Early HIV Diagnosis Research Articles

113. Advanced HIV Disease Among Adults in the African Cohort Study (AFRICOS)

BackgroundIn the “test and treat” era, early ART may decrease the prevalence of advanced HIV disease (AHD), defined as having a CD4 cell count < 200 cells/µL or World Health Organization (WHO) clinical stage III or IV disease. We assessed trends in AHD and ART coverage and describe factors associated with AHD among adults living with HIV (LWH) across four countries before and during the “test and treat” era.MethodsThe African Cohort Study (AFRICOS) is a prospective cohort enrolling adults at risk for HIV or LWH from 12 facilities in Uganda, Kenya, Tanzania and Nigeria. Clinical history review and laboratory testing were performed at enrollment and every 6 months. Serum cryptococcal antigen screening (CrAg) was performed in a subset with CD4 < 200 at enrollment. Logistic regression was used to estimate odds ratios for factors associated with CD4 < 200.ResultsFrom January 2013–December 2019, 2934 adults LWH were enrolled (median age 38 years [interquartile range, 31–46 years], 41.5% men). Of 2903 with CD4 results at enrollment, 567 (19.5%) had CD4 < 200. Despite consistent increases in ART coverage since 2016, across all countries the prevalence of AHD did not decline below levels observed in 2013 until 2019. The prevalence of CD4 < 200 did not significantly decline from 11.9% (range 9.1–25.0%) in 2013 to 10.3% (range 0–16%) in 2019, p=0.7, while ART coverage increased from 74.7% (range 68.3–93.8%) in 2013 to 97.5% (range 86–100%) in 2019, p= < 0.01 (Figure 1). Factors associated with a higher risk of CD4 < 200 at enrollment were being enrolled in Tanzania, male sex, age >29 years, having a primary or some secondary education or above, and WHO stage II disease or higher. Factors associated with a lower risk of CD4 < 200 were >1 year since HIV diagnosis and being on ART for at least 6 months (Table 1). Among those with CD4 < 200 at enrollment, the most commonly reported comorbidities included HIV wasting syndrome (9.3%) and tuberculosis (TB) (2.3%); 19 (3.4%) of 564 adults screened were CrAg positive.Figure 1: Trends in Percentage of Participants with CD4 <200 and ART coverage at Study Enrollment by Country and Year Table 1: Factors associated with CD4 <200 cells/mm3 at Study Enrollment ConclusionDespite the scale-up of ART in the era of “test and treat”, AHD prevalence has only recently trended downward. Continued efforts towards early HIV diagnosis and timely ART initiation are needed to reduce the risk for CD4< 200. Strategies to increase TB screening, prophylaxis, and treatment are essential to reduce morbidity.Disclosures All Authors: No reported disclosures

955. Addressing Gaps and Disparities in HIV testing in the Emergency Department

BackgroundEarly diagnosis of HIV is key to improving outcomes for persons living with HIV (PWH). The Emergency Department (ED) is a critical site for PWH to access care. Previous studies in South Carolina (SC) have shown that two-thirds of individuals newly diagnosed with HIV have visited a health care facility a mean 7 times prior to their HIV diagnosis. Over 80% of these visits were to the ED, thus representing missed opportunities. Failure to test results from a multitude of barriers, including avoidance of testing due to a perceived lack of follow up. To address this gap in care we established a rapid HIV engagement team (RHET) that assumes responsibility for post-HIV testing linkage and reporting. The goal of this study is to evaluate the effectiveness of this intervention. MethodsThis retrospective cohort study compared HIV testing rates and patterns in Prisma Health EDs from May 2018 through October 2018 (pre-RHET) to 5/2019 through 10/2019 (post-RHET). Included persons were ≥18 years of age and had ICD-10 codes for a sexually transmitted infection (STI), trichomonas, herpes simplex, and gonorrhea (GC) or Chlamydia (CT) NAAT, and/or presented with an initial complaint of a STI. Multivariable logistic regression analysis was utilized to examine impact of RHET implementation on HIV testing in ED.ResultsA total of 4104 individuals were identified, 2154 pre-RHET and 1950 post-RHET. Table 1 displays baseline characteristics for the two groups. Overall, 87% had GC testing; 9% had positive results; 95% had CT testing, 12.6% had positive results. Only 6% were tested for HIV pre-RHET implementation. HIV testing improved to 12% post-PHET implementation (p< 0.001). In the multivariate regression analysis predictors for HIV testing were presenting post-RHET (OR 2.27; 95% CI 1.81 to 2.85), male gender (OR 2.98; 95% CI 2.39 to 3.73), white race (OR 2.27; 95% CI 1.81 to 2.85), and presenting to ED for STI (OR 3.58; 95% CI 2.03 6.33).ConclusionHIV testing rates increased post-RHET yet, despite indications for HIV testing, only a small proportion received HIV testing. Further interventions are needed to improve HIV testing in EDs, particularly in women and blacks. The overall HIV testing rate remained low, representing ongoing missed opportunities for early HIV diagnosis.Disclosures All Authors: No reported disclosures

