Last data update: May 06, 2024. (Total: 46732 publications since 2009)
Records 1-16 (of 16 Records) |
Query Trace: Patel HK[original query] |
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HIV risk behaviour, viraemia, and transmission across HIV cascade stages including low-level viremia: Analysis of 14 cross-sectional population-based HIV Impact Assessment surveys in sub-Saharan Africa
Edun O , Okell L , Chun H , Bissek AZ , Ndongmo CB , Shang JD , Brou H , Ehui E , Ekra AK , Nuwagaba-Biribonwoha H , Dlamini SS , Ginindza C , Eshetu F , Misganie YG , Desta SL , Achia TNO , Aoko A , Jonnalagadda S , Wafula R , Asiimwe FM , Lecher S , Nkanaunena K , Nyangulu MK , Nyirenda R , Beukes A , Klemens JO , Taffa N , Abutu AA , Alagi M , Charurat ME , Dalhatu I , Aliyu G , Kamanzi C , Nyagatare C , Rwibasira GN , Jalloh MF , Maokola WM , Mgomella GS , Kirungi WL , Mwangi C , Nel JA , Minchella PA , Gonese G , Nasr MA , Bodika S , Mungai E , Patel HK , Sleeman K , Milligan K , Dirlikov E , Voetsch AC , Shiraishi RW , Imai-Eaton JW . PLOS Glob Public Health 2024 4 (4) e0003030 As antiretroviral treatment (ART) coverage for people living with HIV (PLHIV) increases, HIV programmes require up-to-date information about evolving HIV risk behaviour and transmission risk, including those with low-level viremia (LLV; >50 to ≤1000 copies/mL), to guide prevention priorities. We aimed to assess differences in sexual risk behaviours, distribution of viral load (VL) and proportion of transmission across PLHIV subgroups. We analysed data from Population-based HIV Impact Assessment surveys in 14 sub-Saharan African countries during 2015-2019. We estimated adjusted prevalence ratios (aPR) of self-reported HIV high-risk behaviour (multiple partners and condomless sex) across cascade stages via generalised estimation equations. We modelled the proportions of transmission from each subgroup using relative self-reported sexual risk, a Hill function for transmission rate by VL, and proportions within cascade stages from surveys and UNAIDS country estimates for 2010-2020. Compared to PLHIV with undetectable VL (≤50 copies/mL), undiagnosed PLHIV (aPR women: 1.28 [95% CI: 1.08-1.52]; men: 1.61 [1.33-1.95]) and men diagnosed but untreated (2.06 [1.52-2.78]) were more likely to self-report high-risk sex. High-risk behaviour was not significantly associated with LLV. Mean VL was similar among undiagnosed, diagnosed but untreated, and on ART but non-suppressed sub-groups. Across surveys, undiagnosed and diagnosed but untreated contributed most to transmission (40-91% and 1-41%, respectively), with less than 1% from those with LLV. Between 2010 and 2020, the proportion of transmission from individuals on ART but non-suppressed increased. In settings with high ART coverage, effective HIV testing, ART linkage, and retention remain priorities to reduce HIV transmission. Persons with LLV are an increasing share of PLHIV but their contribution to HIV transmission was small. Improving suppression among PLHIV on ART with VL ≥1000 copies/mL will become increasingly important. |
Progress towards the UNAIDS 95-95-95 targets in the Fifth Botswana AIDS Impact Survey (BAIS V 2021): a nationally representative survey
Mine M , Stafford KA , Laws RL , Marima R , Lekone P , Ramaabya D , Makhaola K , Patel HK , Mapondera P , Wray-Gordon F , Agbakwuru C , Okui L , Matroos S , Onyadile E , Ngidi J , Abimiku A , Bagapi K , Nkomo B , Bodika SM , Kim KJ , Moloney M , Mitchell A , Ehoche A , Ussery FL , Hong SY , Keipeile S , Matlhaga M , Mathumo R , Selato R , Charurat ME , Voetsch AC . Lancet HIV 2024 BACKGROUND: In 2014, UNAIDS set a goal to end the AIDS epidemic by achieving targets for the percentage of people living with HIV who were aware of their status, on antiretroviral therapy (ART), and virally suppressed. In 2020, these targets were revised to 95% for each measure (known as 95-95-95), to be reached among people living with HIV by 2025. We used data from the Fifth Botswana AIDS Impact Survey (BAIS V) to measure progress towards these testing and treatment targets in Botswana. METHODS: BAIS V used a two-stage cluster design to