Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05723484
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2023-01-27
Brief Title:
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
Sponsor:
University of Cape Town
Organization:
University of Cape Town
Study Overview
Official Title:
A Multi-centre Diagnostic Study to Evaluate the Feasibility and Performance of the Genital InFlammation Test GIFT
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GIFT
Brief Summary:
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 To evaluate how the GIFT device can be integrated in a feasible acceptable and cost-effective way into routine care
2 To evaluate how the GIFT device can be integrated in a feasible acceptable and cost-effective way into routine care
Detailed Description:
DIAGNOSTIC Study
Design
The study is a multicentre multidisciplinary cross sectional prospective clinically based research project
The first component is a diagnostic study which will enrol 225 women attending family planning services in each of the three study sites in South Africa Zimbabwe and Madagascar Vaginal samples from the women will be applied to the GIFT device and results will be compared with the composite NAAT reference test for STIs and Nugent score test for BV to determine the performance of the device to detect STIsBV Women will attend only one study visit but will be recalled for treatment if required
The second component to develop a feasible acceptable and economically feasible STIBV management algorithm which includes the use of the GIFT device to be integrated into national guidelines hereafter referred to as the integration study is composed of four activities with different study designs 1User experiences andor perceptions of the GIFT device involving qualitative focus group discussions and in-depth interviews and a quantitative questionnaire for health care professionals 2 Discrete choice experiment 3 Development of a decision tree classification algorithm 4 Economic evaluation of the defined management algorithms
Study Sites
1 Cape Town South Africa Desmond Tutu Health Foundation DTHF Masiphumelele
2 Harare Zimbabwe Chitungwiza Primary Health Care Clinics
3 Antananarivo Madagascar Centre Hospitalier Universitaire Gynéco-Obstétrique de Befelatanana
Diagnostic Device
The GIFT device is an 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
Diagnostic Study Objectives
Primary objectives To assess the sensitivity and specificity of the GIFT device at the point-of-care in non-pregnant sexually active women aged 18-35 years accessing family planning services in South Africa Zimbabwe and Madagascar
Secondary objectives To assess the predictive values of the GIFT device at the point-of-care in non-pregnant sexually active women aged 18-35 years accessing family planning services in South Africa Zimbabwe and Madagascar To assess the performance of the GIFT device at the point-of-care in non-pregnant sexually active women aged 18-35 years accessing family planning services in each of the countries To assess the performance of the device versus syndromic management without any laboratory testing standard of care in South Africa Zimbabwe and Madagascar To determine the robustness of the device by comparing results read by clinicians with those read by laboratory professionals and with the results obtained using an automated reader To evaluate the accuracy of the GIFT device by comparing the GIFT device results with ELISA enzyme-linked immunosorbent assay results using previously validated concentration cut-offs as the gold standard including validation of the GIFT cytokine concentration cut-offs for each cytokine biomarker
Exploratory objectives Determine if other determinants such as intermediate microbiota Nugent 4-6 age parity sexual activity improve the prediction of STIBV status in women To use 16S rRNA gene sequencing and vaginal bacteria specific quantitative NAATs to evaluate the proportion of cases of genital inflammation explained by vaginal dysbiosis that was not diagnosed as an STI or BV by NAATs or Nugent scoring To explore the performance of the device in the presence of vaginal Candida spp colonisation
INTEGRATION Study To evaluate how the GIFT device can be integrated in a feasible acceptable and cost-effective way into routine care the integration study four activities will be conducted 1 User experiences andor perceptions of the GIFT device 2 Discrete choice experiment 3 Development of a decision tree classification algorithm 4 Economic evaluation of the defined management algorithms
Objectives
Primary objective To evaluate how the GIFT device could be integrated into routine care
