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Mycoplasma genitalium Infection in Kenyan and US Women

Balkus, Jennifer E., PhD, MPH*†‡; Manhart, Lisa E., PhD, MPH*†; Jensen, Jørgen S., MD, PhD, DMSc§; Anzala, Omu, PhD; Kimani, Joshua, MBChB; Schwebke, Jane, MD**; Shafi, Juma, MS; Rivers, Charles, PhD**; Kabare, Emanuel, BS; McClelland, R. Scott, MD, MPH*†∥††

doi: 10.1097/OLQ.0000000000000799
Original Studies

Background Little is known about the natural history of Mycoplasma genitalium (MG) infection in women. We retrospectively tested archived vaginal fluid samples to assess MG prevalence, incidence, persistence, recurrence and antimicrobial resistance markers among women participating in the Preventing Vaginal Infections trial, a randomized trial of monthly presumptive treatment to reduce vaginal infections.

Methods High-risk, nonpregnant, HIV-negative women aged 18 to 45 years from Kenya and the United States were randomized to receive metronidazole 750 mg + miconazole 200 mg intravaginal suppositories or placebo for 5 consecutive nights each month for 12 months. Clinician-collected swabs containing cervicovaginal fluid were tested for MG using Hologic nucleic acid amplification testing at enrollment and every other month thereafter. Specimens that were MG+ underwent additional testing for macrolide resistance–mediating mutations by DNA sequencing.

Results Of 234 women enrolled, 221 had available specimens and 25 (11.3%) had MG at enrollment. Among 196 women without MG at enrollment, there were 52 incident MG infections (incidence, 33.4 per 100 person-years). Smoking was independently associated with incident MG infection (adjusted hazard ratio, 3.02; 95% confidence interval, 1.32–6.93), and age less than 25 years trended toward an association (adjusted hazard ratio, 1.70; 95% confidence interval, 0.95–3.06). Median time to clearance of incident MG infections was 1.5 months (interquartile range, 1.4–3.0 months). Of the 120 MG+ specimens, 16 specimens from 15 different women were macrolide resistance–mediating mutation positive (13.3%), with no difference by country.

Conclusions M. genitalium infection is common among sexually active women in Kenya and the Southern United States. Given associations between MG and adverse reproductive health outcomes, this high burden of MG in reproductive-aged women could contribute to substantial morbidity.

Using retrospective testing of archived specimens, a natural history study of Mycoplasma genitalium among Kenyan and US women reported a high prevalence (11.3%) and incidence of M. genitalium (33.4 per 100 person-years).

From the Departments of *Epidemiology and

Global Health, University of Washington;

Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA;

§Statens Serum Institute, Copenhagen, Denmark;

Department of Medical Microbiology,

University of Nairobi Institute for Tropical and Infectious Diseases, University of Nairobi, Nairobi, Kenya;

**Department of Medicine, University of Alabama at Birmingham, Birmingham, AL; and

††Department of Medicine, University of Washington, Seattle, WA

Acknowledgments: The authors sincerely thank the women who participated in this study. They gratefully acknowledge the Preventing Vaginal Infections study team and study sites for their tireless work on data and sample collection, and FHI 360 for their work on data management and study operations.

The Preventing Vaginal Infections trial was supported by the US National Institute of Allergy and Infectious Diseases with contract number HHSN266200400073C through the Sexually Transmitted Infections Clinical Trials Group. Mycoplasma genitalium testing was supported by a Developmental Award from the American Sexually Transmitted Disease Association, and Chlamydia trachomatis and Neisseria gonorrhoeae testing was supported by National Institute of Allergy and Infectious Diseases (R01 AI099106). R.S.M. receives support for mentoring through K24 HD88229. The content is solely the responsibility of the authors and does not necessarily represent the official views of the US National Institutes of Health. Infrastructure and logistical support for the Mombasa site was provided through the University of Washington Center for AIDS Research (P30 AI27757).

Conflict of Interests and Sources of Funding: J.E.B. has received donated reagents and test kits from Hologic. R.S.M. currently receives research funding, paid to the University of Washington, from Hologic. J. Schwebke has received consultancy payments from Akesis, Hologic, Symbiomix, and Starpharma, and has grants/pending grants from Akesis, BD Diagnostic, Hologic, Cepheid, Quidel, Symbiomix, Starpharma, and Viamet. L.E.M. has received donated reagents and test kits from Hologic and honoraria for scientific advisory board membership from Hologic and Qiagen, Inc. J.S.J. has received speaker fees and travel support and research funding via Serum Statens Institute (SSI) from Hologic, and Serum Statens Institute has performed contract work for SpeeDx, Diagenode, Nytor, Cempra, Angelini, and Nabriva. All other authors declare that they do not have a commercial or other association that might pose a conflict of interest.

Author Contributions: J.E.B., L.E.M., and R.S.M. conceptualized the article and analysis plan. J.E.B. conducted the analysis in collaboration with L.E.M., J.S.J., and R.S.M. J.E.B. drafted the initial report, and L.E.M., J.S.J., and R.S.M. contributed to the content and revisions. O.A., J.K., J. Schwebke, J. Shafi, C.R., and E.K. contributed to data collection. All authors contributed to article content and approved the final manuscript.

These data were presented in part at the Infectious Disease Society of Obstetrics and Gynecology, held on August 11–12, 2016, in Annapolis, MD.

Correspondence: Jennifer Ellen Balkus, PhD, MPH, 1959 NE Pacific St, Box 357236, Seattle, WA 98195. E-mail: jbalkus@.uw.edu.

Received for publication November 17, 2017, and accepted January 17, 2018.

© Copyright 2018 American Sexually Transmitted Diseases Association