Inside This Issue: Rising STD incidence, increasing diversity in clinical trials, updated HIV and OI guidelines, infectious disease in correctional and detention settings, new resources on HIV among youth and transgender persons, and more.

Sexually Transmitted Diseases

STD Incidence in the U.S. Continued to Rise During 2020

The reported cases of common sexually transmitted diseases (STDs) declined in the U.S. during the first few months of the COVID-19 pandemic in 2020, but most surged back by the end of that year, according to Sexually Transmitted Disease Surveillance 2020, a recent CDC report. For the full year, reported cases of gonorrhea, syphilis, and congenital syphilis surpassed 2019 levels.  Although reported cases of chlamydia declined, CDC researchers believe that this was likely due to decreased STD screening and underdiagnosis during the pandemic, rather than an actual decline in chlamydia incidence. Selected findings from the 2020 report are highlighted below.

Chlamydia: In 2020, about 1.58 million cases of Chlamydia trachomatis infection were reported to the CDC, making it the most common notifiable sexually transmitted disease (STD) in the U.S. This corresponds to a rate of 481.3 cases per 100,000 population, an decrease of 13% compared to the rate in 2019. As noted above, however, the drop in reported cases may be the result of underdiagnosis. “During the COVID-19 pandemic, many health care clinics limited in-person visits to patients with symptoms or closed entirely, and it is likely that preventive health care visits where STD screening usually happens, such as annual reproductive health visits for young women, decreased,” CDC notes.

Gonorrhea: A total of about 678,000 cases of gonorrhea were reported in the U.S. during 2019, making it the second most common notifiable STD. This corresponds to a rate of 206.5 cases per 100,000 population in 2020, an increase of 5.7% compared to the previous year. The total annual U.S. cases of gonorrhea has more than doubled since 2009. According to CDC, “Since 2013, rates [of gonorrhea] have been higher among men compared to women, likely reflecting cases identified in both men who have sex with men (MSM) and men who have sex with women only.” About half of all gonorrhea infections during 2020 were estimated to be resistant to at least one antibiotic.

Syphilis: In 2020, about 134,000 cases of all stages of syphilis were reported, including about 42,000 cases of primary and secondary (P&S) syphilis, the most infectious stages of the disease. Since reaching historic lows of about 6,000 cases in 2000 and 2001, the rate of P&S syphilis has increased nearly every year – rising 6.8% from 2019 to 2020. MSM accounted for 53% of all P&S syphilis cases during 2020.

Although rates of P&S syphilis are lower among women than men, women’s rates have been rising quickly in recent years – up 21% between 2019 and 2020 and 145% since 2016. This suggests that the heterosexual syphilis epidemic is continuing to grow rapidly, according to CDC.

Of particular concern is a resurgence in cases of syphilis among newborns, with the total number of cases more than doubling from 941 in 2017 to 2,148 in 2020. The national rate of congenital syphilis has more than tripled since 2016, reaching 57.3 per 100,000 live births in 2020.

CDC Commentary: In an announcement accompanying the release of the 2020 STD data, CDC noted, “Even in the face of a pandemic, 2.4 million cases of STDs were reported in the U.S. in 2020. The syphilis epidemic continued to surge, driving another year of increases in congenital syphilis.”

“There is much to be done to rebuild, innovate, and expand STD prevention in the U.S. to close gaps and create lasting change. We must prioritize and focus our efforts to regain lost ground to control the spread of STDs. Despite many challenges, the field remains dedicated to the work by offering innovative solutions to meet people where they are.”

For additional information on this topic, you can visit NEAETC’s Online HIV Resource Library page focusing on Sexually Transmitted Diseases.

 

Clinical Trials

FDA Moves to Increase Racial and Ethnic Diversity in Clinical Trials

This month, the U.S. Food and Drug Administration (FDA) issued new draft guidance designed to increase enrollment of underrepresented racial and ethnic populations in clinical trials. This draft guidance recommends that sponsors of medical products develop and submit a Race and Ethnicity Diversity Plan to FDA early in clinical development.

In its draft guidance, FDA recommends that the following five elements be included in Race and Ethnicity Diversity Plans:

• an overview of the disease/condition, including its impacts on underrepresented racial and ethnic populations;
• the scope of the medical product development program, including planned clinical trials;
• defined enrollment goals for underrepresented racial and ethnic participants based on the epidemiology of the disease and its impact across racial and ethnic groups;
• specific strategies for enrolling and retaining diverse participants for the duration of planned trials; and
• as development of the medical product proceeds, the status of meeting enrollment goals for underrepresented racial and ethnic populations.

 

“The U.S. population has become increasingly diverse, and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health,” noted FDA Commissioner Dr. Robert Califf. “Going forward, achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities.”

