• GIFT Delphi Round 1 Survey

  • Thank you for taking part in this Delphi survey. This is part of the Genital InFlammation Test (GIFT) study, which is developing, testing, evaluating, and generating implementation pathways of the GIFT device. This device is a point-of-care test for detecting genital inflammation caused by sexually transmitted infections (STIs) and/or bacterial vaginosis (BV) in women. The specific STIs referred to during this survey are Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Mycoplasma genitalium

    This Delphi process is being used to gather input from experts including clinicians, researchers, lab scientists, managers, policy makers and others to  ascertain how the GIFT device could be further developed with the aim of integrating it into STI management algorithms.

    We envisage that there will be up to 3 rounds. This first round will use qualitative, open-ended questions to allow respondents to provide as many possible ideas of how the GIFT device could be used in STI and HIV management. These qualitative responses will be analysed using a thematic approach with a framework method in which all responses will be coded, and the codes will be used to generate themes that will then inform a core set of strategies for more quantitative feedback in subsequent rounds.

    This survey has been designed to take ~45 minutes to complete. This will therefore be ~45minutes per survey if completing more than one survey for differnt contexts/settings. You will be able to enter and save your responses, edit or complete them later, if necessary.

  • Information on the GIFT device

  • The GIFT device is a cytokine biomarker lateral flow test that is based on the level of one or more inflammatory cytokines [interleukin-1alpha (IL-1alpha), IL-1beta, and/or interferon-gamma inducible protein of 10 kilodaltons (IP-10)], together with vaginal pH in dacron swab samples from the lateral vaginal wall of women.

    The lateral flow GIFT device is being designed to work in a manner that is similar to an off-the-shelf SARS-CoV2 or HIV rapid test, where positive results can be read by the intensity of a band on a nitrocellulose strip relative to a reference and/or high vaginal pH. This lateral flow design was selected because of its relatively low technology requirements and potentially low cost. Lateral flow tests are true point of care, do not require sophisticated equipment to run, and can be done quickly and easily either by a healthcare professional or as a self-test.

    A video of the GIFT device can be seen below:

  • Youtube

  • The GIFT device is still in its development phase. The device will be optimised and its performance evaluated in a research study across 3 African countries (South Africa, Madagascar and Zimbabwe).The main outcome measures will be performance [sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)] of the GIFT device compared to laboratory-based gold standard nucleic acid amplification testing for STIs (C. trachomatis, N. gonorrhoeae, T. vaginalis and M. genitalium) or Nugent scoring for BV.

    At this stage in the development of the GIFT device, there are several aspects that could be modified, and others that are fixed. The reason for asking your expert input at this stage is to design the GIFT device in the best way possible to make it viable to be integrated into STI management guidelines in resource limited settings.

    Below are the fixed attributes of the GIFT device:

    • A lateral flow immune assay
    • Point of care test format (like a pregnancy test)
    • Uses a lateral vaginal wall swab to collect the clinical sample material
    • Identifies individual infections (detects cytokine biomarkers of genital inflammation that are caused specifically by any of the four STIs and BV and elevated vaginal pH caused by BV)

    Below are attributes of the GIFT device which are in development and can be modified:

    • Choice of biomarker combinations: either [IL-1alpha + pH]; OR [IL-1beta + pH]; OR [IL-1alpha + IL-1beta + IP-10] – each combination has implications on sensitivity, specificity and cost
    • Turnaround time: Results will be given in 10-20 minutes
    • Sensitivity: between 77-86% (depending on a trade-off of biomarker combinations)
    • Specificity: between 68-71% (depending on a trade-off of biomarker combinations)
    • Cost of each cartridge: between USD $0.50-4.00
    • Please note that from economic evaluations, the cost of the test itself is less than 10% of the overall cost of genital inflammation screening, with the majority of costs being for personnel. There is potential to reduce personnel cost by self-testing
    •  The use with an automated reader or not (cost of reader is less than $100)

  • Integration of the GIFT device into national and international STI management pathways

  • The GIFT device may accurately identify asymptomatic STIs and BV in women. This would be particularly beneficial in low and middle-income contexts where STI testing is not available due to limited resources and expensive tests. This questionnaire therefore focuses on low and middle-income contexts.

    Identifying asymptomatic STIs and BV using the GIFT device could avert HIV infections and adverse birth outcomes, as women with asymptomatic STIs and BV have genital inflammation that increases their risk of HIV infection and reproductive complications. The device might also have potential within STI management pathways for symptomatic women. This Delphi survey will ask your expert opinion as to whether and how the GIFT device could fit into either of these (asymptomatic or symptomatic) pathways.

    Given that feedback to the questions will likely be setting-specific, we ask that you respond based on a particular role you have in a particular setting. If you hold/have held multiple roles or would like to respond with relation to different scenarios, please complete more than one questionnaire.

    First, we will ask for some basic demographic information about yourself. Then we will ask your thoughts on implementation of the GIFT device for asymptomatic women. Next, we will ask for your thoughts on the integration of the GIFT device into current guidelines for STI management among women who are symptomatic. Finally, we will seek your feedback on the purpose of the GIFT device (covering both asymptomatic and symptomatic women).

