FDA, CDC, and NIH Co-sponsored Public Workshop Summary-Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea.

There is an unmet need for developing drugs for the treatment of gonorrhea, due to rapidly evolving resistance of Neisseria gonorrhoeae against antimicrobial drugs used for empiric therapy, an increase in globally reported multidrug resistant cases, and the limited available therapeutic options. Furthermore, few drugs are under development. Development of antimicrobials is hampered by challenges in clinical trial design, limitations of available diagnostics, changes in and varying standards of care, lack of robust animal models, and clinically relevant pharmacodynamic targets. On April 23, 2021, the U.S. Food and Drug Administration; Centers for Disease Control and Prevention; and National Institute of Allergy and Infectious Diseases, National Institutes of Health co-sponsored a workshop with stakeholders from academia, industry, and regulatory agencies to discuss the challenges and strategies, including potential collaborations and incentives, to facilitate the development of drugs for the treatment of gonorrhea. This article provides a summary of the workshop.

The Spatial Association Between Federally Qualified Health Centers and County-Level Reported Sexually Transmitted Infections: A Spatial Regression Approach.

BACKGROUND: The number of categorical sexually transmitted disease (STD) clinics is declining in the United States. Federally qualified health centers (FQHCs) have the potential to supplement the needed sexually transmitted infection (STI) services. In this study, we describe the spatial distribution of FQHC sites and determine if reported county-level nonviral STI morbidity were associated with having FQHC(s) using spatial regression techniques. METHODS: We extracted map data from the Health Resources and Services Administration data warehouse on FQHCs (ie, geocoded health care service delivery [HCSD] sites) and extracted county-level data on the reported rates of chlamydia, gonorrhea and, primary and secondary (P&S) syphilis (2008-2012) from surveillance data. A 3-equation seemingly unrelated regression estimation procedure (with a spatial regression specification that controlled for county-level multiyear (2008-2012) demographic and socioeconomic factors) was used to determine the association between reported county-level STI morbidity and HCSD sites. RESULTS: Counties with HCSD sites had higher STI, poverty, unemployment, and violent crime rates than counties with no HCSD sites (P < 0.05). The number of HCSD sites was associated (P < 0.01) with increases in the temporally smoothed rates of chlamydia, gonorrhea, and P&S syphilis, but there was no significant association between the number of HCSD per 100,000 population and reported STI rates. CONCLUSIONS: There is a positive association between STI morbidity and the number of HCSD sites; however, this association does not exist when adjusting by population size. Further work may determine the extent to which HCSD sites can meet unmet needs for safety net STI services.

Hispanic Men in the United States: Acculturation and Recent Sexual Behaviors With Female Partners, 2006-2010.

OBJECTIVES: We examined Hispanic men's recent risky and protective sexual behaviors with female partners by acculturation. METHODS: Using the 2006-2010 National Survey of Family Growth, we performed bivariate analyses to compare acculturation groups (Hispanic Spanish-speaking immigrants, Hispanic English-speaking immigrants, Hispanic US natives, and non-Hispanic White men) by demographics and recent sexual behaviors with women. Multivariable logistic regression models for sexual behaviors by acculturation group were adjusted for demographics. RESULTS: Compared with Hispanic Spanish-speaking immigrants, non-Hispanic White men were less likely to report exchange of money or drugs for sex (adjusted odds ratio [AOR] = 0.3; 95% confidence interval [CI] = 0.1, 0.9), but were also less likely to report condom use at last vaginal (AOR = 0.6; 95% CI = 0.4, 0.8) and anal sex (AOR = 0.4; 95% CI = 0.3, 0.7). Hispanic US natives were less likely to report condom use at last vaginal sex than were Spanish-speaking immigrants (AOR = 0.6; 95% CI = 0.4, 0.8). English- and Spanish-speaking immigrants did not differ in risky or protective sexual behaviors. CONCLUSIONS: Our findings suggest that targeted interventions focusing on unique sexual risks and sociodemographic differences by acculturation level, particularly nativity, may be helpful for preventing sexually transmitted infections.

Estimating the Size and Cost of the STD Prevention Services Safety Net.

The Patient Protection and Affordable Care Act is expected to reduce the number of uninsured people in the United States during the next eight years, but more than 10% are expected to remain uninsured. Uninsured people are one of the main populations using publicly funded safety net sexually transmitted disease (STD) prevention services. Estimating the proportion of the uninsured population expected to need STD services could help identify the potential demand for safety net STD services and improve program planning. In 2013, an estimated 8.27 million people met the criteria for being in need of STD services. In 2023, 4.70 million uninsured people are expected to meet the criteria for being in need of STD services. As an example, the cost in 2014 U.S. dollars of providing chlamydia screening to these people was an estimated $271.1 million in 2013 and is estimated to be $153.8 million in 2023. A substantial need will continue to exist for safety net STD prevention services in coming years.

Summary of comments and recommendations from the CDC consultation on the HIV/AIDS Epidemic and prevention in the Hispanic/Latino community.

In April 2008, the U.S. Centers for Disease Control and Prevention (CDC) hosted a national consultation meeting of academic researchers, public health officials, service providers, and community leaders to examine the HIV/AIDS epidemic and prevention needs of Hispanics/Latinos in the United States and its territories. The consultation engaged key stakeholders to review available information on HIV-related behavioral research and prevention efforts, describe gaps in current HIV prevention programs and research on Hispanics/Latinos, and identify community and societal-level factors that can increase vulnerability of Hispanics/Latinos for acquiring or transmitting HIV infection. Recommendations were also made to CDC for future collaboration with the Hispanic/Latino community in areas of HIV prevention research and prevention programs. This article summarizes participants' recommendations for HIV prevention research, program and capacity building, policy and planning, and partnerships and communication. These recommendations will be used by CDC to inform the development of a National Plan of Action for HIV/AIDS prevention among Hispanics/Latinos, and can provide a framework for use by other federal and non-federal agencies, academic researchers, community-based organizations, and policymakers as they seek to curtail the HIV epidemic among Hispanics/Latinos.

Improving the representativeness of behavioral and clinical surveillance for persons with HIV in the United States: the rationale for developing a population-based approach.

The need for a new surveillance approach to understand the clinical outcomes and behaviors of people in care for HIV evolved from the new challenges for monitoring clinical outcomes in the HAART era, the impact of the epidemic on an increasing number of areas in the US, and the need for representative data to describe the epidemic and related resource utilization and needs. The Institute of Medicine recommended that the Centers for Disease Control and Prevention and the Heath Resources and Services Administration coordinate efforts to survey a random sample of HIV-infected persons in care, in order to more accurately measure the need for prevention and care services. The Medical Monitoring Project (MMP) was created to meet these needs. This manuscript describes the evolution and design of MMP, a new nationally representative clinical outcomes and behavioral surveillance system, and describes how MMP data will be used locally and nationally to identify care and treatment utilization needs, and to plan for prevention interventions and services.