Last data update: May 06, 2024. (Total: 46732 publications since 2009)
Records 1-30 (of 94 Records) |
Query Trace: Parekh B[original query] |
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Persistent colonization of Candida auris among inpatients rescreened as part of a weekly surveillance program
Arenas SP , Persad PJ , Patel S , Parekh DJ , Ferreira TBD , Farinas M , Sexton DJ , Lyman M , Gershengorn HB , Shukla BS . Infect Control Hosp Epidemiol 2023 1-4 We established a surveillance program to evaluate persistence of C. auris colonization among hospitalized patients. Overall, 17 patients (34%) had ≥1 negative result followed by a positive test, and 7 (41%) of these patients had ≥2 consecutive negative tests. |
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. |
Prevalence of Nonsuppressed Viral Load and Associated Factors Among Adults Receiving Antiretroviral Therapy in Eswatini, Lesotho, Malawi, Zambia, and Zimbabwe (2015-2017): Results from Population-Based Nationally-Representative Surveys (preprint)
Haas AD , Radin E , Hakim AJ , Jahn A , Philip NM , Jonnalagadda S , Saito S , Low A , Patel H , Schwitters AM , Rogers JH , Frederix K , Kim E , Bello G , Williams DB , Parekh B , Sachathep K , Barradas DT , Kalua T , Birhanu S , Musuka G , Mugurungi O , Tippett Barr BA , Sleeman K , Mulenga LB , Thin K , Ao TT , Brown K , Voetsch AC , Justman JE . medRxiv 2020 2020.07.13.20152553 Introduction The Joint United Nations Programme on HIV/AIDS (UNAIDS) has set a target of ≥90% of people living with HIV (PLHIV) receiving antiretroviral therapy (ART) to have viral load suppression (VLS). We examined factors associated with nonsuppressed viral Load (NVL).Methods We included PLHIV receiving ART aged 15–59 years from Eswatini, Lesotho, Malawi, Zambia, and Zimbabwe. Blood samples from PLHIV were analyzed for HIV RNA and recent exposure to antiretroviral drugs (ARVs). Outcomes were NVL (viral load ≥1000 copies/mL), virologic failure (VF; ARVs present and viral load ≥1000 copies/mL), interrupted ART (ARVs absent and viral load ≥1000 copies/mL), and receiving second-line ART. We calculated odds ratios and incidence rate ratios for factors associated with NVL, VF, interrupted ART, and switching to second-line ART.Results The prevalence of NVL was 11.2%: 8.2% experienced VF, and 3.0% interrupted ART. Younger age, male gender, less education, suboptimal adherence, receiving nevirapine, HIV non-disclosure, never having married, and residing in Zimbabwe, Lesotho, or Zambia were associated with higher odds of NVL. Among people with NVL, marriage, female gender, shorter ART duration, higher CD4 count, and alcohol use were associated with higher odds for interrupted ART and lower odds for VF. Many people with VF (44.8%) had CD4 counts <200 cells/µL, but few (0.31% per year) switched to second-line ART.Conclusions Countries are approaching UNAIDS VLS targets for adults. Treatment support for people initiating ART with asymptomatic HIV infection, scale-up of viral load monitoring, and optimized ART regimens may further reduce NVL prevalence.Competing Interest StatementThe authors have declared no competing interest.Funding StatementFunding: This research has been supported by the President's Emergency Plan for AIDS Relief (PEPFAR) through the Centers for Disease Control and Prevention (CDC) under the terms of grant number U2GGH001226. ADH was supported by a Swiss National Science Foundation (SNF) Early Postdoc Mobility Fellowship (grant number: P2BEP3_178602). Disclaimer: The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the funding agencies. Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:The Eswatini Scientific and Ethics Committee, the National Health Science Research Committee Malawi, the National Health Research Ethics Committee Lesotho, the National Health Research Ethics Committee Lesotho, the Tropical Diseases Research Centre Ethics Review Committee, Zambia, the Medical Research Council of Zimbabwe, and the Institutional Review Boards at the Centers for Disease Control and Prevention (CDC; Atlanta, GA) and Columbia University Medical Center (New York, NY) approved the PHIA surveys.All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesPublic datasets for Eswatini, Malawi, and Zambia are available. Public datasets for Lesotho and Zimbabwe will be made available soon. For more information see: https://phia-data.icap.columbia.edu/ https://phia-data.icap.columbia.edu/ |
The epidemiology of HIV population viral load in twelve sub-Saharan African countries
Hladik W , Stupp P , McCracken SD , Justman J , Ndongmo C , Shang J , Dokubo EK , Gummerson E , Koui I , Bodika S , Lobognon R , Brou H , Ryan C , Brown K , Nuwagaba-Biribonwoha H , Kingwara L , Young P , Bronson M , Chege D , Malewo O , Mengistu Y , Koen F , Jahn A , Auld A , Jonnalagadda S , Radin E , Hamunime N , Williams DB , Kayirangwa E , Mugisha V , Mdodo R , Delgado S , Kirungi W , Nelson L , West C , Biraro S , Dzekedzeke K , Barradas D , Mugurungi O , Balachandra S , Kilmarx PH , Musuka G , Patel H , Parekh B , Sleeman K , Domaoal RA , Rutherford G , Motsoane T , Bissek AZ , Farahani M , Voetsch AC . PLoS One 2023 18 (6) e0275560 BACKGROUND: We examined the epidemiology and transmission potential of HIV population viral load (VL) in 12 sub-Saharan African countries. METHODS: We analyzed data from Population-based HIV Impact Assessments (PHIAs), large national household-based surveys conducted between 2015 and 2019 in Cameroon, Cote d'Ivoire, Eswatini, Kenya, Lesotho, Malawi, Namibia, Rwanda, Tanzania, Uganda, Zambia, and Zimbabwe. Blood-based biomarkers included HIV serology, recency of HIV infection, and VL. We estimated the number of people living with HIV (PLHIV) with suppressed viral load (<1,000 HIV-1 RNA copies/mL) and with unsuppressed viral load (viremic), the prevalence of unsuppressed HIV (population viremia), sex-specific HIV transmission ratios (number female incident HIV-1 infections/number unsuppressed male PLHIV per 100 persons-years [PY] and vice versa) and examined correlations between a variety of VL metrics and incident HIV. Country sample sizes ranged from 10,016 (Eswatini) to 30,637 (Rwanda); estimates were weighted and restricted to participants 15 years and older. RESULTS: The proportion of female PLHIV with viral suppression was higher than that among males in all countries, however, the number of unsuppressed females outnumbered that of unsuppressed males in all countries due to higher overall female HIV prevalence, with ratios ranging from 1.08 to 2.10 (median: 1.43). The spatial distribution of HIV seroprevalence, viremia prevalence, and number of unsuppressed adults often differed substantially within the same countries. The 1% and 