Postexposure Doxycycline to Prevent Bacterial Sexually Transmitted Infections

Methods: We conducted an open-label, randomized study involving MSM and transgender women who were taking preexposure prophylaxis (PrEP) against human immunodeficiency virus (HIV) infection (PrEP cohort) or living with HIV infection (persons living with HIV infection [PLWH] cohort) and who had had Neisseria gonorrhoeae (gonorrhea), Chlamydia trachomatis (chlamydia), or syphilis in the past year. Participants were randomly assigned in a 2:1 ratio to take 200 mg of doxycycline within 72 hours after condomless sex (doxycycline postexposure prophylaxis) or receive standard care without doxycycline. STI testing was performed quarterly. The primary end point was the incidence of at least one STI per follow-up quarter.

Results: Of 501 participants (327 in the PrEP cohort and 174 in the PLWH cohort), 67% were White, 7% Black, 11% Asian or Pacific Islander, and 30% Hispanic or Latino. In the PrEP cohort, an STI was diagnosed in 61 of 570 quarterly visits (10.7%) in the doxycycline group and 82 of 257 quarterly visits (31.9%) in the standard-care group, for an absolute difference of -21.2 percentage points and a relative risk of 0.34 (95% confidence interval [CI], 0.24 to 0.46; P<0.001). In the PLWH cohort, an STI was diagnosed in 36 of 305 quarterly visits (11.8%) in the doxycycline group and 39 of 128 quarterly visits (30.5%) in the standard-care group, for an absolute difference of -18.7 percentage points and a relative risk of 0.38 (95% CI, 0.24 to 0.60; P<0.001). The incidences of the three evaluated STIs were lower with doxycycline than with standard care; in the PrEP cohort, the relative risks were 0.45 (95% CI, 0.32 to 0.65) for gonorrhea, 0.12 (95% CI, 0.05 to 0.25) for chlamydia, and 0.13 (95% CI, 0.03 to 0.59) for syphilis, and in the PLWH cohort, the relative risks were 0.43 (95% CI, 0.26 to 0.71), 0.26 (95% CI, 0.12 to 0.57), and 0.23 (95% CI, 0.04 to 1.29), respectively. Five grade 3 adverse events and no serious adverse events were attributed to doxycycline. Of the participants with gonorrhea culture available, tetracycline-resistant gonorrhea occurred in 5 of 13 in the doxycycline groups and 2 of 16 in the standard-care groups.

Conclusions: The combined incidence of gonorrhea, chlamydia, and syphilis was lower by two thirds with doxycycline postexposure prophylaxis than with standard care, a finding that supports its use among MSM with recent bacterial STIs. (Funded by the National Institutes of Health; DoxyPEP ClinicalTrials.gov number, NCT03980223.).

Author/s:

Luetkemeyer, A. F., Donnell, D., Dombrowski, J. C., Cohen, S., Grabow, C., Brown, C. E., Malinski, C., Perkins, R., Nasser, M., Lopez, C., Vittinghoff, E., Buchbinder, S. P., Scott, H., Charlebois, E. D., Havlir, D. V., Soge, O. O., Celum, C., DoxyPEP Study Team

Guidelines for the Primary and Gender-Affirming Care of Transgender and Gender Nonbinary People

Brian Desmarais — Wed, 26 Jun 2019 21:56:55 +0000

Date Added:

June 26, 2019

Publisher:

UCSF Center of Excellence for Transgender Health

Publication Date:

June 17, 2019

URL:

Guidelines for the Primary and Gender-Affirming Care of Transgender and Gender Nonbinary People

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

Keywords

MeSH

Antineoplastic Combined Chemotherapy Protocols

Cytarabine

Etoposide

Methotrexate

referral and consultation

Standard of Care

Guidelines for providing gender-affirming care for LGBTQ patients. I recommend pages 15-18 even if you have no interest in the rest of the material in the guideline. James W. Mold, MD, MPH

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Introduction to the guidelines The Center of Excellence for Transgender Health (CoE) at the University of California – San Francisco is proud to present these Guidelines for the Primary and Gender-Affirming Care of Transgender and Gender Nonbinary People. Transgender people have a gender identity that differs from the sex which they were assigned at birth, and are estimated to represent 0.5% of the U.S. population.[1] Numerous needs assessments have demonstrated that transgender people encounter a range of barriers to accessing primary health care. A 2006 survey of more than 600 transgender people in California found that 30% postponed seeking medical care due to prior disrespect or discrimination, and that 10% were primary care outright.[2] The 2011 National Transgender Discrimination Survey of more than 6000 transgender people in all 50 U.S. states found several noteworthy disparities, including 28% who delayed care due to past discrimination and 19% who were denied care outright. Most alarmingly, 50% of respondents reported having to teach their providers about their own healthcare.[3] These guidelines aim to address these disparities by equipping primary care providers and health systems with the tools and knowledge to meet the health care needs of their transgender and gender nonconforming patients. These guidelines expand on the original UCSF Primary Care Protocol for Transgender Care, which since its launch in 2011 has served thousands of providers and policymakers across the U.S. and around the world; the page on hormone administration alone received more than 5000 visitors in the month of November, 2015. These Guidelines complement the existing World Professional Association for Transgender Health Standards of Care and the Endocrine Society Guidelines in that they are specifically designed for implementation in every day evidence-based primary care, including settings with limited resources.[4,5] The overall structure and list of topics for inclusion were developed in consultation with the CoE’s Medical Advisory Board (MAB), a diverse group of expert clinicians from a variety of academic and community based settings. Also contributing to the overall design and structure was a review of the range of consultation requests received by the CoE since the 2011 launch of the original Protocol. The guidelines were then written using an authorship – peer review approach. Primary authors from both within and outside the MAB were invited for individual topics, after which a peer review and modified consensus process was used to arrive at the final guidelines presented here. The diverse authorship allows the development of a broadly applicable document, rather than one that solely reflects the practice at a single academic medical center, such as UCSF. These guidelines would not be possible without the contributions of our Medical Advisory Board and other authors and reviewers, as well as the support of my CoE colleagues JoAnne Keatley, MSW and E. Michael Reyes, MD, MPH, as well as Lissa Moran who assisted immensely with literature reviews, bibliography management, version control, copy editing, formatting, and compiling peer reviewer comments. Ben Zovod also assisted with literature reviews, bibliography management, and compiling peer reviewer comments. Their dedication and hours of hard work has resulted in a final product that is relevant, broadly applicable, evidence based, and scientifically sound. I hope you find these guidelines useful and welcome any feedback or questions, which are June 17, 2016 2 Guidelines for the Primary and Gender-Affirming Care of Transgender and Gender Nonbinary People helpful in framing future revisions. Thank you for caring about the health of transgender and gender nonconforming people. Madeline B. Deutsch, MD, MPH Editor Guidelines for the Primary and Gender-Affirming Care of Transgender and Gender Nonbinary People Director of Clinical Services Center of Excellence for Transgender Health Associate Professor of Clinical Family and Community Medicine Department of Family and Community Medicine University of California, San Francisco Madeline.Deutsch@ucsf.edu