Offering Women with PrEP with Education, shared decision-making and trauma-informed care: the OPENS trial

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Investigator: Christine Dehlendorf, MD, MAS
Sponsor: NIH National Institute of Minority Health and Health Disparities

Location(s): United States

Description

There are striking racial and regional disparities in HIV diagnoses in women in the U.S., as well as in utilization of effective HIV prevention methods such as pre-exposure prophylaxis (PrEP) for HIV prevention. Reasons for these disparities are multifactorial, and require multi-level interventions to address them. The objective of this study is to improve mechanisms of identifying women vulnerable to HIV in the Southern U.S. and offer them comprehensive HIV prevention methods, including PrEP, through use of a patient-level intervention—offering universal education about PrEP via an HIV prevention decision support tool--a provider-level intervention— training on shared decision-making—and a clinic-level intervention--training on trauma-informed care— ultimately mitigating disparities in the HIV epidemic in women by increasing PrEP uptake in Southern U.S. women of color.

Although 13% of the U.S. female population is Black, 60% of new HIV diagnoses in U.S. women are in Black women. The South is the epicenter of the U.S. HIV epidemic, including in women, and Black Southern women are disproportionately affected: Black women account for 69% of new HIV diagnoses in women in the South. As the first highly effective, discrete, woman-controlled HIV prevention method, oral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate/emtricitabine radically expands HIV prevention options for women. However, uptake of PrEP in U.S. women has lagged, particularly among groups most affected by HIV. The Centers for Disease Control and Prevention (CDC) estimates 468,000 women in the U.S. are eligible for PrEP, but only approximately 19,000 have ever been prescribed PrEP. Moreover, despite disparities in incident HIV in U.S. women, White women are 4 times more likely to have received PrEP than Black women. PrEP cascades outline the necessary steps for accessing PrEP, including screening and identifying eligible individuals, linkage to care, prescription and initiation of PrEP. Data suggest there are multilevel barriers related to the process of screening for HIV risk in women and identifying potential PrEP candidates that may drive a significant drop off early in the PrEP cascade for women. The objective of this proposal is to improve mechanisms of offering PrEP to women through use of a patient-level intervention—an HIV prevention decision support tool (DST); a provider-level intervention—training on shared decision-making; and a clinic-level intervention--training on trauma-informed care, with the goal of ultimately mitigating disparities in the HIV epidemic in women by increasing PrEP uptake in Southern U.S. women of color. This study will occur at 2 reproductive health clinics in Duval County, Florida, were HIV incidence in women is high. In Aim 1, participants will be randomized to an HIV prevention DST coupled with standard counseling or standard counseling alone to evaluate the effect of the DST on PrEP prescriptions as well as patient experiences of PrEP care and counseling. In Aim 2, a 3-phase approach will be used to evaluate how provider training on shared decision making and clinic-wide training on trauma-informed care affect patient counseling and decision making about PrEP. Baseline data collected in Phase 1 will be compared to data collected after the trainings without use of the DST (Phase 2), and to data collected after the trainings with use of the DST (Phase 3). Data collection in each 3-month phase will include chart extraction on PrEP prescriptions, exit surveys with women about HIV prevention choices and quality of counseling, audio-taped counseling sessions, and interviews with women of color to explore experiences of HIV prevention counseling and care. In the final aim, the feasibility of disseminating the multilevel interventions described in Aims 1&2 will be assessed using the Consolidated Framework for Implementation Research, providing preliminary data on implementation.