Managing HIV as a chronic disease: Using interactive data collection to improve clinical care

As South Africa and the rest of the developing world respond to the AIDS crisis, a critical task will be to develop scalable systems for sustainable and effective delivery of antiretroviral (ARV) drugs in a variety of resource-restricted settings. With the emergence, from national governments, the World Health Organization (WHO) and major international donors, of the political will and funding to support treatment programmes, it has become urgent that we consider how ARVs will be delivered. In this review, we consider how ARVs allow us to manage HIV/AIDS as a chronic disease, and the data systems that are required to support this approach to therapy. Southern African Journal of HIV Medicine Vol. 5(4) 2004: 7-1

Treatment And Prevention for female Sex workers in South Africa: protocol for the TAPS Demonstration Project.

INTRODUCTION: Updated guidelines from the WHO recommend antiretroviral treatment for adults with HIV at any CD4 count and daily oral pre-exposure prophylaxis (PrEP) for people at substantial risk of HIV infection. However, implementation challenges may hinder the ability of programmes to translate these recommendations into successful practice. This demonstration project is the first to integrate PrEP and immediate treatment (ITx) for female sex workers (FSWs) in South Africa to answer operational research questions. METHODS AND ANALYSIS: This is a prospective cohort study where the main outcome is retention at 12 months. The study population is recruited into two arms across two urban sites: (1) PrEP for HIV-negative FSWs (n=400) and (2) ITx for HIV-positive FSWs with CD4 greater than national guidelines (n=300). We investigate process and other health indicators, uptake and use of PrEP and ITx through qualitative research, and evaluate cost-effectiveness analysis combined with estimates of impact through epidemiological modelling. ETHICS AND DISSEMINATION: The Treatment And Prevention for female Sex workers in South Africa (TAPS) Project was designed as an implementation study before emtricitabine/tenofovir disoproxil fumarate was licenced as an indication for PrEP in South Africa. Therefore, clinical trial requirements for ethical and South African Medicines Control Council approvals were followed. Results will be disseminated to participants, local health officials and other stakeholders, as well as in peer-reviewed journals and at conferences

Healthcare Programmes for Truck Drivers in Sub-Saharan Africa: A Systematic Review and Meta-Analysis.

BACKGROUND: Truck drivers have unique health needs, and by virtue of their continuous travel, experience difficulty in accessing healthcare. Currently, planning for effective care is hindered by lack of knowledge about their health needs and about the impact of on-going programmes on this population's health outcomes. We reviewed healthcare programmes implemented for sub-Saharan African truck drivers, assessed the evaluation methods, and examined impact on health outcomes. METHODS: We searched scientific and institutional databases, and online search engines to include all publications describing a healthcare programme in sub-Saharan Africa where the main clients were truck drivers. We consulted experts and organisations working with mobile populations to identify unpublished reports. Forest plots of impact and outcome indicators with unadjusted risk ratios and 95% confidence intervals were created to map the impact of these programmes. We performed a subgroup analysis by type of indicator using a random-effects model to assess between-study heterogeneity. We conducted a sensitivity analysis to examine both the summary effect estimate chosen (risk difference vs. risk ratio) and model to summarise results (fixed vs. random effects). RESULTS: Thirty-seven publications describing 22 healthcare programmes across 30 countries were included from 5,599 unique records. All programmes had an HIV-prevention focus with only three expanding their services to cover conditions other primary healthcare services. Twelve programmes were evaluated and most evaluations assessed changes in input, output, and outcome indicators. Absence of comparison groups, preventing attribution of the effect observed to the programme and lack of biologically confirmed outcomes were the main limitations. Four programmes estimated a quantitative change in HIV prevalence or reported STI incidence, with mixed results, and one provided anecdotal evidence of changes in AIDS-related mortality and social norms. Most programmes showed positive changes in risk behaviours, knowledge, and attitudes. Our conclusions were robust in sensitivity analyses. CONCLUSION: Diverse healthcare programmes tailored to the needs of truck drivers implemented in 30 sub-Saharan African countries have shown potential benefits. However, information gaps about availability of services and their effects impede further planning and implementation of effective healthcare programmes for truck drivers

Uptake of health services among truck drivers in South Africa: analysis of routine data from nine roadside wellness centres.

