A qualitative concept elicitation study to understand patient-reported symptoms and impacts of Neisseria gonorrhoeae infections in the United States

Sex Transm Dis. 2024 Feb 23. doi: 10.1097/OLQ.0000000000001958. Online ahead of print.

Abstract

Background: Gonorrhea is the second most common bacterial sexually-transmitted infection in the United States (US), with rising rates. Emerging antimicrobial resistance threatens public health; and vaccines are in development. This study documents patient-reported gonorrhea symptoms and health-related quality of life (HRQoL) impact, in women who have sex with men (WSM), men who have sex with women (MSW) and men who have sex with men (MSM).

Methods: Semi-structured qualitative interviews were conducted (April 2021-March 2022) among US adults with recent (≤6 months) confirmed gonorrhea. Concept saturation was achieved, confirming adequate participant numbers to meet objectives. Elicited symptom and HRQoL impacts were used to develop a conceptual disease model. Common patient-reported outcome measure (PROM) items were compared to elicited concepts.

Results: 32 participants (15 WSM, 8 MSW and 9 MSM) were included. Eight were asymptomatic; six had repeat infections; five women and four men had complications (i.e., infertility or pelvic inflammatory disease [PID], and urethritis, respectively).The most frequently reported symptoms were vaginal discharge (n = 11/12), dysuria (n = 10/12), and abdominal/vaginal pain (n = 9/12) for symptomatic WSM; dysuria (n = 5/6) and penile discharge (n = 4/6) for symptomatic MSW; and throat, testicular or rectal pain (n = 4/6) for symptomatic MSM. All (symptomatic and asymptomatic) participants reported HRQoL impacts including negative emotional experiences (n = 31/32), and interference with sexual activity (n = 30/32), relationships (n = 24/32) and social life (n = 17/32). Concepts were poorly represented in existing PROMs.

Conclusion: Participants reported a diverse range of symptoms and HRQoL impacts, to help inform the value of new treatment and prevention options. More research is needed to quantify patient burden and develop PROMs.