Routine Versus Risk-Based HIV Testing and Mortality of Patients With HIV Under National Health Insurance: A Population-Based Cohort Study

Background: Expanding routine opt-out HIV testing to control HIV epidemic is beneficial for vulnerable persons and for the society. However, data are lacking on long-term survival and safety outcomes of those tested HIV-positive by routine opt-out versus non-routine (risk-based) HIV testing under the same treatment and health care. Methods: We analyzed the population-based HIV/AIDS registry and follow-up data under Taiwan National Health Insurance, comparing the clinical outcomes of those diagnosed by routine opt-out testing or risk-based testing. The main outcomes were HIV/AIDS-related mortality, non-HIV-related mortality, and 1-year suicidal/accidental mortality. We matched subjects by year of diagnosis, and adjusted for effects of age, sex, transmission routes, and socioeconomic status using regression models. Findings: This study included all 28,674 Taiwan citizens diagnosed with HIV infection during 1986-2014 (8,431 [29%] by routine opt-out testing, and 18,305 [64%] by risk-based testing), with verified follow-up data. Compared with risk-based testing, routine opt-out HIV testing was associated with a significantly lower likelihood of late diagnosis (adjusted odds ratio 0·20, 95% CI 0·18-0·23; p<0·001), and a significantly lower HIV/AIDS-related mortality (adjusted hazard ratio [aHR] 0·63, 95% CI 0·53-0·75; p<0·001). In addition, routine opt-out HIV testing was not associated with increased non-HIV-related death (aHR, 0·94, 95% CI 0·91-0·98; p=0·001) or suicidal/accidental mortality (aHR 0·80, 95% CI 0·43 -1·49; p=0·48) compared with risk-based HIV testing. Interpretation: Compared with risk-based HIV testing, routine opt-out HIV testing is safe, and associated with favorable clinical relevant outcomes, including early HIV diagnosis and lower HIV/AIDS-related mortality, among individuals who were tested HIV-positive under National Health Insurance. Funding Statement: This work was supported by Taiwan Ministry of Science and Technology (grants no. MOST-102-2628-B-002-037-MY2, MOST-104-2314-B-002-035-MY2, and MOST-106-2314-B-002-115-MY3) and Taiwan Centers for Disease Control (grants no. MOHW-106-CDC-JH-105030, MOHW107-CDC-CB-106040, and MOHW-108-CDC-YH-107030). Declaration of Interests: All authors have no competing interest to disclose. Ethics Approval Statement: The study procedure was approved by the Research Ethics Committee (REC) of National Taiwan University Hospital (Taipei, Taiwan) (#201711046RIND). The REC approved the exemption of informed consent since all personal information had been anonymized.

National-level effectiveness of ART to prevent early mother to child transmission of HIV in Namibia.

BackgroundNamibia introduced the prevention of mother to child HIV transmission (MTCT) program in 2002 and lifelong antiretroviral therapy (ART) for pregnant women (option B-plus) in 2013. We sought to quantify MTCT measured at 4–12 weeks post-delivery.MethodsDuring Aug 2014-Feb 2015, we recruited a nationally representative sample of 1040 pairs of mother and infant aged 4–12 weeks at routine immunizations in 60 public health clinics using two stage sampling approach. Of these, 864 HIV exposed infants had DNA-PCR HIV test results available. We defined an HIV exposed infant if born to an HIV-positive mother with documented status or diagnosed at enrollment using rapid HIV tests. Dried Blood Spots samples from HIV exposed infants were tested for HIV. Interview data and laboratory results were collected on smartphones and uploaded to a central database. We measured MTCT prevalence at 4–12 weeks post-delivery and evaluated associations between infant HIV infection and maternal and infant characteristics including maternal treatment and infant prophylaxis. All statistical analyses accounted for the survey design.ResultsBased on the 864 HIV exposed infants with test results available, nationally weighted early MTCT measured at 4–12 weeks post-delivery was 1.74% (95% confidence interval (CI): 1.00%-3.01%). Overall, 62% of mothers started ART pre-conception, 33.6% during pregnancy, 1.2% post-delivery and 3.2% never received ART. Mothers who started ART before pregnancy and during pregnancy had low MTCT prevalence, 0.78% (95% CI: 0.31%-1.96%) and 0.98% (95% CI: 0.33%-2.91%), respectively. MTCT rose to 4.13% (95% CI: 0.54%-25.68%) when the mother started ART after delivery and to 11.62% (95% CI: 4.07%-28.96%) when she never received ART. The lowest MTCT of 0.76% (95% CI: 0.36% - 1.61%) was achieved when mother received ART and ARV prophylaxis within 72hrs for infant and highest 22.32% (95%CI: 2.78% -74.25%) when neither mother nor infant received ARVs. After adjusting for mother’s age, maternal ART (Prevalence Ratio (PR) = 0.10, 95% CI: 0.03–0.29) and infant ARV prophylaxis (PR = 0.32, 95% CI: 0.10–0.998) remained strong predictors of HIV transmission.ConclusionAs of 2015, Namibia achieved MTCT of 1.74%, measured at 4–12 weeks post-delivery. Women already on ART pre-conception had the lowest prevalence of MTCT emphasizing the importance of early HIV diagnosis and treatment initiation before pregnancy. Studies are needed to measure MTCT and maternal HIV seroconversion during breastfeeding.

