GIFT Delphi Round 2 Survey

GIFT Delphi Round 2 Survey
Thank you for taking part in the second GIFT device Delphi survey. This Delphi process is being used to gather input from key stakeholders, including service providers, health programmers, researchers and policy makers,to inform how the GIFT device could be further developed.

The GIFT device is a lateral flow test that is based on the concentration of one or more inflammatory cytokines in cervicovaginal fluid. This device is intended as a point-of-care test for detecting biomarkers of genital inflammation, indicative of having a sexually transmitted infection (STI) and/or bacterial vaginosis (BV) in women and which can increase the risk of HIV infection and reproductive complications. It is still in the development phase. The device will be optimised, and its performance evaluated in a research study across three countries in Africa (South Africa, Madagascar and Zimbabwe). The aim is for the GIFT device to be integrated into STI and BV management algorithms.

A video of how the GIFT device is intended to work can be seen here

This Round 2 survey has been informed by the findings from the Round 1 Delphi survey, where we gathered ideas for how the GIFT device could be used in STI and BV management algorithms.

In the Round 2 survey below, we will provide you with some statements. We will ask you to indicate your level of agreement with the statements provided by selecting one option on the Likert scale from “strongly agree” to “strongly disagree”. These statements originated from Round 1 survey responses. The purpose of Round 2 is to now build consensus on how the GIFT device can be used and implemented in STI and BV management algorithms.
A video of the GIFT device can be seen below:
Youtube
Participant Consent Form

Consensus for the integration of the GIFT device into the management of sexually transmitted infections: a Delphi approach

Rows	Please Check
I confirm that I have read the information letter for the above named study. I have had the opportunity to consider the information, ask questions and have these answered satisfactorily.
I understand that my participation is voluntary and that I am free to withdraw at any time without giving any reason.
I understand that the raw data from me will not be shared with anyone outside the research team.
I understand that if the data provided by me may be useful to subsequent relevant studies, further ethics committee approval will be sought before any data sharing is conducted.
I agree to take part in the above named study.

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Section 1. Basic information about you:

This will help us understand the context in which you are providing your feedback.
1.1 Name

First NameLast Name
1.2 Organisation
1.3 Email
example@example.com
MaleFemalePrefer not to sayOther
Under 25 years25-34 years35-44 years45-54 years55-64 years65 years or over
DoctorNurse/other healthcare professionalLaboratory scientistClinic manager (including commissioners)Health programmerPolicy makerResearcherOther
1.7a Country/countries where you’ve worked and for which you’re responding:(Please note if you have worked in different settings, we would like you to complete a different form for each different settings)
UrbanSemi-urbanRural
YesNo
YesNo
Section 2: Implementation of the GIFT device for asymptomatic populations
Section 2 focusses on women with ASYMPTOMATIC STIs and/or BV. The consensus view from the Round 1 survey was that GIFT device will primarily be used as a screening tool for this population.

Given that the GIFT device does not determine the cause of genital inflammation, a positive GIFT result may be indicative of any of the following vaginal discharge causing conditions, or combinations of these:

Bacterial vaginosis
Neisseria gonorrhoeae
Chlamydia trachomatis
Trichomonas vaginalis
Mycoplasma genitalium

Most women with these conditions are asymptomatic [1]. In asymptomatic women, [EH1] the GIFT device has a sensitivity of 77% and a specificity of 71% for identifying STI/BV positive women compared to Nucleic Acid Amplification Tests for T. vaginalis, N. gonorrhoeae, C. trachomatis and Nugent scoring for BV [2].
YesNo

2.2. Who would you screen with the GIFT device (please indicate your level of agreement)?(the proposed population groups are those resulting from Round 1 Delphi survey responses)

Rows	Strongly Agree	Agree	Neutral	Disagree	Strongly Disagree
1.Asymptomatic women of any age in high HIV prevalence settings (>5% HIV prevalence)
2. Asymptomatic high-risk women (e.g., transactional sex or commercial sex work) of any age, in any place, in any setting
3. Asymptomatic women using pre-exposure prophylaxis (PrEP) for preventing getting HIV from sex or injection drug use
4. Asymptomatic women attending family planning clinics
5. Asymptomatic women attending screening clinics for cervical cancer

YesNo
Bacterial vaginosisNeisseria gonorrhoeaeChlamydia trachomatisTrichomonas vaginalisMycoplasma genitalium
Bacterial vaginosis: Never, 20% (8 out of 10 people aren’t actually infected), 30%, 40%, 50%, 60%, 80%, 100%Neisseria gonorrhoeae: Never, 20% (8 out of 10 people aren’t actually infected), 30%, 40%, 50%, 60%, 80%, 100%Chlamydia trachomatis: Never, 20% (8 out of 10 people aren’t actually infected), 30%, 40%, 50%, 60%, 80%, 100%Trichomonas vaginalis: Never, 20% (8 out of 10 people aren’t actually infected), 30%, 40%, 50%, 60%, 80%, 100%Mycoplasma genitalium: Never, 20% (8 out of 10 people aren’t actually infected), 30%, 40%, 50%, 60%, 80%, 100%
AsymptomaticSymptomatic
Section 3: Integration of the GIFT device into current guidelines for STI management among women who are symptomatic
Section 3 focuses on SYMPTOMATIC populations. Please indicate your level of agreement using the 5 options presented.

