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Differentiated antiretroviral therapy (ART) delivery models, in which patients are provided with care relevant to their current status (e.g., newly initiating, stable on treatment, or unstable on treatment) has become an essential part of patient-centered health systems. In 2015, the South African government implemented Chronic Disease Adherence Guidelines (AGLs), which involved five interventions: Fast Track Initiation Counseling for newly initiating patients, Enhanced Adherence Counseling for patients with an unsuppressed viral load, Early Tracing of patients who miss visits, and Adherence Clubs (ACs) and Decentralized Medication Delivery (DMD) for stable patients. We evaluated two of these interventions in 24 South African facilities: ACs, in which patients meet in groups outside usual clinic procedures and receive medication; and DMD, in which patients pick up their medication outside usual pharmacy queues. We compared those participating in ACs or receiving DMD at intervention sites to those eligible for ACs or DMD at control sites. Outcomes were retention and sustained viral suppression (<400 copies/mL) 12 months after AC or DMD enrollment (or comparable time for controls). 12 facilities were randomly allocated to intervention and 12 to control arms in four provinces (Gauteng, North West, Limpopo, and KwaZulu Natal). We calculated adjusted risk differences (aRDs) with cluster adjustment using generalized estimating equations (GEEs) using difference in differences (DiD) with patients eligible for ACs/DMD prior to implementation (Jan 1, 2015) for comparison. For DMD, randomization was not preserved, and the analysis was treated as observational. For ACs, 275 intervention and 294 control patients were enrolled; 72% of patients were female, 61% were aged 30-49 years, and median CD4 count at ART initiation was 268 cells/μL. AC patients had higher 1-year retention (89.5% versus 81.6%, aRD: 8.3%; 95% CI: 1.1% to 15.6%) and comparable sustained 1-year viral suppression (<400 copies/mL any time ≤ 18 months) (80.0% versus 79.6%, aRD: 3.8%; 95% CI: -6.9% to 14.4%). Retention associations were apparently stronger for men than women (men RD: 13.1%, 95% CI: 0.3% to 23.5%; women RD: 6.0%, 95% CI: -0.9% to 12.9%). For DMD, 232 intervention and 346 control patients were enrolled; 71% of patients were female, 65% were aged 30-49 years, and median CD4 count at ART initiation was 270 cells/μL. DMD patients had apparently lower retention (81.5% versus 87.2%, aRD: -5.9%; 95% CI: -12.5% to 0.8%) and comparable viral suppression versus standard of care (77.2% versus 74.3%, aRD: -1.0%; 95% CI: -12.2% to 10.1%), though in both cases, our findings were imprecise. We also noted apparently increased viral suppression among men (RD: 11.1%; 95% CI: -3.4% to 25.5%). The main study limitations were missing data and lack of randomization in the DMD analysis. In this study, we found comparable DMD outcomes versus standard of care at facilities, a benefit for retention of patients in care with ACs, and apparent benefits in terms of retention (for AC patients) and sustained viral suppression (for DMD patients) among men. This suggests the importance of alternative service delivery models for men and of community-based strategies to decongest primary healthcare facilities. Because these strategies also reduce patient inconvenience and decongest clinics, comparable outcomes are a potential success. The cost of all five AGL interventions and possible effects on reducing clinic congestion should be investigated. NCT02536768.

Reflecting on progress and challenges in meeting global human immunodeficiency virus (HIV) targets is often done ahead of World AIDS Day. This article reflects on progress and the continuing challenges in meeting targets in South Africa (SA). To review policy and implementation related progress and continuing challenges towards eliminating HIV as a public health threat by 2030. Policy analysis and review of modeling data from Thembisa 4.3. South Africa has made significant progress in the adoption of policies with two exceptions. While there are gaps in reaching the 90-90-90 implementation targets, progress has been made in the past decade. While progress has been made in the past decade towards the global targets, much work remains to ensure that HIV transmission is curtailed and those that require treatment are initiated on treatment and are virally suppressed.