Sexual behaviour change following HIV testing services: a systematic review and meta-analysis.

IntroductionLearning one’s HIV status through HIV testing services (HTS) is an essential step toward accessing treatment and linking to preventive services for those at high HIV risk. HTS may impact subsequent sexual behaviour, but the degree to which this varies by population or is true in the setting of contemporary HIV prevention activities is largely unknown. As part of the 2019 World Health Organization Consolidated Guidelines on HTS, we undertook a systematic review and meta‐analysis to determine the effect of HTS on sexual behaviour.MethodsWe searched nine electronic databases for studies published between July 2010 and December 2019. We included studies that reported on at least one outcome (condom use [defined as the frequency of condom use or condom‐protected sex], number of sex partners, HIV incidence, STI incidence/prevalence). We included studies that prospectively assessed outcomes and that fit into one of three categories: (1) those evaluating more versus less‐intensive HTS, (2) those of populations receiving HTS versus not and (3) those evaluating outcomes after versus before HTS. We conducted meta‐analyses using random‐effects models.Results and discussionOf 29 980 studies screened, 76 studies were included. Thirty‐eight studies were randomized controlled trials, 36 were cohort studies, one was quasi‐experimental and one was a serial cross‐sectional study. There was no significant difference in condom use among individuals receiving more‐intensive HTS compared to less‐intensive HTS (relative risk [RR]=1.03; 95% CI: 0.99 to 1.07). Condom use was significantly higher after receiving HTS compared to before HTS for individuals newly diagnosed with HIV (RR = 1.65; 95% CI: 1.36 to 1.99) and marginally significantly higher for individuals receiving an HIV‐negative diagnosis (RR = 1.63; 95% CI: 1.01 to 2.62). Individuals receiving more‐intensive HTS reported fewer sex partners at follow‐up than those receiving less‐intensive HTS, but the finding was not statistically significant (mean difference = −0.28; 95% CI: −3.66, 3.10).ConclusionsOur findings highlight the importance of using limited resources towards HTS strategies that focus on early HIV diagnosis, treatment and prevention services rather than resources dedicated to supplementing or enhancing HTS with additional counselling or other interventions.

Feasibility and acceptability of implementing early infant diagnosis of HIV in Papua New Guinea at the point of care: a qualitative exploration of health worker and key informant perspectives

IntroductionEarly infant diagnosis (EID) of HIV and timely initiation of antiretroviral therapy can significantly reduce morbidity and mortality among HIV-positive infants. Access to EID is limited in many low-income and...

Prevalence of and factors associated with advanced HIV disease among newly diagnosed people living with HIV in Guangdong Province, China.

IntroductionA high proportion of people living with HIV (PLHIV) present for care with advanced HIV disease (AHD), which is detrimental to “90‐90‐90” targets to end AIDS by 2030. This study aimed to explore the prevalence of and factors related to AHD among newly diagnosed PLHIV in Guangdong Province, China.MethodsNewly diagnosed PLHIV were recruited from six cities in Guangdong Province from May 2018 to June 2019. AHD was defined as an initial CD4 count <200 cells/µL or an AIDS‐defining event within one month of HIV diagnosis. Data from a questionnaire and the national HIV surveillance system were used to explore the potential factors related AHD.ResultsA total of 400 of 997 newly diagnosed PLHIV were defined as having AHD with a proportion of 40.1%. After adjusting for statistically significant variables in univariate analysis, multivariable logistic regressions showed that individuals aged 30 to 39 years (adjusted odds ratio (aOR) = 1.77, 95% confidence interval (CI): 1.13 to 2.79) and ≥50 years (aOR = 1.98, 95% CI: 1.15 to 3.43) were at a higher risk of AHD than those aged 18 to 29 years. Participants diagnosed by voluntary counselling and testing (VCT) clinics were less likely to have AHD (aOR = 0.67, 95% CI: 0.48 to 0.94) than those diagnosed at medical facilities. Participants who had ever considered HIV testing (aOR = 0.66, 95% CI: 0.45 to 0.98) and who had high social support (aOR = 0.73, 95% CI: 0.55 to 0.97) were at a lower risk of AHD, whereas participants who had HIV‐related symptoms within one year before diagnosis were at a higher risk of AHD (aOR = 2.09, 95% CI: 1.58 to 2.77). The most frequent reason for active HIV testing was “feeling sick” (42.4%, 255/601), and the main reason for never considering HIV testing was “never thinking of getting HIV” (74.0%, 542/732).ConclusionsLow‐risk perception and a lack of awareness of HIV‐related symptoms resulted in a high proportion of AHD in Guangdong Province, especially among the elderly, those diagnosed at medical facilities and those with low social support. Strengthening AIDS education and training programmes to scale up HIV testing through provider‐initiated testing and counselling in medical facilities and VCT could facilitate early HIV diagnosis.

