Safety of AZD1222 COVID-19 vaccine and low Incidence of SARS-CoV-2 infection in Botswana following ChAdOx1(AZD1222) vaccination : a single-arm open-label interventional study – final study results

SUPPLEMENTARY FIGURE S1: Binding antibody responses to SARS-CoV-2 spike (Anti-S) following vaccination with ChAdOx1 (AZD1222).SUPPLEMENTARY FIGURE S2: SAR-COV-2 variant Dynamics (Fig S2-A) and cumulative number of cases by COVID-19 zones (showing study sites 1 to 5).SUPPLEMENTARY TABLE S1: Line listing of adverse events of special interest.SUPPLEMENTARY TABLE S2: Line listing of serious adverse events.SUPPLEMENTARY TABLE S3: Incidence (per 1,000 participant-years) of AE, localised and systemic adverse events by prior COVID infection status.SUPPLEMENTARY TABLE S4: Sociodemographic characteristics of participants enrolled in the immunogenicity subcohort of the ChAdOx1(AZD1222) study.SUPPLEMENTARY TABLE S5: geometric mean concentrations of Anti-Nucleocapsid antibody levels by dose and time (days) since first-dose.SUPPLEMENTARY TABLE S6: geometric mean concentrations of Anti-Spike antibody levels by dose and time (days) since first-dose.OBJECTIVES : We report the final analysis of the single-arm open-label study evaluating the safety and COVID-19 incidence after AZD1222 vaccination in Botswana conducted between September 2021 and August 2022. METHODS : The study included three groups of adults (>18 years), homologous AZD1222 primary series and booster (AZ2), heterologous primary series with one dose AZD1222, and AZD1222 booster (HPS), and primary series other than AZD1222 and AZD1222 booster (OPS). We compared the incidence of AEs in participants with and without prior COVID-19 infection using an exact test for rate ratios. RESULTS : Among 10,894 participants, 9192 (84.4%) were enrolled at first vaccine dose, 521 (4.8%) at second vaccine, and 1181 (10.8%) at the booster vaccine. Of 10,855 included in the full analysis set, 1700 received one dose of AZD1222; 5377 received two doses; 98 received a heterologous series including one AZD1222 and a booster; 30 in the HPS group; 1058 in the OPS group; and 2592 in the AZ2 group. No laboratory-confirmed COVID-19 hospitalizations or deaths were reported. The incidence of laboratory-confirmed symptomatic COVID infection for the AZ2 group was 6.22 (95% confidence interval: 2.51-12.78) per 1000 participant-years (1000-PY) and 3.5 (95% confidence interval: 0.42-12.57) per 1000-PY for AZ2+booster group. Most adverse events were mild, with higher incidence in participants with prior COVID-19 infection. Individuals with prior COVID-19 exposure exhibited higher binding antibody responses. No differences in outcomes were observed by HIV status. CONCLUSION : AZD1222 is safe, effective, and immunogenic for people living with and without HIV.AstraZeneca under an externally sponsored collaborative research agreement, partially supported through the Sub-Saharan African Network for TB/HIV Research Excellence (SANTHE 2.0), by the Bill and Melinda Gates Foundation (INV-033558) and the National Institutes of Health NIH Fogarty International Center.http://www.elsevier.com/locate/ijregihj2024School of Health Systems and Public Health (SHSPH)SDG-03:Good heatlh and well-bein

Feasibility of oral HIV self-testing in female sex workers in Gaborone, Botswana.

BackgroundOral HIV self-testing (HIVST) may be useful for increasing testing in persons at elevated risk of acquiring HIV.MethodsWe conducted a pilot study to evaluate the feasibility (defined by uptake) of HIVST among FSW in Gaborone, Botswana. FSW age 18 years and above were recruited through a non-governmental organization serving FSW. FSW with unknown or negative HIV status at screening performed HIVST in the study clinic following brief training. FSW testing HIV-negative were each given two test kits to take home: one kit to perform unassisted HIVST and another to share with others. Feasibility (use) of HIVST (and sharing of test kits with others) was assessed in these women at a study visit four months later.ResultsTwo hundred FSW were screened. Their average age was 34 years (range 18-59), and 115 (58%) were HIV-positive. Eighty-five (42%) tested HIV-negative at entry and were eligible to take part in the HIVST pilot study. All 85 (100%) agreed to take home HIVST kits. Sixty-nine (81%) of these 85 participants had a follow-up visit, 56 (81%) of whom reported performing HIVST at a mean of three and half months after the initial visit. All 56 participants who performed HIVST reported negative HIVST results. Fifty (73%) of the 69 participants who took HIVST kits home shared them with others. Of the 50 women sharing HIVST kits, 25 (50%) shared with their non-client partners, 15 with a family member, 8 with friends, and 3 with a client. One participant did not test herself but shared both her test kits. Most participants 53/56 (95%) found oral HIVST very easy to use whilst 3/56 (5%) felt it was fairly easy.ConclusionOral HIVST is feasible among FSW in Gaborone, Botswana. The majority of FSW used the HIVST kits themselves and also shared extra HIVST kits with other individuals

