Interventions to mitigate the risk factors for high loss to follow-up, deaths and delays before TB treatment are urgently required.
IntroductionKey to pharmacovigilance is spontaneously reporting all Adverse Drug Reactions (ADR) during post-market surveillance. This facilitates the identification and evaluation of previously unreported ADR’s, acknowledging the trade-off between benefits and potential harm of medications. Only 41% Antiretroviral (ARV) ADR’s documented in Harare city clinical records for January to December 2016 were reported to Medicines Control Authority of Zimbabwe (MCAZ). We investigated reasons contributing to underreporting of ARV ADR’s in Harare city.MethodsA descriptive cross-sectional study and the Centers for Disease Control (CDC) guided surveillance evaluation was conducted. Two hospitals were purposively included. Seventeen health facilities and 52 health workers were randomly selected. Interviewer-administered questionnaires, key informant interviews and WHO pharmacovigilance checklists were used to collect data. Likert scales were applied to draw inferences and Epi info 7 used to generate frequencies and proportions.ResultsOf the 52 participants, 32 (61.5%) distinguished the ARV ADR defining criteria. Twenty-nine (55.8%) knew system’s purpose whilst 28 (53.8%) knew the reporting process. Knowledge scored average on the 5-point-Likert scale. Thirty-eight (73.1%) participants identified ARV ADR’s following client complaints and nine (1.3%) enquired clients’ medication response. Forty-six (88.5%) cited non-feedback from MCAZ for underreporting. Inadequate ARV ADR identification skills were cited by 21 (40.4%) participants. Reporting forms were available in five (26.3%) facilities and reports were generated from hospitals only. Forty-two (90.6%) clinicians made therapeutic decisions from ARV ADR’s. Averaged usefulness score was 4, on the 5-point-Likert scale. All 642 generated signals were committed to Vigiflow by MCAZ, reflecting a case detection rate of 4/ 100 000. Data quality was 0.75–1.0 (WHO) and all reports were causally assessed.ConclusionThe pharmacovigilance system was useful, simple, and acceptable despite being unstable, not representative and not sensitive. It was threatened by suboptimal health worker knowledge, weak detection strategies and referral policy preventing ARV ADR identification by person place and time. Revisiting local policy, advocacy, communication and health worker orientation might improve pharmacovigilance performance in Harare city.
Background In 2016, Mashonaland West Province had 7.4% (520) dried blood spot (DBS) samples for early infant diagnosis (EID) rejected by the Zimbabwe National Microbiology Reference Laboratory (NMRL). The samples were suboptimal, delaying treatment initiation for HIV-infected children. EID is the entry point to HIV treatment services in exposed infants. We determined reasons for DBS sample rejections and suggested solutions. Methods A cause-effect analysis, modelled on Ishikawa, was used to identify factors impacting DBS sample quality. Interviewer-administered questionnaires and evaluation of sample collection process, using Standard Operating Procedure (SOP) was conducted. Rejected samples were reviewed. Epi Info™ was used to analyze findings. Results Eleven (73.3%) facilities did not adhere to SOP and (86.7%) did not evaluate DBS sample quality before sending for testing. Delayed feedback (up to 4 weeks) from NMRL extended EID delay for 14 (93.3%) of the facilities. Of the 53 participants, 62% knew valid sample identification. Insufficient samples resulted in most rejections (77.9%). Lack of training (94.3%) and ineffective supervision (69.8%) were also cited. Conclusion Sample rejections could have been averted through SOP adherence. Ineffective supervision, exacerbated by delayed communication of rejections, extended EID delay, disadvantaging potential ART beneficiaries. Following this study, enhanced quality control through perstage evaluations was recommended to enhance DBS sample quality.
HIV positivity yield declined against increasing testing volumes in Zimbabwe, from 20% (1.65 million tests) in 2011 to 6% (3 million tests) in 2018. A screening tool was introduced to aid testers to identify clients likely to obtain a positive diagnosis of HIV. Consequently, testing volumes declined to 2.3 million in 2019 but positivity declined to 5% prompting the evaluation and validation of the tool to improve its precision in predicting positivity yield. A cross-sectional study was conducted. Sixty-four sites were randomly selected where all reporting clients (18+ years) were screened and tested for HIV. Participant responses and test outcomes were documented and uploaded to excel. Multivariable analysis was used to determine the performance of individual, combination questions and screening criteria to achieve >/ = 90% sensitivity for a new screening tool. We evaluated 13 questions among 7,825 participants and obtained 95.7% overall sensitivity, ranging from 3.9% [(95%CI:2.5,5.9) sharing sharp objects] to 86.8% [(95%CI:83.8,89.5) self-perception of risk] for individual questions. A 5-question tool was developed and validated among 2,116 participants. The best combination (self-perception of risk, partner tested positive, history of ill health, last tested >/ = 3months and symptoms of an STI) scored 94.1% (95%CI:89.4,97.1) sensitivity, 18% reduction in testing volumes and 11 Number Needed to Test (NNT). A screening in criteria that combine previously testing >/ = 3 months with a yes to any of the 4 remaining questions was analysed and sensitivity ranged from 89.9% (95%CI:84.4,94.0) for last tested >/ = 3months and sexual partner positive, to 93.5% (95%CI:88.7,96.7) for last tested >/ = 3months and self-perceived risk We successfully developed, evaluated and validated an HIV screening tool. High sensitivity and the fifth reduction in testing volume were acceptable attributes to enhance testing efficiency and effective limited resource utilisation. Screened out clients will be identified through frequent screening and self-testing options.
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