obtain a nationally representative sample of people aged 15-64 years in Botswana. During March-August, 2021, 14 763 consenting participants were interviewed and tested for HIV in their households by survey teams. HIV-positive specimens were tested for viral load, presence of antiretroviral drugs, and recency of infection using the HIV-1 limiting antigen avidity enzyme immunoassay. Estimates of HIV-positive status and use of ART were based on self-report and the analysis of blood specimens for antiretroviral drugs. Viral load suppression was defined as an HIV RNA concentration of less than 1000 copies per mL. HIV incidence was calculated using the recent infection testing algorithm. Data were weighted to account for the complex survey design. FINDINGS: The national HIV prevalence in Botswana among people aged 15-64 years was 20·8% and the annual incidence of HIV infection was 0·2%. 95·1% (men 93·0%, women 96·4%) of people living with HIV aged 15-64 years were aware of their status, 98·0% (men 97·2%, women 98·4%) of those aware were on ART, and 97·9% (men 96·6%, women 98·6%) of those on ART had viral load suppression. Among young people (aged 15-24 years) living with HIV, 84·5% were aware of their status, 98·5% of those aware were on ART, and 91·6% of those on ART had viral load suppression. The prevalance of viral load suppression among all people living with HIV was 91·8%, and varied by district-ranging from 85·3% in Gaborone to 100·0% in Selibe Phikwe. INTERPRETATION: BAIS V is the first population-based survey worldwide to report the achievement of the UNAIDS 95-95-95 goals, both overall and among women. Strategies to reach undiagnosed men and young people, including young women, are needed. FUNDING: US President's Emergency Plan for AIDS Relief. |
Comparison of HIV prevalence, incidence, and viral load suppression in Zambia population-based HIV impact assessments from 2016 and 2021
Mulenga LB , Hines JZ , Stafford KA , Dzekedzeke K , Sivile S , Lindsay B , Chola M , Ussery F , Patel HK , Abimiku A , Birhanu S , Minchella P , Stevens T Jr , Hanunka B , Chisenga T , Shibemba A , Fwoloshi S , Siame M , Mutukwa J , Chirwa L , Siwingwa M , Mulundu G , Agbakwuru C , Mapondera P , Detorio M , Agolory SG , Monze M , Bronson M , Charurat ME . AIDS 2024 BACKGROUND: The Zambian government has implemented a public health response to control the HIV epidemic in the country. Zambia conducted a population-based HIV impact assessment (ZAMPHIA) survey in 2021 to assess the status of the HIV epidemic to guide its public health programs. METHODS: ZAMPHIA 2021 was a cross-sectional two-stage cluster sample household survey among persons aged ≥15 years conducted in Zambia across all 10 provinces. Consenting participants were administered a standardized questionnaire and whole blood was tested for HIV according to national guidelines. HIV-1 viral load (VL), recent HIV infection, and antiretroviral medications were tested for in HIV-seropositive samples. Viral load suppression (VLS) was defined as <1000 copies/ml. ZAMPHIA 2021 results were compared to ZAMPHIA 2016 for persons aged 15-59 years (i.e., the overlapping age ranges). All estimates were weighted to account for nonresponse and survey design. RESULTS: During ZAMPHIA 2021, of 25 483 eligible persons aged ≥15 years, 18 804 (73.8%) were interviewed and tested for HIV. HIV prevalence was 11.0% and VLS prevalence was 86.2% overall, but was <80% among people living with HIV aged 15-24 years and in certain provinces. Among persons aged 15-59 years, from 2016 to 2021, HIV incidence declined from 0.6% to 0.3% (P-value: 0.07) and VLS prevalence increased from 59.2% to 85.7% (P-value: <0.01). DISCUSSION: Zambia has made substantial progress toward controlling the HIV epidemic from 2016 to 2021. Continued implementation of a test-and-treat strategy, with attention to groups with lower VLS in the ZAMPHIA 2021, could support reductions in HIV incidence and improve overall VLS in Zambia. |
Risk factors for recent HIV infections among adults in 14 countries in Africa identified by population-based HIV impact assessment surveys, 2015-2019
