Point of Care CD4 Testing in National Household Surveys - Results and Quality Indicators from Eleven Population-Based HIV Impact Assessment (PHIA) Surveys.

Population-based HIV Impact Assessments (PHIAs) are national household (HH) surveys that provide HIV diagnosis and CD4 testing with an immediate return of results. Accurate CD4 results improve HIV-positive participants' clinical care and inform the effectiveness of HIV programs. Here, we present CD4 results from the PHIA surveys that were conducted in 11 countries in sub-Saharan Africa between 2015 and 2018. All of the HIV-positive participants and 2 to 5% of the HIV-negative participants were offered Pima CD4 (Abbott, IL, USA) point-of-care (POC) tests. The quality of the CD4 test was ensured by conducting instrument verification, comprehensive training, quality control, a review of testing errors and an analysis of unweighted CD4 data by HIV status, age, gender, and antiretroviral (ARV) treatment status. Overall, CD4 testing was completed for 23,085 (99.5%) of the 23,209 HIV-positive and 7,329 (2.7%) of the 270,741 negative participants in 11 surveys. The instrument error rate was 11.3% (range, 4.4% to 15.7%). The median CD4 values among HIV-positive and HIV-negative participants (aged 15+) were 468 cells/mm3 (interquartile range [IQR], 307 to 654) and 811 cells/mm3 (IQR, 647 to 1,013), respectively. Among the HIV-positive participants (aged 15+), those with detectable ARVs had higher CD4 values (508 cells/mm3) than those with undetectable ARVs (385.5 cells/mm3). Among the HIV-positive participants (aged 15+), 11.4% (2,528/22,253) had a CD4 value of less than 200 cells/mm3, and approximately half of them (1,225/2,528 = 48.5%) had detectable ARVs, whereas 51.5% (1,303/2,528) had no detectable ARVs (P < 0.0001). We successfully implemented high quality POC CD4 testing using Pima instruments. Our data come from nationally representative surveys in 11 countries and provide unique insights regarding the CD4 distribution among HIV-positive individuals as well as the baseline CD4 values among HIV-negative individuals. IMPORTANCE The manuscript describes CD4 levels among HIV-positive individuals and baseline CD4 levels among HIV-negative individuals from 11 sub-Saharan countries, thereby highlighting the importance of CD4 markers in the context of the HIV epidemic. Despite increased ARV access in each country, advanced HIV disease (CD4 < 200 cells/mm3) persists among approximately 11% of HIV-positive individuals. Therefore, it is important that our findings are shared with the scientific community to assist with similar implementations of point-of-care testing and to conduct a review of HIV programmatic gaps.

A Comprehensive Approach to Assuring Quality of Laboratory Testing in HIV Surveys: Lessons Learned From the Population-Based HIV Impact Assessment Project.

BACKGROUND: Conducting HIV surveys in resource-limited settings is challenging because of logistics, limited availability of trained personnel, and complexity of testing. We described the procedures and systems deemed critical to ensure high-quality laboratory data in the population-based HIV impact assessments and large-scale household surveys. METHODS: Laboratory professionals were engaged in every stage of the surveys, including protocol development, site assessments, procurement, training, quality assurance, monitoring, analysis, and reporting writing. A tiered network of household, satellite laboratories, and central laboratories, accompanied with trainings, optimized process for blood specimen collection, storage, transport, and real-time monitoring of specimen quality, and test results at each level proved critical in maintaining specimen integrity and high-quality testing. A plausibility review of aggregate merged data was conducted to confirm associations between key variables as a final quality check for quality of laboratory results. RESULTS: Overall, we conducted a hands-on training for 3355 survey staff across 13 surveys, with 160-387 personnel trained per survey on biomarker processes. Extensive training and monitoring demonstrated that overall, 99% of specimens had adequate volume and 99.8% had no hemolysis, indicating high quality. We implemented quality control and proficiency testing for testing, resolved discrepancies, verified >300 Pima CD4 instruments, and monitored user errors. Aggregate data review for plausibility further confirmed the high quality of testing. CONCLUSIONS: Ongoing engagement of laboratory personnel to oversee processes at all levels of the surveys is critical for successful national surveys. High-quality population-based HIV impact assessments laboratory data ensured reliable results and demonstrated the impact of HIV programs in 13 countries.