Perfil clí­nico e epidemiológico de gestantes com HIV positivo atendidas em um hospital municipal de Niterói

Objetivo: Avaliar o perfil epidemiológico das gestantes HIV positivo, acompanhadas no Ambulatório do Hospital Municipal Carlos Tortelly de Niterói – RJ. Metodologia: Trata-se de um estudo epidemiológico retrospectivo, quantitativo e descritivo. Consta de 103 gestantes HIV positivo na faixa etária 18 e 45 anos, atendidas no ambulatório de SIDA/Hospital Municipal Carlos Tortelly (HMCT), durante o perí­odo de dezembro de 2009 a dezembro de 2015. Resultados: A faixa etária predominante entre 21 a 30 anos (57,3%), sendo que 40,8% tinham ensino fundamental, 30,1% com renda familiar em torno de um salário mí­nimo, e a maioria 60,2% procedia no Municí­pio de Niterói. A detecção do HIV, majoritariamente, ocorreu antes da gravidez (57,3%), e apenas 14,6% das gestantes não consumia alguma substância quí­mica durante a gestação e 45,6% não sofreram infecção oportunista durante o acompanhamento, 28,2% já tinham dois ou mais filhos. Cesária não eletiva foi a maior forma de escolha para o nascimento (53,4%). Conclusão: O perfil se caracteriza por situação socioeconômica vulnerável, com baixo ní­vel de escolaridade, e o diagnóstico anterior precedem a gestação atual. A realização do pré-natal, e a terapia TARV na gestação e no parto foi alto. Para tanto, faz-se necessário o melhoramento das informações e ações direcionadas í ampliação da atenção í s mulheres, cuja garantia integral e o diagnóstico precoce do HIV constituem artifí­cios importantes na redução da transmissão vertical.

The contribution of HIV point-of-care tests in early HIV diagnosis: community-based HIV testing monitoring in Catalonia, 1995 to 2018.

BackgroundCommunity-based HIV testing services combined with the use of point-of-care tests (POCT) have the potential to improve early diagnosis through increasing availability, accessibility and uptake of HIV testing.AimTo describe community-based HIV testing activity in Catalonia, Spain, from 1995 to 2018, and to evaluate the impact of HIV POCT on the HIV continuum of care.MethodsA community-based network of voluntary counselling and testing services in Catalonia, Spain has been collecting systematic data on activity, process and results since 1995. A descriptive analysis was performed on pooled data, describing the data in terms of people tested and reactive screening test results.ResultsBetween 1995 and 2018, 125,876 HIV tests were performed (2.1% reactive). Since the introduction of HIV POCT in 2007, a large increase in the number of tests performed was observed, reaching 14,537 tests alone in 2018 (1.3% reactive). Men who have sex with men (MSM), as a proportion of all people tested, has increased greatly over time reaching 74.7% in 2018. The highest percentage of reactive tests was found in people who inject drugs followed by MSM. The contribution of community-based HIV testing to the overall total notified cases in the Catalonia HIV registry has gradually increased, reaching 37.9% in 2018, and 70% of all MSM cases. In 2018, the percentage of individuals with a reactive screening test who were linked to care was 89.0%.ConclusionOur study reinforces the important role that community-based HIV POCT has on the diagnosis of HIV in key populations.

