Protocol: the American Women: Assessing Risk Epidemiologically (AWARE) cohort study

Area of Science:

• Public Health
• Epidemiology
• Social and Behavioral Sciences

Background:

• Despite progress, HIV incidence among cisgender women remains a significant public health concern, falling short of epidemic control goals.
• Key populations, including cisgender women, require targeted strategies to reduce HIV transmission and improve health outcomes.

Purpose of the Study:

• To recruit and retain a large, diverse national sample (N=1,800) of cisgender women aged 14+ at higher risk for HIV seroconversion.
• To investigate predictors of HIV-related sexual risk and HIV incidence using a social-ecological framework.
• To employ innovative electronic recruitment methods, including social media with community-informed advertisements.

Main Methods:

• A US-based national longitudinal cohort study involving cisgender women at higher likelihood of HIV seroconversion.
• Collection of demographic data, substance use, mental health symptoms, interpersonal violence, and social factors via surveys.
• Collection of biospecimens (vaginal/rectal swabs, blood) every 6 months for 2 years to test for HIV and other sexually transmitted infections.

Main Results:

• Participant recruitment commenced in June 2023.
• Baseline enrollment is projected to conclude in July 2025.

Conclusions:

• Culturally sensitive and innovative strategies are crucial for enhancing access to HIV prevention and treatment for cisgender women.
• Study findings will guide future research, intervention development, and public policy to combat the HIV epidemic in this population.