5% of PLHIV with the highest VL on average accounted for 34% and 66%, respectively, of countries' total VL. HIV transmission ratios varied widely across countries and were higher for male-to-female (range: 2.3-28.3/100 PY) than for female-to-male transmission (range: 1.5-10.6/100 PY). In all countries mean log10 VL among unsuppressed males was higher than that among females. Correlations between VL measures and incident HIV varied, were weaker for VL metrics among females compared to males and were strongest for the number of unsuppressed PLHIV per 100 HIV-negative adults (R2 = 0.92). CONCLUSIONS: Despite higher proportions of viral suppression, female unsuppressed PLHIV outnumbered males in all countries examined. Unsuppressed male PLHIV have consistently higher VL and a higher risk of transmitting HIV than females. Just 5% of PLHIV account for almost two-thirds of countries' total VL. Population-level VL metrics help monitor the epidemic and highlight key programmatic gaps in these African countries. |
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. |
Evaluation of the Nigeria national HIV rapid testing algorithm
Iriemenam NC , Mpamugo A , Ikpeazu A , Okunoye OO , Onokevbagbe E , Bassey OO , Tapdiyel J , Alagi MA , Meribe C , Ahmed ML , Ikwulono G , Aguolu R , Ashefor G , Nzelu C , Ehoche A , Ezra B , Obioha C , Baffa Sule I , Adedokun O , Mba N , Ihekweazu C , Charurat M , Lindsay B , Stafford KA , Ibrahim D , Swaminathan M , Yufenyuy EL , Parekh BS , Adebajo S , Abimiku A , Okoye MI . PLOS Glob Public Health 2022 2 (11) e0001077 Human Immunodeficiency Virus (HIV) diagnosis remains the gateway to HIV care and treatment. However, due to changes in HIV prevalence and testing coverage across different geopolitical zones, it is crucial to evaluate the national HIV testing algorithm as false positivity due to low prevalence could be detrimental to both the client and the service delivery. Therefore, we evaluated the performance of the national HIV rapid testing algorithm using specimens collected from multiple HIV testing services (HTS) sites and compared the results from different HIV prevalence levels across the six geopolitical zones of Nigeria. The evaluation employed a dual approach, retrospective, and prospective. The retrospective evaluation focused on a desktop review of program data (n = 492,880) collated from patients attending routine HTS from six geopolitical zones of Nigeria between January 2017 and December 2019. The prospective component utilized samples (n = 2,895) collected from the field at the HTS and tested using the current national serial HIV rapid testing algorithm. These samples were transported to the National Reference Laboratory (NRL), Abuja, and were re-tested using the national HIV rapid testing algorithm and HIV-1/2 supplementary assays (Geenius to confirm positives and resolve discordance and multiplex assay). The retrospective component of the study revealed that the overall proportion of HIV positives, based on the selected areas, was 5.7% (28,319/492,880) within the study period, and the discordant rate between tests 1 and 2 was 1.1%. The prospective component of the study indicated no significant differences between the test performed at the field using the national HIV rapid testing algorithm and the re-testing performed at the NRL. The comparison between the test performed at the field using the national HIV rapid testing algorithm and Geenius HIV-1/2 supplementary assay showed an agreement rate of 95.2%, while that of the NRL was 99.3%. In addition, the comparison of the field results with HIV multiplex assay indicated a sensitivity of 96.6%, the specificity of 98.2%, PPV of 97.0%, and Kappa Statistic of 0.95, and that of the NRL with HIV multiplex assay was 99.2%, 99.4%, 99.0%, and 0.99, respectively. Results show that the Nigeria national serial HIV rapid testing algorithm performed very well across the target settings. However, the algorithm's performance in the field was lower than the performance outcomes under a controlled environment in the NRL. There is a need to target testers in the field for routine continuous quality improvement implementation, including refresher trainings as necessary. |
Improving biomarker-based HIV incidence estimation in the treatment era
Fellows IE , Hladik W , Eaton JW , Voetsch AC , Parekh BS , Shiraishi RW . Epidemiology 2023 34 (3) 353-364 BACKGROUND: Estimating HIV-1 incidence using biomarker assays in cross-sectional surveys is important for understanding the HIV pandemic. However, the utility of these estimates has been limited by uncertainty about what input parameters to use for false recency rate (FRR) and mean duration of recent infection (MDRI) after applying a recent infection testing algorithm (RITA). METHODS: This article shows how testing and diagnosis reduce both FRR and mean duration of recent infection compared to a treatment-naive population. A new method is proposed for calculating appropriate context-specific estimates of FRR and mean duration of recent infection. The result of this is a new formula for incidence that depends only on reference FRR and mean duration of recent infection parameters derived in an undiagnosed, treatment-naive, nonelite controller, non-AIDS-progressed population. RESULTS: Applying the methodology to eleven cross-sectional surveys in Africa results in good agreement with previous incidence estimates, except in 2 countries with very high reported testing rates. CONCLUSIONS: Incidence estimation equations can be adapted to account for the dynamics of treatment and recent infection testing algorithms. This provides a rigorous mathematical foundation for the application of HIV recency assays in cross-sectional surveys. |
Estimation of HIV-1 incidence using a testing history-based method; analysis from the population-based HIV impact assessment survey data in 12 African countries