Exploration of Long-term CD4 Profile in HIV Patients Under HAART at Mizan-Tepi University Teaching Hospital and Tepi General Hospital, South Western Ethiopia

Background : Currently, because of the wide availability and free service of HAART, HIV/AIDS related morbidity and mortality has decreased significantly. However, patients accessing antiretroviral treatment (ART) programmes in sub-Saharan Africa frequently have very advanced immunodeficiency and various reserches suggest that such patients may have diminished capacity for CD4 cell count recovery. The objective of this study was to investigate the long-term effect of highly active antiretroviral therapy on the CD4 lymphocyte count of HIV-infected Patients. Method : Subjects from the multicenter HAART Program cohort (from Mizan-Tepi University Teaching Hospital and Tepi General Hospital), aged 18 years or older and had an ART treatment start date in between February 1, 2017 to January 31, 2019 were enrolled in the present study and followed for a maximum of 3 years. Liner mixed model with nested random effect were used to model the longitudianl CD4 count over time. Result : The data reveal robust CD4 responses to ART that are continual over several years. Being under HAART for long period and having baseline CD4 count greater than 150 were postively associated with CD4 increment over time while starting ART at late stage (Stage 3 or 4) and being male are negatively assocted with CD4 increment over time. Conclusion : These data show strong and repetitive CD4 response to ART among patients remaining on therapy. Earlier HIV diagnosis and initiation of ART could significantly progress patient outcomes in the study area. Keywords: CD4counts, HAART, ART, Liner mixed model, Patients DOI: 10.7176/JNSR/11-19-02 Publication date: October 31 st 2020

Association Between CD4 Count and Chemoradiation Therapy Outcomes Among Cervical Cancer Patients With HIV.

In Botswana, nearly two-thirds of cervical cancer patients are HIV-positive. This study examined the relationship between CD4 count and chemoradiation therapy outcomes among cervical cancer patients with HIV. A prospective cohort study of 231 HIV-positive women with locally invasive cervical cancer was conducted in Gaborone, Botswana from January 2015 to February 2018. Primary outcome was survival, defined as time from scheduled end of chemoradiation therapy to death or last contact with patient. Nadir CD4 count was defined as lowest CD4 available before cancer diagnosis. Delta CD4 count was defined as improvement from nadir CD4 to CD4 at cancer diagnosis. Hazard ratio (HR) analyses were adjusted for presenting variables (age, baseline hemoglobin, cancer stage, and performance status) and treatment variables (chemotherapy cycles and radiation dose). Two hundred thirty-one patients were included in nadir CD4 analysis; 139 were included in delta CD4 analysis. Higher delta CD4 was significantly associated with reduced mortality after adjusting for presenting and treatment variables (CD4 100-249: HR 0.45, 95% CI: 0.21 to 0.95; CD4 ≥250: HR 0.45, 95% CI: 0.20 to 1.02). Higher nadir CD4 showed a trend toward reduced mortality after adjusting for presenting and treatment variables (HR 0.94, 95% CI: 0.84 to 1.06). Higher delta CD4 (greater improvement from nadir CD4 to CD4 at cervical cancer diagnosis) is significantly associated with lower mortality. Although not statistically significant, data suggest that higher nadir CD4 may reduce mortality. These results reinforce the importance of early HIV diagnosis and antiretroviral therapy initiation, as their effects influence cervical cancer outcomes years later.

Gender difference in all-cause mortality of people living with HIV in Iran: findings from a 20-year cohort study.

Gender differences in the efficacy of treatment and the mortality of HIV-infected patients have not yet been fully elucidated. For the first time, we used data from a 20-year cohort of people living with HIV (PLWH) in four provinces (Fars, Bushehr, Bandar Abbas, and Kohgiluyeh and Boyer-Ahmad) in the southern part of Iran to assess the gender difference in all-cause mortality in PLWH in Iran. We analysed data for 1216 patients aged ≥ 15years who were diagnosed with HIV/AIDS between 1997 and 2017. Three hundred and fourteen (25.8%) were women. The death rate from all causes among women was 13.7% vs. 43.8% among men (P<0.001). All-cause mortality was significantly associated with gender [the adjusted hazard ratio (aHR) for men compared with women was 3.20], not being on antiretroviral therapy (ART) compared with being on ART at the last visit (aHR5.42), older age (aHR1.03), delayed HIV diagnosis compared with early diagnosis (aHR1.72), history of incarceration (aHR1.57), higher log CD4 count at diagnosis (aHR0.54), and prophylaxis for Pneumocystis pneumonia (aHR0.09). The results of this 20-year cohort study suggest that gender is an important predictor of survival among HIV-infected patients. Improving early HIV diagnosis and early ART initiation in men, as well as increased access to hepatitis C virus treatment are needed to increase the survival rate of HIV-infected patients in Iran.

Prevalence and Predictors of Virological Failure Among Adults Living with HIV in South Wollo Zone, Northeast Ethiopia: A Retrospective Cohort Study.

