Comparing a Novel Point-of-care Cytokine Biomarker Lateral Flow Test With Nucleic Acid Amplification Tests for Detection of Sexually Transmitted Infections and Bacterial Vaginosis

NCT05723484 | Completed

• 1 other identifier: GIFT_EDCTP-RIA2020I-3297
• Study Type: observational
• Target: 675
• Locations: 3 countries
• Sites: 3

Brief Summary

1. 1.To evaluate the performance of a lateral flow POC test, namely the Genital InFlammation Test (GIFT), for identifying women with inflammatory STIs and BV, who are at higher risk of HIV infection and reproductive complications;
2. 2.To evaluate how the GIFT device can be integrated in a feasible, acceptable, and cost-effective way into routine care.

Conditions

STI

Outcome Measures

Primary Outcomes (2)

• Estimates of sensitivity and specificity for the GIFT device

  Detecting the presence of any STI or BV with 95% confidence intervals, using NAATs and Nugent scoring in a composite reference standard.

  Start- quarter 1/2023; End- quarter 4/2023

• How the GIFT device could be integrated into routine care

  Integration into healthcare guidelines

  Start- quarter 1/2023; End- quarter 4/2023

Secondary Outcomes (10)

• Positive and negative predictive values of the GIFT device

  Start- quarter 1/2023; End- quarter 4/2023

• Overall sensitivity of NAAT and Nugent scoring

  Start- quarter 1/2023; End- quarter 4/2023

• Overall sensitivity

  Start- quarter 1/2023; End- quarter 4/2023

• Comparison of sensitivity, specificity, predictive values in each country and likelihood ratios calculated with both methods

  Start- quarter 1/2023; End- quarter 4/2023

• Positive and negative agreement proportion and Kappa coefficient between results readings of 1/clinician and technician

  Start- quarter 1/2023; End- quarter 4/2023

Other Outcomes (1)

• Expository Endpoint: Post-estimation classifications

  Start- quarter 3/2023; End- quarter 4/2024

Interventions

GIFT Device DEVICE

The GIFT device - immune-based lateral flow test for reproductive-aged, non-pregnant in resource-limited settings attending sexual reproductive health (family planning) clinics, community health centers, hospitals, and mobile clinics. The test involves the qualitative detection of genital inflammation caused by asymptomatic STIs and BV in self- or clinician-collected lateral vaginal wall swabs, with results available in less than 20 minutes.

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Diagnostic: Non-pregnant, sexually active women aged 18-35 years accessing family planning services. Integration: * Local or regional policy makers: maximum 36 * Healthcare professionals: maximum 40 * Pregnant and non-pregnant, sexually active women of 18-35 years attending family planning services: maximum 45 * Pregnant and non-pregnant, sexually active women of 18-35 years attending family planning services: up to 200 participants per site for discrete choice experiment * Data from pregnant and non-pregnant, sexually active women of 18-35 years attending family planning services recruited in diagnostic study * Healthcare workers from diagnostic study sites

You may qualify if:

• 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
• 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
• 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:

You may not qualify if:

• \<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
• 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

Sponsors & Collaborators

• University of Cape Town: lead
• Macfarlane Burnet Institute for Medical Research and Public Health Ltd: collaborator
• Desmond Tutu HIV Foundation: collaborator
• London School of Hygiene and Tropical Medicine: collaborator
• UMC Utrecht: collaborator
• Institut Pasteur: collaborator
• Institut Pasteur de Madagascar: collaborator
• Hitotsubashi University: collaborator

Study Sites (3)

Centre Hospitalier Universitaire Gynéco-Obstétrique de Befelatanana

Antananarivo, Madagascar

Location

Desmond Tutu Health Foundation

Cape Town, Western Cape, 7975, South Africa

Location

Chitungwiza Primary Health Care Clinics

Harare, Zimbabwe

Location

Related Publications (1)

• Ramboarina S, Crucitti T, Gill K, Bekker LG, Harding-Esch EM, van de Wijgert JHHM, Huynh BT, Fortas C, Harimanana A, Mayouya Gamana T, Randremanana RV, Mangahasimbola R, Dziva Chikwari C, Kranzer K, Mackworth-Young CRS, Bernays S, Thomas N, Anderson D, Tanko FR, Manhanzva M, Lurie M, Khumalo F, Sinanovic E, Honda A, Pidwell T, Francis SC, Masson L, Passmore JA; GIFT study group. Novel point-of-care cytokine biomarker lateral flow test for the screening for sexually transmitted infections and bacterial vaginosis: study protocol of a multicentre multidisciplinary prospective observational clinical study to evaluate the performance and feasibility of the Genital InFlammation Test (GIFT). BMJ Open. 2024 May 1;14(5):e084918. doi: 10.1136/bmjopen-2024-084918.

  PMID: 38692732 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine - Pregnancy test Finger prick blood - HIV testing Dacron vaginal swab-SWAB 1 - GIFT device Dacron vaginal swab- SWAB 2 - Cytokine ELISA Dacron vaginal swab- SWAB 3 - pH Dacron vaginal swab-SWAB 3 - Nugent score Copan flocked vaginal swab- SWAB 4 - STI NAAT Copan flocked vaginal swab- SWAB 5 - STI NAAT Copan flocked vaginal swab- SWAB 5 - Quantitative PCR for Lactobacilli, Gardnerella vaginalis and Fannyhessea vaginae; Semen NAAT/ELISA Copan flocked vaginal swab-SWAB 6 and 7 - 16S rRNA sequencing

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jo-Ann Passmore, Professor

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 10, 2023
• Study Start: June 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1); ZA (1); ZI (1)