A Multi-centre Diagnostic Study to Evaluate the Feasibility and Performance of the Genital InFlammation Test (GIFT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 675
- 试验地点
- 3
- 主要终点
- Estimates of sensitivity and specificity for the GIFT device
研究概览
简要总结
- 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;
- To evaluate how the GIFT device can be integrated in a feasible, acceptable, and cost-effective way into routine care.
详细描述
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 STIs/BV. 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 STI/BV 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: 1.User experiences and/or 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •<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
- •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
- •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
结局指标
主要结局
Estimates of sensitivity and specificity for the GIFT device
时间窗: Start- quarter 1/2023; End- quarter 4/2023
Detecting the presence of any STI or BV with 95% confidence intervals, using NAATs and Nugent scoring in a composite reference standard.
How the GIFT device could be integrated into routine care
时间窗: Start- quarter 1/2023; End- quarter 4/2023
Integration into healthcare guidelines
次要结局
- User experiences(Start- quarter 1/2023; End- quarter 4/2023)
- Overall sensitivity of NAAT and Nugent scoring(Start- quarter 1/2023; End- quarter 4/2023)
- Cost and budget impact(Start- quarter 3/2023; End- quarter 2/2024)
- Positive and negative predictive values of the GIFT device(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)
- Optimal case finding and STI management strategies(Start: - quarter 1/2024; End- quarter 4/2024)
- Positive and negative agreement proportion and Kappa coefficient between results readings of 1/clinician and technician(Start- quarter 1/2023; End- quarter 4/2023)
- Positive and negative agreement proportion and Kappa coefficient between results readings of GIFT device and cytokine ELISA measurements(Start- quarter 1/2023; End- quarter 4/2023)
- User preferences(Start- quarter 2/2023; End- quarter 1/2024)
研究者
Jo-An Passmore
Professor
University of Cape Town