Zipime-Weka-Schista study protocol: a longitudinal cohort study and economic evaluation of an integrated home-based approach for genital multipathogen screening in women, including female genital schistosomiasis, human papillomavirus, Trichomonas and HIV in Zambia

BMJ Open, vol. 14, pp. e080395

Abstract

Introduction Multiplathogen home-based self-sampling offers an opportunity to increase access to screening and treatment in endemic settings with high coinfection prevalence of sexually transmitted (HIV, Trichomonas vaginalis (Tv), human papillomavirus (HPV)) and non-sexually transmitted pathogens ( Schistosoma haematobium (Sh )). Chronic coinfections may lead to disability (female genital schistosomiasis) and death (cervical cancer). The Zipime-Weka-Schista (Do self-testing sister!) study aims to evaluate the validity, acceptability, uptake, impact and cost-effectiveness of multipathogen self-sampling for genital infections among women in Zambia. Methods and analysis This is a longitudinal cohort study aiming to enrol 2500 non-pregnant, sexually active and non-menstruating women aged 15–50 years from two districts in Zambia with 2-year follow-up. During home visits, community health workers offer HIV and Tv self-testing and cervicovaginal self-swabs for (1) HPV by GeneXpert and, (2) Sh DNA detection by conventional (PCR)and isothermal (recombinase polymerase assay) molecular methods. Schistosoma ova and circulating anodic antigen are detected in urine. At a clinic follow-up, midwives perform the same procedures and obtain hand-held colposcopic images. High-risk HPV positive women are referred for a two-quadrant cervical biopsy according to age and HIV status. A cost-effectiveness analysis is conducted in parallel. Ethics and dissemination The University of Zambia Biomedical Research Ethics Committee (UNZABREC) (reference: 1858-2021), the London School of Hygiene and Tropical Medicine (reference: 25258), Ministry of Health and local superintendents approved the study in September 2021.Written informed consent was obtained from all participants prior to enrolment. Identifiable data collected are stored securely and their confidentiality is protected in accordance with the Data Protection Act 1998.

Authors 21

1. Kwame Shanaube

   Zambart

   Affiliation as printed

   Zambart, Lusaka, Zambia

2. Rhoda Ndubani

   Zambart

   Affiliation as printed

   Zambart, Lusaka, Zambia

3. Helen A. Kelly

   London School of Hygiene & Tropical Medicine

   Affiliation as printed

   Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, UK

4. Emily L. Webb

   London School of Hygiene & Tropical Medicine

   Affiliation as printed

   Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK

5. Philippe Mayaud

   London School of Hygiene & Tropical Medicine

   Affiliation as printed

   Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, UK

6. Olimpia Lamberti

   London School of Hygiene & Tropical Medicine

   Affiliation as printed

   Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, UK

7. Jennifer L. Fitzpatrick

   Zambart

   Affiliation as printed

   Zambart, Lusaka, Zambia

8. Nkatya Kasese

   Zambart

   Affiliation as printed

   Zambart, Lusaka, Zambia

9. Amy S. Sturt

   VA Palo Alto Health Care System

   Affiliation as printed

   Department of Infectious Diseases, Veterans Affairs Health Care System, Palo Alto, UK

10. Lisette van Lieshout Aachen

    Leiden University Medical Center

    Affiliation as printed

    Leiden University Medical Center, Leiden, The Netherlands

11. Govert J. van Dam Aachen

    Leiden University Medical Center

    Affiliation as printed

    Leiden University Medical Center, Leiden, The Netherlands

12. Paul L. A. M. Corstjens Aachen Department of Cell and Chemical Biology

    Leiden University Medical Center

    Affiliation as printed

    Department of Cell and Chemical Biology, Leiden University Medical Center, Leiden, The Netherlands

13. Barry R. Kosloff

    Zambart

    Affiliation as printed

    Longhorn Vaccines & Diagnostics, Bethesda, Maryland, USA

    Zambart, Lusaka, Zambia

14. Virginia Anne Bond

    London School of Hygiene & Tropical Medicine · Zambart

    Affiliation as printed

    London School of Hygiene & Tropical Medicine Centre of Global Change and Health, London, UK

    Zambart, Lusaka, Zambia

15. Richard Hayes

    London School of Hygiene & Tropical Medicine

    Affiliation as printed

    Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK

16. Fern Terris‐Prestholt

    London School of Hygiene & Tropical Medicine

    Affiliation as printed

    London School of Hygiene & Tropical Medicine, London, UK

17. Bonnie Lee Webster

    Natural History Museum

    Affiliation as printed

    Natural History Museum, London, UK

18. Bellington Vwalika

    University of Zambia

    Affiliation as printed

    Department of Obstetrics & Gynaecology, University of Zambia School of Medicine, Lusaka, Zambia

19. Isaiah Hansingo
    Affiliation as printed

    Gynecology, Livingstone Central Hospital, Livingstone, Zambia

20. Helen Ayles

    London School of Hygiene & Tropical Medicine · Zambart

    Affiliation as printed

    Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, UK

    Zambart, Lusaka, Zambia

21. Amaya L. Bustinduy corresponding

    London School of Hygiene & Tropical Medicine

    Affiliation as printed

    Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, UK