Building a national framework for multicentre research and clinical trials: experience from the Nigeria Implementation Science Alliance.

There is limited capacity and infrastructure in sub-Saharan Africa to conduct clinical trials for the identification of efficient and effective new prevention, diagnostic and treatment modalities to address the disproportionate burden of disease. This paper reports on the process to establish locally driven infrastructure for multicentre research and trials in Nigeria known as the Nigeria Implementation Science Alliance Model Innovation and Research Centres (NISA-MIRCs). We used a participatory approach to establish a research network of 21 high-volume health facilities selected from all 6 geopolitical zones in Nigeria capable of conducting clinical trials, implementation research using effectiveness-implementation hybrid designs and health system research. The NISA-MIRCs have a cumulative potential to recruit 60 000 women living with HIV and an age-matched cohort of HIV-uninfected women. We conducted a needs assessment, convened several stakeholder outreaches and engagement sessions, and established a governance structure. Additionally, we selected and trained a core research team, developed criteria for site selection, assessed site readiness for research and obtained ethical approval from a single national institutional review board. We used the Exploration, Preparation, Implementation, Sustainment framework to guide our reporting of the process in the development of this network. The NISA-MIRCs will provide a nationally representative infrastructure to initiate new studies, support collaborative research, inform policy decisions and thereby fill a significant research infrastructure gap in Africa's most populous country.

Water safety, antifungal-resistant aflatoxigenic aspergillus flavus and other pathogenic fungi in a community hand-dug wells.

AIM: To investigate hand-dug well water used for drinking and domestic purposes in a rural community in Southwest Nigeria for water safety and fungal presence as well as to determine the antifungal resistance and aflatoxigenic potentials of isolated fungi. METHODS AND RESULTS: Water samples were analysed for risk of contamination, bacteriological and mycological parameters using a standard sanitary survey checklist and microbiological culturing. Isolates were identified and subjected to antifungal resistance profiling using the diffusion method for susceptibility testing of filamentous fungi. Multidrug-resistant strains were confirmed with DNA barcoding identification. Fungal isolates were screened for aflatoxigenic potentials by culture methods and confirmed by densitometric analysis. From the 23 hand-dug wells assessed, 56.52% had a high risk of contamination (ROC) score, nitrate >50 mg/L (73.9%), and the presence of total coliforms (100%), Escherichia coli (43.48%) and fungi (91.3%). Spearman rank correlation coefficient gave a positive and strong correlation between Total Fungi and Faecal Coliform (r = 0.701; p = 0.016; n = 23) at 0.05 significance level (2-tailed). Aspergillus sp. (34%), Penicillium sp. (18%) and Rhizopus sp. (17%) were the most dominant fungal genera. Isolates were resistant to fluconazole (76.19%), ketoconazole (73.80%), clotrimazole (92.86%), griseofulvin (88.09%) and nystatin (100%). Penicillium and Aspergillus (50%) were positive for cultural mycotoxin screening. A strain of antifungal-resistant A. flavus produced aflatoxin B1 (752 ppb) and B2 (15 ppb). SIGNIFICANCE OF THE STUDY: The existence of antifungal-resistant and aflatoxigenic fungi in water used for drinking and domestic purposes shows that filamentous fungi constitute greater threats than previously recognized and this call for a paradigm shift from the perceived safety of untreated hand-dug well-water.

The Effect of a Continuous Quality Improvement Intervention on Retention-In-Care at 6 Months Postpartum in a PMTCT Program in Northern Nigeria: Results of a Cluster Randomized Controlled Study.

BACKGROUND: Retention in care is critical for improving HIV-infected maternal outcomes and reducing vertical transmission. Health systems' interventions such as continuous quality improvement (CQI) may support health services to address factors that affect the delivery of HIV-related care and thereby influence rates of retention-in-care. METHODOLOGY: We evaluated the effect of a CQI intervention on retention-in-care at 6 months postpartum of pregnant women and mothers living with HIV who had been started on lifelong antiretroviral treatment. Thirty-two health care facilities were randomized to either implement the intervention or not. We considered women fully retained in care when they attended the 6-month postpartum visit and did not miss any previous scheduled visit by more than 30 days. RESULTS: Five hundred eleven women living with HIV attending antenatal clinics at 26 facilities were included in the analysis. Median age at enrolment was 27 years and gestational age was 20 weeks. Seventy-one percent of women were seen at 6-month postpartum irrespective of missing any scheduled visit. However, 43% of women were fully retained at 6-month postpartum and did not miss any scheduled visit based on our stringent study definition of retention. There was no significant difference in retention at 6 months between the intervention and control arms [44% vs. 41%, relative risk: 1.08; 95% confidence interval (CI): 0.78 to 1.49]. Initiation of ARV prophylaxis among infants within 72 hours was not different by study arm (66.0% vs. 74.7%, relative risk = 0.95; 95% CI: 0.84 to 1.07) but rates of early infant testing at 4-6 weeks were higher in intervention sites (48.8% vs. 25.3%, adjusted relative risk: 1.76; 95% CI: 1.27 to 2.42). CONCLUSIONS: CQI as implemented in this study did not differ across study arms in the rates of retention. Several intervention design or implementation issues or other contextual constraints may explain the absence of effect.

Increasing retention in care of HIV-positive women in PMTCT services through continuous quality improvement-breakthrough (CQI-BTS) series in primary and secondary health care facilities in Nigeria: a cluster randomized controlled trial. The Lafiyan Jikin Mata Study.

BACKGROUND: Rates of retention in care of HIV-positive pregnant women in care programs in Nigeria remain generally poor with rates around 40% reported for specific programs. Poor quality of services in health facilities and long waiting times are among the critical factors militating against retention of these women in care. The aim of the interventions in this study is to assess whether a continuous quality improvement intervention using a Breakthrough Series approach in local district hospitals and primary health care clinics will lead to improved retention of HIV-positive women and mothers. METHODS/DESIGN: A cluster randomized controlled trial with 32 health facilities randomized to receive a continuous quality improvement/Breakthrough Series intervention or not. The care protocol for HIV-infected pregnant women and mothers is the same in all sites. The quality improvement intervention started 4 months before enrollment of individual HIV-infected pregnant women and initially focused on reducing waiting times for women and also ensuring that antiretroviral drugs are dispensed on the same day as clinic attendance. The primary outcome measure is retention of HIV-positive mothers in care at 6 months postpartum. DISCUSSION: Results of this trial will inform whether quality improvement interventions are an effective means of improving retention in prevention of mother-to-child transmission of HIV programs and will also guide where health system interventions should focus to improve the quality of care for HIV-positive women. This will benefit policymakers and program managers as they seek to improve retention rates in HIV care programs.