Currie DW , West CA , Patel HK , Favaloro J , Asiimwe F , Ndagije F , Silver R , Mugurungi O , Shang J , Ndongmo CB , Williams DB , Dzinotyiweyi E , Waruru A , Pasipamire M , Nuwagaba-Biribonwoha H , Dlamini S , McLeod N , Kayirangwa E , Rwibasira G , Minchella PA , Auld AF , Nyirenda R , Getaneh Y , Hailemariam AH , Tondoh-Koui I , Kohemun N , Mgomella GS , Njau PF , Kirungi WL , Dalhatu I , Stafford KA , Bodika SM , Ussery F , McCracken S , Stupp P , Brown K , Duong YT , Parekh BS , Voetsch AC . Emerg Infect Dis 2023 29 (11) 2325-2334 Identifying persons who have newly acquired HIV infections is critical for characterizing the HIV epidemic direction. We analyzed pooled data from nationally representative Population-Based HIV Impact Assessment surveys conducted across 14 countries in Africa for recent infection risk factors. We included adults 15-49 years of age who had sex during the previous year and used a recent infection testing algorithm to distinguish recent from long-term infections. We collected risk factor information via participant interviews and assessed correlates of recent infection using multinomial logistic regression, incorporating each survey's complex sampling design. Compared with HIV-negative persons, persons with higher odds of recent HIV infection were women, were divorced/separated/widowed, had multiple recent sex partners, had a recent HIV-positive sex partner or one with unknown status, and lived in communities with higher HIV viremia prevalence. Prevention programs focusing on persons at higher risk for HIV and their sexual partners will contribute to reducing HIV incidence. |
The state of the pediatric HIV epidemic in Lesotho: results from a population-based survey
Frederix K , Schwitters A , Chung G , McCracken S , Kupamundi T , Patel HK , Arpadi S , Domaoal RA , Ntene-Sealiete K , Thin K , Wiesner L , Low A . AIDS 2023 37 (9) 1377-1386 OBJECTIVE: Lesotho does not have reliable data on HIV prevalence in children, relying on estimates generated from program data. The 2016 Lesotho Population-based HIV Impact Assessment (LePHIA) aimed to determine HIV prevalence among children 0-14 years to assess the effectiveness of the prevention of mother to child transmission (PMTCT) program and guide future policy. METHODS: A nationally representative sample of children under 15 years underwent household-based, two-stage HIV testing from November 2016-May 2017. Children <18 months with a reactive screening test were tested for HIV infection using total nucleic acid (TNA) PCR. Parents (61.1%) or legal guardians (38.9%) provided information on children's clinical history. Children aged 10-14 years also answered a questionnaire on knowledge and behaviors. RESULTS: HIV prevalence was 2.1% (95% CI: 1.5-2.6%). Prevalence in 10-14 year olds (3.2%; 95% CI: 2.1%, 4.2%) was significantly greater compared to 0-4 year olds (1.0%; 95% CI: 0.5%, 1.6%). HIV prevalence in girls and boys was 2.6% (95% CI: 1.8% - 3.3%) and 1.5% (95% CI: 1.0% - 2.1%), respectively. Based on reported status and/or the presence of detectable antiretrovirals, 81.1% (95% CI: 71.7-90.4%) of HIV-positive children were aware of their status, 98.2% (95% CI: 90.7 - 100.0%) of those aware were on ART and 73.9% (95% CI: 62.1-85.8%) of those on ART were virally suppressed. CONCLUSIONS: Despite the roll-out of Option B+ in Lesotho in 2013, pediatric HIV prevalence remains high. Further research is required to understand the greater prevalence among girls, barriers to PMTCT, and how to better achieve viral suppression in children living with HIV. |
Point of care CD4 testing in national household surveys - results and quality indicators from eleven population-based HIV impact assessment (PHIA) surveys
Birhanu S , Winterhalter FS , Stupp P , Cates M , Rottinghaus E , Yavo D , Wray-Gordon F , Lupoli K , Ndongmo CB , Longwe H , Reid GA , Metz M , Saito S , McCracken S , Brown K , Voetsch AC , Duong YT , Parekh BS , Patel HK . Microbiol Spectr 2023 11 (3) e0314822 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 (P < 0.0001). 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. 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. |