Background Globally low- and middle-income countries are investing in community health worker (CHW) programs. These programs are viewed as fundamental to ensuring universal health coverage for all. Where CHW programs are doing what they should be doing and doing it adequately, they should make a difference in population health outcomes, reflecting health system changes. However, there are not many studies exploring the contributions and effectiveness of large-scale, comprehensive community health worker programs on health system performance. Methods This study takes place in the Ekurhuleni health district, in urban South Africa. A before (pre) and after (post) intervention study (quasi-experimental) using routine health service variables (secondary data) from district clinics over nine years was conducted. Performance of intervention clinics with community health worker teams that had more than 60% population coverage were compared to similar control clinics that had no teams or teams with less than 30% coverage. Results Both groups of clinics generally improved over time for routine health service variables for maternal, child health, infectious diseases, and cervical cancer programmes. Over nine years, intervention clinics showed more improved performance, statistically significant, in six health variables while controls improved in four. But importantly, intervention clinics improved proportionately better pre to post in seven of the nine (78%) variables studied compared to controls, demonstrating reduced diarrhoeal disease and pneumonia in children, better Vitamin A coverage, fewer severely malnourished children, better testing for HIV, and better screening for Tuberculosis and cervical cancer. Illustrating the comprehensive range of services provided by CHWs, the seven routine health service variables represented maternal, child health, infectious and non-communicable diseases. We also observed less uncontrolled hypertensive and diabetics in intervention clinics compared to control clinics. Conclusion Large-scale, sustained and comprehensive community health worker programs adequately covering populations contributed to improved urban district health system performance in Ekurhuleni, demonstrating their effectiveness. This was explored through improvements in health system performance over time. These findings, using routine health service variables, have policy implications for financial and other resource allocations in health districts in low- and middle-income countries.

Introduction The proven effectiveness of injectable cabotegravir (CAB‐LA) is higher than that of any other HIV prevention intervention ever trialled or implemented, surpassing medical male circumcision, condoms and combination antiretroviral treatment. Based on our own analyses and experience with the South African oral pre‐exposure prophylaxis (PrEP) programme, we review the supply and demand side factors that would need to be in place for a successful rollout of CAB‐LA, and delineate lessons for the launch of other long‐acting and extended delivery (LAED) antiretroviral drugs. Discussion On the supply side, CAB‐LA will have to be offered at a price that makes the drug affordable and cost‐effective to low‐ and middle‐income countries, especially those with high HIV prevalence. An important factor in lowering prices is a guaranteed market volume, which in turn necessitates the involvement of large funders, such as PEPFAR and the Global Fund, and a fairly rapid scale‐up of the drug. Such a scale‐up would have to involve speedy regulatory approval and WHO pre‐qualification, swift integration of CAB‐LA into national guidelines and planning for large enough manufacturing capacity, including the enabling of local manufacture. On the demand side, existing demand for HIV prevention products has to be harnessed and additional demand created, which will be aided by designing CAB‐LA programmes at the primary healthcare or community level, and involving non‐traditional outlets, such as private pharmacies and doctors’ practices. Conclusions CAB‐LA could be the game changer for HIV prevention that we have been hoping for, and serve as a useful pilot for other LAEDs. A successful rollout would involve building markets of a guaranteed size; lowering the drug's price to a level possibly below the cost of production, while also lowering the cost of production altogether; harnessing, creating and sustaining demand for the product over the long term, wherever possible, in national programmes rather than single demonstration sites; and establishing and maintaining manufacturing capacity and supply chains. For this, all parties have to work together—including originator and generic manufacturers, donor organizations and other large funders, and the governments of low‐ and middle‐income countries, in particular those with high HIV prevalence.

We estimated the incremental cost and impact on diagnosis and treatment uptake of national rollout of Xpert MTB/RIF technology (Xpert) for the diagnosis of pulmonary TB above the cost of current guidelines for the years 2011 to 2016 in South Africa. We parameterised a population-level decision model with data from national-level TB databases (n = 199,511) and implementation studies. The model follows cohorts of TB suspects from diagnosis to treatment under current diagnostic guidelines or an algorithm that includes Xpert. Assumptions include the number of TB suspects, symptom prevalence of 5.5%, annual suspect growth rate of 10%, and 2010 public-sector salaries and drug and service delivery costs. Xpert test costs are based on data from an in-country pilot evaluation and assumptions about when global volumes allowing cartridge discounts will be reached. At full scale, Xpert will increase the number of TB cases diagnosed per year by 30%-37% and the number of MDR-TB cases diagnosed by 69%-71%. It will diagnose 81% of patients after the first visit, compared to 46% currently. The cost of TB diagnosis per suspect will increase by 55% to USD 60-61 and the cost of diagnosis and treatment per TB case treated by 8% to USD 797-873. The incremental capital cost of the Xpert scale-up will be USD 22 million and the incremental recurrent cost USD 287-316 million over six years. Xpert will increase both the number of TB cases diagnosed and treated and the cost of TB diagnosis. These results do not include savings due to reduced transmission of TB as a result of earlier diagnosis and treatment initiation.

