Abstract: Men who have sex with men (MSM) are at higher risk for HIV and sexually transmitted infections (STIs) that increase HIV risk, such as Neisseria gonorrhoeae and Chlamydia trachomatis. HIV pre-exposure prophylaxis (PrEP) users—many of whom are MSM—are also at increased risk for STIs. U.S. guidelines recommend that PrEP users undergo frequent screening in multiple anatomic sites (pharyngeal, urogenital, and rectal) for asymptomatic infections. However, lower- and middle-income countries (LMICs) lack such guidelines, resulting in missed opportunities for STI screening and treatment among LMIC PrEP users. Antimicrobial resistance (AMR) in N. gonorrhoeae is an urgent global health threat and the prevalence is highest in LMICs, where access to diagnostics is limited. In particular, the Western Pacific Region, which includes the LMIC of Vietnam, has seen increasing spread of AMR in N. gonorrhoeae, which has spread worldwide. Major gaps exist in understanding the drivers of AMR in N. gonorrhoeae in LMICs. In this study, investigators from UCLA and Hanoi Medical University will investigate the acceptability and feasibility of C. trachomatis and N. gonorrhoeae screening among MSM and transwomen engaged in an HIV PrEP program in Hanoi, Vietnam. We hypothesize that screening will be acceptable and feasible. We will also investigate risk factors for AMR and genomic relationships between commensal Neisseria and N. gonorrhoeae at genetic loci associated with AMR, hypothesizing that recent antibiotic use is a risk factor for AMR. AIM 1: (a) To determine the distribution of anorectal, pharyngeal, and urogenital C. trachomatis and N. gonorrhoeae infections among MSM and transgender women PrEP users (n=1,300) in Hanoi, Vietnam and (b) To evaluate the acceptability and feasibility, including willingness to pay, of rapid, triple-site testing. AIM 2: (a) To collect, culture, and perform antibiotic susceptibility testing on N. gonorrhoeae and oropharyngeal Neisseria species to investigate the prevalence and correlates of AMR and b) To perform whole-genome sequencing on pairs of N. gonorrhoeae and Neisseria species isolated from within the same individual to investigate relationships within genes associated with antimicrobial resistance in N. gonorrhoeae. This two-year project has four phases. Phase 1 will last three months and will involve development of study materials, planning, and training. Phase 2 will last one year and will evaluate acceptability and feasibility of C. trachomatis and N. gonorrhoeae screening. Phase 3 will last 9 months and will involve antimicrobial susceptibility testing and whole genome sequencing. Phase 4 will last 3 months and will involve dissemination of findings through manuscripts, presentations, and sharing of data with local government and health agencies. Findings from the study will form the foundation for a future R01-proposal to investigate the impact of routine screening and treatment of STIs on the development of antimicrobial resistance is N. gonorrhoeae.

Project Number: 7R21AI157817-02

https://reporter.nih.gov/search/yKo7fj4CsEeWn001nA2peA/project-details/10389089

 

Contact PI/ Project Leader

KLAUSNER, JEFFREY DAVID, CLINICAL PROFESSOR (jdklausner@med.usc.edu)

 

Organization

UNIVERSITY OF SOUTHERN CALIFORNIA

 

PUBLIC HEALTH RELEVANCE: In the proposed study, we will evaluate the acceptability and feasibility of rapid, triple-anatomic-site screening for Chlamydia trachomatis and Neisseria gonorrhoeae infections within a cohort of men who have sex with men (MSM) and transgender women on HIV pre-exposure prophylaxis (PrEP) in Hanoi, Vietnam. We will determine the distribution of C. trachomatis and N. gonorrhoeae infections by anatomic site, test N. gonorrhoeae and commensal Neisseria species for antimicrobial susceptibility, and perform whole genome sequencing on N. gonorrhoeae and Neisseria species to investigate genetic markers of antimicrobial resistance. Findings from this study will characterize the burden of STIs among PrEP users in Vietnam while also providing insight into the correlates of antimicrobial resistance in N. gonorrhoeae and identifying genetic factors associated of with resistance.

 

 

Project Start Date: 05-February-2021

Project End Date: 31-January-2023

Budget Start Date:  12-May-2021

Budget End Date: 31-January-2022

 

NIH Categorical Spending

Funding IC:  NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES/ FY Total Cost by IC: $220,833