# Offering women PrEP with education, shared decision-making and trauma-informed care: the OPENS trial

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2020 · $469,972

## Abstract

PROJECT SUMMARY
 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 Co...

## Key facts

- **NIH application ID:** 9892890
- **Project number:** 5R01MD013565-03
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** Christine E Dehlendorf
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $469,972
- **Award type:** 5
- **Project period:** 2018-09-01 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9892890

## Citation

> US National Institutes of Health, RePORTER application 9892890, Offering women PrEP with education, shared decision-making and trauma-informed care: the OPENS trial (5R01MD013565-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9892890. Licensed CC0.

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