NIH – Strengthening HIV Prevention Efforts for Women in the Southern U.S. (R01 Clinical Trial Optional)

November 20, 2020 by


This Funding Opportunity Announcement (FOA) invites applications for Research Project Grants (R01) that will increase the use of HIV prevention strategies among women in the southern U.S. by elucidating barriers and facilitators to their utilization and developing and testing interventions to enhance uptake, adherence, and persistence. Research should focus on strategies within the following three potentially overlapping areas: implementation science, health communication research, and services research.

This FOA uses the R01 grant mechanism, while RFA-MH-21-150 uses the R34 mechanism. Applications with preliminary data and/or those including longitudinal analysis should consider using the R01 mechanism. Applicants proposing to develop and pilot test an intervention should consider the R34 mechanism.


One out of every five new HIV diagnoses in the United States occurs in a cisgender or transgender woman. This translated to almost 8,000 women (21%) in 2018. The majority of new cases were among African American and Latina women. Although the overall HIV incidence rates have been decreasing among cisgender women in the US, they have remained relatively unchanged among transgender women and significant disparities persist for racial and ethnic minorities.

Just over 7,000 cisgender women acquired HIV in 2018. The majority of women reported that they acquired HIV due to heterosexual contact (85%), while a smaller percentage was attributed to injection drug use (15%). Significant racial and ethnic disparities were evident as African American cisgender women comprised 57% of new diagnoses, Whites made up 21%, Latinas 18%, and other racial groups (Multiple Races, Asian, American Indian/Alaska Native and Native Hawaiian and Other Pacific Islander) each made up two percent or less.

Transgender women have some of the highest rates of HIV in the US, as an estimated 14% of transgender women are living with HIV. From 2014 through 2018, 2,808 transgender women were diagnosed with HIV in the U.S. The majority of transgender women who acquired HIV in 2018 identified as Black or Latinx (49% and 33%, respectively), and were emerging adults (age 20-24; 27%) or young adults (age 25-34; 29%).

There is also significant geographic variability in HIV incidence, with the preponderance of new diagnoses among cisgender women occurring in the South. In 2018, the South had the highest rate of new diagnoses among all individuals with 15.6 per 100,000 persons, compared to 9.9, 9.7, and 7.2 per 100,000 persons in the Northeast, West, and Midwest, respectively. The South accounted for 55% of the new HIV diagnoses among cisgender women in 2017, highlighting the importance of geographical considerations in addressing HIV prevention among cisgender women in the U.S. Similar to HIV rates among cisgender women, a significant proportion of HIV transmission among transgender women occurs in the South, accounting for 42.8% of all new diagnoses among transgender women.

There are now a number of effective strategies to reduce the risk of HIV acquisition among cisgender and transgender women, with even more strategies in development. However, awareness, uptake, adherence, and persistence to HIV prevention strategies remains low among women in the U.S. For example, despite FDA approval in 2012, the uptake of pre-exposure prophylaxis (PrEP) among women is low. In 2015, more than 170,000 cisgender women had indications for PrEP use, however, only 2.1% were prescribed PrEP. There is also inequitable prescription of PrEP among racial and ethnic groups; in 2016, nearly 6 times as many PrEP prescriptions were written for White women than were written for African American women.

Research suggests limited PrEP awareness and use in the southern U.S. despite a high proportion of eligibility and acceptability. Once informed of PrEP, both cisgender and transgender women in this region encounter a variety of barriers to PrEP uptake that stem from social, economic, structural, and institutional sources of influence. Barriers to use include concerns about costs related to PrEP; need to maintain high rates of adherence; side effects that result from PrEP use alone and drug-drug interactions; and fear of negative perceptions from partners and family. For marginalized communities, a history of medical mistrust and negative patient-provider interactions can deter clinic-based discussions on perceived HIV risk and subsequent PrEP use.

Barriers to use may include substance use (including opioids and stimulants) and psychiatric disorders, exposure to intimate partner violence, marginal housing, and material insufficiencies. In turn, addressing unmet needs for substance use disorder treatment, harm reduction, mental health care and adequate social service support may enhance uptake of PrEP and other HIV prevention practices.

Effective strategies exist to reduce the rates of new diagnoses but there continue to be new diagnoses among women in the southern U.S. that could be averted. A renewed focus on counties and states in the southern U.S. with high rates of new diagnoses among women is needed.

Key Dates:

Posted Date: November 17, 2020
Open Date (Earliest Submission Date): December 11, 2020
Letter of Intent Due Date(s): December 11, 2020
Application Due Date(s): January 11, 2021

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Filed Under: Funding Opportunities