Background Community-based delivery of antiretroviral therapy (ART) for HIV, including ART initiation, clinical and laboratory monitoring, and refills, could reduce barriers to treatment and improve viral suppression, reducing the gap in access to care for individuals who have detectable HIV viral load, including men who are less likely than women to be virally suppressed. We aimed to test the effect of community-based ART delivery on viral suppression among people living with HIV not on ART. Methods We did a household-randomised, unblinded trial (DO ART) of delivery of ART in the community compared with the clinic in rural and peri-urban settings in KwaZulu-Natal, South Africa and the Sheema District, Uganda. After community-based HIV testing, people living with HIV were randomly assigned (1:1:1) with mobile phone software to community-based ART initiation with quarterly monitoring and ART refills through mobile vans; ART initiation at the clinic followed by mobile van monitoring and refills (hybrid approach); or standard clinic ART initiation and refills. The primary outcome was HIV viral suppression at 12 months. If the difference in viral suppression was not superior between study groups, an a-priori test for non-inferiority was done to test for a relative risk (RR) of more than 0•95. The cost per person virally suppressed was a co-primary outcome of the study. This study is registered with ClinicalTrials.gov, NCT02929992.
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Background
We hypothesized that community-based HIV testing with counselor support and point-of-care CD4 count testing would increase uptake of antiretroviral therapy (ART) and male circumcision.
Methods
We conducted a randomized study of linkage strategies following community-based HIV testing in rural South Africa and Uganda. HIV-positive persons were randomized to 1) lay counselor follow-up home visits, lay counselor clinic linkage facilitation, or standard clinic referral; and then to either 2) point-of-care CD4 testing, or referral for CD4. HIV-negative uncircumcised men who could receive secure text messages were randomized to text message reminders, lay counselor visits, or referral. The primary outcomes were viral suppression at 9 months in HIV-positive persons and uptake of male circumcision by HIV-negative, uncircumcised men at 3 months. The study was registered at ClinicalTrials.gov (NCT02038582).
Findings
Between June 2013 and February 2015, 15,332 participants were tested; 1,325 HIV-positive persons and 750 HIV-negative uncircumcised men were randomized to linkage strategies. Among HIV-positive persons, overall clinic linkage was 93% (1,218/1,303) but ART initiation was only 37% (488/1,303). The proportion of persons who were virally suppressed ranged from 47%-52% (214/422 in the clinic referral arm, 219/419 in the clinic facilitation arm, and 202/431 in the lay counselor follow-up arm; p=0.668 and p=0.273, for the clinic facilitation and lay counselor follow-up arms, respectively, compared with clinic referral). There was no difference in viral suppression at 9 months by study arm. In the male circumcision clinic referral (standard of care) arm, 62/224 men (28%) were circumcised, compared to 137/284 (48%) in the text message reminder arm (RR=1.72, 95% CI 1.36-2.17) and 106/226 (47%) in the lay counselor follow-up arm (RR=1.67, 95% CI 1.29-2.14).
Interpretation
All the community-based strategies achieved very high rates of linkage of HIV positive persons to HIV clinics, approximately one-third of whom initiated ART, and approximately half were virally suppressed by 9 months. Clinic barriers to ART initiation must be addressed in future strategies to increase knowledge of HIV serostatus and linkage to HIV care. Uptake of male circumcision was almost two-fold higher among men who received text message reminders or lay counselor visits.
BackgroundPneumonia and diarrhea are leading causes of death for children under five (U5). It is challenging to estimate the total number of deaths and cause-specific mortality fractions. Two major efforts, one led by the Institute for Health Metrics and Evaluation (IHME) and the other led by the World Health Organization (WHO)/Child Health Epidemiology Reference Group (CHERG) created estimates for the burden of disease due to these two syndromes, yet their estimates differed greatly for 2010.MethodsThis paper discusses three main drivers of the differences: data sources, data processing, and covariates used for modelling. The paper discusses differences in the model assumptions for etiology-specific estimates and presents recommendations for improving future models.ResultsIHME’s Global Burden of Disease (GBD) 2010 study estimated 6.8 million U5 deaths compared to 7.6 million U5 deaths from CHERG. The proportional differences between the pneumonia and diarrhea burden estimates from the two groups are much larger; GBD 2010 estimated 0.847 million and CHERG estimated 1.396 million due to pneumonia. Compared to CHERG, GBD 2010 used broader inclusion criteria for verbal autopsy and vital registration data. GBD 2010 and CHERG used different data processing procedures and therefore attributed the causes of neonatal death differently. The major difference in pneumonia etiologies modeling approach was the inclusion of observational study data; GBD 2010 included observational studies. CHERG relied on vaccine efficacy studies.DiscussionGreater transparency in modeling methods and more timely access to data sources are needed. In October 2013, the Bill & Melinda Gates Foundation (BMGF) hosted an expert meeting to examine possible approaches for better estimation. The group recommended examining the impact of data by systematically excluding sources in their models. GBD 2.0 will use a counterfactual approach for estimating mortality from pathogens due to specific etiologies to overcome bias of the methods used in GBD 2010 going forward.Electronic supplementary materialThe online version of this article (doi:10.1186/s12879-014-0728-4) contains supplementary material, which is available to authorized users.
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