Dataset Information

Multisite evaluation of point of care CD4 testing in Papua New Guinea.

ABSTRACT: Laboratory-based CD4 monitoring of HIV patients presents challenges in resource limited settings (RLS) including frequent machine breakdown, poor engineering support and limited cold chain and specimen transport logistics. This study assessed the performance of two CD4 tests designed for use in RLS; the Dynal assay and the Alere PIMA test (PIMA). Accuracy of Dynal and PIMA using venous blood was assessed in a centralised laboratory by comparison to BD FACSCount (BD FACS). Dynal had a mean bias of -50.35 cells/µl (r(2) = 0.973, p<0.0001, n = 101) and PIMA -22.43 cells/µl (r(2)= 0.964, p<0.0001, n = 139) compared to BD FACS. Similar results were observed for PIMA operated by clinicians in one urban (n = 117) and two rural clinics (n = 98). Using internal control beads, PIMA precision was 10.34% CV (low bead mean 214.24 cells/µl) and 8.29% (high bead mean 920.73 cells/µl) and similar %CV results were observed external quality assurance (EQA) and replicate patient samples. Dynal did not perform using EQA and no internal controls are supplied by the manufacturer, however duplicate testing of samples resulted in r(2) = 0.961, p<0.0001, mean bias = -1.44 cells/µl. Using the cut-off of 350 cells/µl compared to BD FACS, PIMA had a sensitivity of 88.85% and specificity of 98.71% and Dynal 88.61% and 100%. A total of 0.44% (2/452) of patient samples were misclassified as "no treat" and 7.30% (33/452) "treat" using PIMA whereas with Dynal 8.91% (9/101) as "treat" and 0% as "no treat". In our setting PIMA was found to be accurate, precise and user-friendly in both laboratory and clinic settings. Dynal performed well in initial centralized laboratory evaluation, however lacks requisite quality control measures, and was technically more difficult to use, making it less suitable for use at lower tiered laboratories.

SUBMITTER: Malagun M

PROVIDER: S-EPMC4245096 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:IntroductionLeft untreated, sexually transmitted and genital infections (henceforth STIs) in pregnancy can lead to serious adverse outcomes for mother and child. Papua New Guinea (PNG) has among the highest prevalence of curable STIs including syphilis, chlamydia, gonorrhoea, trichomoniasis and bacterial vaginosis, and high neonatal mortality rates. Diagnosis and treatment of these STIs in PNG rely on syndromic management. Advances in STI diagnostics through point-of-care (PoC) testing using GeneXpert technology hold promise for resource-constrained countries such as PNG. This paper describes the planned economic evaluation of a cluster-randomised cross-over trial comparing antenatal PoC testing and immediate treatment of curable STIs with standard antenatal care in two provinces in PNG.Methods and analysisCost-effectiveness of the PoC intervention compared with standard antenatal care will be assessed prospectively over the trial period (2017-2021) from societal and provider perspectives. Incremental cost-effectiveness ratios will be calculated for the primary health outcome, a composite measure of the proportion of either preterm birth and/or low birth weight; for life years saved; for disability-adjusted life years averted; and for non-health benefits (financial risk protection and improved health equity). Scenario analyses will be conducted to identify scale-up options, and budget impact analysis will be undertaken to understand short-term financial impacts of intervention adoption on the national budget. Deterministic and probabilistic sensitivity analysis will be conducted to account for uncertainty in key model inputs.Ethics and disseminationThis study has ethical approval from the Institutional Review Board of the PNG Institute of Medical Research; the Medical Research Advisory Committee of the PNG National Department of Health; the Human Research Ethics Committee of the University of New South Wales; and the Research Ethics Committee of the London School of Hygiene and Tropical Medicine. Findings will be disseminated through national stakeholder meetings, conferences, peer-reviewed publications and policy briefs.Trial registration numberISRCTN37134032.

Project description:BackgroundThe importance of engaging men in maternal and child health programs is well recognised internationally. In Papua New Guinea (PNG), men's involvement in maternal and child health services remains limited and barriers and enablers to involving fathers in antenatal care have not been well studied. The purpose of this paper is to explore attitudes to expectant fathers participating in antenatal care, and to identify barriers and enablers to men's participation in antenatal care with their pregnant partner in PNG.MethodsTwenty-eight focus group discussions were conducted with purposively selected pregnant women, expectant fathers, older men and older women across four provinces of PNG. Fourteen key informant interviews were also conducted with health workers. Qualitative data generated were analysed thematically.ResultsWhile some men accompany their pregnant partners to the antenatal clinic and wait outside, very few men participate in antenatal consultations. Factors supporting fathers' participation in antenatal consultations included feelings of shared responsibility for the unborn child, concern for the mother's or baby's health, the child being a first child, friendly health workers, and male health workers. Sociocultural norms and taboos were the most significant barrier to fathers' participation in antenatal care, contributing to men feeling ashamed or embarrassed to attend clinic with their partner. Other barriers to men's participation included fear of HIV or sexually transmitted infection testing, lack of separate waiting spaces for men, rude treatment by health workers, and being in a polygamous relationship. Building community awareness of the benefits of fathers participating in maternal and child health service, inviting fathers to attend antenatal care if their pregnant partner would like them to, and ensuring clinic spaces and staff are welcoming to men were strategies suggested for increasing fathers' participation in antenatal care.ConclusionThis study identified significant sociocultural and health service barriers to expectant fathers' participation in antenatal care in PNG. Our findings highlight the need to address these barriers - through health staff training and support, changes to health facility layout and community awareness raising - so that couples in PNG can access the benefits of men's participation in antenatal care.

Project description:BackgroundSince 2004, the Global Fund-supported National Malaria Control Programme of Papua New Guinea (PNG) has been implementing country-wide free long-lasting insecticidal net (LLIN) distribution campaigns. In 2009, after the first distribution, only 32.5% of the population used a LLIN, mainly due to an insufficient number of nets available. This study investigated changes in mosquito net ownership and use following the continued free distribution of LLINs across PNG.MethodsFive villages from each province and 30 households from each village were randomly sampled in a country-wide household survey in 2010/11. A structured questionnaire administered to household heads recorded information on mosquito net ownership and use alongside household characteristics. Revised ownership and access indicators were applied in the analysis to reveal coverage gaps.ResultsThe survey covered 1,996 households in 77 villages. Ownership of at least one LLIN was reported by 81.8% of households, compared to 64.6% in 2009 (P?=?0.002). Sufficient LLINs to cover all household members (one net per two people) were found in 41.3% of the households (21.4% in 2009, P?<?0.001). Of all household members, 61.4% had access to a LLIN within their household (44.3% in 2009 P?=?0.002), and 48.3% slept under a LLIN (32.5% in 2009, P?=?0.001). LLIN use in children under five years amounted to 58.2%, compared to 39.5% in 2009 (P?<?0.001). Significant regional differences in coverage and changes over time were observed. A recent LLIN distribution was a key determinant of LLIN ownership (adj. OR?=?3.46) while families in high quality houses would frequently not own a LLIN (adj. OR?=?0.09). Residents were more likely to use LLINs than household guests (OR?=?2.04).ConclusionsRepeated LLIN distribution has led to significant increases in mosquito net ownership and use with few regional exceptions. Additional nets are required in areas where access is low, while major efforts are required to encourage the use of existing nets in region where access is high but use remains low. Complementary vector control approaches should also be considered in such settings.

Dataset Information

Multisite evaluation of point of care CD4 testing in Papua New Guinea.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets