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.
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 vaginosisNeisseria gonorrhoeaeChlamydia trachomatisTrichomonas vaginalisMycoplasma 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].
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
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”)
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
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