 

Guidelines and Recommendations

Updated Guidelines for Pediatric HIV Treatment and for Prevention and Treatment of OIs in Adults and Adolescents

The U.S. Department of Health and Human Services (HHS) has recently updated its guidelines for pediatric HIV treatment and for the prevention and treatment of opportunistic infections (OIs) in adults and adolescents. 

Sections of the pediatric guidelines that have been updated include:

• clinical and laboratory monitoring of pediatric HIV infection;
• regimens recommended – and not recommended – when starting antiretroviral therapy (ART) in children;
• special considerations for ART use in adolescents with HIV;
• ART adherence in children and adolescents with HIV;
• management of medication toxicity or intolerance; and
• other issues related to managing ART in children.

 

The main updates to the OI guidelines for adults and adolescents are related to bacterial enteric infections, specifically Clostridioides difficile (C. difficile). In the updated guidelines, the recommendations for the management and treatment of C. difficile disease are now aligned with those in recent guidelines from the Infectious Diseases Society of America. HHS’s revised OI guidelines also include an expanded discussion of the role of the drugs fidaxomicin and bezlotoxumab in the treatment of C. difficile disease.

 

CDC Issues Brief Infectious Disease Guide for Correctional and Detention Settings

Earlier this month, CDC published a brief summary of its recommendations for the testing, vaccination, and treatment of HIV, viral hepatitis, STDs, and tuberculosis (TB) in U.S. correctional and detention settings. “Correctional health is important to us because a higher proportion of people in correctional settings have, or are at risk for HIV, viral hepatitis, TB, and STIs because of social and economic factors, mental and substance use disorders, a history of experiences with homelessness, sex work, or injection drug use,” notes Dr. Jonathan Mermin, director of CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention.

“Compared with the general population, prevalence of HIV, viral hepatitis, TB, and STIs is higher among people who are incarcerated:

• HIV – 3 times higher in state and federal prisons;
• Hepatitis C – 10 times higher in jails and prisons;
• TB – 6 times higher in jails and federal prisons; and
• STIs – higher rates of chlamydia and gonorrhea among people aged ≤35 years in juvenile and adult detention facilities.”

 

This quick reference document includes recommended actions for testing, vaccinating, and treating people in correctional and detention settings at intake,  during the period of incarceration/detention, and as part of release planning and linkage to prevention and care services. Another section of the guidance document focuses on the specific needs of pregnant women in these settings. The guide also summarizes CDC’s recommendations on reporting new diagnoses of HIV, viral hepatitis, STDs, and TB to appropriate public health authorities, and provides links to the agency’s health education materials, as well as to full government guidance documents by disease area.

 

Affected Population Groups

New and Updated Resources on HIV Among Youth from AIDSVu

To mark National Youth HIV/AIDS Awareness Day on April 10, AIDSVu published two blog items highlighting HIV among youth. In one post, Char’Lee King of Advocates for Youth discusses the unique impacts of HIV on youth, barriers to care, and intervention that are particularly effective for young people who are at risk for, or living with, HIV. The second blog post focuses on new HIV diagnoses among youth, including the disproportionately high rates of new HIV diagnoses seen in both young Black men and women.

AIDSVu also published the following infographics focusing on the use of HIV pre-exposure prophylaxis, new HIV diagnoses, linkage to care, viral suppression, and social determinants of health among youth at risk for or living with HIV:

• HIV Pre-Exposure Prophylaxis (PrEP) Use Among Youth
• Five States with the Highest Linkage to Care Rates in Young People
• Five States with the Highest Viral Suppression Rates Among Youth
• One-Fifth of All U.S. HIV Diagnoses Were Among Youth
• Black Americans Account for More than Half of New HIV Diagnoses Among Youth
• Youth Have the Lowest Rates of Linkage to HIV Care and Viral Suppression
• Young Black Women Make Up the Majority of All Young Women Living with HIV
• HIV Transmission Categories for Young Men and Women Newly Diagnosed with HIV
• Social Determinants of Health and Youth with HIV

 

CDC and AIDSVu Highlight HIV Among Transgender People

In conjunction with National Transgender HIV Testing Day (NTHTD), CDC and AIDSVu have published new resources spotlighting the impact of HIV on transgender people. CDC’s HIV web resources now include the following topics about HIV and transgender people: terminology, HIV testing, HIV prevention, HIV diagnoses, HIV prevalence, viral suppression, prevention challenges, and what CDC is doing to address HIV among transgender people. Spanish-language versions of these topic pages are also available. In addition, a recent Dear Colleague letter from Dr. Demetre Daskalakis, director of CDC’s Division of HIV Prevention, highlighted the high rates of HIV diagnosis, HIV prevalence, and health disparities among transgender people.