Gurley SA , Stupp PW , Fellows IE , Parekh BS , Young PW , Shiraishi RW , Sullivan PS , Voetsch AC . J Acquir Immune Defic Syndr 2023 92 (3) 189-196 BACKGROUND: Estimating HIV incidence is essential to monitoring progress in sub-Saharan African nations toward global epidemic control. One method for incidence estimation is to test nationally representative samples using laboratory-based incidence assays. An alternative method based on reported HIV testing history and the proportion of undiagnosed infections has recently been described. METHODS: We applied an HIV incidence estimation method which uses history of testing to nationally representative cross-sectional survey data from 12 sub-Saharan African nations with varying country-specific HIV prevalence. We compared these estimates with those derived from laboratory-based incidence assays. Participants were tested for HIV using the national rapid test algorithm and asked about prior HIV testing, date and result of their most recent test, and date of antiretroviral therapy initiation. RESULTS: The testing history-based method consistently produced results that are comparable and strongly correlated with estimates produced using a laboratory-based HIV incidence assay (ρ = 0.85). The testing history-based method produced incidence estimates that were more precise compared with the biomarker-based method. The testing history-based method identified sex-, age-, and geographic location-specific differences in incidence that were not detected using the biomarker-based method. CONCLUSIONS: The testing history-based method estimates are more precise and can produce age-specific and sex-specific incidence estimates that are informative for programmatic decisions. The method also allows for comparisons of the HIV transmission rate and other components of HIV incidence among and within countries. The testing history-based method is a useful tool for estimating and validating HIV incidence from cross-sectional survey data. |
A stable dried tube specimen for quality assurance and training programs for HIV rapid test for recent infection
Di Germanio C , Yufenyuy EL , Hampton DC , Thorbrogger C , Parekh BS , Norris PJ . Microbiol Spectr 2023 11 (1) e0339822 The HIV epidemic is still one of the world's most serious public health challenges, affecting about 38 million people worldwide, especially in sub-Saharan African and Southeast Asian countries. In recent years, tests have been developed to discriminate recent from long-term infection in HIV-infected populations, and these tools can help identify new outbreaks and networks of transmission and target prevention and treatment plans. New rapid tests for recent infection are being deployed in point-of-care settings; however, quality assurance programs need to be implemented to ensure consistency and reliability of the results. We have developed a dried tube specimen (DTS) stabilized with disaccharide trehalose as a quality control reagent for rapid recency testing that can be stored unrefrigerated prior to reconstitution at temperatures up to 37°C for up to 12 weeks. Analysis of 10 trehalose-stabilized DTSs showed that they maintained the same recency classification in all of the samples stored at 4°C and 37°C up to 12 weeks and at 56°C for 2 weeks, while the DTSs prepared without trehalose changed their classification from long-term to recent or recent to negative after storage at 37°C for 12 weeks. Development of DTS quality control reagents will facilitate proficiency and training programs, particularly in settings without cold chain capability in field environments. IMPORTANCE Implementation of stabilized dried tube specimens (DTSs) for quality control and training would facilitate HIV recency programs, especially in point-of-care settings without cold chain availability. This study shows that addition of the disaccharide trehalose to DTSs prior to drying the samples increased stability of the samples across a range of temperatures. This finding provides an affordable way to increase the availability of these key reagents for quality control in resource-constrained settings. |
HIV incidence, recent HIV infection, and associated factors, Kenya, 2007-2018
Young PW , Musingila P , Kingwara L , Voetsch D , Zielinski-Gutierrez E , Bulterys M , Kim AA , Bronson MA , Parekh B , Dobbs T , Patel H , Reid G , Achia T , Keter A , Mwalili S , Ogollah FM , Ondondo R , Longwe H , Chege D , Bowen N , Umuro M , Ngugi C , Justman J , Cherutich P , De Cock KM . AIDS Res Hum Retroviruses 2022 39 (2) 57-67 BACKGROUND: Nationally-representative surveys provide an opportunity to assess trends in recent HIV infection based on assays for recent HIV infection. METHODS: We assessed HIV incidence in Kenya in 2018 and trends in recent HIV infection among adolescents and adults in Kenya using nationally representative household surveys conducted in 2007, 2012 and 2018. To assess trends, we defined a recent HIV infection testing algorithm (RITA) that classified as recently infected (<12 months) those HIV-positive participants that were recent on the HIV-1 limiting antigen (LAg)-avidity assay without evidence of antiretroviral use. We assessed factors associated with recent and long-term (≥12 months) HIV infection versus no infection using a multinomial logit model while accounting for complex survey design. FINDINGS: Of 1,523 HIV-positive participants in 2018, 11 were classified as recent. Annual HIV incidence was 0.14% in 2018 (95% confidence interval [CI] 0.057-0.23), representing 35,900 (95% CI 16,300-55,600) new infections per year in Kenya among persons aged 15-64 years. The percentage of HIV infections that were determined to be recent was similar in 2007 and 2012 but fell significantly from 2012 to 2018 (adjusted odds ratio [aOR]=0.31, p<0.001). Compared to no HIV infection, being aged 25-34 versus 35-64 years (aOR=4.2, 95% CI 1.4-13), having more lifetime sex partners (aOR=5.2, 95% CI 1.6-17 for 2-3 partners and aOR=8.6, 95% CI 2.8-26 for ≥4 partners versus 0-1 partners), and never having tested for HIV (aOR=4.1, 95% CI 1.5-11) were independently associated with recent HIV infection. INTERPRETATION: Though HIV remains a public health priority in Kenya, HIV incidence estimates and trends in recent HIV infection support a significant decrease in new HIV infections from 2012 to 2018, a period of rapid expansion in HIV diagnosis, prevention, and treatment. |
Evaluation of accuracy and performance of self-reported HIV and antiretroviral therapy status in the Nigeria AIDS Indicator and Impact Survey (2018)