BackgroundHighly active antiretroviral therapy has dramatically altered progression of HIV infection and significantly improved patients’ quality of life. However, drug resistance with consequent treatment failure raises the need for much more expensive and toxic second-line regimens. Thus, this study aimed at investigating the predictors of virologic failure among adults in Northeast Ethiopia.MethodsA retrospective cohort study was carried out among adults who started first-line antiretroviral treatment from September 2005 to January 2018. Data were collected from patients’ medical records, entered and validated using EpiData version 3.1 and then exported to SPSS version 20 for analysis. Binary logistic regression was carried out; odds ratio with 95% CI was used to identify covariates associated with virologic failure. Statistical significance was considered at p-value <0.05.ResultsA total of 384 patients with mean age of 35.73±9.44 years were consecutively enrolled; of which, 213 (55.5%) were females, 255 (66.4%) had WHO clinical stage III/IV, and 130 (33.9%) had baseline CD4 count <100 cells/mm3. Mean baseline CD4 count was 179 cells/mm3 (range: 2–853 cells), and 158 (41.1%) participants were on AZT/3TC/NVP. Virological failure was diagnosed among 61 (15.9%) patients. The mean time to virologic failure after initiation of ART was 63.80 months (range: 17–150 months). After adjusting for other confounders, risk of experiencing virologic failure was significantly associated with being divorced (AOR 3.40, 95% CI 1.20–9.59), being naïve to ART (AOR 2.55, 95% CI 1.23–5.28), low (<100) baseline CD4 count (AOR 2.39, 95% CI 1.03–5.54) and nonadherence (AOR 6.73, 95% CI 3.29–13.76).ConclusionIn this study, the prevalence of antiretroviral treatment failure was 15.9%. Being divorced, being naïve to antiretroviral therapy, low (<100 cells/mm3) baseline CD4 count and nonadherence were found to be significant predictors of virologic failure. ART programs should focus on early HIV diagnosis and ART initiation as well as enhanced adherence support.

The potential for quality assurance systems to save costs and lives: the case of early infant diagnosis of HIV.

Scaling up of point-of-care testing (POCT) for early infant diagnosis of HIV (EID) could reduce the large gap in infant testing. However, suboptimal POCT EID could have limited impact and potentially high avoidable costs. This study models the cost-effectiveness of a quality assurance system to address testing performance and screening interruptions, due to, for example, supply stockouts, in Kenya, Senegal, South Africa, Uganda and Zimbabwe, with varying HIV epidemics and different health systems. We modelled a quality assurance system-raised EID quality from suboptimal levels: that is, from misdiagnosis rates of 5%, 10% and 20% and EID testing interruptions in months, to uninterrupted optimal performance (98.5% sensitivity, 99.9% specificity). For each country, we estimated the 1-year impact and cost-effectiveness (US$/DALY averted) of improved scenarios in averting missed HIV infections and unneeded HIV treatment costs for false-positive diagnoses. The modelled 1-year costs of a national POCT quality assurance system range from US$ 69359 in South Africa to US$ 334341 in Zimbabwe. At the country level, quality assurance systems could potentially avert between 36 and 711 missed infections (i.e. false negatives) per year and unneeded treatment costs between US$ 5808 and US$ 739030. The model estimates adding effective quality assurance systems are cost-saving in four of the five countries within the first year. Starting EQA requires an initial investment but will provide a positive return on investment within five years by averting the costs of misdiagnoses and would be even more efficient if implemented across multiple applications of POCT.

Pooled testing: A tool to increase efficiency of infant HIV diagnosis and virological monitoring.

BackgroundPooled testing, or pooling, has been used for decades to efficiently diagnose relatively rare conditions, such as infection in blood donors. Programmes for the prevention of mother-to-child transmission of HIV and for antiretroviral therapy (ART) are being rolled out in much of Africa and are largely successful. This increases the need for early infant diagnosis (EID) of HIV using qualitative nucleic acid testing and for virological monitoring of patients on ART using viral load testing. While numbers of patients needing testing are increasing, infant HIV infections and ART failures are becoming rarer, opening an opportunity for pooled testing approaches.AimThis review highlights the need for universal EID and viral load coverage as well as the challenges faced. We introduce the concept of pooled testing and highlight some important considerations before giving an overview of studies exploring pooled testing for EID and virological monitoring.ResultsFor ART monitoring, pooling has been shown to be accurate and efficient; for EID it has not been tried although modelling shows it to be promising. The final part attempts to place pooling into the context of current mother-to-child transmission of HIV and ART programmes and their expected trajectories over the next years.ConclusionSeveral points warrant consideration: pre-selection to exclude samples with an elevated pre-test probability of positivity from pooled testing, the use of dried blood or plasma spots, and choosing a pooling strategy that is both practically feasible and economical. Finally, novel ideas are suggested to make pooling even more attractive.

