Sisonke phase 3B open-label study: Lessons learnt for national and global vaccination scale-up during epidemics.

Sisonke is a multicentre, open-label, single-arm phase 3B vaccine implementation study of healthcare workers (HCWs) in South Africa, with prospective surveillance for 2 years. The primary endpoint is the rate of severe COVID­19, including hospitalisations and deaths. The  Sisonke study enrolled and vaccinated participants nationally at potential vaccination roll-out sites between 17 February and 26 May 2021. After May 2021, additional HCWs were vaccinated as part of a sub-study at selected clinical research sites. We discuss 10 lessons learnt to strengthen national and global vaccination strategies:(i) consistently advocate for vaccination to reduce public hesitancy; (ii) an electronic vaccination data system (EVDS) is critical; (iii) facilitate access to a choice of vaccination sites, such as religious and community centres, schools, shopping malls and drive-through centres; (iv) let digitally literate people help elderly and marginalised people to register for vaccination; (v) develop clear 'how to' guides for vaccine storage, pharmacy staff and vaccinators; (vi) leverage instant messaging platforms, such as WhatsApp, for quick communication among staff at vaccination centres; (vii) safety is paramount - rapid health assessments are needed at vaccination centres to identify people at high risk of serious adverse events, including anaphylaxis or thrombosis with thrombocytopenia syndrome. Be transparent about adverse events and contextualise vaccination benefits, while acknowledging the small risks; (viii) provide real-time, responsive support to vaccinees post vaccination and implement an accessible national vaccine adverse events surveillance system; (ix) develop efficient systems to monitor and investigate COVID­19 breakthrough infections; and (x) flexibility and teamwork are essential in vaccination centres across national, provincial and district levels and between public and private sectors.

Quality and turnaround times of viral load monitoring under prevention of mother-to-child transmission of HIV Option B+ in six South African districts with a high antenatal HIV burden.

BACKGROUND: Barriers to monitoring maternal HIV viral load (VL) and achieving 90% viral suppression during pregnancy and breastfeeding still need to be understood in South Africa (SA). OBJECTIVES: To measure quality of VL care and turnaround times (TATs) for returning VL results to women enrolled in the prevention of mother-to-child transmission of HIV (PMTCT) programme in primary healthcare facilities. METHODS: Data were obtained from a 2018 cross-sectional evaluation of the PMTCT Option B+ programme in six SA districts with high antenatal and infant HIV prevalence. Quality of VL care was measured as the proportion of clients reporting that results were explained to them. TATs for VL results were calculated using dates abstracted from four to five randomly selected facility-based client records to report overall facility 'short TAT' (≥80% of records with TAT ≤7 days). Logistical regression and logit-based risk difference statistics were used. RESULTS: Achieving overall short TAT was uncommon. Only 50% of facilities in one rural district, zero in one urban metro district and 9 - 38% in other districts had short TAT. The significant difference between districts was influenced by the duration of keeping results in facilities after receipt from the laboratory. Expected quality of VL care received ranged between 66% and 85%. Client-related factors significantly associated with low quality of care, observed in two urban districts and one rural district, included lower education, recent initiation of antiretroviral treatment and experiencing barriers to clinic visits. Experiencing clinic visit barriers was also negatively associated with short TATs. CONCLUSIONS: We demonstrate above-average quality of care and delayed return of results to PMTCT clients. Context-specific interventions are needed to shorten TATs.

Leveraging the Road to Health booklet as a unique patient identifier to monitor the prevention of mother-to-child transmission programme.

BACKGROUND: Currently there is no unique patient identification system in the South African public health sector. Therefore, routine laboratory data cannot effectively be de-duplicated, thereby hampering surveillance of laboratory-diagnosed diseases such as mother-to-child transmission of HIV. OBJECTIVES: To determine the uptake of Road to Health booklet (RTHB) identifiers at HIV polymerase chain reaction (PCR) birth test and describe their performance in linking follow-up test results in the early infant diagnosis programme. METHODS: Between May 2016 and May 2017, Tshwane District Clinical Services implemented a unique patient identifier pilot project in which a sticker-page of unique, readable, barcoded patient identifiers was incorporated in the patient-retained immunisation record (the RTHB) before distribution. Uptake of RTHB identifiers at birth was calculated as the proportion of HIV PCR tests in infants aged <6 days registered with an RTHB identifier over the total number of registered HIV PCR tests. Descriptive analysis of demographic details was performed among infants with two registered HIV PCR tests linked by the RTHB identifier, and performance of the National Health Laboratory Service Corporate Data Warehouse (NHLS CDW)-linking algorithm in matching RTHB-linked results was calculated using a 2 × 2 table. RESULTS: A total of 5 309 HIV PCR birth tests registered with an RTHB identifier were extracted from the NHLS CDW over the 13-month period of the pilot project. The number of registered RTHB identifiers increased from 24 (2% of birth PCR tests) in May 2016, peaking at 728 (56% of birth PCR tests) in May 2017. Among infants with a registered RTHB identifier at birth, 635 (12%) had a subsequent linked HIV PCR test, as indicated by the same RTHB number registered for a later specimen. Demographic details at the time of birth and subsequent PCR test were compared, demonstrating that <4% of infants had exact matches for name, surname, date of birth and sex; 74% of birth tests had variations such as 'born to' or 'baby of ' in place of a first name; surnames matched exactly in 61% of cases; 18% (n=116) of infants had both tests performed at the same facility, of which only 27% (n=31) had the same patient folder number on both test results. CONCLUSIONS: Leveraging RTHBs as unique patient identifiers, even if used temporarily until linkage to other future national unique identifiers, promises to be an effective scalable approach to laboratory-based surveillance, facilitating healthcare provider access to all test results from birth.

Free formula milk for infants of HIV-infected women: blessing or curse?

There is vigorous controversy around whether HIV-infected women in developing countries should choose formula or breastfeeding for their infants. Formula eliminates HIV transmission but incurs risk of increased mortality, whereas breastfeeding has multiple benefits but entails risk of HIV transmission. International guidelines are available but need to be strengthened. This commentary summarizes data on the scale and rate of mother-to-child transmission (MTCT) of HIV through breastfeeding, and the hazards and benefits of breast- and formula-feeding. The case against providing free or subsidized formula to HIV-infected mothers is based on the following: it exacerbates disadvantages of formula feeding; compromises free choice; targets beneficiaries erroneously; creates a false perception of endorsement by health workers; compromises breastfeeding; results in disclosure of HIV status; ignores hidden costs of preparation of formula; increases mixed breastfeeding, which is an unsatisfactory method for all women; requires organization and management of programmes that are complicated and costly; and finally increases the 'spill-over' effect into the normal breastfeeding population. Recommendations to minimize these drawbacks include use of affordable antiretrovirals to reduce MTCT; investments in high-quality, widely available HIV counselling; support for choice of feeding; and exclusive breastfeeding for those who choose to breastfeed.