Development of a framework to improve the utilisation of malaria research for policy development in Malawi.

BACKGROUND: The existing gap between research evidence and public health practice has attributed to the unmet Millennium Development Goals in Africa and consequently, has stimulated the development of frameworks to enhance knowledge translation. These efforts aim at maximising health research utilisation in policy and practice to address the world's disease burdens, including malaria. This study aimed at developing a contextual framework to improve the utilisation of malaria research for policy development in Malawi. METHODS: The study used two approaches including: two case studies of policy analysis exploring the policy-making process in Malawi, utilisation of local malaria research, and the role of key stakeholders in policy formulation process; and the assessment of facilitating factors and barriers to malaria research utilisation for policy-making in Malawi. RESULTS: From the case studies' lessons and elements identified during the assessment of facilitating factors and barriers, a framework is developed to promote an integrated approach to knowledge translation. In this framework the Ministry of Health is considered as the main user of knowledge from research through the demand created by the research directorate and the National Malaria Control Programme. Key documents identified as being particularly relevant to the Ministry of Health for purposes of knowledge translation include the National Health Research Agenda, Guidelines for Policy Development and Analysis, and Guidelines for Evidence Use in Policy-making. Institutions conducting academic and policy-relevant malaria research in Malawi are identified and a consolidation of their linkages with the users of research is established through the Knowledge Translation Unit, the Evidence Informed decision-making Centre, and the African Institute for Development Policy. Equally, key players in this framework are the funding partners for both research and programmes that need to see accountability and impact of their support. Independent advisors, partners, and consultants also have their vital role in the process. CONCLUSION: The framework offers a practical basis for the factors identified and their linkages to promote a co-ordinated approach to malaria research utilisation in policy-making. Its applicability and success hinges on its wider dissemination and ownership by the government through the National Malaria Control Programme.

Malaria research in Malawi from 1984 to 2016: a literature review and bibliometric analysis.

BACKGROUND: Malaria research can play a vital role in addressing the malaria burden in Malawi. An organized approach in addressing malaria in Malawi started in 1984 by the establishment of the first National Malaria Control Programme and research was recognized to be significant. This study aimed to assess the type and amount of malaria research conducted in Malawi from 1984 to 2016 and its related source of funding. METHODS: A systematic literature search was conducted in the Medline/PubMed database for Malawian publications and approved malaria studies from two Ethical Committees were examined. Bibliometric analysis was utilized to capture the affiliations of first and senior/last authors, funding acknowledgements, while titles, abstracts and accessed full text were examined for research type. RESULTS: A total of 483 publications and 165 approved studies were analysed. Clinical and basic research in the fields of malaria in pregnancy 105 (21.5%), severe malaria 97 (20.1%) and vector and/or agent dynamics 69 (14.3%) dominated in the publications while morbidity 33 (20%), severe malaria 28 (17%) and Health Policy and Systems Research 24 (14.5%) dominated in the approved studies. In the publications, 146 (30%) first authors and 100 (21%) senior authors, and 88 (53.3%) principal investigators in approved studies were affiliated to Malawian-based institutions. Most researchers were affiliated to the Malawi-Liverpool Wellcome Trust, College of Medicine, Blantyre Malaria Project, Ministry of Health, and Malaria Alert Centre. The major malaria research funders were the National Institute for Health/USA, Wellcome Trust and the US Agency for International Development. Only three (2.5%) out of 118 journals publishing research on malaria in Malawi were from Africa and the Malaria Journal, with 76 (15.7%) publications, published most of the research from Malawi, followed by the American Journal of Tropical Medicine and Hygiene with 57 (11.8%) in comparison to only 13 (2.7%) published in the local Malawi Medical Journal. CONCLUSIONS: Clinical and basic research, which is mostly funded externally, in the fields of malaria in pregnancy, severe malaria and vector and/or agent dynamics dominated, while health policy and system research was least supported. The quantity may reflect scientific research activity but the initial primary impact is contribution to policy development.