CRUSH-PrEP for Women Project

Summary

UCSF is conducting an evaluation of a demonstration project. The aims of the CRUSH-PrEP for Women project are to integrate the delivery of a comprehensive PrEP package for HIV-negative at-risk women into primary care settings. The delivery of the PrEP package will leverage the well regarded reputation of the LifeLong primary care clinicians to provide a highly effective combination HIV prevention strategy including; PrEP, post-exposure prophylaxis (nPEP), repeat HIV and STI testing, treatment of sexually transmitted infections. Counselling for for sexual health promotion and services specifically designed for vulnerable women such as staying free of violence and domestic abuse will be offered as an integrated part of this package. UCSF will conduct evaluation activities only. The investigators expect that UCSF will enroll 50 participants in the evaluation assessments across the 15 months of data collection. Evaluation cohort participants will provide quantitative data to evaluate the linkage and engagement in care among clinic attendees as well as the uptake and use of Pre-Exposure Prophylaxis.

Conditions

• Sexually Transmitted Diseases
• HIV

Interventions

OTHER

Pre Exposure Prophylaxis

Uptake will be measured as the proportion of female patients at the LifeLong clinic who are approached that start PrEP after being offered PrEP, the numbers and rate of PrEP discontinuation, the reasons given for PrEP discontinuation (side effects, no longer at risk, fear of stigma, inability to adhere), and drug concentrations. Drug concentrations are monitored using dried blood spots, which have a large dynamic range capable of detecting use of a few pills every month up through daily use. The main measure of PrEP utilization is the proportion of time that PrEP is used effectively among those attempting to use PrEP.

BEHAVIORAL

Characteristics of women who enroll

The investigators are interested in characterizing the women who decide to take PrEP through this project. Demographic and psychosocial variables will be used to describe the population who enroll. Sexual and behavioral risk profiles of those who decide to initiate PrEP will also be described as part of this study. Demographics of women who uptake PrEP through community partners will also be compared to the demographics of Alameda County women who have incident HIV infection. In addition to demographics and risk behavior, the investigators will also describe the contraceptive use and intentions of women on PrEP towards future pregnancies as these may be important factors driving interest in PrEP among women.

BEHAVIORAL

referral sources of women who enroll

Process data will capture the outreach efforts made to recruit participants for this study. At the time of baseline visit, the investigators will capture the source of referral for each woman screened, as well as the primary reason for joining the study. Enrollment progress will be carefully tracked against outreach activities to monitor the relationship between outreach efforts and demand generation. This will help to inform future implementation of PrEP among women.

Sponsors & Collaborators

• Gilead Sciences

  collaborator INDUSTRY

• Lifelong Medical Care

  collaborator UNKNOWN

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Janet Myers, PhD · UCSF Center for AIDS Prevention

• Mi-Suk Kang Dufour, PhD · UCSF Center for AIDS Prevention

• Kimberly A Koester, MA · UCSF Center for AIDS Prevention

• Rebecca Packard, BA · UCSF Center for AIDS Prevention

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-05-31

Primary Completion

2017-08-31

Completion

2017-08-31

Countries

• United States

Study Locations