Jahun I , Ehoche A , Bamidele M , Yakubu A , Bronson M , Dalhatu I , Greby S , Agbakwuru C , Baffa I , Iwara E , Alagi M , Asaolu O , Mukhtar A , Ikpeazu A , Nzelu C , Tapdiyel J , Bassey O , Abimiku A , Patel H , Parekh B , Aliyu S , Aliyu G , Charurat M , Swaminathan M . PLoS One 2022 17 (8) e0273748 BACKGROUND: Data on awareness of HIV status among people living with HIV (PLHIV) are critical to estimating progress toward epidemic control. To ascertain the accuracy of self-reported HIV status and antiretroviral drug (ARV) use in the Nigeria HIV/AIDS Indicator and Impact Survey (NAIIS), we compared self-reported HIV status with HIV rapid diagnostic test (RDT) results and self-reported ARV use with detectable blood ARV levels. METHODS: On the basis of responses and test results, participants were categorized by HIV status and ARV use. Self-reported HIV status and ARV use performance characteristics were determined by estimating sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Proportions and other analyses were weighted to account for complex survey design. RESULTS: During NAIIS, 186,405 participants consented for interview out of which 58,646 reported knowing their HIV status. Of the 959 (weighted, 1.5%) who self-reported being HIV-positive, 849 (92.1%) tested HIV positive and 64 (7.9%) tested HIV negative via RDT and polymerase chain reaction test for discordant positive results. Of the 849 who tested HIV positive, 743 (89.8%) reported using ARV and 72 (10.2%) reported not using ARV. Of 57,687 who self-reported being HIV negative, 686 (1.2%) tested HIV positive via RDT, with ARV biomarkers detected among 195 (25.1%). ARV was detected among 94.5% of those who self-reported using ARV and among 42.0% of those who self-reported not using ARV. Overall, self-reported HIV status had sensitivity of 52.7% (95% confidence interval [CI]: 49.4%-56.0%) with specificity of 99.9% (95% CI: 99.8%-99.9%). Self-reported ARV use had sensitivity of 95.2% (95% CI: 93.6%-96.7%) and specificity of 54.5% (95% CI: 48.8%-70.7%). CONCLUSIONS: Self-reported HIV status and ARV use screening tests were found to be low-validity measures during NAIIS. Laboratory tests to confirm self-reported information may be necessary to determine accurate HIV and clinical status for HIV studies in Nigeria. |
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. |
High HIV prevalence and associated factors in Lesotho: Results from a population-based survey
Schwitters A , McCracken S , Frederix K , Tierney R , Koto M , Ahmed N , Thin K , Dobbs T , Sithole S , Letsie M , Parekh B , Patel H , Birhanu S , Wiesner L , Low A . PLoS One 2022 17 (7) e0271431 Despite extensive global efforts, sub-Saharan Africa remains disproportionately affected by the HIV epidemic. This generalized epidemic can be seen in Lesotho which in 2014 the HIV prevalence rate of those aged 15-49 years was 24.6%, with and incidence of 1.9 new infections per 100-person-year exposures. To better understand the impact of Lesotho's national HIV response and significant predictors associated with HIV infection, the Lesotho Population-based HIV Impact Assessment was conducted. This survey provided a nationally representative sample of individuals aged 15-59 years old in which participants were tested for HIV and given an individual questionnaire that included socio-demographic and behavioral risk questions. The association of factors between survey questions and HIV incident was assessed using logistic regression. Multivariate logistic regression models for men and women were constructed for each outcome using variables known to be or plausibly associated with recent or chronic infection. Overall annualized incidence among people aged 15-49 was 1.19% (95% CI 0.73-1.65) per year. The overall prevalence of HIV was 25.6% with women having significantly higher prevalence. Multiple variables, including decreased wealth status, lower education levels, marital status, condom use at first sex, and circumcision (men only) were identified as being significantly associated with HIV infection for both men and women. In combination with improving the awareness of HIV status, an increased focus is needed on AGYW and men 35-49 years old to prevent new infections. HIV education and prevention programs should focus heavily on younger age groups prior to and soon after sexual debut to prevent HIV transmission. The findings of the survey showed significant room for improvement in increasing awareness of HIV status and reinforcing the need for continued HIV prevention and treatment efforts in Lesotho to prevent new infections. |
A mixed-methods pilot evaluation of Manhood 2.0, a program to reduce unintended pregnancy among young men
Manlove J , Parekh J , Whitfield B , Griffith I , Garg A , Fasula AM . Am J Mens Health 2022 16 (3) 15579883221104895 One promising though understudied approach to addressing race/ethnic disparities in teen pregnancy rates is through sexual and reproductive health (SRH) programming for young men. This pilot study assessed the feasibility, quality, and preliminary efficacy of Manhood 2.0-a group-based, after-school SRH program for young Black and Latino men, which examines gender norms. This mixed-methods study describes program attendance and quality; participant experiences and engagement in the program; and changes in participant gender norms, knowledge, attitudes, self-efficacy, and social support. Quantitative data from baseline and post-intervention surveys (n = 51) were analyzed using paired t-tests and McNemar's tests. Qualitative data from five post-intervention focus groups (n = 27) were transcribed, coded, and analyzed for themes. At baseline, participants were ages 15 to18 years (M = 16.4 years), 30% were Latino, 66% were Black, 34% ever had sex, and 44% of sexually active participants had sex without any contraceptive method or condom. Quality ratings by program observers were high. The majority of participants (61%) attended at least 75% of sessions, and 96% rated Manhood 2.0 as "very good" or "excellent." Pre-post comparisons showed increases in receipt of SRH information; contraception knowledge; positive attitudes about supporting partners in pregnancy prevention; self-efficacy in partner communication about sex; discussing program content with friends and family; and social competence and support. Focus group participants described benefits from the Manhood 2.0 content (i.e., full range of contraceptive methods, sexual consent, gender norms) and delivery (i.e., reflective discussion, nonjudgmental facilitators). Findings suggest that Manhood 2.0 is a promising SRH program for young men. |
Prevalence of and factors associated with late diagnosis of HIV in Malawi, Zambia, and Zimbabwe: results from population-based nationally representative surveys
Haas AD , Radin E , Birhanu S , Low AJ , Saito S , Sachathep K , Balachandra S , Manjengwa J , Duong YT , Jonnalagadda S , Payne D , Bello G , Hakim AJ , Smart T , Ahmed N , Cuervo-Rojas J , Auld A , Hetal Patel , Parekh B , Williams DB , Barradas DT , Mugurungi O , Mulenga LB , Voetsch AC , Justman JE . PLoS Glob Public Health 2022 2 (2) e0000080 Introduction: Late diagnosis of HIV (LD) increases the risk of morbidity, mortality, and HIV transmission. We used nationally representative data from population-based HIV impact assessment (PHIA) surveys in Malawi, Zambia, and Zimbabwe (2015-2016) to characterize adults at risk of LD and to examine associations between LD and presumed HIV transmission to cohabiting sexual partners. |
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. |
Development of a Bead-Based Multiplex Assay for Use in Multianalyte Screening and Surveillance of HIV, Viral Hepatitis, Syphilis, and Herpes.