Low mortality rates at two years in HIV-infected individuals undergoing systematic tuberculosis testing with rapid assays at initiation of antiretroviral treatment in Mozambique

BackgroundFew studies have evaluated the mortality rate in individuals with HIV initiating antiretroviral therapy (ART), undergoing screening with combined or repeated rapid tests for tuberculosis (TB). MethodsAll individuals with HIV starting ART, irrespective of the presence of TB-related symptoms, received two consecutive Xpert tests plus a rapid test for the detection of mycobacterial lipoarabinomannan in urine (LAM). Mortality was evaluated by Kaplan–Meier analysis using the log-rank test in univariate analyses and Cox regression models with time-dependent covariates in multivariate analyses. ResultsAmong 972 individuals screened with combined tests, 98 (10.1%) tested positive for TB with Xpert, LAM, or both. At the end of the study, 780 (80.2%) had completed 2 years of follow-up, 39 (4.0%) had died, and 153 (15.7%) were lost to follow-up. In the multivariate analyses, the factors significantly associated with mortality were missed ART (hazard ratio (HR) 7.05, 95% confidence interval (CI) 2.33–21.35), symptomatic HIV disease (WHO-HIV stage >1) (HR 3.31, 95% CI 1.28–8.54), and low CD4 count (<200/mm3) (HR 2.72, 95% CI 1.21–6.13), with no significant effect of TB status. In the subgroup of the 98 TB-positive individuals, only missed ART (HR 4.12, 95% CI 1.03–16.46) and missed anti-TB treatment (HR 9.25, 95% CI 2.65–32.28) were significantly associated with mortality. ConclusionsA low mortality rate was observed among individuals with HIV undergoing systematic testing for TB at initiation of ART. After adjusting for confounders, mortality was significantly associated with missed ART, advanced disease, and missed anti-TB treatment. These findings reinforce the need to promote early diagnosis of HIV and the adoption of screening strategies for TB that prevent presentation with severe disease.

Human Resource Time Use for Early Infant HIV Diagnosis: A Comparative Time‐Motion Study at Centralized and Point‐of‐Care Health Facilities in Zimbabwe

Research ObjectivePoint‐of‐care (POC) assays for early infant diagnosis of HIV (EID) increase access to testing, shorten time to results, and expedite initiation of antiretroviral therapy when compared with laboratory‐based (centralized) assays. However, there is a significant gap in our understanding of its human resource impact at the facility‐level. This study evaluated the human resource labor time associated with the use of EID platforms by facility‐based health workers (HWs).Study DesignUsing time‐motion methodology, we collected direct observation and self‐reported time‐use data on EID tasks performed by HWs at health facilities in Zimbabwe. Data collection occurred at three EID facility types in Zimbabwe—five POC hubs (test samples from the hub and lower‐volume, nearby facilities), nine POC spokes (lower‐volume), and eleven facilities that use centralized laboratories.EID activities were grouped into pre‐result (counseling, administrative, blood sampling, and preparation) and total EID time (counseling to result communication). Total EID time was observed in POC hub facilities. Since EID tests were not performed on‐site at facilities using centralized laboratories and POC spoke facilities, tasks related to logging and communicating results were not observed. Instead, direct observation data were complemented with HW surveys at those facilities.Mean difference comparisons between centralized and POC EID services were performed with a two‐sample t test with allowance for unequal variances. Bootstrapping with 10 000 replicates was used to estimate the bias‐corrected and accelerated 95% confidence intervals for each measure and difference in means test. To assess whether results were robust, group comparison was performed with two‐sided permutation tests with 10 000 replicates, with same inference to those from the bootstrapped two‐sample t tests. A P‐value of &lt;0.05 was considered statistically significant.Population StudiedFacility‐based health workers in Zimbabwe.Principal FindingsData collectors observed 30 EID processes and 30 HWs provided self‐reported time. Observed average total labor time per EID test at POC hubs was 28 minutes, 22 seconds (95% CI, 22:51‐35:48). HWs performed other tasks while the POC EID machine processed assays.Observed average pre‐result time (counseling to sample preparation) was 18 minutes, 6 seconds (95% CI, 13:00‐23:42) for POC compared with 27 minutes, 48 seconds (95% CI, 23:48‐32:50) for facilities using centralized laboratories. The mean difference of 9 minutes, 42 seconds (95% CI, 03:04‐16:18) was statistically significant. The major driver of this difference was the longer time to prepare dried blood spots (DBS) compared with POC assays.Self‐reported average labor time per negative EID was 49 minutes, 30 seconds (95% CI, 0:42:56‐0:57:08) for facilities using centralized laboratories compared with 53 minutes, 4 seconds (95% CI, 0:40:24‐1:04:44) for POC assays. The differences for self‐reported time were not statistically significant, and results were similar for positive EIDs.ConclusionsPOC EID did not incur significant additional facility‐based human resource time compared to centralized EID.Implications for Policy or PracticeThis study, combined with previously published data demonstrating that POC EID significantly improves timely ART initiation and is cost‐effective, furthers the evidence that POC EID is a feasible intervention for low‐resource contexts, where health facilities are short‐staffed.Primary Funding SourceUNITAID.