Factors associated with viral suppression among adults living with HIV on antiretroviral therapy in Nigeria: Analysis of a population-based survey, 2018
Abimiku A , Ramadhani HO , Moloney M , Stafford KA , Chang JC , Patel HK , Domaoal RA , Okoye M , Jelpe T , Bronson M , Ibrahim D , Swaminathan M , Gambo A , Charurat ME . HIV Med 2023 24 (7) 827-837 OBJECTIVE: Viral load suppression (VLS) is critical in reducing morbidity and mortality associated with HIV as well as minimizing the likelihood of HIV transmission to uninfected persons. The objective of this study was to identify factors associated with VLS among people living with HIV (PLWH) on antiretroviral (ARV) therapy to inform HIV programme strategies in Nigeria. METHODS: Adult participants, aged 15-64 years, from the 2018 Nigeria HIV/AIDS Indicator and Impact Survey (NAIIS), who self-reported to be a PLWH or had detectable ARVs, were analysed to examine factors associated with VLS defined as HIV RNA <1000 copies/mL. NAIIS measured HIV prevalence, viral load, ARV and hepatitis B in PLWH. Logistic regression models were used and reported weighted prevalence. RESULTS: Of 1322 participants, 949 (68.25%) were women and 1287 (96.82%) had detectable ARVs. The median age was 39.31 [interquartile range (IQR): 31.47-47.63] years. Prevalence of VLS was 80.88%. Compared with participants with detectable ARVs, those with undetectable ARVs in their blood specimens had lower odds of VLS [adjusted odds ratio (aOR) = 0.24, 95% confidence interval (CI): 0.08-0.64). Coinfection with hepatitis B and nonnucleoside reverse transcriptase inhibitor metabolites were also associated with lower odds of VLS. Older people (45-54 vs 15-24 years) had increased odds of VLS (aOR = 2.81, 95% CI: 1.14-6.90). CONCLUSION: Young people and those with undetectable ARVs had lower odds of virological suppression. Targeted interventions focusing on young people and adherence to medication are needed to achieve the UNAIDS 95-95-95 goals for HIV epidemic control. |
A national household survey on HIV prevalence and clinical cascade among children aged 15 years in Kenya (2018)
Mutisya I , Muthoni E , Ondondo RO , Muthusi J , Omoto L , Pahe C , Katana A , Ngugi E , Masamaro K , Kingwara L , Dobbs T , Bronson M , Patel HK , Sewe N , Naitore D , De Cock K , Ngugi C , Nganga L . PLoS One 2022 17 (11) e0277613 We analyzed data from the 2018 Kenya Population-Based HIV Impact Assessment (KENPHIA), a cross-sectional, nationally representative survey, to estimate the burden and prevalence of pediatric HIV infection, identify associated factors, and describe the clinical cascade among children aged < 15 years in Kenya. Interviewers collected information from caregivers or guardians on child's demographics, HIV testing, and treatment history. Blood specimens were collected for HIV serology and if HIV-positive, the samples were tested for viral load and antiretrovirals (ARV). For participants <18 months TNA PCR is performed. We computed weighted proportions with 95% confidence intervals (CI), accounting for the complex survey design. We used bivariable and multivariable logistic regression to assess factors associated with HIV prevalence. Separate survey weights were developed for interview responses and for biomarker testing to account for the survey design and non-response. HIV burden was estimated by multiplying HIV prevalence by the national population projection by age for 2018. Of 9072 survey participants (< 15 years), 87% (7865) had blood drawn with valid HIV test results. KENPHIA identified 57 HIV-positive children, translating to an HIV prevalence of 0.7%, (95% CI: 0.4%-1.0%) and an estimated 138,900 (95% CI: 84,000-193,800) of HIV among children in Kenya. Specifically, children who were orphaned had about 2 times higher odds of HIV-infection compared to those not orphaned, adjusted Odds Ratio (aOR) 2.2 (95% CI:1.0-4.8). Additionally, children whose caregivers had no knowledge of their HIV status also had 2 times higher odds of HIV-infection compared to whose caregivers had knowledge of their HIV status, aOR 2.4 (95% CI: 1.1-5.4)". From the unconditional analysis; population level estimates, 78.9% of HIV-positive children had known HIV status (95% CI: 67.1%-90.2%), 73.6% (95% CI: 60.9%-86.2%) were receiving ART, and 49% (95% CI: 32.1%-66.7%) were virally suppressed. However, in the clinical cascade for HIV infected children, 92% (95% CI: 84.4%-100%) were receiving ART, and of these, 67.1% (95% CI: 45.1%-89.2%) were virally suppressed. The KENPHIA survey confirms a substantial HIV burden among children in Kenya, especially among orphans. |