AIDSVu recently added a NTHTD blog post about the disproportionate impact of HIV on the transgender community and barriers to healthcare, including stigma and discrimination, lack of awareness of transgender health among medical providers, and social exclusion. A second AIDSVu post summarizes key data on transgender people and HIV, including recent surveillance figures, prevention challenges and social determinants of health, the HIV care continuum, and PrEP use. AIDSVu has also just updated the following infographics about the transgender community:

• Disproportional Impact of HIV on Black and Hispanic/Latina Transgender Women
• Poverty Rates Among Transgender Women and Men with HIV
• Age Distribution of Transgender Women with HIV
• Rates of HIV Viral Suppression Among Transgender Men and Women
• Percentage of Transgender Women Living with HIV
• HIV Prevalence Among Transgender Women in Seven Major Cities
• Linkage to HIV Care After Diagnosis Among Transgender Women

 

Funding Awards and Opportunities

36 CBOs Receive Funding for High-Impact HIV Prevention Programs

The U.S. Centers for Disease Control and Prevention (CDC) recently awarded funds to 36 community-based organizations (CBOs) under CDC’s Comprehensive High-Impact HIV Prevention Programs for Young Men of Color Who have Sex with Men and Young Transgender Persons of Color (PS22-2203). The CBO funding recipients will develop and implement high-impact HIV prevention programs for young men of color who have sex with men, young transgender persons of color, and their partners regardless of age, gender, and race/ethnicity. This funding opportunity supports key goals of the Ending the HIV Epidemic in the U.S. (EHE) initiative: achieving health equity, reducing disparities, and addressing social determinants of health. PS22-2203 is a $72 million, 5-year program, with first-year funding of about $14.4 million. The full list of funded CBOs can be found here.

 

Opportunities for Community Health Worker Training and Sexual Health Services

The Health Resources and Services Administration (HRSA) Bureau of Health Workforce recently released a funding opportunity (HRSA-22-124) for projects “that will increase the number of Community Health Workers (CHWs) and Health Support Workers and equip them with the skillsets needed to provide effective community outreach, build trust with communities, support connections to and retention in care and support services, and other strategies to increase access to care and to assist individuals in prevention services, and recovery from the COVID-19 pandemic and other public health emergencies in underserved communities.” HRSA expects to make 75 awards totaling $226.5 million. The application due date is June 14, 2022.

The National Association of County and City Health Officials (NACCHO), with the support of CDC, has also recently announced two funding opportunities for health departments to partner with other healthcare entities to expand sexually transmitted infection (STI) and HIV services, treatment, and care in their communities. 

The Leveraging Pharmacies for STI Services and Care opportunity will provide funding to develop, design, and implement a collaborative partnership between pharmacies and health departments to expand STI services and care. Two to five health department/pharmacy teams will be funded up to $75,000 per partnership for this work. Applications are due on May 27.

The Leveraging Retail Health Clinics for STI/HIV Services and Care for Underserved Minorities opportunity will “support integration of sexual health services for underserved and under-diagnosed racial/ethnic and sexual minorities, including young people, across retail health clinics (RHCs), health department, primary care, and other healthcare settings.” Up to three health department-RHC teams will be funded up to $300,000 per partnership for this work. Applications are due on May 31.

 

 

Educational Resources

HHS Releases New Best Practice Guide on Telehealth and HIV Care

Telehealth.hhs.gov has recently published an online practice guide, Telehealth for HIV Care. The guide has the following six sections:

• Getting Started, which provides information about setting up an HIV telehealth program, tracking and sharing the success of a telehealth program, and other program measurement considerations;
• Billing for HIV Telehealth, which provides guidance on billing codes and payment policies for the use of telehealth in HIV diagnosis and management.
• Telehealth and HIV Diagnosis, which provides information on telehealth’s role in HIV screening, supporting HIV self-testing, and preparing patients to begin treatment.
• Treating HIV through Telehealth, which describes the role of telehealth in antiretroviral therapy, laboratory testing, and telementoring.
• Preventing HIV with Telehealth, which includes information on incorporating the delivery of PrEP and post-exposure prophylaxis (PEP) services into telehealth practice; and
• HIV Response and Telehealth, which includes information about the role of cultural humility training in combatting HIV stigma and misinformation.

 

TPAN Publishes 2022 HIV Drug Guide

TPAN recently published its annual HIV Drug Guide for 2022. The guide includes a drug class list that is an A-to-Z listing of approved HIV drugs with information on each individual drug or combination’s brand name, drug class/category, and generic name and common abbreviations. For each medication and combination listed, the guide’s provides detailed information about the standard dosing, potential side effects and toxicity, potential drug interactions, drug manufacturer, wholesale price, and additional relevant information. The drug listings also include different perspectives on each drug and combination through physician and activist comments. In addition, the guide includes an HIV drug chart, as well as articles providing information about the HIV life cycle, common questions and answers about HIV treatment, HHS guidelines for starting HIV treatment, and new drugs under development.