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.

Improving uptake of prevention of mother-to-child HIV transmission services in Benue State, Nigeria through a faith-based congregational strategy.

BACKGROUND: Nigeria has low antiretroviral therapy (ART) coverage among HIV-positive pregnant women. In a previous cluster-randomized trial in Nigeria, Baby Shower events resulted in higher HIV testing coverage and linkage of pregnant women to ART; here, we assess outcomes of Baby Shower events in a non-research setting. METHODS: Baby Shower events, including a prayer ceremony, group education, music, gifting of a "mama pack" with safe delivery supplies, and HIV testing with ART linkage support for HIV-positive pregnant women, were conducted in eighty sites in Benue State, Nigeria. Client questionnaires (including demographics, ANC attendance, and HIV testing history), HIV test results, and reported linkage to ART were analyzed. Descriptive data on HIV testing and ART linkage data for facility-based care at ANC clinics in Benue State were also analyzed for comparison. RESULTS: Between July 2016 and October 2017, 10,056 pregnant women and 6,187 male partners participated in Baby Shower events; 61.5% of women attended with a male partner. Nearly half of female participants (n = 4515, 44.9%) were not enrolled in ANC for the current pregnancy, and 22.3% (n = 2,241) of female and 24.8% (n = 1,532) of male participants reported they had never been tested for HIV. Over 99% (n = 16,240) of participants had their HIV status ascertained, with 7.2% of females (n = 724) and 4.0% of males (n = 249) testing HIV-positive, and 2.9% of females (n = 274) and 2.3% of males (n = 138) receiving new HIV-positive diagnoses. The majority of HIV-positive pregnant women (93.0%, 673/724) were linked to ART. By comparison, at health facilities in Benue State during a similar time period, 99.7% of pregnant women had HIV status ascertained, 8.4% had a HIV-positive status, 2.1% were newly diagnosed HIV-positive, and 100% were linked to ART. CONCLUSION: Community-based programs such as the faith-based Baby Shower intervention complement facility-based approaches and can reach individuals who would not otherwise access facility-based care. Future Baby Showers implementation should incorporate enhanced support for ART linkage and retention to maximize the impact of this intervention on vertical HIV transmission.