Mother-to-child transmission of HIV (MTCT) depends on the timing of HIV infection. We estimated HIV-seroconversion during pregnancy (HSP) after having a HIV-negative result antenatally, and its contribution to early MTCT in South Africa (SA). Between August 2011 and March 2012, we recruited a nationally representative sample of mother-infant pairs with infants aged 4-to-8 weeks from 578 health facilities. Data collection included mother interviews, child health-card reviews, and infant dried-blood-spots sample (iDBS). iDBS were tested for HIV antibodies and HIV-deoxyribonucleic-acid (HIV-DNA). HSP was defined as maternal self-report of an HIV-negative test during this pregnancy, no documented use of antiretroviral drugs and a matched HIV sero-positive iDBS. We used 20 imputations from a uniform distribution for time from reported antenatal HIV-negative result to delivery to estimate time of HSP. Early MTCT was defined based on detection of HIV-DNA in iDBS. Estimates were adjusted for clustering, nonresponse, and weighted by SA's 2011 live-births. Of 9802 mother-infant pairs, 2738 iDBS were HIV sero-positive, including 212 HSP, resulting in a nationally weighted estimate of 3.3% HSP (95% Confidence Interval: 2.8%-3.8%). Median time of HIV-seroconversion was 32.8weeks gestation;28.3% (19.7%- 36.9%) estimated to be >36 weeks. Early MTCT was 10.7% for HSP (6.2%-16.8%) vs. 2.2% (1.7%-2.8%) for mothers with known HIV-positive status. Although they represent 2.2% of all mothers and 6.7% of HIV-infected mothers, HSP accounted for 26% of early MTCT. Multivariable analysis indicated the highest risk for HSP was among women who knew the baby's father was HIV-infected (adjusted-hazard ratio (aHR) 4.71; 1.49-14.99), or who had been screened for tuberculosis (aHR 1.82; 1.43-2.32). HSP risk is high and contributes significantly to early MTCT. Identification of HSP by repeat-testing at 32 weeks gestation, during labor, 6 weeks postpartum, in tuberculosis-exposed women, and in discordant couples might reduce MTCT.

The World Health Organization has produced clear guidelines for the prevention of mother-to-child transmission (PMTCT) of the human immunodeficiency virus (HIV). However, ensuring that all PMTCT programme components are implemented to a high quality in all facilities presents challenges. Although South Africa initiated its PMTCT programme in 2002, later than most other countries, political support has increased since 2008. Operational research has received more attention and objective data have been used more effectively. In 2010, around 30% of all pregnant women in South Africa were HIV-positive and half of all deaths in children younger than 5 years were associated with the virus. Between 2008 and 2011, the estimated proportion of HIV-exposed infants younger than 2 months who underwent routine polymerase chain reaction (PCR) tests to detect early HIV transmission increased from 36.6% to 70.4%. The estimated HIV transmission rate decreased from 9.6% to 2.8%. Population-based surveys in 2010 and 2011 reported transmission rates of 3.5% and 2.7%, respectively. CRITICAL ACTIONS FOR IMPROVING PROGRAMME OUTCOMES INCLUDED: ensuring rapid implementation of changes in PMTCT policy at the field level through training and guideline dissemination; ensuring good coordination with technical partners, such as international health agencies and international and local nongovernmental organizations; and making use of data and indicators on all aspects of the PMTCT programme. Enabling health-care staff at primary care facilities to initiate antiretroviral therapy and expanding laboratory services for measuring CD4+ T-cell counts and for PCR testing were also helpful.

There has been an appreciable increase in the number of people in Africa with metabolic syndrome and Type 2 diabetes (T2DM) in recent years as a result of a number of factors. Factors include lifestyle changes, urbanisation, and the growing consumption of processed foods coupled with increasing levels of obesity. Currently there are 19 million adults in Africa with diabetes, mainly T2DM (95%), estimated to grow to 47 million people by 2045 unless controlled. This has a considerable impact on morbidity, mortality and costs in the region. There are a number of issues to address to reduce the impact of T2DM including improving detection rates and current access to services alongside addressing issues of adherence to prescribed medicines. There are also high rates of co-morbidities with infectious diseases such as HIV and tuberculosis in patients in Africa with T2DM that require attention. Document ongoing activities across Africa to improve the care of patients with T2DM especially around issues of identification, access, and adherence to changing lifestyles and prescribed medicines. In addition, discussing potential ways forward to improve the care of patients with T2DM based on ongoing activities and experiences including addressing key issues associated with co-morbidities with infectious diseases. Contextualise the findings from a wide range of publications including internet based publications of national approaches coupled with input from senior level government, academic and other professionals from across Africa to provide future guidance. A number of African countries are actively instigating programmes to improve the care of patients with T2DM starting with improved diagnosis. This recognises the growing burden of non-communicable diseases across Africa, which has been neglected in the past. Planned activities include programmes to improve detection rates and address key issues with diet and lifestyle changes, alongside improving monitoring of care and activities to enhance adherence to prescribed medicines. In addition, addressing potential complexities involving diabetes patients with infectious disease co-morbidities. It is too early to fully assess the impact of such activities. There are a number of ongoing activities across Africa to improve the management of patients with diabetes including co-morbidities. However, more needs to be done considering the high and growing burden of T2DM in Africa. Ongoing research will help further benefit resource allocation and subsequent care.