Figure 1. Flowchart for healthcare providers to manage vaginal discharge according to local availability of resources and preferences (From: “Guidelines for the management of symptomatic sexually transmitted infections. Geneva: World Health Organization; 2021. Licence: CC BY-NC-SA 3.0 IGO. Page 53”)
Feedback from the Round 1 survey suggested the GIFT device will be best used as a screening tool (paths 3 and 4). Consider the flow chart in the Figure above from the guidelines for management of symptomatic STIs. Please indicate your level of agreement using the 5 options presented.

3.1a. Pathway 3: One pathway of STI management for symptomatic women for the GIFT device could be when a speculum is available and acceptable, but molecular assays or rapid point-of-care tests are not available. In this case, if a woman presents with symptoms of vaginal discharge, after a medical and sexual history, the GIFT device could be used to assess whether to treat for one or more of the candidate STIs (BV, N. gonorrhoeae, C. trachomatis,T. vaginalis, M. genitalium. Please indicate your level of agreement whether the GIFT device could be used in this pathway

Rows	Strongly Agree	Agree	Neutral	Disagree	Strongly Disagree

3.1b If you selected either strongly agree or agree, where in this pathway would you use the GIFT device?

Rows	Strongly Agree	Agree	Neutral	Disagree	Strongly Disagree
At the time of vaginal clinical exam
Alongside a speculum exam to assess if there is evidence of cervicitis
After observing evidence of cervicitis during the speculum exam, to assess whether to treat for N. gonorrhoeae, C.trachomatis and M. genitalium
After observing no evidence of cervicitis from a speculum exam, to assess whether to treat for BV and T. vaginalis

3.2a. Pathway 4: One pathway of STI management for symptomatic women for the GIFT device could be when a speculum is not available or not acceptable, and other tests are not available. In this case, if a woman presents with symptoms of vaginal discharge, after a medical and sexual history, the GIFT device could be used to assess whether to treat for one or more of the candidate STIs (BV, N. gonorrhoeae, C. trachomatis,T. vaginalis, M. genitalium. Please indicate your level of agreement whether the GIFT device could be used in this pathway.

Rows	Strongly Agree	Agree	Neutral	Disagree	Strongly Disagree

3.2b. If you selected either strongly agree or agree, where in this pathway would you use the GIFT device?

Rows	Strongly Agree	Agree	Neutral	Disagree	Strongly Disagree
At the time of vaginal clinical exam (regardless of vaginal discharge presence)
At the time of vaginal clinical exam, when vaginal discharge is observed
At the time of vaginal clinical exam, when vaginal discharge is not observed but the woman is at high risk for STIs

DefinitelyProbablyPossiblyProbably notDefinitely not

3.3. The GIFT device can be best used in a pathway different from 3 & 4

Rows	Strongly Agree	Agree	Neutral	Disagree	Strongly Disagree

3.4 If you selected strongly agree or agree, please describe this/these separate path(s) briefly

Section 4: Prioritising GIFT device attributes to maximise its integration into STI and BV management algorithms

4.1. From the Round 1 survey, the following attributes were suggested as required for integrating the GIFT device into existing pathways. Please rank these attributes in order of importance (more than one attribute can be ranked equally) for integration into pathways as a screening tool for i.) asymptomatic women; ii.) symptomatic womenPlease use the following rankings: Very Important (1); Moderately Important (2); Not Important (3)

Rows	*Asymptomatic women*	Symptomatic women
Storage (e.g., stable at room temperature)
Simple and easy to use
Little or no training needed to use the test at the primary healthcare levels
Self-sample collection
Fast result turnaround time (e.g. time to read results in 10-15min)
Ease of interpretation of results (e.g., two line -positive and one line- negative)
High sensitivity
High specificity
High PPV
High NPV
Affordable
Cost-effective

4.2. The following are possible barriers to integration of the GIFT device into existing guidelines for asymptomatic and symptomatic women, identified in the Round 1 survey. Please indicate your level of agreement that each is a barrier.Please use the following rankings: Very Important (1); Moderately Important (2); Not Important (3)

Rows	*Very Important*	*Moderately Important*	*Not Important*
Lack of provider awareness
Lack of availability/ stock outs of test
High cost
Implementation - added layer of complexity to existing algorithms
In some settings, private space to collect the vaginal sample

4.3 Additional comments (if any)
4.4 Could the GIFT device be used for a purpose other than being a screening tool? Why?
4.5 Additional feedback or comments on how the GIFT device could be integrated into STI guidelines
THE END

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GIFT Delphi Round 2 Survey

A video of the GIFT device can be seen below:

Participant Consent Form

Section 1. Basic information about you:

Section 2: Implementation of the GIFT device for asymptomatic populations

Section 3: Integration of the GIFT device into current guidelines for STI management among women who are symptomatic

Section 4: Prioritising GIFT device attributes to maximise its integration into STI and BV management algorithms

THE END