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BACKGROUND The relationship between sexual violence and HIV risk has been extensively documented through social and behavioral research; however, the underlying biological mechanisms are poorly understood. OBJECTIVE The purpose of the THRIVE (Trauma and HIV Risk: Investigating Stress and the Immune Disruption of the Vaginal Environment) Study is to examine the impact of sexual trauma due to sexual violence on HIV susceptibility through dysregulation of soluble inflammatory and anti-inflammatory and anti-HIV biomarkers in the female genital tract and dysregulation of the hypothalamic-pituitary-adrenal axis among adolescent girls and adult women. METHODS The THRIVE Study is a longitudinal case-control study conducted in San Diego, CA, among a racially diverse sample. Cases are adolescent girls (aged 14-19 years) or adult women (aged 20-45 years) who have experienced forced vaginal penetration by a phallus perpetrated by a man within the past 15 days. Controls are adolescent girls or adult women who have engaged in consensual vaginal sex with a man within the past 15 days. At baseline and 1- and 3-month follow-up study visits, participants undergo a urine-based pregnancy test; venipuncture blood draw for HIV, C-reactive protein, adrenocorticotropic hormone, and progesterone testing; a 45-min interviewer-administered computer survey; and cervicovaginal lavage to measure proinflammatory and anti-inflammatory and anti-HIV soluble immune biomarkers. After each study visit, participants self-collect saliva specimens (upon waking, 30 min after waking, and 45 min after waking) at home for 3 consecutive days, which are later assayed for cortisol and dehydroepiandrosterone sulfate. Participants receive compensation at each study visit and for the return of saliva specimens, and a list of local medical and support services. Study procedures use trauma-informed care methods, given the sensitive nature of the study and enrollment of women in the acute phase after sexual trauma. All research staff and investigators adhere to ethical principles and guidelines in the conduct of research activities. Data will be analyzed for descriptive and inferential analyses. RESULTS The recruitment of participants is ongoing. The publication of the first results is expected by late 2021. CONCLUSIONS The THRIVE Study will provide foundational knowledge on how sexual trauma due to sexual violence increases susceptibility to HIV acquisition via alterations in cervicovaginal immune regulation and the psychobiology of the stress responses. These findings will inform future research on mechanistic models of in vitro and in vivo injury and cervicovaginal wound healing processes, which may lead to the development of nonvaccine biomedical HIV prevention products for girls and women. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/18190

Background The relationship between sexual violence and HIV risk has been extensively documented through social and behavioral research; however, the underlying biological mechanisms are poorly understood. Objective The purpose of the THRIVE (Trauma and HIV Risk: Investigating Stress and the Immune Disruption of the Vaginal Environment) Study is to examine the impact of sexual trauma due to sexual violence on HIV susceptibility through dysregulation of soluble inflammatory and anti-inflammatory and anti-HIV biomarkers in the female genital tract and dysregulation of the hypothalamic-pituitary-adrenal axis among adolescent girls and adult women. Methods The THRIVE Study is a longitudinal case-control study conducted in San Diego, CA, among a racially diverse sample. Cases are adolescent girls (aged 14-19 years) or adult women (aged 20-45 years) who have experienced forced vaginal penetration by a phallus perpetrated by a man within the past 15 days. Controls are adolescent girls or adult women who have engaged in consensual vaginal sex with a man within the past 15 days. At baseline and 1- and 3-month follow-up study visits, participants undergo a urine-based pregnancy test; venipuncture blood draw for HIV, C-reactive protein, adrenocorticotropic hormone, and progesterone testing; a 45-min interviewer-administered computer survey; and cervicovaginal lavage to measure proinflammatory and anti-inflammatory and anti-HIV soluble immune biomarkers. After each study visit, participants self-collect saliva specimens (upon waking, 30 min after waking, and 45 min after waking) at home for 3 consecutive days, which are later assayed for cortisol and dehydroepiandrosterone sulfate. Participants receive compensation at each study visit and for the return of saliva specimens, and a list of local medical and support services. Study procedures use trauma-informed care methods, given the sensitive nature of the study and enrollment of women in the acute phase after sexual trauma. All research staff and investigators adhere to ethical principles and guidelines in the conduct of research activities. Data will be analyzed for descriptive and inferential analyses. Results The recruitment of participants is ongoing. The publication of the first results is expected by late 2021. Conclusions The THRIVE Study will provide foundational knowledge on how sexual trauma due to sexual violence increases susceptibility to HIV acquisition via alterations in cervicovaginal immune regulation and the psychobiology of the stress responses. These findings will inform future research on mechanistic models of in vitro and in vivo injury and cervicovaginal wound healing processes, which may lead to the development of nonvaccine biomedical HIV prevention products for girls and women. International Registered Report Identifier (IRRID) DERR1-10.2196/18190