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1.
J Glob Health ; 12: 04004, 2022.
Article in English | MEDLINE | ID: mdl-35136596

ABSTRACT

BACKGROUND: South Africa, with the highest burden of HIV infection globally, has made huge strides in its HIV/ART programme, but AIDS deaths have not decreased proportionally to ART uptake. Advanced HIV disease (CD4 < 200 cells/mm3) persists, and CD4 count testing is being overlooked since universal test-and-treat was implemented. Point-of-care CD4 testing could address this gap and assure differentiated care to these vulnerable patients with low CD4 counts. METHODS: A time randomised implementation trial was conducted, enrolling 603 HIV positive non-ART, not pregnant patients at a primary health care clinic in Durban, South Africa. Weeks were randomised to either point-of-care CD4 testing (n = 305 patients) or standard-of-care central laboratory CD4 testing (n = 298 patients) to assess the proportion initiating ART at 3 months. Cox regression, with robust standard errors adjusting for clustering by week, were used to assess the relationship between treatment initiation and arm. RESULTS: Among the 578 (299 point-of-care and 279 standard-of-care) patients eligible for analysis, there was no significant difference in the number of eligible patients initiating ART within 3 months in the point-of-care (73%) and the standard-of-care (68%) groups (P = 0.112). The time-to-treat analysis was not significantly different in patients with CD4 counts of 201-500 cells/mm3 which could have been due to appointment scheduling to cope with the large burden of cases. However, in patients with advanced HIV disease (CD4 < 200cells/mm3) 65% more patients started ART earlier in the point-of-care group (HR 1.65 (95% confidence interval (CI) = 0.99-2.75; P = 0.052) compared to the standard-of-care group. CONCLUSIONS: Point-of-care testing decreased time-to-treatment in those with advanced HIV disease. With universal test and treat for HIV, rollout of simple point-of-care CD4 testing would ensure early diagnosis of advanced HIV disease and facilitate differentiated care for these vulnerable patients as per the World Health Organisation 2020 target product profile for point-of-care CD4 testing. TRIAL REGISTRATION: ISRCTN14220457.


Subject(s)
Anti-HIV Agents , HIV Infections , Anti-HIV Agents/therapeutic use , CD4 Lymphocyte Count , Female , HIV Infections/drug therapy , HIV Infections/therapy , Humans , Point-of-Care Systems , Pregnancy , South Africa
2.
Diagnostics (Basel) ; 10(2)2020 Feb 01.
Article in English | MEDLINE | ID: mdl-32024166

ABSTRACT

BACKGROUND: The high burden of disease in South Africa presents challenges to public health services. Point-of-care (POC) technologies have the potential to address these gaps and improve healthcare systems. This study ascertained the acceptability and impact of POC CD4 testing on patients' health and clinical management. METHODS: We conducted a qualitative survey study with patients (n = 642) and healthcare providers (n = 13) at the Lancers Road (experienced POC) and Chesterville (non-experienced POC) primary healthcare (PHC) clinics from September 2015 to June 2016. RESULTS: Patients (99%) at Lancers and Chesterville PHCs were positive about POC CD4 testing, identifying benefits: No loss/delay of test results (6.4%), cost/time saving (19.5%), and no anxiety (5.1%), and 58.2% were ready to initiate treatment. Significantly more patients at Chesterville than Lancers Road PHC felt POC would provide rapid clinical decision making (64.7% vs. 48.1%; p < 0.0001) and better clinic accessibility (40.4% vs. 24.7%; p < 0.0001) respectively. Healthcare providers thought same-day CD4 results would impact: Clinical management (46.2%), patient readiness (46.2%), and adherence (23.0%), and would reduce follow-up visits (7.7%), while 38.5% were concerned that further tests and training (15.4%) were required before antiretroviral therapy (ART) initiation. CONCLUSION: The high acceptability of POC CD4 testing and the immediate health, structural, and clinical management benefits necessitates POC implementation studies.

