Person:

Bassett, Ingrid

Background: Resource-limited countries increasingly depend on quality indicators to improve outcomes within HIV treatment programs, but indicators of program performance suitable for use at the local program level remain underdeveloped. Methods: Using the existing literature as a guide, we applied standard quality improvement (QI) concepts to the continuum of HIV care from HIV diagnosis, to enrollment and retention in care, and highlighted critical service delivery process steps to identify opportunities for performance indicator development. We then identified existing indicators to measure program performance, citing examples used by pivotal donor agencies, and assessed their feasibility for use in surveying local program performance. Clinical delivery steps without existing performance measures were identified as opportunities for measure development. Using National Quality Forum (NQF) criteria as a guide, we developed measurement concepts suitable for use at the local program level that address existing gaps in program performance assessment. Results: This analysis of the HIV continuum of care identified seven critical process steps providing numerous opportunities for performance measurement. Analysis of care delivery process steps and the application of NQF criteria identified 24 new measure concepts that are potentially useful for improving operational performance in HIV care at the local level. Conclusion: An evidence-based set of program-level quality indicators is critical for the improvement of HIV care in resource-limited settings. These performance indicators should be utilized as treatment programs continue to grow.

Background: World Health Organization (WHO) recommends tuberculosis (TB) screening at HIV diagnosis. We evaluated the inclusion of rapid urine lipoarabinomannan (LAM) testing in TB screening algorithms. Methods: We enrolled ART-naïve adults who screened HIV-infected in KwaZulu-Natal, assessed TB-related symptoms (cough, fever, night sweats, weight loss), and obtained sputum specimens for mycobacterial culture. Trained nurses performed clinic-based urine LAM testing using a rapid assay. We used diagnostic accuracy, negative predictive value (NPV), and negative likelihood ratio, stratified by CD4 count, to evaluate screening for culture-positive TB. Results: Among 675 HIV-infected adults with median CD4 of 213/mm3 (interquartile range 85-360/mm3), 123 (18%) had culture-confirmed pulmonary TB. The WHO-recommended algorithm of any TB-related symptom had a sensitivity of 77% [95% confidence interval (CI) 69-84%] and NPV of 89% (95% CI 84-92%) for identifying active pulmonary TB. Including the LAM assay improved sensitivity (83%; 95% CI 75-89%) and NPV (91%; 95% CI 86-94%), while decreasing the negative likelihood ratio (0.45 versus 0.57). Among participants with CD4 < 100/mm3, including urine LAM testing improved the negative predictive value of symptom based screening from 83% to 87%. All screening algorithms with urine LAM performed better among participants with CD4 < 100/mm3, compared to those with CD4 ≥ 100/mm3. Conclusion: Clinic-based urine LAM screening increased the sensitivity of symptom-based screening by 6% among ART-naïve HIV-infected adults in a TB-endemic setting, thereby providing marginal benefit.

Abstract Background: Urinary lipoarabinomannan (LAM) has limited sensitivity for diagnosing active human immunodeficiency virus (HIV)-associated tuberculosis (TB) disease, but LAM screening at HIV diagnosis might identify adults with more severe clinical disease or greater risk of mortality. Methods: We enrolled antiretroviral therapy-naive HIV-infected adults from 4 clinics in Durban. Nurses performed urine LAM testing using a rapid assay (Determine TB LAM) graded from low (1+) to high (≥3+) intensity. Urine LAM results were not used to guide anti-TB therapy. We assessed TB-related symptoms and obtained sputum for mycobacterial smear and culture. Participants were observed for 12 months, and we used multivariable Cox proportional hazard models to determine hazard ratios for all-cause mortality. Results: Among 726 HIV-infected adults with median CD4 of 205 cells/mm3 (interquartile range, 79–350 cells/mm3), 93 (13%) were LAM positive and 89 (12%) participants died during the follow-up period. In multivariable analyses, urine LAM-positive participants had a mortality hazard ratio (MHR) of 3.58 (95% confidence interval [CI], 2.20–5.81) for all-cause mortality. Among participants with mycobacterial-confirmed TB, urine LAM-positivity had a 2.91 (95% CI, 1.26–6.73) MHR for all participants and a 4.55 (95% CI, 1.71–12.1) MHR for participants with CD4 ≤100 cell/mm3. Participants with LAM-positive TB had significantly more clinical signs and symptoms of disease, compared with participants with LAM-negative TB disease. Conclusions: Among HIV-infected adults, urinary LAM-positive patients had more clinical disease severity and a 3-fold increase in 12-month mortality compared with those who were LAM negative.