BACKGROUND: Long-distance truck drivers are occupationally susceptible to poor health outcomes. Their patterns of healthcare utilisation and the suitability of healthcare services available to them are not well documented. We report on truck driver healthcare utilisation across South Africa and characterise the client population of the clinics serving them for future service development. METHODS: We analysed anonymised data routinely collected over a two-year period at nine Roadside Wellness Centres. Associations between services accessed and socio-demographic characteristics were assessed using univariable and multivariable logistic regression models. RESULTS: We recorded 16,688 visits by 13,252 individual truck drivers (average of 1.26 visits/person) who accessed 17,885 services for an average of 1.07 services/visit and 1.35 services/person. The mean age of truck drivers was 39 years. Sixty-seven percent reported being in stable relationships. The most accessed services were primary healthcare (PHC)(62%) followed by HIV (32%). Low proportions (≤6%) accessed STI,TB and malaria services. Most visits were characterised by only one service being accessed (93%, n = 15,523/16,688). Of the remaining 7% of visits, up to five services were accessed per visit and the combination of TB /HIV services in one visit remained extremely low (<1%, n = 14/16,688). Besides PHC services at the beginning of the reporting period, all service categories displayed similar seasonal utilisation trends(i.e. service utilisation peaked in the immediate few months post clinics opening and substantially decreased before holidays). Across all service categories, younger truck drivers, those with a stable partner currently, and those of South African origin were the main clinic attendees. Older truck drivers (≥40 years) were more likely to access TB and PHC services, yet less likely to access HIV and STI services. Those with stable partners were less likely to access STI and TB services but more likely to access malaria and PHC services. South African attendees were more likely to access PHC, while attendees from other nationalities were more likely to access HIV and malaria services. CONCLUSIONS: This utilisation analysis shows that tailored services assist in alleviating healthcare access challenges faced by truck drivers, but it underscores the importance of ensuring that service packages and clinics speak to truck drivers' needs in terms of services offered and clinic location

Improvements in the South African HIV care cascade: findings on 90-90-90 targets from successive population-representative surveys in North West Province.

IntroductionTo achieve epidemic control of HIV by 2030, countries aim to meet 90-90-90 targets to increase knowledge of HIV-positive status, initiation of antiretroviral therapy (ART) and viral suppression by 2020. We assessed the progress towards these targets from 2014 to 2016 in South Africa as expanded treatment policies were introduced using population-representative surveys.MethodsData were collected in January to March 2014 and August to November 2016 in Dr. Ruth Segomotsi Mompati District, North West Province. Each multi-stage cluster sample included 46 enumeration areas (EA), a target of 36 dwelling units (DU) per EA, and a single resident aged 18 to 49 per DU. Data collection included behavioural surveys, rapid HIV antibody testing and dried blood spot collection. We used weighted general linear regression to evaluate differences in the HIV care continuum over time.ResultsOverall, 1044 and 971 participants enrolled in 2014 and 2016 respectively with approximately 77% undergoing HIV testing. Despite increases in reported testing, known status among people living with HIV (PLHIV) remained similar at 68.7% (95% Confidence Interval (CI)&nbsp;=&nbsp;60.9-75.6) in 2014 and 72.8% (95% CI&nbsp;=&nbsp;63.6-80.4) in 2016. Men were consistently less likely than women to know their status. Among those with known status, PLHIV on ART increased significantly from 80.9% (95% CI&nbsp;=&nbsp;71.9-87.4) to 91.5% (95% CI&nbsp;=&nbsp;84.4-95.5). Viral suppression (&lt;5000 copies/mL using DBS) among those on ART increased significantly from 55.0% (95% CI&nbsp;=&nbsp;39.6-70.4) in 2014 to 81.4% (95% CI&nbsp;=&nbsp;72.0-90.8) in 2016. Among all PLHIV an estimated 72.0% (95% CI&nbsp;=&nbsp;63.8-80.1) of women and 45.8% (95% CI&nbsp;=&nbsp;27.0-64.7) of men achieved viral suppression by 2016.ConclusionsOver a period during which fixed-dose combination was introduced, ART eligibility expanded, and efforts to streamline treatment were implemented, major improvements in the second and third 90-90-90 targets were achieved. Achieving the first 90 target will require targeted and improved testing models for men