3.
BMJ Open ; 7(9): e017507, 2017 Sep 27.
Article in English | MEDLINE | ID: mdl-28963304

ABSTRACT

INTRODUCTION: Achieving the Joint United Nations Programme on HIV and AIDS 90-90-90 targets requires models of HIV care that expand antiretroviral therapy (ART) coverage without overburdening health systems. Point-of-care (POC) viral load (VL) testing has the potential to efficiently monitor ART treatment, while enrolled nurses may be able to provide safe and cost-effective chronic care for stable patients with HIV. This study aims to demonstrate whether POC VL testing combined with task shifting to enrolled nurses is non-inferior and cost-effective compared with laboratory-based VL monitoring and standard HIV care. METHODS AND ANALYSIS: The STREAM (Simplifying HIV TREAtment and Monitoring) study is an open-label, non-inferiority, randomised controlled implementation trial. HIV-positive adults, clinically stable at 6 months after ART initiation, will be recruited in a large urban clinic in South Africa. Approximately 396 participants will be randomised 1:1 to receive POC HIV VL monitoring and potential task shifting to enrolled nurses, versus laboratory VL monitoring and standard South African HIV care. Initial clinic follow-up will be 2-monthly in both arms, with VL testing at enrolment, 6 months and 12 months. At 6 months (1 year after ART initiation), stable participants in both arms will qualify for a differentiated care model involving decentralised ART pickup at community-based pharmacies. The primary outcome is retention in care and virological suppression at 12 months from enrolment. Secondary outcomes include time to appropriate entry into the decentralised ART delivery programme, costs per virologically suppressed patient and cost-effectiveness of the intervention compared with standard care. Findings will inform the scale up of VL testing and differentiated care in HIV-endemic resource-limited settings. ETHICS AND DISSEMINATION: Ethical approval has been granted by the University of KwaZulu-Natal Biomedical Research Ethics Committee (BFC296/16) and University of Washington Institutional Review Board (STUDY00001466). Results will be presented at international conferences and published in academic peer-reviewed journals. TRIAL REGISTRATION: NCT03066128; Pre-results.


Subject(s)
HIV Infections/diagnosis , Point-of-Care Testing , Viral Load/methods , Anti-Retroviral Agents/therapeutic use , CD4 Lymphocyte Count , Cost-Benefit Analysis , HIV Infections/drug therapy , Humans , Logistic Models , Multivariate Analysis , Research Design , South Africa
4.
BMJ Open ; 6(7): e010656, 2016 07 12.
Article in English | MEDLINE | ID: mdl-27406638

ABSTRACT

INTRODUCTION: No randomised controlled trial (RCT) has examined the efficacy of cotrimoxazole (CTX) prophylaxis in HIV-exposed uninfected (HEU) infants during the breastfeeding period, in this new era of effective prevention of mother-to-child transmission (PMTCT) prophylaxis. The efficacy of CTX prophylaxis has presently been demonstrated only in HIV-infected children. The absence of proven benefits in HEU breastfed infants associated with infectious diseases justifies an RCT as proposed. Herewith lies the rationale for conducting the proposed study. METHODS: A partially blinded RCT is proposed to evaluate the efficacy of CTX prophylaxis administered from 6 weeks of age to HEU infants receiving a PMTCT regimen. A non-inferiority design will be used, randomising 1298 infants to receive CTX or not to receive CTX. Participants will be reviewed at the following time points: 6 weeks (enrolment and randomisation), 10 weeks, 14 weeks, 4 months and monthly thereafter until 12 months of age. They will be evaluated for anthropometric growth, interval illness, CTX adherence, signs and symptoms of study drug toxicity, concomitant medication use, breastfeeding status and HIV infection status. The study will compare the incidence of grade 3 and grade 4 common childhood illnesses (focusing on pneumonia and diarrhoea) and all-cause mortality until 12 months of age. In a subset of participants, we will compare grade 3 and grade 4 haemoglobin and alanine aminotransferase results as well as investigate gut integrity. ETHICS AND DISSEMINATION: The study has ethical approval from the University of KwaZulu-Natal Biomedical Research Ethics Committee (BFC212/13). TRIAL REGISTRATION NUMBERS: PACTR201311000621110 and DOH-27-0614-4728; Pre-results.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Breast Feeding , HIV Infections/prevention & control , Infant Health , Infant Mortality , Infectious Disease Transmission, Vertical/prevention & control , Trimethoprim, Sulfamethoxazole Drug Combination/therapeutic use , Anti-Bacterial Agents/adverse effects , Anti-HIV Agents/adverse effects , Anti-HIV Agents/therapeutic use , Cause of Death , Diarrhea/epidemiology , Female , Growth Disorders/epidemiology , HIV , HIV Infections/epidemiology , HIV Infections/transmission , HIV Infections/virology , Humans , Incidence , Infant , Male , Morbidity , Mothers , Pneumonia/epidemiology , Pregnancy , Pregnancy Complications, Infectious/virology , Research Design , Trimethoprim, Sulfamethoxazole Drug Combination/adverse effects
5.
South Afr J HIV Med ; 17(1): 444, 2016.
Article in English | MEDLINE | ID: mdl-29568605