Secondary objectives To qualitatively and quantitatively assess the user-experience usability and acceptability of the GIFT device at the point of care To examine patient preferences for various STI management aspects attributes to inform the development of STI management algorithms that integrate the GIFT device To generate algorithms that integrate the GIFT device to optimise case finding and STIsvaginal infection management in women using the complete dataset from the study To determine the cost and budget impact of the identified screening or diagnostic algorithm with the GIFT device and to model the cost- effectiveness of different strategies of integration of GIFT into care
Design
The study is a multicentre multidisciplinary cross sectional prospective clinically based research project
The first component is a diagnostic study which will enrol 225 women attending family planning services in each of the three study sites in South Africa Zimbabwe and Madagascar Vaginal samples from the women will be applied to the GIFT device and results will be compared with the composite NAAT reference test for STIs and Nugent score test for BV to determine the performance of the device to detect STIsBV Women will attend only one study visit but will be recalled for treatment if required
The second component to develop a feasible acceptable and economically feasible STIBV management algorithm which includes the use of the GIFT device to be integrated into national guidelines hereafter referred to as the integration study is composed of four activities with different study designs 1User experiences andor perceptions of the GIFT device involving qualitative focus group discussions and in-depth interviews and a quantitative questionnaire for health care professionals 2 Discrete choice experiment 3 Development of a decision tree classification algorithm 4 Economic evaluation of the defined management algorithms
Study Sites
1 Cape Town South Africa Desmond Tutu Health Foundation DTHF Masiphumelele
2 Harare Zimbabwe Chitungwiza Primary Health Care Clinics
3 Antananarivo Madagascar Centre Hospitalier Universitaire Gynéco-Obstétrique de Befelatanana
Diagnostic Device
The GIFT device is an 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
Diagnostic Study Objectives
Primary objectives To assess the sensitivity and specificity of the GIFT device at the point-of-care in non-pregnant sexually active women aged 18-35 years accessing family planning services in South Africa Zimbabwe and Madagascar
Secondary objectives To assess the predictive values of the GIFT device at the point-of-care in non-pregnant sexually active women aged 18-35 years accessing family planning services in South Africa Zimbabwe and Madagascar To assess the performance of the GIFT device at the point-of-care in non-pregnant sexually active women aged 18-35 years accessing family planning services in each of the countries To assess the performance of the device versus syndromic management without any laboratory testing standard of care in South Africa Zimbabwe and Madagascar To determine the robustness of the device by comparing results read by clinicians with those read by laboratory professionals and with the results obtained using an automated reader To evaluate the accuracy of the GIFT device by comparing the GIFT device results with ELISA enzyme-linked immunosorbent assay results using previously validated concentration cut-offs as the gold standard including validation of the GIFT cytokine concentration cut-offs for each cytokine biomarker
Exploratory objectives Determine if other determinants such as intermediate microbiota Nugent 4-6 age parity sexual activity improve the prediction of STIBV status in women To use 16S rRNA gene sequencing and vaginal bacteria specific quantitative NAATs to evaluate the proportion of cases of genital inflammation explained by vaginal dysbiosis that was not diagnosed as an STI or BV by NAATs or Nugent scoring To explore the performance of the device in the presence of vaginal Candida spp colonisation
INTEGRATION Study To evaluate how the GIFT device can be integrated in a feasible acceptable and cost-effective way into routine care the integration study four activities will be conducted 1 User experiences andor perceptions of the GIFT device 2 Discrete choice experiment 3 Development of a decision tree classification algorithm 4 Economic evaluation of the defined management algorithms
Objectives
Primary objective To evaluate how the GIFT device could be integrated into routine care
Secondary objectives To qualitatively and quantitatively assess the user-experience usability and acceptability of the GIFT device at the point of care To examine patient preferences for various STI management aspects attributes to inform the development of STI management algorithms that integrate the GIFT device To generate algorithms that integrate the GIFT device to optimise case finding and STIsvaginal infection management in women using the complete dataset from the study To determine the cost and budget impact of the identified screening or diagnostic algorithm with the GIFT device and to model the cost- effectiveness of different strategies of integration of GIFT into care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None