Progress towards the UNAIDS 90-90-90 targets among persons aged 50 and older living with HIV in 13 African countries
Farley SM , Wang C , Bray RM , Low AJ , Delgado S , Hoos D , Kakishozi AN , Harris TG , Nyirenda R , Wadonda N , Li M , Amuri M , Juma J , Kancheya N , Pietersen I , Mutenda N , Natanael S , Aoko A , Ngugi EW , Asiimwe F , Lecher S , Ward J , Chikwanda P , Mugurungi O , Moyo B , Nkurunziza P , Aibo D , Kabala A , Biraro S , Ndagije F , Musuka G , Ndongmo C , Shang J , Dokubo EK , Dimite LE , McCullough-Sanden R , Bissek AC , Getaneh Y , Eshetu F , Nkumbula T , Tenthani L , Kayigamba FR , Kirungi W , Musinguzi J , Balachandra S , Kayirangwa E , Ayite A , West CA , Bodika S , Sleeman K , Patel HK , Brown K , Voetsch AC , El-Sadr WM , Justman JJ . J Int AIDS Soc 2022 25 Suppl 4 e26005 INTRODUCTION: Achieving optimal HIV outcomes, as measured by global 90-90-90 targets, that is awareness of HIV-positive status, receipt of antiretroviral (ARV) therapy among aware and viral load (VL) suppression among those on ARVs, respectively, is critical. However, few data from sub-Saharan Africa (SSA) are available on older people (50+) living with HIV (OPLWH). We examined 90-90-90 progress by age, 15-49 (as a comparison) and 50+ years, with further analyses among 50+ (55-59, 60-64, 65+ vs. 50-54), in 13 countries (Cameroon, Cote d'Ivoire, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Namibia, Rwanda, Tanzania, Uganda, Zambia and Zimbabwe). METHODS: Using data from nationally representative Population-based HIV Impact Assessments, conducted between 2015and 2019, participants from randomly selected households provided demographic and clinical information and whole blood specimens for HIV serology, VL and ARV testing. Survey weighted outcomes were estimated for 90-90-90 targets. Country-specific Poisson regression models examined 90-90-90 variation among OPLWH age strata. RESULTS: Analyses included 24,826 HIV-positive individuals (15-49 years: 20,170; 50+ years: 4656). The first, second and third 90 outcomes were achieved in 1, 10 and 5 countries, respectively, by those aged 15-49, while OPLWH achieved outcomes in 3, 13 and 12 countries, respectively. Among those aged 15-49, women were more likely to achieve 90-90-90 targets than men; however, among OPLWH, men were more likely to achieve first and third 90 targets than women, with second 90 achievement being equivalent. Country-specific 90-90-90 regression models among OPLWH demonstrated minimal variation by age stratum across 13 countries. Among OLPWH, no first 90 target differences were noted by age strata; three countries varied in the second 90 by older age strata but not in a consistent direction; one country showed higher achievement of the third 90 in an older age stratum. CONCLUSIONS: While OPLWH in these 13 countries were slightly more likely than younger people to be aware of their HIV-positive status (first 90), this target was not achieved in most countries. However, OPLWH achieved treatment (second 90) and VL suppression (third 90) targets in more countries than PLWH <50. Findings support expanded HIV testing, prevention and treatment services to meet ongoing OPLWH health needs in SSA. |
Performance of HIV rapid testing algorithm in Nigeria: findings from a household-based Nigeria HIV/AIDS Indicator and Impact Survey (NAIIS)