  • Participant Consent Form

  • Consensus for the integration of the GIFT device into the management of sexually transmitted infections: a Delphi approach
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  • Section 1. Basic information about you:

    This will help us understand the context in which you are providing your feedback.
  • 1.4 Role (Capacity in which you are completing this survey):
  • 1.5b Settings within the country/countries in 1.5a above
  • 1.6 What is your Gender
  • 1.7 Age range:

  • Section 2: Implementation of the GIFT device for asymptomatic populations

  • Now we’re going to ask you about women with asymptomatic STIs or BV and the GIFT device.

    Current World Health Organization (WHO) STI and BV management guidelines focus on syndromic management. It is known that this misses many STI and BV cases, as the majority of women are asymptomatic. We are interested in how the GIFT device could be used to identify asymptomatic STI and BV cases in women among different population groups. The answers to these questions will help both in the design of the modifiable characteristics of the GIFT device, as well as informing the implementation of the GIFT device into national and international guidelines (rather than at a local level).

    Consider the use of the GIFT device among women who do not have symptoms of an STI or BV. The GIFT device could be used in different ways within different population groups. We will ask you to imagine this among different asymptomatic population groups which are examples of groups in which the GIFT device could be used.

  • A reminder that this survey focuses on low- and middle-income contexts. For the scenarios below, please think of your regular work/practice settings

    Scenario 1: An asymptomatic young woman (16-24 years), in a high/moderate HIV prevalence setting (>5% HIV prevalence), attending a non-antenatal care (ANC) healthcare setting

    Scenario 2: Asymptomatic young woman (16-24yrs), in a low HIV prevalence setting >5% HIV prevalence, attending a non-ANC healthcare setting 

     

    Scenario 3: An asymptomatic adult woman (>=25 years) in a high/moderate HIV prevalence setting (>5% HIV prevalence), attending a non-ANC healthcare setting


    Scenario 4: An asymptomatic adult woman (>=25 years) in a low HIV prevalence setting 


    Scenario 5: An asymptomatic woman of any age attending ANC


    Scenario 6: An asymptomatic woman of any age at high risk for having an STI (e.g. transactional sex, commercial sex workers, discordant couples or others at high risk for having an STI)

  • 2.1. Could the GIFT device be used among the following population groups, considering asymptomatic women?
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  • 2.4. For each population that you selected ‘definitely’, ‘probably' or 'possibly' please describe how best the GIFT device could be used among those population groups? Please refer back to the test description in the background section to remind yourself of modifiable and fixed attributes for the GIFT device
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  • Section 3: Integration of the GIFT device into current guidelines for STI management among women who are symptomatic

  • Now we’re going to ask you about symptomatic populations and the GIFT device.

    Current WHO guidelines provide guidance for STI management for symptomatic women (WHO, June 2021). Consider the below figure from the new WHO guidelines for Vaginal Discharge Syndrome. There are four different paths according to the local availability of resources and preference. The questions below ask you to imagine how the GIFT device could be used in these different WHO-recommended paths.

  • Image field 45
  • 3.1 Do you think the GIFT device could fit into the symptomatic guidelines for low- and middle-income contexts described above for symptomatic women? If so, in which path(s) do you think the GIFT device could be best used? (select all that apply)
  •  3.3 For each path (selected in 3.1 above) where the GIFT device could be used, what attributes would be required?
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  • Section 4: Purpose of the GIFT device (covering both asymptomatic and symptomatic women)

    Now that you have thought about how the GIFT device could be used for asymptomatic and symptomatic women, separately, we would like your thoughts on the different ways in which the GIFT device could be used overall. The different ways could impact the requirements needed for the GIFT device, for example sensitivity and specificity, PPV, NPV, and cost (please see list of modifiable attributes of the GIFT device). 
  • 4.1. In your opinion, how important is it for the GIFT device to be used as a screening tool? Screening would lead to follow-up investigations, such as a diagnostic test to confirm the specific aetiological agent.

  • 4.3. In your view, how important is it for the GIFT device to be used as a diagnostic tool? A diagnostic tool would lead to better case finding for C. trachomatis, N. gonorrhoeae, T. vaginalis and M. genitalium and BV, if positive.

  • 4.6 How sure do you want to be before treating a person for C. trachomatis, N. gonorrhoeae, T. vaginalis, M. genitalium and BV? What is your desired level of certainty before treating a person

  • Rows
  • 4.8 How sure do you want to be about NOT treating a person for C. trachomatis, N. gonorrhoeae, T. vaginalis, M. genitalium and BV? What is your desired level of certainty about NOT treating a person
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  • Section 5. Ending

  • Thank you very much for completing this survey. Your input at this stage is highly valued, as decisions are being made for the development of the GIFT device, so that it can best be integrated into STI management pathways. We aim to collate feedback from up to 100 international experts. We will be contacting you again in a few weeks’ time, to ask for your participation in the round 2 survey. 
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