Fransen, Katrien; Benson, Tumwesigye T.; Savane, Aboubacar; Nganga, Anne; MSF-OCA (2018-07)
      Objectives 3.1 Primary objective  To evaluate the overall and site-specific performance of the diagnostic algorithm performed at 6 MSF African program sites (i.e. using RDT results from the program sites) comparing using the diagnostic algorithm with ELISA, LIA, EIA-Ag and DNA-PCR as gold standard. 3.2 Secondary objectives  To evaluate the accuracy (sensitivity, specificity and predictive values) of Orgenics ImmunoComb® II HIV 1&2 Combfirm as an HIV confirmatory test.  To model different HIV RDT testing algorithms in order to define acceptable testing algorithm in each study setting (i.e. using RDT results from reference laboratory).  To determine the inter-user reliability of RDT testing (i.e. program sites vs. reference laboratory)  To evaluate accuracy of each HIV RDT measured by the sensitivity (SN), specificity (SP) and predictive values based on the prevalence of each testing centre.  To evaluate the accuracy of HIV testing using DPS samples for quality control purpose in HIV testing.  To assess whether additional confirmatory testing (i.e. Orgenics ImmunoComb® II HIV 1&2 Combfirm) improves the accuracy of the diagnostic algorithm used at the different study sites.  To perform a descriptive analysis on the differentiation between HIV 1 and 2 of the discriminative RDTs.
    • Predicting Visceral Leishmaniasis in HIV Infected Patients (PreLeisH)

      Griensven, JV; Diro, Ermias; MSF-OCA (2018-07)
      Aim To study the asymptomatic period preceding the onset of active VL in HIV‐infected individuals from VL endemic regions in Ethiopia as an avenue to develop an evidence‐based screen and treat strategy to prevent progression to active VL.Primary: 1. To estimate the prevalence of asymptomatic Leishmania infection . 2. To estimate the incidence rate of asymptomatic Leishmania infection. 3. To describe the evolution of Leishmania infection markers over time. 4. To estimate the incidence rate of active VL. 5. To identify risk factors associated with the development of active VL. 6. To translate these risk factors into a clinical prognostic tool to identify individuals at high risk to develop active VL within 12 months . Secondary: 1. To identify patterns in host immune markers that are associated with asymptomatic Leishmania infection. 2. To describe the evolution of host immune markers over time. 3. To identify patterns in host immune markers that are associated with treatment failure. 4. To identify patterns in host immune markers that are associated with VL relapse.
    • Research Protocol - An Evaluation of False Positive HIV Results due to Testing Errors

      Maparo, Tatenda; Mungofa, Stanley; Bara, Hilda T.; Chirisa, Florence; MSF-OCA; Harare City Council, Harare, Zimbabwe; Harare City Council, Harare, Zimbabwe (2014-06)
      An unacceptably high frequency of false positive HIV test results has been reported in various settings. Given the severity and implications of an HIV+ diagnosis, a false positive result is likely to be psychologically traumatic and may result in inappropriate and potentially harmful treatment. The current HIV testing algorithm being used in Zimbabwe does not include repeat testing for HIV positive results, and it is not currently known whether testing errors are leading to false positive diagnoses at a significant rate. WHO recommends that an additional specimen for testing be collected at some point after the initial diagnosis is made. This procedure aims to rule out possible technical or clerical errors including specimen mislabelling and transcription errors. STUDY OBJECTIVE: To evaluate the number of false positive HIV results due to testing errors, using the WHO retesting recommendations, in 6 clinics in Harare, Zimbabwe.
    • Secondary prophylaxis of visceral leishmaniasis relapses in HIV co-infected patients using pentamidine as a prophylactic agent: a prospective cohort study

      Diro, Ermias; Griensven, Johan van; Woldegebreal, Teklu; Belew, Zewdu; Taye, Melese; Yifru, Sisay; Davidson, Robert N.; Balasegaram, Manica; Lynen, Lut; Boelaert, Marleen; et al. (2018-07)
      2.1 OBJECTIVES 2.1.1 General objective: To document the effectiveness, safety and feasibility of monthly PM secondary prophylaxis (PSP) in VL/HIV co-infected patients that have documented parasite clearance after VL treatment when used for prevention of VL relapse. 2.1.2 Specific objectives of the primary study period 2.1.2.1 Primary objectives In VL/HIV co-infected patients that have documented parasite clearance after VL treatment: - to assess the effectiveness of PSP in terms of preventing relapse and death; - to assess the safety of PSP in terms of drug-related serious adverse events or permanent drug discontinuations due to adverse events; - to assess the feasibility of PSP in terms of number of patients compliant to therapy during the first year of monthly PM secondary prophylaxis. 2.1.2.2 Secondary objectives; In VL/HIV co-infected patients that have documented parasite clearance after VL treatment: - to assess the safety of PSP in terms of: - drug-related non-serious adverse events - serious adverse events (drug-related or not) - to assess the feasibility of PSP in terms of: - number of treatment interruptions/discontinuations, - number of therapeutic interventions needed to treat adverse drug reactions