Trend and predictors for early infant diagnosis by PCR among HIV-exposed infants in Dar es Salaam region, Tanzania, 2014-2016

BACKGROUND&#x0D; Early infant diagnosis (EID) of HIV and timely initiation of antiretroviral therapy reduces morbidity and mortality in HIV-infected infants and children. Although the WHO had a global target for 2018 that 90% of HIV-exposed infants (HEI) should be tested by the age of 8 weeks, by 2015 only half were being tested. This study describes trends and predictors for HIV first testing in HEI in Dar es Salaam, Tanzania, from 2014 to 2016.&#x0D; METHODS&#x0D; We conducted a cross-sectional study of HEI attending HIV services using secondary data collected at health facilities and collated at the national level. We estimated odds ratios and 95% confidence intervals for factors affecting uptake of HIV testing.&#x0D; RESULTS&#x0D; Of 12,117 HEI, the proportion tested for HIV by age 8 weeks increased from 53.2% in 2014 to 69.2% in 2016; 2.3% were HIV-positive. Replacement feeding (aOR=2.94, 95% CI 2.31 – 3.74) and receiving nevirapine prophylaxis (aOR=1.55, 95% CI 1.28-1.88) were predictors for EID testing uptake. HEI born to mothers with WHO stage II (aOR=0.53, 95% CI 0.41 – 0.67), stage III (aOR=0.64, 95% CI; 0.52 – 0.79) and stage IV (aOR=0.58, 95% CI 0.34 – 0.99) were less likely to be tested than those born to mothers with WHO stage I disease progression.&#x0D; CONCLUSION&#x0D; There was an increasing trend in the uptake of HIV testing of infants at age 8 weeks during the study period. However, it is still below the global target. Efforts to promote EID testing are still needed.

Accelerating progress towards the elimination of mother-to-child transmission of HIV: a narrative review.

IntroductionFindings from biomedical, behavioural and implementation studies provide a rich foundation to guide programmatic efforts for the prevention of mother‐to‐child HIV transmission (PMTCT).MethodsWe summarized the current evidence base to support policy makers, programme managers, funding agencies and other stakeholders in designing and optimizing PMTCT programmes. We searched the scientific literature for PMTCT interventions in the era of universal antiretroviral therapy for pregnant and breastfeeding women (i.e. 2013 onward). Where evidence was sparse, relevant studies from the general HIV treatment literature or from prior eras of PMTCT programme implementation were also considered. Studies were organized into six categories: HIV prevention services for women, timely access to HIV testing, timely access to ART, programme retention and adherence support, timely engagement in antenatal care and services for infants at highest risk of HIV acquisition. These were mapped to specific missed opportunities identified by the UNAIDS Spectrum model and embedded in UNICEF operational guidance to optimize PMTCT services.Results and discussionFrom May to November 2019, we identified numerous promising, evidence‐based strategies that, properly tailored and adopted, could contribute to population reductions in vertical HIV transmission. These spanned the HIV and maternal and child health literature, emphasizing the importance of continued alignment and integration of services. We observed overlap between several intervention domains, suggesting potential for synergies and increased downstream impact. Common themes included integration of facility‐based healthcare; decentralization of health services from facilities to communities; and engagement of partners, peers and lay workers for social support. Approaches to ensure early HIV diagnosis and treatment prior to pregnancy would strengthen care across the maternal lifespan and should be promoted in the context of PMTCT.ConclusionsA wide range of effective strategies exist to improve PMTCT access, uptake and retention. Programmes should carefully consider, prioritize and plan those that are most appropriate for the local setting and best address existing gaps in PMTCT health services.

‘If the results are negative, they motivate us’. Experiences of early infant diagnosis of HIV and engagement in Option B+

ABSTRACT Few studies have explored the relationship between early infant diagnosis (EID) of HIV and mothers’ engagement in care under Option B+. We conducted in-depth interviews with 20 women who initiated antiretroviral therapy (ART) under Option B+ in rural South Africa to explore the interactions between EID and maternal care engagement. Drawing on practice theory, we identified themes relating to Option B+ care engagement and EID. Women’s practice of engagement with HIV care shaped their decision-making around EID. Mothers who disengaged from care during pregnancy were less inclined to utilise EID as they lacked information about its availability and benefits. For some mothers, tensions between wanting to breastfeed and perceptions that it could facilitate transmission led to repeated utilisation of EID as reassurance that the child remained negative. Some mothers used their child’s negative result as a proxy for their status, subsequently disengaging from care. For some participants, an HIV diagnosis of their infant and the subsequent double burden of treatment visits for themselves and their infant, contributed to their disengagement. Women’s care-seeking practices for themselves and their infants work in a symbiotic ecosystem and should be viewed interdependently to tailor interventions to improve EID uptake and Option B+ care engagement.