Yufenyuy EL , Vedapuri S , Zheng A , Cooley G , Danavall D , Mayur S , Kodani M , Chen C , Tun Y , Fakile YF , Martin D , Kamili S , Karem K , Parekh BS . J Clin Microbiol 2022 60 (5) e0234821 Diagnostic assays that can simultaneously determine the presence of infection with multiple pathogens are key for diagnosis and surveillance. Current multiplex diagnostic assays are complex and often have limited availability. We developed a simple, multianalyte, pathogen detection assay for screening and serosurveillance using the Luminex Magpix platform that is high throughput and can be helpful in monitoring multiple diseases. The Luminex bead-based 10-plex immunoassay for the detection of HIV-1, HIV-2, Treponema pallidum, hepatitis B virus (HBV), hepatitis C virus (HCV), herpes simplex virus 1 (HSV-1), and HSV-2 infections was accomplished by coupling beads with specific antigens to detect IgG antibodies in plasma or serum samples. Each coupled antigen was systematically optimized, and the performance was evaluated using a panel of well-characterized specimens (n=417) that contained antibodies to HIV-1, HIV-2, T. pallidum, HBV, HCV, HSV-1, and HSV-2. The multiplex assay had a sensitivity of 92.2% (95% Clopper-Pearson confidence interval [CI], 90.2 to 94.0%) and a specificity of 98.1% (95% CI, 97.6 to 98.7%). The sensitivities and specificities for disease-specific biomarker detection ranged from 68.7 to 100% and 95.6 to 100%, respectively. The results showed that the 10-plex immunoassay had an overall agreement of 96.7% (95% CI, 96.7 to 97.3%) with reference tests and a corresponding kappa value of 0.91 (95% CI, 0.90 to 0.93). Kappa values for the individual pathogens ranged from 0.69 to 1.00. The assay is robust and allows the simultaneous detection of antibodies to multiple antigens using a small sample volume in a high-throughput format. This assay has the potential to simplify disease surveillance by providing an alternative to expensive and highly specialized individual tests. |
The small HDL particle hypothesis of Alzheimer's disease
Martinez AE , Weissberger G , Kuklenyik Z , He X , Meuret C , Parekh T , Rees JC , Parks BA , Gardner MS , King SM , Collier TS , Harrington MG , Sweeney MD , Wang X , Zlokovic BV , Joe E , Nation DA , Schneider LS , Chui HC , Barr JR , Han SD , Krauss RM , Yassine HN . Alzheimers Dement 2022 19 (2) 391-404 We propose the hypothesis that small high-density lipoprotein (HDL) particles reduce the risk of Alzheimer's disease (AD) by virtue of their capacity to exchange lipids, affecting neuronal membrane composition and vascular and synaptic functions. Concentrations of small HDLs in cerebrospinal fluid (CSF) and plasma were measured in 180 individuals ≥60 years of age using ion mobility methodology. Small HDL concentrations in CSF were positively associated with performance in three domains of cognitive function independent of apolipoprotein E (APOE) ε4 status, age, sex, and years of education. Moreover, there was a significant correlation between levels of small HDLs in CSF and plasma. Further studies will be aimed at determining whether specific components of small HDL exchange across the blood, brain, and CSF barriers, and developing approaches to exploit small HDLs for therapeutic purposes. |
Acceptability and feasibility of HIV recent infection surveillance by healthcare workers using a rapid test for recent infection at HIV testing sites - Malawi, 2019
Arons MM , Curran KG , Msukwa M , Theu J , O'Malley G , Ernst A , Namakhoma I , Bello G , Telford C , Shanmugam V , Parekh B , Kim E , Dobbs T , Payne D , Gugsa S . BMC Health Serv Res 2022 22 (1) 341 BACKGROUND: The Malawi Ministry of Health implemented a new surveillance activity in April 2019 to detect recent HIV infections using a rapid test for recent infection (RTRI) to identify areas of ongoing transmission and guide response activities. SETTING: At 23 health facilities in Blantyre District, healthcare workers (HCWs) were trained to conduct recent infection testing. In September 2019, we conducted a cross-sectional survey at these sites to explore the acceptability and feasibility of integrating this activity into routine HIV testing services (HTS). METHODS: Research assistants interviewed HCWs using a semi-structured survey. Descriptive statistics were used to summarize quantitative responses and thematic analysis was used to group open-ended text. RESULTS: We interviewed 119 HCWs. Eighty-two percent of participants reported the RTRI was easy-to-use. HCWs perceived high client acceptability; 100% reported clients as 'somewhat' or 'very accepting'. Challenges included 68% of HCWs estimating they spend 20min beyond routine HTS per client for this activity and 51% performing at least two additional finger pricks to complete the testing algorithm. HCWs differed in their perceptions of whether results should be returned to clients. CONCLUSION: This study assessed HCW experiences using point-of-care RTRIs for HIV recent infection surveillance. Overall, HCWs perceived RTRIs to be acceptable, easy-to-use, and valuable. Though only clients withnew HIV diagnoses are tested for recent infection, additional time may be substantial at high-volume health service delivery points. Providing response plans or aggregated recent infection results to HCWs and/or clients may support motivation and sustainability of this novel surveillance activity. |
Geospatial transmission hotspots of recent HIV infection - Malawi, October 2019-March 2020