Efavirenz use during pregnancy and for women of child-bearing potential

BACKGROUND: Efavirenz is the preferred non-nucleoside reverse transcriptase inhibitor for first-line antiretroviral treatment in many countries. For women of childbearing potential, advantages of efavirenz are balanced by concerns that it is teratogenic. This paper reviews evidence of efavirenz teratogenicity and considers implications in common clinical scenarios. FINDINGS: Concerns of efavirenz-induced fetal effects stem from animal studies, although the predictive value of animal data for humans is unknown. Four retrospective cases of central nervous system birth defects in infants with first trimester exposure to efavirenz have been interpreted as being consistent with animal data. In a prospective pregnancy registry, which is subject to fewer potential biases, no increase was detected in overall risk of birth defects following exposure to efavirenz in the first-trimester. DISCUSSION: For women planning a pregnancy or not using contraception, efavirenz should be avoided if alternatives are available. According to WHO guidelines for resource-constrained settings, benefits of efavirenz are likely to outweigh risks for women using contraception. Women who become pregnant while receiving efavirenz often consider drug substitution or temporarily suspending treatment. Both options have substantial risks for maternal and fetal health which, we argue, appear unjustified after the critical period of organogenesis (3–8 weeks post-conception). Efavirenz-based triple regimens, initiated after the first trimester of pregnancy and discontinued after childbirth, are potentially an important alternative for reducing mother-to-child transmission in pregnant women who do not yet require antiretroviral treatment. CONCLUSION: Current recommendations for care for women who become pregnant while receiving efavirenz may need to be re-considered, particularly in settings with limited alternative drugs and laboratory monitoring. With current data limitations, additional adequately powered prospective studies are needed

HIV pre-exposure prophylaxis and early antiretroviral treatment among female sex workers in South Africa: Results from a prospective observational demonstration project.

BACKGROUND: Operational research is required to design delivery of pre-exposure prophylaxis (PrEP) and early antiretroviral treatment (ART). This paper presents the primary analysis of programmatic data, as well as demographic, behavioural, and clinical data, from the TAPS Demonstration Project, which offered both interventions to female sex workers (FSWs) at 2 urban clinic sites in South Africa. METHODS AND FINDINGS: The TAPS study was conducted between 30 March 2015 and 30 June 2017, with the enrolment period ending on 31 July 2016. TAPS was a prospective observational cohort study with 2 groups receiving interventions delivered in existing service settings: (1) PrEP as part of combination prevention for HIV-negative FSWs and (2) early ART for HIV-positive FSWs. The main outcome was programme retention at 12 months of follow-up. Of the 947 FSWs initially seen in clinic, 692 were HIV tested. HIV prevalence was 49%. Among those returning to clinic after HIV testing and clinical screening, 93% of the women who were HIV-negative were confirmed as clinically eligible for PrEP (n = 224/241), and 41% (n = 110/270) of the women who were HIV-positive had CD4 counts within National Department of Health ART initiation guidelines at assessment. Of the remaining women who were HIV-positive, 93% were eligible for early ART (n = 148/160). From those eligible, 98% (n = 219/224) and 94% (n = 139/148) took up PrEP and early ART, respectively. At baseline, a substantial fraction of women had a steady partner, worked in brothels, and were born in Zimbabwe. Of those enrolled, 22% on PrEP (n = 49/219) and 60% on early ART (n = 83/139) were seen at 12 months; we observed high rates of loss to follow-up: 71% (n = 156/219) and 30% (n = 42/139) in the PrEP and early ART groups, respectively. Little change over time was reported in consistent condom use or the number of sexual partners in the last 7 days, with high levels of consistent condom use with clients and low use with steady partners in both study groups. There were no seroconversions on PrEP and 7 virological failures on early ART among women remaining in the study. Reported adherence to PrEP varied over time between 70% and 85%, whereas over 90% of participants reported taking pills daily while on early ART. Data on provider-side costs were also collected and analysed. The total cost of service delivery was approximately US$126 for PrEP and US$406 for early ART per person-year. The main limitations of this study include the lack of a control group, which was not included due to ethical considerations; clinical study requirements imposed when PrEP was not approved through the regulatory system, which could have affected uptake; and the timing of the implementation of a national sex worker HIV programme, which could have also affected uptake and retention. CONCLUSIONS: PrEP and early ART services can be implemented within FSW routine services in high prevalence, urban settings. We observed good uptake for both PrEP and early ART; however, retention rates for PrEP were low. Retention rates for early ART were similar to retention rates for the current standard of care. While the cost of the interventions was higher than previously published, there is potential for cost reduction at scale. The TAPS Demonstration Project results provided the basis for the first government PrEP and early ART guidelines and the rollout of the national sex worker HIV programme in South Africa

Performance evaluation of the Pima™ point-of-care CD4 analyser using capillary blood sampling in field tests in South Africa