Innovative mobile health (mHealth) interventions can improve maternal knowledge, thereby supporting national efforts to reduce preventable maternal and child mortality in South Africa. Studies have documented a potential role for mobile video content to support perinatal health messaging, enhance maternal satisfaction, and overcome literacy barriers. Short, animated storytelling (SAS) is an innovative, emerging approach to mHealth messaging. We aimed to measure the effect of SAS videos on maternal knowledge and user satisfaction for mothers enrolled in antenatal care programs at 2 public health facilities in the Tshwane District of South Africa. We used a randomized controlled trial with a nested evaluation of user satisfaction. Participants were randomized 1:1 into Standard-of-Care (SOC) Control, and SAS Intervention groups. The intervention videos were delivered through WhatsApp, and 1 month later, participants responded to telephone surveys assessing their knowledge. The intervention group then participated in a nested evaluation of user satisfaction. We surveyed 204 participants. Of them, 49.5% (101/204) were aged between 25 and 34 years. Almost all participants self-identified as Black, with the majority (190/204, 93.2%) having completed secondary school. The mean overall knowledge score was 21.92/28. We observed a slight increase of 0.28 (95% uncertainty interval [UI] -0.58 to 1.16) in the overall knowledge score in the intervention arm. We found that those with secondary education or above scored higher than those with only primary education by 2.24 (95% UI 0.76-4.01). Participants aged 35 years or older also scored higher than the youngest age group (18-24 years) by 1.83 (95% CI 0.39-3.33). Finally, the nested user satisfaction evaluation revealed high maternal satisfaction (4.71/5) with the SAS video series. While the SAS videos resulted in high user satisfaction, measured knowledge gains were small within a participant population that was already receiving perinatal health messages through antenatal clinics. The higher knowledge scores observed in older participants with higher education levels suggest that boosting maternal knowledge in younger mothers with lower education levels should continue to be a public health priority in South Africa. Given the high maternal satisfaction among the SAS video-users in this study, policy makers should consider integrating similar approaches into existing, broad-reaching perinatal health programs, such as MomConnect, to boost satisfaction and potentially enhance maternal engagement. While previous studies have shown the promise of animated video health education, most of this research has been conducted in high-income countries. More research in underresourced settings is urgently needed, especially as access to mobile technology increases in the Global South. Future studies should explore the effect of SAS videos on maternal knowledge in hard-to-reach populations with limited access to antenatal care, although real-world logistical challenges persist when implementing studies in underresourced South African populations. Pan African Clinical Trials Registry PACTR202203673222680; https://tinyurl.com/362cpuny.

Remarkable progress has been made towards halving of maternal deaths and deaths of children aged 1–59 months, although the task is incomplete. Newborn deaths and stillbirths were largely invisible in the Millennium Development Goals, and have continued to fall between maternal and child health efforts, with much slower reduction. This Series and the Every Newborn Action Plan outline mortality goals for newborn babies (ten or fewer per 1000 livebirths) and stillbirths (ten or fewer per 1000 total births) by 2035, aligning with A Promise Renewed target for children and the vision of Every Woman Every Child. To focus political attention and improve performance, goals for newborn babies and stillbirths must be recognised in the post-2015 framework, with corresponding accountability mechanisms. The four previous papers in this Every Newborn Series show the potential for a triple return on investment around the time of birth: averting maternal and newborn deaths and preventing stillbirths. Beyond survival, being counted and optimum nutrition and development is a human right for all children, including those with disabilities. Improved human capital brings economic productivity. Efforts to reach every woman and every newborn baby, close gaps in coverage, and improve equity and quality for antenatal, intrapartum, and postnatal care, especially in the poorest countries and for underserved populations, need urgent attention. We have prioritised what needs to be done differently on the basis of learning from the past decade about what has worked, and what has not. Needed now are four most important shifts: (1) intensification of political attention and leadership; (2) promotion of parent voice, supporting women, families, and communities to speak up for their newborn babies and to challenge social norms that accept these deaths as inevitable; (3) investment for effect on mortality outcome as well as harmonisation of funding; (4) implementation at scale, with particular attention to increasing of health worker numbers and skills with attention to high-quality childbirth care for newborn babies as well as mothers and children; and (5) evaluation, tracking coverage of priority interventions and packages of care with clear accountability to accelerate progress and reach the poorest groups. The Every Newborn Action Plan provides an evidence-based roadmap towards care for every woman, and a healthy start for every newborn baby, with a right to be counted, survive, and thrive wherever they are born.