Telford CT , Tessema Z , Msukwa M , Arons MM , Theu J , Bangara FF , Ernst A , Welty S , O'Malley G , Dobbs T , Shanmugam V , Kabaghe A , Dale H , Wadonda-Kabondo N , Gugsa S , Kim A , Bello G , Eaton JW , Jahn A , Nyirenda R , Parekh BS , Shiraishi RW , Kim E , Tobias JL , Curran KG , Payne D , Auld AF . MMWR Morb Mortal Wkly Rep 2022 71 (9) 329-334 Persons infected with HIV are more likely to transmit the virus during the early stages (acute and recent) of infection, when viral load is elevated and opportunities to implement risk reduction are limited because persons are typically unaware of their status (1,2). Identifying recent HIV infections (acquired within the preceding 12 months)* is critical to understanding the factors and geographic areas associated with transmission to strengthen program intervention, including treatment and prevention (2). During June 2019, a novel recent infection surveillance initiative was integrated into routine HIV testing services in Malawi, a landlocked country in southeastern Africa with one of the world's highest prevalences of HIV infection.(†) The objectives of this initiative were to collect data on new HIV diagnoses, characterize the epidemic, and guide public health response (2). New HIV diagnoses were classified as recent infections based on a testing algorithm that included results from the rapid test for recent infection (RTRI)(§) and HIV viral load testing (3,4). Among 9,168 persons aged ≥15 years with a new HIV diagnosis who received testing across 103 facilities during October 2019-March 2020, a total of 304 (3.3%) were classified as having a recent infection. Higher proportions of recent infections were detected among females, persons aged <30 years, and clients at maternal and child health and youth clinics. Using a software application that analyzes clustering in spatially referenced data, transmission hotspots were identified with rates of recent infection that were significantly higher than expected. These near real-time HIV surveillance data highlighted locations across Malawi, allowing HIV program stakeholders to assess program gaps and improve access to HIV testing, prevention, and treatment services. Hotspot investigation information could be used to tailor HIV testing, prevention, and treatment to ultimately interrupt transmission. |
Performance of a novel rapid test for recent HIV infection among newly-diagnosed pregnant adolescent girls and young women in four high-HIV-prevalence districts-Malawi, 2017-2018
Agyemang EA , Kim AA , Dobbs T , Zungu I , Payne D , Maher AD , Curran K , Kim E , Kwalira H , Limula H , Adhikari A , Welty S , Kandulu J , Nyirenda R , Auld AF , Rutherford GW , Parekh BS . PLoS One 2022 17 (2) e0262071 Tests for recent HIV infection (TRI) distinguish recent from long-term HIV infections using markers of antibody maturation. The limiting antigen avidity enzyme immunoassay (LAg EIA) is widely used with HIV viral load (VL) in a recent infection testing algorithm (RITA) to improve classification of recent infection status, estimate population-level HIV incidence, and monitor trends in HIV transmission. A novel rapid test for recent HIV infection (RTRI), Asanté™, can determine HIV serostatus and HIV recency within minutes on a lateral flow device through visual assessment of test strip or reader device. We conducted a field-based laboratory evaluation of the RTRI among pregnant adolescent girls and young women (AGYW) attending antenatal clinics (ANC) in Malawi.We enrolled pregnant AGYW aged <25 years testing HIV-positive for the first time at their first ANC visit from 121 ANCs in four high-HIV burden districts. Consenting participants provided blood for recency testing using LAg EIA and RTRI, which were tested in central laboratories. Specimens with LAg EIA normalized optical density values ≤2.0 were classified as probable recent infections. RTRI results were based on: (1) visual assessment: presence of a long-term line (LT) indicating non-recent infection and absence of the line indicating recent infection; or (2) a reader; specimens with LT line intensity units <3.0 were classified as probable recent infections. VL was measured for specimens classified as a probable recent infections by either assay; those with HIV-1 RNA ≥1,000 copies/mL were classified as confirmed recent infections. We evaluated the performance of the RTRI by calculating correlation between RTRI and LAg EIA results, and percent agreement and kappa between RTRI and LAg EIA RITA results.Between November 2017 to June 2018, 380 specimens were available for RTRI evaluation; 376 (98.9%) were confirmed HIV-positive on RTRI. Spearman's rho between RTRI and LAg EIA was 0.72 indicating strong correlation. Percent agreement and kappa between RTRI- and LAg EIA-based RITAs were >90% and >0.65 respectively indicating substantial agreement between the RITAs.This was the first field evaluation of an RTRI in sub-Saharan Africa, which demonstrated good performance of the assay and feasibility of integrating RTRI into routine HIV testing services for real-time surveillance of recent HIV infection. |
HIV incidence, viremia, and the national response in Eswatini: Two sequential population-based surveys
Nkambule R , Philip NM , Reid G , Mnisi Z , Nuwagaba-Biribonwoha H , Ao TT , Ginindza C , Duong YT , Patel H , Saito S , Solmo C , Brown K , Moore CS , Voetsch AC , Bicego G , Bock N , Mhlanga F , Dlamini T , Mabuza K , Zwane A , Sahabo R , Dobbs T , Parekh BS , El-Sadr W , Ryan C , Justman J . PLoS One 2021 16 (12) e0260892 With the highest HIV incidence and prevalence globally, the government of Eswatini started a substantial scale-up of HIV treatment and prevention services in 2011. Two sequential large population-based surveys were conducted before and after service expansion to assess the impact of the national response. Cross-sectional, household-based, nationally representative samples of adults, ages 18 to 49 years, were sampled in 2011 and 2016. We measured HIV prevalence, incidence (recent infection based on limiting antigen ≤1.5 optical density units and HIV RNA ≥1000 copies/mL), viral load suppression (HIV RNA <1000 copies/mL among all seropositive adults) and unsuppressed viremia (HIV RNA ≥1000 copies/mL among all, regardless of HIV status) and assessed for temporal changes by conducting a trend analysis of the log ratio of proportions, using a Z statistic distribution. HIV prevalence remained stable from 2011 to 2016 [32% versus 30%, p = 0.10]. HIV incidence significantly declined 48% [2.48% versus 1.30%, p = 0.01]. Incidence remained higher among women than men [2011: 3.16% versus 1.83%; 2016: 1.76% versus 0.86%], with a smaller but significant relative reduction among women [44%; p = 0.04] than men [53%; p = 0.09]. The proportion of seropositive adults with viral load suppression significantly increased from 35% to 71% [p < .001]. The proportion of the total adult population with unsuppressed viremia decreased from 21% to 9% [p < .001]. National HIV incidence in Eswatini decreased by nearly half and viral load suppression doubled over a five-year period. Unsuppressed viremia in the total population decreased 58%. These population-based findings demonstrate the national impact of expanded HIV services in a hyperendemic country. |