Acceptability of oral HIV self-testing among female sex workers in Gaborone, Botswana.

BackgroundHIV prevalence among female sex workers (FSW) in sub-Saharan Africa is much higher than in the general population. HIV self-testing (HIVST) may be useful for increasing testing rates in FSW.MethodsWe conducted semi-structured in-depth interviews among FSW, nurses and lay counsellors providing services to FSWs in Botswana. We aimed to gain understanding of perceived acceptability, anticipated barriers, and preferred approaches to HIVST among FSW. Interviews were audio-recorded, transcribed and translated. Transcripts were reviewed and coded independently by two investigators; high inter-coder agreement was achieved (Kappa = 0.80).ResultsWe interviewed five care providers whose average age was 40 years (SD = 2,64, range = 37-43); three nurses and two counsellors. Thirty FSW were interviewed, with mean age 34 years (range = 20-52). Most (27; 90%) FSW expressed great interest in using HIVST kits. Facilitators of HIVST were: awareness of own risky sexual behaviours, desire to stay healthy, and perceived autonomy over one's healthcare decisions. Perceived advantages of HIVST included convenience, privacy, and perception of decreased stigma. Identified barriers to HIVST included lack of knowledge about the HIVST kit, fear of testing due to anticipated stigma, mistrust of the test's accuracy, doubt of self-competency to perform HIVST, and concerns about not linking to care. Assisting someone to test was noted as good for providing emotional support, but there were concerns about confidentiality breaches. Providers expressed concerns over low literacy among FSWs which could affect comprehension of testing instructions, and competency to perform testing and interpret results. Participants' recommendations for implementation of HIVST included: ensuring wide dissemination of information on HIVST, engaging peers in information-sharing and education, making test kits accessible in FSW-friendly centres, and having clear instructions for linkage to healthcare and support.ConclusionHIVST shows high acceptability among FSWs in Gaborone Botswana, with providers expressing some concerns. Implementation should be peer-driven with healthcare provider oversight

Virologic outcomes in early antiretroviral treatment: HPTN 052

<p><b>Introduction:</b> The HIV Prevention Trials Network (HPTN) 052 trial demonstrated that early antiretroviral therapy (ART) prevented 93% of HIV transmission events in serodiscordant couples. Some linked infections were observed shortly after ART initiation or after virologic failure.</p> <p><b>Objective:</b> To evaluate factors associated with time to viral suppression and virologic failure in participants who initiated ART in HPTN 052.</p> <p><b>Methods:</b> 1566 participants who had a viral load (VL) > 400 copies/mL at enrollment were included in the analyses. This included 832 in the early ART arm (CD4 350–550 cells/mm³ at ART initiation) and 734 in the delayed ART arm (204 with a CD4 < 250 cells/mm³ at ART initiation; 530 with any CD4 at ART initiation). Viral suppression was defined as two consecutive VLs ≤ 400 copies/mL after ART initiation; virologic failure was defined as two consecutive VLs > 1000 copies/mL > 24 weeks after ART initiation.</p> <p><b>Results:</b> Overall, 93% of participants achieved viral suppression by 12 months. The annual incidence of virologic failure was 3.6%. Virologic outcomes were similar in the two study arms. Longer time to viral suppression was associated with younger age, higher VL at ART initiation, and region (Africa vs. Asia). Virologic failure was strongly associated with younger age, lower educational level, and lack of suppression by three months; lower VL and higher CD4 at ART initiation were also associated with virologic failure.</p> <p><b>Conclusions:</b> Several clinical and demographic factors were identified that were associated with longer time to viral suppression and virologic failure. Recognition of these factors may help optimize ART for HIV treatment and prevention.</p