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Nonvirologic algorithms for predicting HIV infection among HIV-exposed infants younger than 12 weeks of age.

ABSTRACT: Early initiation of antiretroviral therapy has been shown to reduce mortality among perinatally HIV-infected infants, but availability of virologic testing remains limited in many settings.We collected cross-sectional data from mother-infant pairs in three primary care clinics in Lusaka, Zambia, to develop predictive models for HIV infection among infants younger than 12 weeks of age. We evaluated algorithm performance for all possible combinations of selected characteristics using an iterative approach. In primary analysis, we identified the model with the highest combined sensitivity and specificity.Between July 2009 and May 2011, 822 eligible HIV-infected mothers and their HIV-exposed infants were enrolled; of these, 44 (5.4%) infants had HIV diagnosed. We evaluated 382,155,260 different characteristic combinations for predicting infant HIV infection. The algorithm with the highest combined sensitivity and specificity required 5 of the following 7 characteristic thresholds: infant CD8 percentage >22; infant CD4 percentage ?44; infant weight-for-age Z score ?0; infant CD4 ?1600 cells/µL; infant CD8 >2200 cells/µL; maternal CD4 ?600 cells/µL; and mother not currently using antiretroviral therapy for HIV treatment. This combination had a sensitivity of 90.3%, specificity of 78.4%, positive predictive value of 22.4%, negative predictive value of 99.2% and area under the curve of 0.844.Predicting HIV infection in HIV-exposed infants in this age group is difficult using clinical and immunologic characteristics. Expansion of polymerase chain reaction capacity in resource-limited settings remains urgently needed.

SUBMITTER: Chi BH

PROVIDER: S-EPMC3552126 | biostudies-literature | 2013 Feb

REPOSITORIES: biostudies-literature

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Nonvirologic algorithms for predicting HIV infection among HIV-exposed infants younger than 12 weeks of age.

Chi Benjamin H BH Limbada Mohammed I MI Giganti Mark J MJ Li Michelle S MS Bweupe Maximillian M Musonda Patrick P Bubala Peggy P Mubiana-Mbewe Mwangelwa M Chintu Namwinga T NT Bolton-Moore Carolyn C Stringer Jeffrey S A JS

The Pediatric infectious disease journal 20130201 2

<h4>Background</h4>Early initiation of antiretroviral therapy has been shown to reduce mortality among perinatally HIV-infected infants, but availability of virologic testing remains limited in many settings.<h4>Methods</h4>We collected cross-sectional data from mother-infant pairs in three primary care clinics in Lusaka, Zambia, to develop predictive models for HIV infection among infants younger than 12 weeks of age. We evaluated algorithm performance for all possible combinations of selected ...[more]

PMID: 22935865

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Project description:Adherence to an antiretroviral regimen is imperative for treatment success in both HIV infected adults and children. Likewise, adherence to antiretroviral prophylaxis is critical in HIV prevention. Studies on pediatric adherence are limited, particularly the prophylactic use of antiretroviral drugs and treatment adherence in very young infants. The HIV Prevention Trials Network (HPTN) 046 study (Clinical Trial Registration NCT00074412) determined the safety and efficacy of an extended regimen of nevirapine suspension in infants born to HIV-1 infected women for the prevention of vertical HIV transmission during breastfeeding. As per protocol, adherence to nevirapine prophylaxis was measured by maternal verbal reports. In addition, the pharmacy assessed the unused returned suspension. The aim of this sub-study was to determine the reliability of maternal verbal reports in measuring adherence to antiretroviral prophylaxis in infants in the first 6 weeks of life and evaluating the unused returned nevirapine as an alternative method of measuring adherence.Maternal verbal reports and pharmacy returns indicative of "missed < 2 doses" were evaluated against a plasma nevirapine concentration of >100 ng/ml in a subgroup of infants at 2, 5 and 6 weeks of age. Plasma nevirapine concentration of >100 ng/ml was used as a marker of adherence (10 times the in vitro IC50 against HIV).Adherence was 87.7% (maternal verbal report) and 71.3% (unused returned medication), as compared to 85.6% by plasma nevirapine concentration. Evaluated against plasma nevirapine concentration <100 ng/ml, the sensitivity and specificity of maternal verbal reports to detect a missed dose in the last 3 days were 75% and 78% (p = 0.03) respectively. Overall, among infants who were classified as adherent based on missed doses by maternal verbal reports and unused returned medication, 88.4% and 87.4% of infants attained a nevirapine concentration above 100 ng/ml respectively.Maternal verbal reports are a reliable measure of adherence to infant antiretroviral prophylaxis in the first 6 weeks of life and could be useful in assessing adherence to antiretroviral treatment in infants younger than 6 weeks. In the absence of resources or expertise to determine plasma drug concentration, we would recommend random assessments of unused returned medication.

Project description:BackgroundDespite the availability of individual-level data of infants accessing HIV DNA-PCR testing service, there has been little in-depth analysis of such data. Therefore, we describe trends in risk of HIV infection among Malawi's HIV-exposed infants (HEI) with DNA-PCR HIV test result from 2013 to 2020.MethodsThis is an implementation study using routinely collected patient-level HIV DNA-PCR test result data extracted from the national Laboratory Management Information System database managed by the Department of HIV/AIDS between 1 January 2013 and 30 June 2020. We calculated frequencies, proportions and odds ratio (OR) with their associated 95% CI. We performed a random-effects logistic regression to determine the risk factors associated with HIV infection in infants, controlling for the spatial autocorrelation between districts and adjusting for other variables.ResultsWe evaluated 255 229 HEI across 750 facilities in 28 districts. The HIV DNA-PCR test was performed within 2 months in 57% of the children. The overall HIV prevalence among all tested HEI between 2013 and 2020 was 7.2% (95% CI 7.1% to 7.3%). We observed a decreasing trend in the proportion of HEI that tested HIV positive from 7.0% (95% CI 6.6% to 7.4%) in 2013 to 5.7% (95% CI 5.4% to 5.9%) in 2015 followed by an increase to 9.9% (95% CI 9.6% to 10.2%) in 2017 and thereafter a decreasing trend between 2017 (i.e. 9.72% (95%CI: 9.43-10.01)) and 2020 (i.e. 3.86% (95%CI: 3.34-4.37)). The HIV prevalence increased by age of the HEI. There was spatial heterogeneity of HIV prevalence between districts of Malawi. The prevalence of HIV was higher among the HEI from the Northern region of Malawi.ConclusionThe main findings of the study are that the DNA test is performed within 2 months only in 57% of the children, that the decreasing trend of HIV prevalence among HEI observed up to 2015 was followed by an increase up to 2017 and a decrease afterwards, and that the risk of HIV infection increased with age at HIV testing. We summarised spatial and temporal trends of risk of HIV infection among HEI in Malawi between 2013 and 2020. There is need to ensure that all the HEI are enrolled in HIV care by 8 weeks of age in order to further reduce the risk of HIV in this population.

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Nonvirologic algorithms for predicting HIV infection among HIV-exposed infants younger than 12 weeks of age.

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Nonvirologic algorithms for predicting HIV infection among HIV-exposed infants younger than 12 weeks of age.

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