Genital InFlammation Test (GIFT) for HIV prevention and reproductive health: point-of-care screening tool for sexually transmitted infections and bacterial vaginosis — ASN Events
  1. Schedule
  2. Concurrent Session - Remote diseases surveillance and therapy
  3. Genital InFlammation Test (GIFT) for HIV prevention and reproductive health: point-of-care screening tool for sexually transmitted infections and bacterial vaginosis

Genital InFlammation Test (GIFT) for HIV prevention and reproductive health: point-of-care screening tool for sexually transmitted infections and bacterial vaginosis (94378)

Lindi Masson 1 2 3 4 , Elise Smith 5 , Eneyi Kpokiri 6 , Shaun Barnabas 1 7 , Angela Kairu 5 , Bahiah Meyer 1 , Monalisa Manhanzva 1 , Fezile Khumalo 1 , Ramla Tanko 1 , Tanya Pidwell 1 , Micaela Lurie 1 , Hoyam Gamieldien 1 , Conita Lombard 1 , Celia Mehou-Loko 1 , Jennifer Deese 8 , Lut van Damme 9 , Khatija Ahmed 10 11 , Tania Crucitti 12 , Katherine Gill 13 , Suzanna Francis 6 14 , Janneke van de Wijgert 15 , Bich-Tram Huynh 16 , Rindra Vatosoa Randremanana 12 , Chido Dziva Chikwari 6 17 18 , Katharina Kranzer 6 , David Anderson 4 , Lyndon Mungur 19 , Ashley Uys 19 , Darryl Uys 19 , Ayako Honda 20 , Camille Fortas 16 , Sarah Bernays 6 21 , Glenda Gray 22 23 , Janan Dietrich 22 , Linda-Gail Bekker 1 13 , Saberi Marais 24 , Constance Mackworth-Young 6 , Emma Harding-Esch 6 , Edina Sinanovic 5 , Jo-Ann Passmore 1 2 25
  1. Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa
  2. Centre for the AIDS Programme of Research in South Africa, Durban, South Africa
  3. Central Clinical School, Monash University, Melbourne, Australia
  4. Burnet Institute, Melbourne, VIC, Australia
  5. Health Economics Unit, School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa
  6. London School of Hygiene & Tropical Medicine, London, UK
  7. Family Centre for Research with Ubuntu (FAMCRU), University of Stellenbosch, Stellenbosch, South Africa
  8. Pfizr Inc., Pennsylvania, US
  9. Bill & Melinda Gates Foundation, Seeattle, US
  10. Setshaba Research Centre, Pretoria, South Africa
  11. Department of Medical Microbiology, University of Pretoria, Pretoria, South Africa
  12. Institut Pasteur de Madagascar, Antananarivo, Madagascar
  13. Desmond Tutu HIV Centre, Cape Town, South Africa
  14. International AIDS Vaccine Initiative, Amsterdam, Netherlands
  15. University Medical Center Utrecht, Utrecht, Netherlands
  16. Institut Pasteur, Paris, France
  17. Organization for Public Health Interventions and Development, Harare, Zimbabwe
  18. Biomedical Research and Training Institute, Harare, Zimbabwe
  19. Medical Diagnostech, Cape Town, South Africa
  20. Hitotsubashi University, Kunitachi, Japan
  21. School of Public Health, University of Sydney, Sydney, Australia
  22. Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa
  23. South African Medical Research Council, Cape Town, South Africa
  24. Research Contracts and Innovation, University of Cape Town, Cape Town, South Africa
  25. National Health Laboratory Service, Cape Town, South Africa

Background: Female genital tract inflammation increases risk of HIV acquisition and adverse reproductive outcomes. This inflammation is primarily caused by sexually transmitted infections (STIs) and vaginal dysbiosis, predominantly bacterial vaginosis (BV). In resource-limited populations, etiological tests are currently too expensive for implementation and women are only treated if they have signs/symptoms (syndromic management). However, many women with these infections are asymptomatic, but have equivalent vaginal inflammation and HIV risk as symptomatic women. We have identified biomarkers of vaginal inflammation caused by STIs and BV and are optimizing a low-cost Genital InFlammation Test (GIFT) to measure these biomarkers.

 

Methods: We validated the performance of three biomarkers (IL-1α, IL-1β, IP-10) in five cohorts of South African and Kenyan women. Biomarkers were measured using Luminex/ELISA, STIs diagnosed using nucleic acid amplification tests (NAATs) and BV using Nugent scoring. We conducted cost, budget impact, cost-effectiveness analyses and a DELPHI survey to evaluate stakeholder recommendations for implementation.

 

Results: We found that GIFT identified 76% of the women with a STI/BV with 71% specificity and improved accuracy compared to syndromic management (sensitivity 41%, specificity 57%; p=0.0003). Inclusion of vaginal pH with only one biomarker (IL-1α or IL-1β) increased the accuracy to 82%. GIFT was more cost-effective than NAATs and Nugent scoring (incremental cost-effectiveness ratio USD11.08 per woman diagnosed). Sixty-four stakeholders, mainly healthcare professionals, responded to the DELPHI survey. The majority (84%) would offer sexually active asymptomatic women screening with GIFT and most agreed that GIFT could be included in the WHO-recommended management guidelines for symptomatic women.

 

Conclusion: If offered to women attending primary healthcare clinics in resource-limited settings or used for self-testing, GIFT could provide a cost-effective means to increase STI and BV case-finding. The next step will be to test the GIFT device in three settings in Africa to evaluate performance, feasibility, user experience and cost-effectiveness.