Progress toward the 90-90-90 HIV targets in Zimbabwe and identifying those left behind
Hakim AJ , Tippett Barr BA , Kinchen S , Musuka G , Manjengwa J , Munyati S , Gwanzura L , Mugurungi O , Ncube G , Saito S , Parekh BS , Patel H , Duong YT , Gonese E , Sleeman K , Ruangtragool L , Justman J , Herman-Roloff A , Radin E . J Acquir Immune Defic Syndr 2021 88 (3) 272-281 OBJECTIVE: We present findings from the nationally representative Zimbabwe Population-based HIV Impact Assessment (ZIMPHIA) that characterize Zimbabwe's progress toward the Joint United Nations Programme on HIV/AIDS 90-90-90 targets. DESIGN: We conducted a cross-sectional household survey. METHODS: Consenting adults and children in the household were eligible to participate in ZIMPHIA (October 2015-August 2016). Participants completed face-to-face interviews and provided blood for HIV, CD4, viral load, and syphilis testing. VLS was defined as HIV RNA <1,000 copies/mL. HIV-positive specimens were tested for the presence of selected antiretroviral drugs. Data were weighted. Analysis was restricted to HIV-positive adults aged 15-64 years. RESULTS: We enrolled 11,098 men and 14,033 women aged 15-64 years. HIV prevalence was 14.1%. Of those living with HIV, 76.8% (95% confidence interval [CI]: 74.9-78.7) were aware of their HIV status or had detectable antiretroviral levels. Of these, 88.4% (95% CI: 87.1-89.7) were receiving ART, and of these people, 85.3% (95% CI: 83.4-87.1) had VLS. Male sex age 15-34 years and having one or more sexual partners were associated with being unaware of one's HIV-positive status. Age <50 years and not taking cotrimoxazole were associated with being less likely to be being both aware and taking ART. Male sex, age <50 years, and taking cotrimoxazole were associated with being on ART but not having VLS. CONCLUSIONS: Zimbabwe has made great strides toward epidemic control. Focusing resources on case finding, particularly among men, people aged<35 years, and sexually active individuals can help Zimbabwe attain 90-90-90 targets. |
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. |
Lessons From Rapid Field Implementation of an HIV Population-Based Survey in Nigeria, 2018
Jahun I , Greby SM , Adesina T , Agbakwuru C , Dalhatu I , Yakubu A , Jelpe T , Okoye M , Ikpe S , Ehoche A , Abimiku A , Aliyu G , Charurat M , Greenwell G , Bronson M , Patel H , McCracken S , Voetsch AC , Parekh B , Swaminathan M , Adewole I , Aliyu S . J Acquir Immune Defic Syndr 2021 87 S36-s42 BACKGROUND: The need for accurate HIV annual program planning data motivated the compressed timeline for the 2018 Nigerian HIV/AIDS Indicator and Impact Survey (NAIIS). The survey team used stakeholder cooperation and responsive design, using survey process and paradata to refine survey implementation, to quickly collect high-quality data. We describe processes that led to generation of data for program and funding decisions, ensuring HIV services were funded in 2019. SETTING: Nigeria is the most populous country in Africa, with approximately 195 million people in 36 states and the Federal Capital Territory. Challenges include multiple security threats, poor infrastructure, seasonal rains, and varied health system capacity. METHODS: Stakeholders worked together to plan and implement NAIIS. Methods from other population-based HIV impact assessments were modified to meet challenges and the compressed timeline. Data collection was conducted in 6 webs. Responsive design included reviewing survey monitoring paradata and laboratory performance. Costs required to correct data errors, for example, staff time and transportation, were tracked. RESULTS: NAIIS data collection was completed in 23 weeks, ahead of the originally scheduled 24 weeks. Responsive design identified and resolved approximately 68,000 interview errors, affecting approximately 62,000 households, saving about US$4.4 million in costs. Biweekly field laboratory test quality control improved from 50% to 100% throughout NAIIS. CONCLUSIONS: Cooperation across stakeholders and responsive design ensured timely release of NAIIS results and informed planning for HIV epidemic control in Nigeria. Based on NAIIS results, funds were provided to place an additional 500,000 HIV-positive Nigerians on antiretroviral therapy by the end of 2020, pushing Nigeria toward epidemic control. |
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. |
Population-Based HIV Impact Assessments Survey Methods, Response, and Quality in Zimbabwe, Malawi, and Zambia
Sachathep K , Radin E , Hladik W , Hakim A , Saito S , Burnett J , Brown K , Phillip N , Jonnalagadda S , Low A , Williams D , Patel H , Herman-Roloff A , Musuka G , Barr B , Wadondo-Kabonda N , Chipungu G , Duong Y , Delgado S , Kamocha S , Kinchen S , Kalton G , Schwartz L , Bello G , Mugurungi O , Mulenga L , Parekh B , Porter L , Hoos D , Voetsch AC , Justman J . J Acquir Immune Defic Syndr 2021 87 S6-s16 BACKGROUND: The population-based HIV impact assessment (population-based HIV impact assessments) surveys are among the first to estimate national adult HIV incidence, subnational prevalence of viral load suppression, and pediatric HIV prevalence. We summarize the survey methods implemented in Zimbabwe, Malawi, and Zambia, as well as response rates and quality metrics. METHODS: Each cross-sectional, household-based survey used a 2-stage cluster design. Survey preparations included sample design, questionnaire development, tablet programming for informed consent and data collection, community mobilization, establishing a network of satellite laboratories, and fieldworker training. Interviewers collected demographic, behavioral, and clinical information using tablets. Blood was collected for home-based HIV testing and counseling (HBTC) and point-of-care CD4+ T-cell enumeration with results immediately returned. HIV-positive blood samples underwent laboratory-based confirmatory testing, HIV incidence testing, RNA polymerase chain reaction (viral load), DNA polymerase chain reaction (early infant diagnosis), and serum antiretroviral drug detection. Data were weighted for survey design, and chi square automatic interaction detection-based methods were used to adjust for nonresponse. RESULTS: Each survey recruited a nationally representative, household-based sample of children and adults over a 6-10-month period in 2015 and 2016. Most (84%-90%) of the 12,000-14,000 eligible households in each country participated in the survey, with 77%-81% of eligible adults completing an interview and providing blood for HIV testing. Among eligible children, 59%-73% completed HIV testing. Across the 3 surveys, 97.8% of interview data were complete and had no errors. CONCLUSION: Conducting a national population-based HIV impact assessment with immediate return of HIV and other point-of-care test results was feasible, and data quality was high. |
