Analysis of aflatoxin biomarkers in the hair of experimental animals

Data Availability Statement: Not applicable.Copyright © 2021 by the authors. Analysis of body fluids and tissues of aflatoxin exposed individuals for the presence of aflatoxins and aflatoxin metabolites has emerged as a reliable indicator of exposure and metabolism of aflatoxins. However, current aflatoxin biomarkers are not appropriate for investigating the long-term effects of aflatoxin exposure. In this explorative study, we investigated the analysis of hair as a complementary or alternative matrix for the assessment of biomarkers of long-term aflatoxin exposure. Three groups of guinea pigs were orally dosed with 5 ugkg−1bw−1, 50 ugkg−1bw−1, and 100 ugkg−1bw−1 of AFB1. Urine and hair samples were collected on days 0, 1, 2, 3, 7, 30, 60, and 90 and analysed for AFB1 and AFM1 using UHPLC-MS/MS. AFB1 and AFM1 were detected in 75% and 13.6%, respectively, of the day 1 to day 7 urine samples. AFB1 was detected in hair samples collected from day 3 up to day 60. This is the first report to confirm the deposition of AFB1 in the hair of experimental animals. These findings indicate that hair analysis has the potential to provide an accurate long-term historical record of aflatoxin exposure with potentially important implications for the field of aflatoxin biomarkers.This research received no external funding

Co-enrollment in multiple HIV prevention trials — Experiences from the CAPRISA 004 Tenofovir gel trial

Background: In settings where multiple HIV prevention trials are conducted in close proximity, trial participants may attempt to enroll in more than one trial simultaneously. Co-enrollment impacts on participant's safety and validity of trial results. We describe our experience, remedial action taken, inter-organizational collaboration and lessons learnt following the identification of co-enrolled participants. Experiences: Between February and April 2008, we identified 185 of the 398 enrolled participants as ineligible. In violation of the study protocol exclusion criteria, there was simultaneous enrollment in another HIV prevention trial (ineligible co-enrolled, n = 135), and enrollment of women who had participated in a microbicide trial within the past 12 months (ineligible not co-enrolled, n = 50). Following a complete audit of all enrolled participants, ineligible participants were discontinued via study exit visits from trial follow-up. Custom-designed education program on co-enrollment impacting on participants' safety and validity of the trial results was implemented. Shared electronic database between research units was established to enable verification of each volunteer's trial participation and to prevent future co-enrollments. Lessons learnt: Interviews with ineligible enrolled women revealed that high-quality care, financial incentives, altruistic motives, preference for sex with gel, wanting to increase their likelihood of receiving active gel, perceived low risk of discovery and peer pressure are the reasons for their enrollment in the CAPRISA 004 trial. Conclusion: Instituting education programs based on the reasons reported by women for seeking enrollment in more than one trial and using a shared central database system to identify co-enrollments have effectively prevented further co-enrollments

Transcription as a Key Phase of Data Analysis in Qualitative Research: Experience from KwaZulu-Natal, South Africa.

Transforming spoken words into written text in qualitative research is a vital step in familiarizing and immersing oneself in the data. We share a three-step approach of how data transcription facilitated an interpretative act of analysis in a study using qualitative data collection methods on the barriers and facilitators of HIV testing and treatment in KwaZulu-Natal, South Africa

Adaptation and pre-test of a shortened Stepping Stones and Creating Futures intervention focused on HIV for young men in rural South Africa

This is the final version. Available on open access from Public Library of Science via the DOI in this recordData Availability: All data are available via the AHRI data repository: https://data.ahri.org/index.php/home with access based on their guidelines.Men’s engagement in HIV prevention and treatment is suboptimal, including in South Africa. We sought to address this through adapting an evidence-based intervention, Stepping Stones and Creating Futures (SSCF), to strengthen its HIV content and provide a more scalable (shorter) intervention in rural South Africa. We then conducted a mixed methods pre-test of the intervention among young men aged 18–35 years. To adapt SSCF, we reviewed the current evidence base and worked with male Peer Navigators to update the SSCF theory of change (ToC) and manual. The revised intervention was ~45 hours (9 sessions) as opposed to ~63 hours and included a greater focus on HIV prevention and treatment technologies. Overall, 64% (n = 60) of men approached agreed to participate in the intervention, uptake (attending one session) among those who agreed was n = 35(58%) and retention (attending 6 or more sessions) was n = 25(71%). Qualitative data emphasized the intervention was acceptable, with young men describing it as something they liked. The qualitative data also broadly supported the intervention ToC, including the normalization of HIV in men’s lives, and the importance of health for men in achieving their life goals. However, it also highlighted the need to focus more on HIV-related stigma and fear, and the importance of HIV self-testing kits in encouraging testing. We revised the ToC and manual in light of this data. The adapted SSCF is acceptable and supports the ToC. Next steps is an evaluation to look at effectiveness of the intervention.Medical Research Council (MRC)Wellcome TrustNational Institutes of Health (NIH)South African Medical Research Counci