ABSTRACT

INTRODUCTION: Limited information is available on the usefulness of the PIMA™ analyser in predicting antiretroviral treatment eligibility and outcome in a primary healthcare clinic setting in disadvantaged communities in KwaZulu-Natal, South Africa. MATERIALS AND METHODS: The study was conducted under the eThekwini Health Unit, Durban, KwaZulu-Natal. Comparison of the enumeration of CD4+ T-cells in 268 patients using the PIMA™ analyser and the predicate National Health Laboratory Services (NHLS) was undertaken during January to July 2013. Bland-Altman analysis to calculate bias and limits of agreement, precision and levels of clinical misclassification at various CD4+ T-cell count thresholds was performed. RESULTS: There was high precision of the PIMA™ control bead cartridges with low and normal CD4+ T-cell counts using three different PIMA™ analysers (%CV < 5). Under World Health Organization (WHO) guidelines (≤ 500 cells/mm3), the sensitivity of the PIMA™ analyser was 94%, specificity 78% and positive predictive value (PPV) 95%. There were 24 (9%) misclassifications, of which 13 were false-negative in whom the mean bias was 149 CD4+ T-cells/mm3. Most (87%) patients returned for their CD4 test result but only 67% (110/164) of those eligible (≤ 350 cells/mm3) were initiated on antiretroviral therapy (ART) with a time to treatment of 49 days (interquartile range [IQR], 42-64 days). CONCLUSION: There was adequate agreement between PIMA™ analyser and predicate NHLS CD4+ T-cell count enumeration (≤ 500 cells/mm3) in adult HIV-positive individuals. The high PPV, sensitivity and acceptable specificity of the PIMA™ analyser technology lend it as a reliable tool in predicting eligibility and rapid linkage to care in ART programmes.

6.
Article in English | AIM (Africa) | ID: biblio-1272210

ABSTRACT

Introduction: Limited information is available on the usefulness of the PIMATM analyser in predicting antiretroviral treatment eligibility and outcome in a primary healthcare clinic setting in disadvantaged communities in KwaZulu-Natal; South Africa.Materials and methods: The study was conducted under the eThekwini Health Unit; Durban; KwaZulu-Natal. Comparison of the enumeration of CD4+ T-cells in 268 patients using the PIMATM analyser and the predicate National Health Laboratory Services (NHLS) was undertaken during January to July 2013. Bland-Altman analysis to calculate bias and limits of agreement; precision and levels of clinical misclassification at various CD4+ T-cell count thresholds was performed.Results: There was high precision of the PIMATM control bead cartridges with low and normal CD4+ T-cell counts using three different PIMATM analysers (%CV 5). Under World Health Organization (WHO) guidelines (


Subject(s)
Anti-Retroviral Agents , HIV Infections/therapy , Potassium Iodide
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