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Background: Management of co-morbidities among persons living with HIV is an emerging priority, which may require additional medication over and above life-long antiretroviral therapy (ART). We explored factors associated with adherence to the trial drug among children and adolescents with perinatally acquired HIV taking antiretroviral therapy (ART) in the Bronchopulmonary Function in Response to Azithromycin Treatment for Chronic Lung Disease in HIV-Infected Children (BREATHE) trial., Methods: The BREATHE trial recruited 6-19 year olds with perinatally acquired HIV and co-morbid chronic lung disease as measured by FEV1. This two-site trial was individually randomised (1:1), double-blind and placebo-controlled. Participants received a once-weekly weight-based dose of 1-5 tablets of azithromycin (AZM: 250mg) or placebo, taken orally. We used pharmacy dispensing records and count of returned pills to measure adherence to study medication. Logistic regression was used to explore factors associated with adherence coverage. Poisson regression with Lexis expansion for time was used to explore whether adherence modified the effect of azithromycin on the incidence of acute respiratory exacerbation, a secondary outcome of the trial. Trial registration: ClinicalTrials.gov NCT02426112., Results: The 347 participants (median age 15.3, 51% male) consumed 14,622 doses of study medication over 16,220 person-weeks under study. Adherence was higher for those randomised to AZM (73.4%) than placebo (68.4%) and declined over the 48 weeks of the study (Score test for trend <0.02). Those with unsuppressed HIV viral load at baseline had 2.08 (95% CI: 1.19, 3.63) times the odds of non-adherence than those with viral suppression. Differences were also observed between trial sites., Conclusion: The majority of children and adolescents tolerated the addition of a once-weekly dose of medication to their pill burden. Barriers in adhering to treatment for co-morbid conditions are likely common to barriers in adhering to ART. Control of co-morbidities will therefore present additional challenges in HIV care., Competing Interests: The authors have declared that no competing interests exist.

Background: Blood collected in conventional EDTA tubes requires laboratory analysis within 48 hours to provide valid CD4 cell count results. This restricts access to HIV care for patients from rural areas in resource-constraint settings due to sample transportation problems. Stabilization Tubes with extended storage duration have been developed but not yet evaluated comprehensively., Objective: To investigate stability of absolute CD4 cell count measurement of samples in BD Vacutainer CD4 Stabilization Tubes over the course of 30 days., Methods: This was a laboratory-based method comparison study conducted at a rural district hospital in Beitbridge, Zimbabwe. Whole peripheral blood from 88 HIV positive adults was drawn into BD Vacutainer CD4 Stabilization Tubes and re-tested 1, 2, 3, 5, 7, 14 and 30 days after collection on BD FacsCount and Partec Cyflow cytometers in parallel. Absolute CD4 cell levels were compared to results from paired samples in EDTA tubes analysed on BD FacsCount at the day of sample collection (references methodology). Bland-Altman analysis based on ratios of the median CD4 counts was used, with acceptable variation ranges for Limits of Agreements of +/-20%., Results: Differences in ratios of the medians remained below 10% until day 21 on BD FacsCount and until day 5 on Partec Cyflow. Variations of Limits of Agreement were beyond 20% after day 1 on both cytometers. Specimen quality decreased steadily after day 5, with only 68% and 40% of samples yielding results on BD FacsCount and Partec Cyflow at day 21, respectively., Conclusions: We do not recommend the use of BD Vacutainer CD4 Stabilization Tubes for absolute CD4 cell count measurement on BD FacsCount or Partec Cyflow due to large variation of results and decay of specimen quality. Alternative technologies for enhanced CD4 testing in settings with limited laboratory and sample transportation capacity still need to be developed.

Background: CD4 cell count measurement remains an important diagnostic tool for HIV care in developing countries. Insufficient laboratory capacity in rural Sub-Saharan Africa is frequently mentioned but data on the impact at an individual patient level are lacking. Urban-rural discrepancies in CD4 testing have not been quantified to date. Such evidence is crucial for public health planning and to justify new yet more expensive diagnostic procedures that could circumvent access constraints in rural areas., Objective: To compare CD4 testing among rural and urban HIV patients during the first year of treatment., Methods: Records from 2,145 HIV positive adult patients from a Médecins sans Frontières (Doctors without Borders) HIV project in Beitbridge, Zimbabwe, during 2011 and 2012 were used for a retrospective cohort analysis. Covariate-adjusted risk ratios were calculated to estimate the effects of area of residence on CD4 testing at treatment initiation, six and 12 months among rural and urban patients., Findings: While the proportion of HIV patients returning for medical consultations at six and 12 months decreased at a similar rate in both patient groups, CD4 testing during consultations dropped to 21% and 8% for urban, and 2% and 1% for rural patients at six and 12 months, respectively. Risk ratios for missing CD4 testing were 0.8 (95% CI 0.7-0.9), 9.2 (95% CI 5.5-15.3), and 7.6 (95% 3.7-17.1) comparing rural versus urban patients at treatment initiation, six and 12 months, respectively., Conclusions: CD4 testing was low overall, and particularly poor in rural patients. Difficulties with specimen transportation were probably a major factor underlying this difference and requires new diagnostic approaches. Our findings point to severe health system constraints in providing CD4 testing overall that need to be addressed if effective monitoring of HIV patients is to be achieved, whether by alternative CD4 diagnostics or newly-recommended routine viral load testing.