Testing a new point-of-care device for detecting STIs and bacterial vaginosis in women
A Multi-centre Diagnostic Study to Evaluate the Feasibility and Performance of the Genital InFlammation Test (GIFT)
This study is testing a new device that quickly checks for sexually transmitted infections and bacterial vaginosis in women to see if it works well compared to standard tests.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 675 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | University of Cape Town Academic / other |
| Locations | 3 sites (Antananarivo and 2 other locations) |
| Trial ID | NCT05723484 on ClinicalTrials.gov |
What this trial studies
This study evaluates the Genital InFlammation Test (GIFT), a novel lateral flow point-of-care device, for its effectiveness in identifying women with inflammatory sexually transmitted infections (STIs) and bacterial vaginosis (BV). Conducted across three sites in South Africa, Zimbabwe, and Madagascar, the study will enroll 225 women attending family planning services. Participants will provide vaginal samples for testing, and results will be compared to established nucleic acid amplification tests (NAAT) and Nugent score tests. Additionally, the study aims to develop a management algorithm for integrating the GIFT device into routine care.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18-35 who are sexually active and accessing family planning services.
Not a fit: Patients who are pregnant or not sexually active may not receive any benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and management of STIs and BV, potentially reducing the risk of HIV infection and reproductive complications in women.
How similar studies have performed: Other studies have shown promise in using point-of-care testing for STIs, but the GIFT device represents a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Diagnostic Inclusion Criteria: * 18-35 years old * Willing and able to provide informed consent to participate in the study * Self-reported to be sexually active * Not pregnant (determined by pregnancy test) * Accessing family planning service Integration Inclusion Criteria: For all: Willing and able to provide informed consent to participate in the study User experiences/perceptions activity: * Local or regional policy makers, programmers and other opinion leaders and decision makers * Healthcare professionals at health facilities * Women who are eligible for the diagnostic study (including pregnant and menstruating women), but who are not part of the diagnostic study * 18-35 years old * Willing and able to provide informed consent to participate in the study * Self-reported to be sexually active * Accessing family planning service diagnostic study Discrete choice experiments: * Women who are eligible for the diagnostic study (including pregnant and menstruating women), who are either part of, or not part of, the diagnostic study * 18-35 years old * Self-reported to be sexually active * Accessing family planning service diagnostic study Decision tree classification algorithm: * Data from diagnostic study participants Economic evaluation: * Healthcare professionals at health facilities involved in GIFT device implementation able to complete timesheets Diagnostic Exclusion Criteria: * \<18 years or \>35 years * Refusal by a participant to participate in the study * Treatment for any STI/BV in the past 30 days * Pregnancy * Enrolled in a study which does not allow co-enrolment in other studies Integration Exclusion Criteria: For all: Not willing or able to provide informed consent to participate in the study User experiences/perceptions activity: * Non-relevant policy makers * Healthcare professionals at health facilities not included in diagnostic study Women who are: * Part of the diagnostic study * \<18 years or \>35 years * Treated for any STI/BV in the past 30 days * Pregnant * Enrolled in a study which does not allow co-enrolment in other studies Discrete choice experiments: Women who are: * \<18 years or \>35 years * Treated for any STI/BV in the past 30 days * Pregnant * Enrolled in a study which does not allow co-enrolment in other studies Decision tree classification algorithm: * Participants for whom there are no diagnostic study data Economic evaluation: * Healthcare professionals not at study sites, not involved in GIFT device implementation, and/or not able to complete timesheets
Where this trial is running
Antananarivo and 2 other locations
- Centre Hospitalier Universitaire Gynéco-Obstétrique de Befelatanana — Antananarivo, Madagascar (Recruiting)
- Desmond Tutu Health Foundation — Cape Town, Western Cape, South Africa (Recruiting)
- Chitungwiza Primary Health Care Clinics — Harare, Zimbabwe (Recruiting)
Study contacts
- Principal investigator: Jo-Ann Passmore, Professor — University of Cape Town
- Study coordinator: Jo-Ann Passmore, Professor
- Email: jo-ann.passmore@uct.ac.za
- Phone: +27 78 421 2701
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.