PMID- 37071009 OWN - NLM STAT- MEDLINE DCOM- 20230801 LR - 20240216 IS - 2165-0497 (Electronic) IS - 2165-0497 (Linking) VI - 11 IP - 3 DP - 2023 Jun 15 TI - Point of Care CD4 Testing in National Household Surveys - Results and Quality Indicators from Eleven Population-Based HIV Impact Assessment (PHIA) Surveys. PG - e0314822 LID - 10.1128/spectrum.03148-22 [doi] LID - e03148-22 AB - 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/mm(3) (interquartile range [IQR], 307 to 654) and 811 cells/mm(3) (IQR, 647 to 1,013), respectively. Among the HIV-positive participants (aged 15+), those with detectable ARVs had higher CD4 values (508 cells/mm(3)) than those with undetectable ARVs (385.5 cells/mm(3)). Among the HIV-positive participants (aged 15+), 11.4% (2,528/22,253) had a CD4 value of less than 200 cells/mm(3), 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/mm(3)) 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. FAU - Birhanu, Sehin AU - Birhanu S AUID- ORCID: 0000-0003-1006-4772 AD - Division of Global HIV and TB, Center for Global Health, CDC, Atlanta, Georgia, USA. FAU - Winterhalter, Frieda S AU - Winterhalter FS AD - ICAP at Columbia University, New York, New York, USA. FAU - Stupp, Paul AU - Stupp P AD - Division of Global HIV and TB, Center for Global Health, CDC, Atlanta, Georgia, USA. FAU - Cates, Melissa AU - Cates M AD - Division of Global HIV and TB, Center for Global Health, CDC, Atlanta, Georgia, USA. FAU - Rottinghaus, Erin AU - Rottinghaus E AD - Division of Global HIV and TB, Center for Global Health, CDC, Atlanta, Georgia, USA. FAU - Yavo, Daniel AU - Yavo D AD - Division of Global HIV and TB, Center for Global Health, CDC, Atlanta, Georgia, USA. FAU - Wray-Gordon, Floris AU - Wray-Gordon F AD - Division of Global HIV and TB, Center for Global Health, CDC, Atlanta, Georgia, USA. FAU - Lupoli, Kathryn AU - Lupoli K AD - Division of Global HIV and TB, Center for Global Health, CDC, Atlanta, Georgia, USA. FAU - Ndongmo, Clement B AU - Ndongmo CB AD - Division of Global HIV and TB, Center for Global Health, CDC, Atlanta, Georgia, USA. FAU - Longwe, Herbert AU - Longwe H AD - ICAP at Columbia University, New York, New York, USA. FAU - Reid, Giles A AU - Reid GA AD - ICAP at Columbia University, New York, New York, USA. FAU - Metz, Melissa AU - Metz M AD - ICAP at Columbia University, New York, New York, USA. FAU - Saito, Suzue AU - Saito S AD - ICAP at Columbia University, New York, New York, USA. FAU - McCracken, Stephen AU - McCracken S AD - Division of Global HIV and TB, Center for Global Health, CDC, Atlanta, Georgia, USA. FAU - Brown, Kristin AU - Brown K AD - Division of Global HIV and TB, Center for Global Health, CDC, Atlanta, Georgia, USA. FAU - Voetsch, Andrew C AU - Voetsch AC AD - Division of Global HIV and TB, Center for Global Health, CDC, Atlanta, Georgia, USA. FAU - Duong, Yen T AU - Duong YT AD - ICAP at Columbia University, New York, New York, USA. FAU - Parekh, Bharat S AU - Parekh BS AD - Division of Global HIV and TB, Center for Global Health, CDC, Atlanta, Georgia, USA. FAU - Patel, Hetal K AU - Patel HK AD - Division of Global HIV and TB, Center for Global Health, CDC, Atlanta, Georgia, USA. LA - eng GR - U2G GH001226/GH/CGH CDC HHS/United States GR - U2G GH001271/GH/CGH CDC HHS/United States PT - Journal Article PT - Research Support, U.S. Gov't, P.H.S. DEP - 20230418 PL - United States TA - Microbiol Spectr JT - Microbiology spectrum JID - 101634614 RN - 0 (Anti-Retroviral Agents) SB - IM MH - Humans MH - Anti-Retroviral Agents/therapeutic use MH - CD4 Lymphocyte Count MH - HIV MH - *HIV Infections/diagnosis/drug therapy/epidemiology MH - *Point-of-Care Systems MH - Point-of-Care Testing MH - Quality Indicators, Health Care PMC - PMC10269725 OTO - NOTNLM OT - HIV surveys OT - PHIA OT - Pima OT - household testing OT - point-of-care CD4 COIS- The authors declare no conflict of interest. EDAT- 2023/04/19 06:00 MHDA- 2023/06/19 13:08 PMCR- 2023/04/18 CRDT- 2023/04/18 10:07 PHST- 2023/06/19 13:08 [medline] PHST- 2023/04/19 06:00 [pubmed] PHST- 2023/04/18 10:07 [entrez] PHST- 2023/04/18 00:00 [pmc-release] AID - 03148-22 [pii] AID - spectrum.03148-22 [pii] AID - 10.1128/spectrum.03148-22 [doi] PST - ppublish SO - Microbiol Spectr. 2023 Jun 15;11(3):e0314822. doi: 10.1128/spectrum.03148-22. Epub 2023 Apr 18.