Patel HK , Ikpe S , Bronson M , Birhanu S , Abimiku A , Jahun I , Detorio M , Lupoli K , Yavo D , Bassey OO , Jelpe TD , Kagurusi B , Iriemenam NC , Patel D , Okoye MI , Dalhatu IT , Ohakanu S , Voetsch AC , Aliyu S , Ashefor G , Gambo A , Ikwulono GO , Nzelu C , Adewole IF , Swaminathan M , Parekh B . PLoS Glob Public Health 2022 2 (7) e0000466 Background: The Nigeria AIDS Indicator and Impact Survey (NAIIS), a cross-sectional household survey, was conducted in 2018 with primary objectives to estimate HIV prevalence, HIV-1 incidence, and status of UNAIDS 90-90-90 cascade. We conducted retrospective analysis of the performance of HIV rapid tests and the national HIV testing algorithm used in Nigeria. |
Performance evaluation of the Asante Rapid Recency Assay for verification of HIV diagnosis and detection of recent HIV-1 infections: implications for epidemic control
Yufenyuy EL , Detorio M , Dobbs T , Patel HK , Jackson K , Shanmugam Vedapuri , Parekh BS . PLoS Glob Public Health 2022 2 (4) e0000316 We previously described development of a rapid test for recent infection (RTRI) that can diagnose HIV infection and detect HIV-1 recent infections in a single device. This technology was transferred to a commercial partner as Asante Rapid Recency Assay (ARRA). We evaluated performance of the ARRA kits in the laboratory using a well-characterized panel of specimens. The plasma specimen panel (N=1500) included HIV-1 (N=570), HIV-2 (N=10), and HIV-negatives (N=920) representing multiple subtypes and geographic locations. Reference diagnostic data were generated using the Bio-Rad HIV-1-2-O EIA/Western blot algorithm with further serotyping performed using the Multispot HIV-1/2 assay. The LAg-Avidity EIA was used to generate reference data on recent and long-term infection for HIV-1 positive specimens at a normalized optical density (ODn) cutoff of 2.0 corresponding to a mean duration of about 6 months. All specimens were tested with ARRA according to the manufacturer's recommendations. Test strips were also read for line intensities using a reader and results were correlated with visual interpretation. ARRA's positive verification line (PVL) correctly classified 575 of 580 HIV-positive and 910 of 920 negative specimens resulting in a sensitivity of 99.1% (95% CI: 98.0-99.6) and specificity of 98.9% (95% CI: 98.1-99.4), respectively. The reader-based classification was similar for PVL with sensitivity of 99.3% (576/580) and specificity of 98.8% (909/920). ARRA's long-term line (LTL) classified 109 of 565 HIV-1 specimens as recent and 456 as long-term compared to 98 as recent and 467 as long-term (LT) by LAg-Avidity EIA (cutoff ODn=2.0), suggesting a mean duration of recent infection (MDRI) close to 6 months. Agreement of ARRA with LAg recent cases was 81.6% (80/98) and LT cases was 93.8% (438/467), with an overall agreement of 91.7% (kappa=0.72). The reader (cutoff 2.9) classified 109/566 specimens as recent infections compared to 99 by the LAg-Avidity EIA for recency agreement of 81.8% (81/99), LT agreement of 9% (439/467) with overall agreement of 91.9% (kappa=0.72). The agreement between visual interpretation and strip reader was 99.9% (95% CI: 99.6-99.9) for the PVL and 98.1% (95% CI: 96.6-98.9) for the LTL. ARRA performed well with HIV diagnostic sensitivity >99% and specificity >98%. Its ability to identify recent infections is comparable to the LA-Avidity EIA corresponding to an MDRI of about 6 months. This point-of-care assay has implications for real-time surveillance of new infections among newly diagnosed individuals for targeted prevention and interrupting ongoing transmission thus accelerating epidemic control. |
Successful Use of Near Point-of-Care Early Infant Diagnosis in NAMPHIA to Improve Turnaround Times in a National Household Survey
Domaoal RA , Sleeman K , Sawadogo S , Dzinamarira T , Frans N , Shatumbu SP , Kakoma LN , Shuumbwa TK , Cox MH , Stephens S , Nisbet L , Metz M , Saito S , Williams DB , Voetsch AC , Patel HK , Parekh BS , Duong YT . J Acquir Immune Defic Syndr 2021 87 S67-s72 BACKGROUND: In the population-based HIV impact assessment surveys, early infant diagnosis (EID) was provided to infants <18 months without a prior diagnosis. For the Namibia population-based HIV impact assessment (NAMPHIA), the GeneXpert platform was assessed for the feasibility of near POC EID testing compared with the standard Roche COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) platform. Quality