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. |
Recent HIV infection among pregnant women in the 2017 antenatal sentinel cross-sectional survey, South Africa: Assay-based incidence measurement
Woldesenbet S , Kufa-Chakezha T , Lombard C , Manda S , Cheyip M , Ayalew K , Chirombo B , Barron P , Diallo K , Parekh B , Puren A . PLoS One 2021 16 (4) e0249953 INTRODUCTION: New HIV infection during pre-conception and pregnancy is a significant contributor of mother-to-child transmission of HIV in South Africa. This study estimated HIV incidence (defined as new infection within the last one year from the time of the survey which included both new infections occurred during pregnancy or just before pregnancy) among pregnant women and described the characteristics of recently infected pregnant women at national level. METHODS: Between 1 October and 15 November 2017, we conducted a national cross-sectional survey among pregnant women aged 15-49 years old attending antenatal care at 1,595 public facilities. Blood specimens were collected from pregnant women and tested for HIV in a centralised laboratory. Plasma viral load and Limiting Antigen Avidity Enzyme Immunosorbent Assay (LAg) tests were further performed on HIV positive specimens to differentiate between recent and long-term infections. Recent infection was defined as infection that occurred within one year from the date of collection of blood specimen for the survey. Data on age, age of partner, and marital status were collected through interviews. Women whose specimens were classified as recent by LAg assay and with viral loads >1,000 copies/mL were considered as recently infected. The calculated proportion of HIV positive women with recent infection was adjusted for assay-specific parameters to estimate annual incidence. Survey multinomial logistic regression was used to examine factors associated with being recently infected using HIV negative women as a reference group. Age-disparate relationship was defined as having a partner 5 or more years older. RESULTS: Of 10,049 HIV positive participants with LAg and viral load data, 1.4% (136) were identified as recently infected. The annual HIV incidence was 1.5% (95% confidence interval (CI): 1.2-1.7). In multivariable analyses, being single (adjusted odds ratio, aOR: 3.4, 95% CI: 1.8-6.2) or cohabiting (aOR: 3.8, 95% CI: 1.8-7.7), compared to being married as well as being in an age-disparate relationship among young women (aOR: 3.1, 95% CI: 2.0-4.7; reference group: young women (15-24years) whose partners were not 5 years or more older) were associated with higher odds of recent infection. CONCLUSIONS: Compared to previous studies among pregnant women, the incidence estimated in this study was substantially lower. However, the UNAIDS target to reduce incidence by 75% by 2020 (which is equivalent to reducing incidence to <1%) has not been met. The implementation of HIV prevention and treatment interventions should be intensified, targeting young women engaged in age-disparate relationship and unmarried women to fast track progress towards the UNAIDS target. |
HIV incidence by male circumcision status from the population-based HIV impact assessment (PHIA) surveys-eight sub-Saharan African countries, 2015-2017
Hines JZ , Sachathep K , Pals S , Davis SM , Toledo C , Bronson M , Parekh B , Carrasco M , Xaba S , Mandisarisa J , Kamobyi R , Chituwo O , Kirungi WL , Alamo S , Kabuye G , Awor AC , Mmbando S , Simbeye D , Aupokolo MA , Zemburuka B , Nyirenda R , Msungama W , Tarumbiswa T , Manda R , Nuwagaba-Biribonwoha H , Kiggundu V , Thomas AG , Watts H , Voetsch AC , Williams DB . J Acquir Immune Defic Syndr 2021 87 S89-S96 BACKGROUND: Male circumcision (MC) offers men lifelong partial protection from heterosexually-acquired HIV infection. The impact of MC on HIV incidence has not been quantified in nationally-representative samples. Data from the Population-based HIV Impact Assessments (PHIAs) were used to compare incidence by MC status in countries implementing voluntary medical MC (VMMC) programs. METHODS: Data were pooled from PHIAs conducted in Eswatini, Lesotho, Malawi, Namibia, Tanzania, Uganda, Zambia and Zimbabwe from 2015-2017. Incidence was measured using a recent infection testing algorithm, and analyzed by self-reported MC status distinguishing between medical and non-medical MC. Country, marital status, urban setting, sexual risk behaviors, and mean population HIV viral load among women as an indicator of treatment scale-up were included in a random effects logistic regression model using pooled survey weights. Analyses were age-stratified (15-34 and 35-59 years). Annualized incidence rates and 95% confidence intervals (CIs) and incidence differences were calculated between medically circumcised and uncircumcised men. RESULTS: Men 15-34 years reporting medical MC had lower HIV incidence than uncircumcised men (0.04% [95% CI: 0.00, 0.10%] versus 0.34% [95% CI: 0.10, 0.57%], respectively; p-value = 0.01); whereas among men 35-59 years, there was no significant incidence difference (1.36% [95% CI: 0.32, 2.39%] versus 0.55% [95% CI: 0.14, 0.67%], respectively; p-value = 0.14). DISCUSSION: Medical MC was associated with lower HIV incidence in men aged 15-34 years in nationally-representative surveys in Africa. These findings are consistent with the expected ongoing VMMC program impact and highlight the importance of VMMC for the HIV response in Africa. |
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