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  • This manuscript complies with the STROBE reporting standard for observational studies. Ethics approval for the evaluation was given to the Institute of Human Virology Nigeria by the National Health Research Ethics Committee of Nigeria under the title: “Engaging indigenous organization to sustain and enhance clinical services for the prevention, care and treatment of HIV/AIDS in the Federal Republic of Nigeria under the President’s Emergency Plan for AIDS Relief (PEPFAR)”; Number: NHREC/01/01/2007; dated August 12, 2016. The workshop was conducted in the Federal Capital Territory, Abuja but the participants were selected from health facilities and institutions in the six geopolitical regions of Nigeria. Nigeria has six geopolitical regions with a population of 170 million inhabitants. These regions include the North-east, North-west, North-central, South-west, South-east and South-south. The study population consisted of health care workers (Nurses, Physicians and Pharmacists) who were selected for the SPHAR-TI course based on rigorous selection criteria (Table A in S2 File). A prospective cohort design was deployed for the evaluation of the SPHAR-TI model. Participants that attended the SPHAR-TI’s workshop described in S2 File were followed up for 12 months through internet and telephone communication. Performance was evaluated based on meeting defined milestones. Bio-demographic characteristics were recorded and participants’ knowledge assessed prior to the workshop. Five days after the workshop, participants’ knowledge was re-assessed without giving them a prior warning they would be re-assessed. ICSRs were submitted online every three months (31st May, 29th July, 30th September and 30th November 2016). Data on the number of healthcare workers trained by the participants and the Pharmacovigilance Committees activated were submitted online not later than 10th December 2016. The aim of the model was to improve the reporting of ADRs from both hospitals based and more importantly, community based public health programs controlling the AIDS epidemic, Tuberculosis and Malaria. The primary outcomes were knowledge gained and the number of ICSRs submitted to NAFDAC. We expected to see a significant gain in knowledge and a remarkable increase in the reporting of ADRs if the model was effective. The secondary outcomes were the health facility staff trained by the participants through the step-down training and the Pharmacovigilance Committees activated. The secondary outcomes were evaluated because NAFDAC encourages the setting up of Pharmacovigilance Committees in health facilities as a pragmatic strategy for promoting the reporting of ADRs. During the workshop, participants were taught and encouraged to step-down the workshop and activate the committees. We expected the participants to be able to train others and set up new Pharmacovigilance Committees if the model was effective. Evaluation of the outcomes of the model: The overall outcome of the model was assessed by comparing the number of ICSRs submitted by the national health workforce in seven months with the number submitted by the participants in seven months. The primary and secondary outcomes were evaluated as described below: Gain in knowledge was assessed using a structured questionnaire, consisting of 24 questions developed by expert physicians and pharmacists in the three diseases (HIV, TB and Malaria). The questions covered the clinical management of HIV/AIDS, Tuberculosis and Malaria and the ADRs associated with the use of antiretroviral, anti-tuberculosis and anti-malaria drugs. The questionnaire also assessed the knowledge of Nigeria’s ADR reporting and pharmacovigilance system. Prior to the commencement of the workshop, the questionnaire was administered for an hour (pre-test). At the end of the workshop, which was five days after the pre-test, the same questionnaire was re-administered (post-test). To minimize measurement biases, the questionnaire was withdrawn immediately after the pre-test and participants were not warned the questionnaire would be re-administered after the workshop. Participants did not also know the result of the pre-test until after the post-test. The pass mark for the pre and post-tests was 45%. Individual case safety reports submission: The correctness and completeness of the ICSR and the quantities submitted online were assessed. All submitted ICSRs were manually checked for correctness and completeness and the total number of correctly completed forms were counted and recorded in each cycle. The number of ICSRs submitted within seven months were summed up and compared with the amount that would have been submitted by the national health workforce in seven months in 2015. Pharmacovigilance committees activated and training of health facility staff by participants: To assess the two variables, participants were given a spreadsheet for recording their step-down activities after the workshop. The spreadsheet included the following variables: Status of the health facilityDate of trainingDescription of trainingObjectives of the trainingMode of delivery of training contentNumber of doctors, nurses and pharmacists in attendanceNumber of Pharmacovigilance Committees activatedInvolvement of hospital managementCollaboration with a pharmaceutical company in the trainingCollaboration with NAFDAC.The completed spreadsheets were submitted to NAFDAC online at different times but not later than 10th December, 2016. We extracted the number of health facility staff trained and the number of Pharmacovigilance Committees’ activated into a template for analysis. We applied descriptive statistics (mean, percentage and summation) in the analysis of the bio-demographic data and primary and secondary outcomes. The overall outcome of the model was analyzed by calculating the percentage increase in ADR submission using the arithmetic formula: T-M/M*100 [Where T = total number of ICSRs submitted by the participants in seven months; M = total number of ICSR submitted by the national health workforce in seven month]. According to NAFDAC, in 2015, the over 323,941 national health workforce submitted 1,385 ICSRs (refer to Figure B in S1 File), equivalents to 805 ICSRs in seven months. The 3000 ICSRs (T) (submitted by the participants) and 805 ICSRs (M) were plucked into the arithmetic formula to determine the percentage increase in ICSRs submission. Participants gain in knowledge was analyzed by calculating the difference between the mean pre-test and post-test scores. Summation was applied in analyzing the number of ICSR submitted by the participants, health staff trained by the participants and Pharmacovigilance Committees activated.
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