Focus: HIV and TB
Affiliation: Centre for Infectious Disease Research in Zambia (CIDRZ)
Site and Background: Centre for Infectious Disease Research in Zambia (CIDRZ) was established in 2001, as a field office for a U.S.-based university. CIDRZ has since evolved into a successful and independent non-profit local organization in Zambia supporting the Ministry of Health in the provision of quality health services. CIDRZ offers a wealth of expertise and infrastructure gained from over a decade of experience in identifying locally-relevant, culturally-acceptable research from implementation science grounded from our work in implementing PEPFAR/CDC HIV programs across four provinces in Zambia and as part of a wide network of multicentre, international clinical trial networks including the U.S. NIH (Alabama Clinical Trials Unit – IMPAACT and HIV Vaccine Trials Network) and the Global Alliance for TB Drug Development.
CIDRZ has over 40 active grants and is funded to support both program implementation and research in HIV/AIDS prevention, care and treatment, tuberculosis diagnosis, treatment and control, hepatitis, women’s health, family planning and reproductive cancer screening, newborn and child health, primary health/health systems strengthening including the correctional (prison) system, and community outreach. Programs span across all ten Zambian provinces, with the bulk of our work focused in Lusaka, Western, Southern and Eastern provinces. This geographic and thematic diversity provides trainees a rare opportunity to partake in research across a wide range of topics and access distinct populations with different healthcare needs and opportunities.
Since inception, CIDRZ has been the recipient of multi-year clinical research projects funded by US Government agencies. CIDRZ is currently part of the NIH- funded Alabama CTU with three IMPAACT studies: 1) IMPAACT 1077 – promoting mother and infant survival everywhere; 2) IMPAACT 1093 – safety, tolerability and antiviral activity of Dolutegravir, a novel integrase inhibitor in combination regimens in HIV-1 infected children; and 3) IMPAACT 1115 – early, intensive ART to newborns. We are also an HVTN site – HIV vaccine trial site development in Southern Africa - and are awaiting activation of two new vaccine trials. Funding from PEPFAR/CDC (with an annual budget of around USD20 million) supports various HIV implementation programs and studies including: 1) Performance validation of the simple amplification assay (SAMBA 2) for early infant diagnosis of HIV-1 infection; 2) Point-of-care CD4 testing to increase antenatal ART use; and 3) Implementation of HIV care and treatment services in support of the HPTN 071 PopART study.
Recognizing the need for robust implementation research in public health focus areas within Zambia, CIDRZ has been granted funding from more than eight non-USG agencies to undertake implementation research studies around HIV/ AIDS, and expanded program for immunizations and water and sanitation. These studies include: 1) Bill & Melinda Gates Foundation - Better Information for Health in Zambia: a cross-sectional study of HIV care outcomes across four provinces; and Differentiated Care for improved health systems efficiency and health outcomes in Zambia; 2) UNICEF – advocacy and capacity-building for menstrual hygiene management through water sanitation and hygiene in school programs; and 3) Village Reach – Catalyzing Zambia’s shift to a next generation immunization supply chain.
CIDRZ has a longstanding and well-developed research infrastructure with dedicated Research and Regulatory Affairs, and Quality Control and Assurance units, with specially trained staff. Every study receives Zambian National Health Research Authority approval as well as other local and international ethical and regulatory approvals prior to initiation and undergoes continuing ethical review, and reporting at least annually. In 2015, CIDRZ reconstituted a larger and much broader skilled and experienced Community Advisory Board that performs a CIDRZ-wide research consultation function advising research teams on potential research topics of need, and acceptable recruitment and retention strategies.
Other support infrastructure for research and routine HIV program implementation include a state-of-the-art high-capacity medical and research diagnostic laboratory and on-site specimen repository unique in Zambia for its external accreditation programs and U.S. NIH DAIDS certification for research trials. We are one of two Zambian labs assessed for the Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA) by international auditors of the Africa Society for Laboratory Medicine, and are awaiting evaluation of ISO15189 lab accreditation through the Southern Africa Development Community Accreditation Service (SADCAS). In-house CIDRZ laboratory services include: flow cytometry, chemistry, haematology, serology, micro-biology, polymerase chain reaction and TB culture.
CIDRZ also houses a robust data management and data analysis unit. This unit provides support across programs and works closely with program managers from study inception through to data analysis. The team, consisting of an experienced head of data analysis, a senior data manager, a junior data manager and 5 data coordinators, has skills in SAS, STATA, Nvivo. This team oversees 120 data entry staff based in 76 public health clinics. The unit also provides regular in-house training and workshops for junior scientists. As part of our capacity building efforts, the training department runs weekly research meetings, which are attended by local and international research and clinical faculty and diverse program and ministry staff. We have developed a structured research curriculum and hold regular didactic research-focused training sessions. The research department holds quarterly Research-to-Policy meetings with the relevant Ministry of Health personnel to share research findings to ensure our work remains in alignment with current national research priorities. Furthermore, the majority of the senior level staff and principle investigators are affiliated with the oldest university (University of Zambia) and the University Teaching Hospital. This has opened opportunities to engage in clinical work, teaching and research with both institutions. Over the last ten years, CIDRZ has worked hard to build strategic partnerships and relationships with both international and national stakeholders. This facilitates access to a wide range of highly skilled and specialized individuals and allows us to retain a wide range of senior research mentors on site from UAB, JHU, UCSF and other visiting academics. We also host 6-10 junior researchers per annum.