A Phase 2b Study to Evaluate the Safety and Efficacy of VRC01 Broadly Neutralizing Monoclonal Antibody in Reducing Acquisition of HIV-1 Infection in Women in Sub-Saharan Africa: Baseline Findings

Background: HIV Vaccine Trials Network 703/HIV Prevention Trials Network 081 is a phase 2b randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of passively infused monoclonal antibody VRC01 in preventing HIV acquisition in heterosexual women between the ages of 18 and 50 years at risk of HIV. Participants were enrolled at 20 sites in Botswana, Kenya, Malawi, Mozambique, South Africa, Tanzania, and Zimbabwe. It is one of the 2 Antibody Mediated Prevention efficacy trials, with HIV Vaccine Trials Network 704/HIV Prevention Trials Network 085, evaluating VRC01 for HIV prevention. Methods: Intense community engagement was used to optimize participant recruitment and retention. Participants were randomly assigned to receive intravenous VRC01 10 mg/kg, VRC01 30 mg/kg, or placebo in a 1:1:1 ratio. Infusions were given every 8 weeks with a total of 10 infusions and 104 weeks of follow-up after the first infusion. Results: Between May 2016 and September 2018, 1924 women from sub-Saharan Africa were enrolled. The median age was 26 years (interquartile range: 22-30), and 98.9% were Black. Sexually transmitted infection prevalence at enrollment included chlamydia (16.9%), trichomonas (7.2%), gonorrhea (5.7%), and syphilis (2.2%). External condoms (83.2%) and injectable contraceptives (61.1%) were the methods of contraception most frequently used by participants. In total, through April 3, 2020, 38,490 clinic visits were completed with a retention rate of 96% and 16,807 infusions administered with an adherence rate of 98%. Conclusions: This proof-of-concept, large-scale monoclonal antibody study demonstrates the feasibility of conducting complex trials involving intravenous infusions in high incidence populations in sub-Saharan Africa

Agricultural Method: MAG 411

Agricultural Method: MAG 411, degree examination June 2011

Biology Method: MBI 412

Biology Method: MBI 412, degree examination June 2011

Electronic Integrated Management of Childhood Illness (eIMCI): a randomized controlled trial to evaluate an electronic clinical decision-making support system for management of sick children in primary health care facilities in South Africa

Abstract Background Electronic clinical decision-making support systems (eCDSS) aim to assist clinicians making complex patient management decisions and improve adherence to evidence-based guidelines. Integrated management of Childhood Illness (IMCI) provides guidelines for management of sick children attending primary health care clinics and is widely implemented globally. An electronic version of IMCI (eIMCI) was developed in South Africa. Methods We conducted a cluster randomized controlled trial comparing management of sick children with eIMCI to the management when using paper-based IMCI (pIMCI) in one district in KwaZulu-Natal. From 31 clinics in the district, 15 were randomly assigned to intervention (eIMCI) or control (pIMCI) groups. Computers were deployed in eIMCI clinics, and one IMCI trained nurse was randomly selected to participate from each clinic. eIMCI participants received a one-day computer training, and all participants received a similar three-day IMCI update and two mentoring visits. A quantitative survey was conducted among mothers and sick children attending participating clinics to assess the quality of care provided by IMCI practitioners. Sick child assessments by participants in eIMCI and pIMCI groups were compared to assessment by an IMCI expert. Results Self-reported computer skills were poor among all nurse participants. IMCI knowledge was similar in both groups. Among 291 enrolled children: 152 were in the eIMCI group; 139 in the pIMCI group. The mean number of enrolled children was 9.7 per clinic (range 7-12). IMCI implementation was sub-optimal in both eIMCI and pIMCI groups. eIMCI consultations took longer than pIMCI consultations (median duration 28 minutes vs 25 minutes; p = 0.02). eIMCI participants were less likely than pIMCI participants to correctly classify children for presenting symptoms, but were more likely to correctly classify for screening conditions, particularly malnutrition. eIMCI participants were less likely to provide all required medications (124/152; 81.6% vs 126/139; 91.6%, p= 0.026), and more likely to prescribe unnecessary medication (48/152; 31.6% vs 20/139; 14.4%, p = 0.004) compared to pIMCI participants. Conclusions Implementation of eIMCI failed to improve management of sick children, with poor IMCI implementation in both groups. Further research is needed to understand barriers to comprehensive implementation of both pIMCI and eIMCI. (349) Clinical trials registration Clinicaltrials.gov ID: BFC157/19, August 2019