assurance measures and turnaround time were compared to improve EID results reporting. METHODS: NAMPHIA participants were screened for HIV exposure using Determine HIV-1/2 rapid test; samples reactive on Determine received EID testing on the GeneXpert instrument and Xpert HIV-1 Qual assay using whole blood. Results were confirmed at the Namibia Institute of Pathology using dried blood spots on the Roche CAP/CTM platform per national guidelines. RESULTS: Of the 762 screened infants, 61 (8.0%) were Determine-reactive and considered HIV-exposed. Of the 61 exposed infants, 2 were found to be HIV-infected whereas 59 were negative on both GeneXpert and Roche platforms, achieving 100% concordance. Average turnaround time was 3.4 days for the Xpert HIV-1 Qual assay, and average time from collection to testing was 1.0 days for GeneXpert compared with 10.7 days for Roche. No samples failed using GeneXpert whereas 1 sample failed using Roche and was repeated. CONCLUSION: Quality POC EID testing is feasible in a national survey through extensive training and external quality assurance measures. The use of decentralized POC EID for national testing would provide rapid diagnosis and improve TATs which may prevent loss to follow-up, ensure linkage to care, and improve clinical outcomes for infants. |
A Comprehensive Approach to Assuring Quality of Laboratory Testing in HIV Surveys: Lessons Learned From the Population-Based HIV Impact Assessment Project
Patel HK , Duong YT , Birhanu S , Dobbs T , Lupoli K , Moore C , Detorio M , Sleeman K , Manjengwa J , Wray-Gordon F , Yavo D , Jackson K , Domaoal RA , Yufenyuy EL , Vedapuri S , Ndongmo CB , Ogollah FM , Dzinamarira T , Rubinstein P , Sachathep KK , Metz M , Longwe H , Saito S , Brown K , Voetsch AC , Parekh BS . J Acquir Immune Defic Syndr 2021 87 S17-s27 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. |
HIV-1 Recent Infection Testing Algorithm With Antiretroviral Drug Detection to Improve Accuracy of Incidence Estimates
Voetsch AC , Duong YT , Stupp P , Saito S , McCracken S , Dobbs T , Winterhalter FS , Williams DB , Mengistu A , Mugurungi O , Chikwanda P , Musuka G , Ndongmo CB , Dlamini S , Nuwagaba-Biribonwoha H , Pasipamire M , Tegbaru B , Eshetu F , Biraro S , Ward J , Aibo D , Kabala A , Mgomella GS , Malewo O , Mushi J , Payne D , Mengistu Y , Asiimwe F , Shang JD , Dokubo EK , Eno LT , Zoung-Kanyi Bissek AC , Kingwara L , Junghae M , Kiiru JN , Mwesigwa RCN , Balachandra S , Lobognon R , Kampira E , Detorio M , Yufenyuy EL , Brown K , Patel HK , Parekh BS . J Acquir Immune Defic Syndr 2021 87 S73-s80 BACKGROUND: HIV-1 incidence calculation currently includes recency classification by HIV-1 incidence assay and unsuppressed viral load (VL ≥ 1000 copies/mL) in a recent infection testing algorithm (RITA). However, persons with recent classification not virally suppressed and taking antiretroviral (ARV) medication may be misclassified. SETTING: We used data from 13 African household surveys to describe the impact of an ARV-adjusted RITA on HIV-1 incidence estimates. METHODS: HIV-seropositive samples were tested for recency using the HIV-1 Limiting Antigen (LAg)-Avidity enzyme immunoassay, HIV-1 viral load, ARVs used in each country, and ARV drug resistance. LAg-recent result was defined as normalized optical density values ≤1.5. We compared HIV-1 incidence estimates using 2 RITA: RITA1: LAg-recent + VL ≥ 1000 copies/mL and RITA2: RITA1 + undetectable ARV. We explored RITA2 with self-reported ARV use and with clinical history. RESULTS: Overall, 357 adult HIV-positive participants were classified as having recent infection with RITA1. RITA2 reclassified 55 (15.4%) persons with detectable ARV as having long-term infection. Those with detectable ARV were significantly more likely to be aware of their HIV-positive status (84% vs. 10%) and had higher levels of drug resistance (74% vs. 26%) than those without detectable ARV. RITA2 incidence was lower than RITA1 incidence (range, 0%-30% decrease), resulting in decreased estimated new infections from 390,000 to 341,000 across the 13 countries. Incidence estimates were similar using detectable or self-reported ARV (R2 > 0.995). CONCLUSIONS: Including ARV in RITA2 improved the accuracy of HIV-1 incidence estimates by removing participants with likely long-term HIV infection. |
