Browsing by Author "Chiu C"

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    Fourth Controlled Human Infection Model (CHIM) meeting, CHIM regulatory issues, May 24, 2023.
    (2024-Feb) Cavaleri M; Kaslow D; Boateng E; Chen WH; Chiu C; Choy RKM; Correa-Oliveira R; Durbin A; Egesa M; Gibani M; Kapulu M; Katindi M; Olotu A; Pongsuwan P; Simuyandi M; Speder B; Talaat KR; Weller C; Wills B; Baay M; Balasingam S; Olesen OF; Neels P; MRC/UVRI and LSHTM Uganda Research Unit, Uganda; London School of Hygiene and Tropical Medicine, UK. Electronic address: Moses.Egesa@mrcuganda.org.; IABS-EU, Lyon, France. Electronic address: pieter.neels@vaccine-advice.be.; Imperial College London, UK. Electronic address: m.gibani@imperial.ac.uk.; Oxford University Clinical Research Unit, Ho Chi Minh City, Viet Nam. Electronic address: bwills@oucru.org.; Katindi & Company, Kenya. Electronic address: mkatindi@katindilawyers.co.ke.; KEMRI-Wellcome Trust Research Programme, Kenya. Electronic address: mkapulu@kemri-wellcome.org.; Johns Hopkins Bloomberg School of Public Health, Baltimore, USA. Electronic address: adurbin1@jhu.edu.; Fundação Oswaldo Cruz (Fiocruz), Brazil.; Food and Drugs Authority, Ghana. Electronic address: gus4tee@gmail.com.; Wellcome Trust, London, UK. Electronic address: shobana.balasingam@wellcome.org.; Johns Hopkins Bloomberg School of Public Health, Baltimore, USA. Electronic address: ktalaat@jhu.edu.; US Food & Drugs Administration, USA. Electronic address: david.kaslow@fda.hhs.gov.; Centre for Infectious Disease Research, Zambia. Electronic address: Michelo.Simuyandi@cidrz.org.; European Vaccine Initiative, Heidelberg, Germany. Electronic address: ole.olesen@euvaccine.eu.; Wellcome Trust, London, UK. Electronic address: C.Weller@wellcome.org.; Mahidol Oxford Tropical Medicine Research Unit, Bangkok, Thailand.; European Medicines Agency, Netherlands. Electronic address: marco.cavaleri@ema.europa.eu.; Ifakara Health Institute, Tanzania. Electronic address: aolotu@ihi.or.tz.; HVIVO plc, UK. Electronic address: b.speder@hvivo.com.; Center for Vaccine Development, University of Maryland School of Medicine, USA. Electronic address: wilbur.chen@som.umaryland.edu.; Imperial College London, UK. Electronic address: c.chiu@imperial.ac.uk.; P95 Epidemiology & Pharmacovigilance, Leuven, Belgium. Electronic address: marc.baay@p-95.com.; PATH Center for Vaccine Innovation and Access, Seattle, WA, USA. Electronic address: rchoy@path.org.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    Many aspects of Controlled Human Infection Models (CHIMs, also known as human challenge studies and human infection studies) have been discussed extensively, including Good Manufacturing Practice (GMP) production of the challenge agent, CHIM ethics, environmental safety in CHIM, recruitment, community engagement, advertising and incentives, pre-existing immunity, and clinical, immunological, and microbiological endpoints. The fourth CHIM meeting focused on regulation of CHIM studies, bringing together scientists and regulators from high-, middle-, and low-income countries, to discuss barriers and hurdles in CHIM regulation. Valuable initiatives for regulation of CHIMs have already been undertaken but further capacity building remains essential. The Wellcome Considerations document is a good starting point for further discussions.
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    The impact of the SKILLZ intervention on sexual and reproductive health empowerment among Zambian adolescent girls and young women: results of a cluster randomized controlled trial.
    (2025-Jun-05) Sheira LA; Mulubwa C; Chiu C; Chipungu J; Coakley C; Smith H; Upadhyay UD; Chilambe C; Chibwe B; Pry JM; Mkandawire B; Musonda M; Moore CB; Liu J; School of Population Health, University of New South Wales, Sydney, Australia.; Grassroot Soccer Zambia, Lusaka, Zambia.; Institute for Health & Aging, School of Nursing, University of California, San Francisco, USA.; Centre for Social Science Research, University of Cape Town, Cape Town, South Africa.; Department of Obstetrics, Gynecology, & Reproductive Sciences, University of California, San Francisco, USA.; Desmond Tutu HIV Centre, Department of Medicine, University of Cape Town, Cape Town, South Africa.; Division of Epidemiology, School of Medicine, University of California, Davis, USA.; Institute for Health & Aging, School of Nursing, University of California, San Francisco, USA. Lila.sheira@ucsf.edu.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    BACKGROUND: Zambian adolescent girls and young women (AGYW, age 15–24) experience a disproportionate burden of HIV and unintended pregnancy. Sports-based interventions, which affect sexual health behaviors via improving sexual and reproductive empowerment, may be an innovative and effective approach for promoting HIV and unintended pregnancy prevention. We sought to evaluate the impact of a peer-led, sports-based intervention on sexual and reproductive empowerment among in-school Zambian adolescent girls and young women. METHODS: Data come from the ‘SKILLZ’ study, a cluster randomized controlled trial evaluating the impact of a peer-led, sports-based health education program. Sexual and reproductive empowerment, a secondary outcome of SKILLZ, was measured via the 23-item Sexual and Reproductive Empowerment for adolescents and young adults scale (range 0–92, higher = more sexual and reproductive empowerment) three times over approximately 24 months. We conducted a difference-in-differences analysis to evaluate intervention impact over time. RESULTS: The study enrolled 2,153 AGYW (1134 intervention; 1019 control) across 46 secondary schools in Lusaka. Median age at baseline was 17; participants were largely unmarried (96%), with 20% reporting any sexual activity. By endline, nearly 40% reported being sexually active. Between baseline and midline, attending an intervention school was associated with a 6.21-point increase in overall score calculated using the imputed sample (standard error [SE]: 0.75, CONCLUSION: The intervention moderately impacted Sexual and Reproductive Empowerment scores; results were magnified among sexually active AGYW. Given adolescence is a critical period for sexuality and gender programming, as well as for sexual debut, empowerment interventions at schools may support downstream sexual health behaviors that will impact the life-course of AGYW. TRIAL REGISTRATION: This study was registered in ClinicalTrials.gov (NCT04429061) on March 17th, 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12978-025-02046-6.