Boostability after single-visit pre-exposure prophylaxis with rabies vaccine: a randomised controlled non-inferiority trial.

BACKGROUND: After rabies pre-exposure prophylaxis (PrEP) vaccination, scarcely available rabies immunoglobulins are not required for post-exposure prophylaxis (PEP). However, PrEP is not sufficiently accessible as it is cost-intensive and time-intensive. This study investigates whether rabies PrEP schedules can be shortened to one visit, removing some of these barriers. METHODS: In a block-randomised (2:2:2:1) controlled, multicentre non-inferiority trial, healthy adult travellers (aged 18-50 years and >50 years) were randomly assigned to (A) single-visit intramuscular (1·0 mL); (B) single-visit intradermal (0·2 mL); (C) standard two-visit intramuscular (1·0 mL; day 0 and 7) PrEP; or (D) no rabies vaccination. 6 months later, participants received simulated intramuscular rabies PEP (1·0 mL; day 0 and 3). Rabies virus neutralising antibody (RVNA) concentrations were measured repeatedly. The primary outcome was the fold increase in geometric mean RVNA concentrations between day 0 and 7 after simulated PEP for all participants. The two main comparisons of this primary outcome are between the standard two-visit schedule and the one-visit intramuscular schedule, and between the standard two-visit schedule and the one-visit intradermal schedule. The non-inferiority margin was 0·67. This study is registered with EudraCT, 2017-000089-31. FINDINGS: Between May 16, 2018, and March 26, 2020, 288 healthy adult travellers were randomly assigned and 214 participants were evaluated for the primary outcome. Single-visit intramuscular rabies PrEP induced an anamnestic antibody response non-inferior compared with the two-visit intramuscular schedule; single-visit intradermal PrEP did not. The fold increases in the single-visit intramuscular and the single-visit intradermal schedule were 2·32 (95% CI [1·43-3·77]) and 1·11 (0·66-1·87) times as high as the fold increase in the standard schedule, respectively. No vaccine-related serious adverse events were observed. Adverse events related to vaccination were mostly mild. INTERPRETATION: Single intramuscular rabies vaccination can effectively prime travellers (aged 18-50 years), and potentially other populations, and could replace current standard two-visit rabies vaccination as PrEP. FUNDING: ZonMW. TRANSLATION: For the Dutch translation of the abstract see Supplementary Materials section.

'We are the advocates for the babies' - understanding interactions between patients and health care providers during the prevention of mother-to-child transmission of HIV in South Africa: a qualitative study.

Background: HIV/AIDS has had a significant impact on maternal and child health in South Africa. It is thus of vital importance to implement interventions to prevent mother-to-child transmission of HIV (PMTCT) as early as possible during pregnancy. Negative interactions between patients and health care providers (HCPs) can be an important barrier to antenatal care, PMTCT use and PMTCT adherence. Research about respectful maternity care has focused more on the patient perspective. We therefore compared the patient and HCP perspectives and reflected on how interactions between HCPs and patients can be improved. Objective: To obtain insights into the attitudes of HCPs in the context of HIV and PMTCT-related care, by studying patient and HCP perceptions of their interactions, in a peri-urban hospital setting in Gauteng province, South Africa. Methods: A qualitative study was conducted in a public tertiary-level hospital. Fourteen semi-structured in-depth interviews were conducted with nurses and doctors in the antenatal clinic and postnatal ward. Thirty-one semi-structured in-depth interviews and two focus group discussions were conducted with HIV positive and negative women on the postnatal ward. Results: HCPs experienced a difficult work environment due to a high workload. This was combined with frustrations when they felt that patients did not take responsibility for their own or their child's health. They were motivated by the need to help the child. Patients experienced judging comments by HCPs especially towards younger, older and foreign women. They expressed fear to ask questions and self-blame, which in some cases delayed health care seeking. No discrimination or isolation of HIV infected patients was reported by patients and HCPs. Conclusion: We hypothesize that more humane working conditions for obstetric HCPs and a caring, personalised approach to patient management can improve patient-provider interactions and access to respectful care. These are critical to preventing mother-to-child transmission of HIV.