RESUMO
Human infection studies (HIS) have generally been used as a tool in the pathway for vaccine development in high income settings. Over the last decade, this model has been implemented in LMICs with the aim of accelerating development of next generation vaccines that would perform better in these settings. However, in most LMICs, the ethics and regulatory framework for the conduct of these studies are not in place. In Zambia, these studies are yet to be conducted and thus we conducted a stakeholder engagement workshop in October 2019. We engaged with bioethicists, regulatory authority officials, and scientists from within Zambia and other African countries to anticipate and address foreseeable ethical and regulatory issues when conducting HIS in Zambia for the first time. The workshop largely focused on sensitizing the stakeholders on the benefits of these studies with the following main points for consideration on the implementation of these studies in Zambia: need for in-country legal framework and guidelines; need for adequate informed consent based on comprehensive understanding of the concept of HIS and study requirements; and requirements for heightened vigilance to assure participant safety including good ethical and clinical practice with regulatory, ethical, data safety, and community oversight. Additionally, the workshop emphasized the need for rigorous health screening prior to enrolment; suitable infrastructure for containment; and personnel to provide appropriate treatment including emergency resuscitation and evacuation if indicated. Specific recommendations included compensation for burden of participation; access to care and provision for study related injury (e.g. no-fault insurance); and withdrawal and exit procedures to preserve individual and community safety. Finally, the meeting concluded that researchers should actively engage key gate keepers including civic leaders such as parliamentarians, universities, researchers, potential participants and laypersons to avoid circulation of misinformation.
RESUMO
Background: A study of patient records in four HIV clinics in three sub-Saharan African countries examined routine clinical care patterns and variations. Methods: Clinic characteristics were described, and patient data extracted from a sample of medical records. Data on treatment, CD4 count and viral load (VL) were obtained for the last visit in the records, dates mainly between 2015 and 2017, patient demographic data were obtained from the first clinic visit. Results: Four clinics, two in Nigeria, one in Zambia and one in Uganda, all public facilities, using national HIV treatment guidelines were included. Numbers of patients and health professionals varied, with some variation in stated frequency of testing for CD4 count and VL. Clinical guidelines were available in each clinic, and most drugs were available free to patients. The proportion of patients with a CD4 count in the records varied from 84 to 100 percent, the latest median count varied from 269 to 593 between clinics. 35% had a record of a VL test, varying from 1% to 63% of patients. Lamivudine (3TC) was recorded for more than 90% of patients in each clinic, and although there was variation between clinics in the choice of antiretroviral therapy (ART), the majority were on first line drugs consistent with guidelines. Only about 2% of the patients were on second-line ARTs. In two clinics, 100% and 99% of patients were prescribed co-trimoxazole, compared with 7% and no patients in the two other clinics. Conclusions: The wide variation in available clinic health work force, levels and frequency of CD4 counts, and VL assessment and treatment indicate sub-optimal adherence to current guidelines in routine clinical care. There is room for further work to understand the reasons for this variation, and to standardise record keeping and routine care of HIV positive patients.