<p>Abstract</p> <p>Background</p> <p>Point-of-care CD4 testing can provide immediate CD4 reporting at HIV-testing sites. This study evaluated performance of capillary blood sampling using the point-of-care Pima™ CD4 device in representative primary health care clinics doing HIV testing.</p> <p>Methods</p> <p>Prior to testing, prescribed capillary-sampling and instrument training was undertaken by suppliers across all sites. Matching venous EDTA samples were drawn throughout for comparison to laboratory predicate methodology (PLG/CD4). In Phase I, Pima™ cartridges were pipette-filled with EDTA venous blood in the laboratory (N = 100). In Phase II (N = 77), Pima™ CD4 with capillary sampling was performed by a single operator in a hospital-based antenatal clinic. During subsequent field testing, Pima™ CD4 with capillary sampling was performed in primary health care clinics on HIV-positive patients by multiple attending nursing personnel in a rural clinic (Phase-IIIA, N = 96) and an inner-city clinic (Phase-IIIB, N = 139).</p> <p>Results</p> <p>Pima™ CD4 compared favourably to predicate/CD4 when cartridges were pipette-filled with venous blood (bias -17.3 ± STDev = 36.7 cells/mm³; precision-to-predicate %CV < 6%). Decreased precision of Pima™ CD4 to predicate/CD4 (varying from 17.6 to 28.8%SIM CV; mean bias = 37.9 ± STDev = 179.5 cells/mm³) was noted during field testing in the hospital antenatal clinic. In the rural clinic field-studies, unacceptable precision-to-predicate and positive bias was noted (mean 28.4%SIM CV; mean bias = +105.7 ± STDev = 225.4 cells/mm³). With additional proactive manufacturer support, reliable performance was noted in the subsequent inner-city clinic field study where acceptable precision-to-predicate (11%SIM CV) and less bias of Pima™ to predicate was shown (BA bias ~11 ± STDev = 69 cells/mm³).</p> <p>Conclusions</p> <p>Variable precision of Pima™ to predicate CD4 across study sites was attributable to variable capillary sampling. Poor precision was noted in the outlying primary health care clinic where the system is most likely to be used. Stringent attention to capillary blood collection technique is therefore imperative if technologies like Pima™ are used with capillary sampling at the POC. Pima™ CD4 analysis with venous blood was shown to be reproducible, but testing at the point of care exposes operators to biohazard risk related to uncapping vacutainer samples and pipetting of blood, and is best placed in smaller laboratories using established principles of Good Clinical Laboratory Practice. The development of capillary sampling quality control methods that assure reliable CD4 counts at the point of care are awaited.</p

Adrenocortical function in hospitalised patients with active pulmonary tuberculosis receiving a rifampicin-based regimen - a pilot study

Objective: To assess whether adrenocortical function was compromised in patients with active tuberculosis (TB) during the first 5 days of therapy with either a rifampicin-based or ciprofloxacin-based regimen.Design: Patients were randomised into two groups of 10 each. Adrenocortical function was compared in both groups by the measurement of biochemical indices, electrolytes, osmolality and pituitary-adrenocortical hormones. Adrenal reserve was assessed by intravenous 250 µg adrenocorticotropin hormone (ACTH) stimulation tests. Setting: Department of Medicine, Johannesburg Hospital. Subjects : Twenty hospitalised patients who were diagnosed with TB. Outcome measures: Respiratory rate, pulse rate and blood pressure were recorded, and urinary sodium and osmolality were measured. Serum ACTH, cortisol, dehydroepiandros-terone-sulphate (DHEA-S) and aldosterone were assayed.Results: None of the patients demonstrated biochemical evidence of overt adrenal insufficiency. There were no significant differences between the two groups before or during therapy for any biochemical indices, electrolytes, hormones or calculated osmolality. Mean basal cortisol concentrations were substantially elevated and DHEA-S levels were consistently subnormal, resulting in a high cortisol / DHEA-S ratio. In the ciprofloxacin group, cortisol responses to ACTH stimulation on day 1 were not significantly lower than on day 5. In the rifampicin group, cortisol concentrations decreased at each time point on day 5 compared with day 1 (p = 0.001). However, a significantly higher mean incremental rise from the basal cortisol concentration was measured on day 5 at 60 minutes (p = 0.04). In the entire cohort of 20 patients, 40% demonstrated an incremental cortisol rise of < 250 nmol/l after ACTH stimulation on day 1. Conclusions: Rifampicin did not additionally impair adrenocortical function during the initial period of therapy. The high cortisol / DHEA-S ratio might be of clinical relevance. Journal of Endocrinology, Metabolism and Diabetes of South Africa Vol. 11(1) 2006: 16-2