Unawareness of HIV Infection Among Men Aged 15-59 Years in 13 Sub-Saharan African Countries: Findings From the Population-Based HIV Impact Assessments, 2015-2019
West CA , Chang GC , Currie DW , Bray R , Kinchen S , Behel S , McCullough-Sanden R , Low A , Bissek A , Shang JD , Ndongmo CB , Dokubo EK , Balachandra S , Lobognon LR , Dube L , Nuwagaba-Biribonwoha H , Li M , Pasipamire M , Getaneh Y , Lulseged S , Eshetu F , Kingwara L , Zielinski-Gutierrez E , Tlhomola M , Ramphalla P , Kalua T , Auld AF , Williams DB , Remera E , Rwibasira GN , Mugisha V , Malamba SS , Mushi J , Jalloh MF , Mgomella GS , Kirungi WL , Biraro S , Awor AC , Barradas DT , Mugurungi O , Rogers JH , Bronson M , Bodika SM , Ajiboye A , Gaffga N , Moore C , Patel HK , Voetsch AC . J Acquir Immune Defic Syndr 2021 87 S97-s106 BACKGROUND: Identifying men living with HIV in sub-Saharan Africa (SSA) is critical to end the epidemic. We describe the underlying factors of unawareness among men aged 15-59 years who ever tested for HIV in 13 SSA countries. METHODS: Using pooled data from the nationally representative Population-based HIV Impact Assessments, we fit a log-binomial regression model to identify characteristics related to HIV positivity among HIV-positive unaware and HIV-negative men ever tested for HIV. RESULTS: A total of 114,776 men were interviewed and tested for HIV; 4.4% were HIV-positive. Of those, 33.7% were unaware of their HIV-positive status, (range: 20.2%-58.7%, in Rwanda and Cote d'Ivoire). Most unaware men reported they had ever received an HIV test (63.0%). Age, region, marital status, and education were significantly associated with HIV positivity. Men who had HIV-positive sexual partners (adjusted prevalence ratio [aPR]: 5.73; confidence interval [95% CI]: 4.13 to 7.95) or sexual partners with unknown HIV status (aPR: 2.32; 95% CI: 1.89 to 2.84) were more likely to be HIV-positive unaware, as were men who tested more than 12 months compared with HIV-negative men who tested within 12 months before the interview (aPR: 1.58; 95% CI: 1.31 to 1.91). Tuberculosis diagnosis and not being circumcised were also associated with HIV positivity. CONCLUSION: Targeting subgroups of men at risk for infection who once tested negative could improve yield of testing programs. Interventions include improving partner testing, frequency of testing, outreach and educational strategies, and availability of HIV testing where men are accessing routine health services. |
Purified inactivated Zika vaccine candidates afford protection against lethal challenge in mice
Baldwin WR , Livengood JA , Giebler HA , Stovall JL , Boroughs KL , Sonnberg S , Bohning KJ , Dietrich EA , Ong YT , Danh HK , Patel HK , Huang CY , Dean HJ . Sci Rep 2018 8 (1) 16509 In response to the 2016 global public health emergency of international concern announced by the World Health Organization surrounding Zika virus (ZIKV) outbreaks, we developed a purified inactivated Zika virus vaccine (PIZV) candidate from ZIKV strain PRVABC59, isolated during the outbreak in 2015. The virus isolate was plaque purified, creating six sub-isolated virus stocks, two of which were selected to generate PIZV candidates for preclinical immunogenicity and efficacy evaluation in mice. The alum-adjuvanted PIZV candidates were highly immunogenic in both CD-1 and AG129 mice after a 2-dose immunization. Further, AG129 mice receiving 2 doses of PIZV formulated with alum were fully protected against lethal ZIKV challenge and mouse immune sera elicited by the PIZV candidates were capable of neutralizing ZIKVs of both African and Asian genetic lineages in vitro. Additionally, passive immunization of naive mice with ZIKV-immune serum showed strong positive correlation between neutralizing ZIKV antibody (NAb) titers and protection against lethal challenge. This study supported advancement of the PIZV candidate toward clinical development. |
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