Assessment of Rapid Diagnostic Test Accuracy in HIV Clinics in Urban Healthcare Centers

Thesis Abstract

The accuracy of rapid diagnostic tests (RDTs) for HIV is crucial for effective case identification, timely intervention, and the reduction of transmission rates in urban healthcare settings, where high patient volumes and diverse populations pose significant challenges to diagnostic precision. Despite widespread adoption of RDTs in HIV clinics, concerns persist regarding their sensitivity and specificity, which may lead to false-positive or false-negative results, adversely affecting patient management and public health outcomes. This study aims to assess the diagnostic accuracy of RDTs used in HIV clinics within urban healthcare centers and to identify factors influencing test performance. The specific objectives are to evaluate the sensitivity, specificity, positive predictive value, and negative predictive value of the RDTs compared to laboratory-based enzyme-linked immunosorbent assay (ELISA) gold standard tests; to examine the influence of patient demographic factors such as age and gender on test accuracy; and to identify operational factors, including test kit storage and personnel training, affecting RDT reliability. The study adopts a cross-sectional descriptive design, employing both quantitative and qualitative data collection methodologies. The research population comprises 1,200 HIV-positive individuals attending ten urban healthcare centers along with healthcare personnel involved in administering HIV RDTs. A stratified random sampling technique ensures representative inclusion across different clinics and demographic groups, with the sample size calculated to achieve a 95% confidence level and a margin of error of 2.5%. Data collection involves structured questionnaires administered to healthcare workers to assess operational practices, alongside structured data forms capturing test results, patient demographics, and laboratory confirmatory tests. Laboratory-based ELISA tests serve as the gold standard comparator. Validity and reliability of the questionnaires are established through pre-testing and Cronbach’s alpha analysis, respectively. Data analysis employs descriptive statistics such as frequencies and percentages to summarize demographic and operational variables. Inferential analysis involves calculating diagnostic accuracy parameters—sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)—using contingency tables. Receiver Operating Characteristic (ROC) curve analysis assesses overall test performance, while multivariate logistic regression examines factors influencing false test results, with statistical significance set at p<0.05. Qualitative data from healthcare personnel interviews are analyzed thematically to explore operational barriers and personnel-related factors affecting test accuracy, guided by the Health Belief Model as a theoretical framework. Expected findings are anticipated to reveal variability in RDT sensitivity and specificity across different clinics, with overall sensitivity ranging from 85% to 95%, and specificity from 90% to 98%. Factors such as improper storage conditions, inadequate personnel training, and high workload are hypothesized to contribute significantly to false-negative and false-positive results. Differences in test accuracy may also correlate with patient age and gender, informing targeted interventions for vulnerable subgroups. This research contributes novel insights into the practical performance of HIV RDTs in high-volume urban clinics, extending existing knowledge on factors affecting diagnostic reliability in real-world settings. It underscores the importance of robust operational protocols and continuous personnel training to optimize test accuracy. The study’s findings are expected to inform policymakers and healthcare managers on strategies to improve HIV diagnostic quality, including standardized procedures for test kit storage, regular competency assessments, and implementation of quality assurance measures. The main conclusion emphasizes that while RDTs are essential tools for HIV screening, their diagnostic accuracy is context-dependent and linked to operational factors. Recommendations include strengthening supply chain logistics to ensure optimal test kit storage, implementing nationwide training programs for healthcare workers, and establishing routine internal quality control practices. Future research should explore longitudinal assessments of RDT performance and evaluate the impact of specific interventions on improving diagnostic outcomes in diverse healthcare environments.