CRUSH-PrEP for Women Project

HIV Clinical Trial

Official title: Connecting Resources for Urban Sexual Health: CRUSH-PrEP for Women

Status Completed

Clinical Trial 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.

Clinical Trial Description

The overall goal of the CRUSH PrEP for Women Project is to enhance and extend a response to the local HIV/AIDS epidemic in Alameda County with a set of innovative, evidence-based interventions across the continuum of HIV prevention and care, which target the individuals and communities that are the most vulnerable to HIV infection. The investigators hypothesize that women in Oakland will be interested in accessing PrEP through a community based clinic. Specifically, the CRUSH PrEP for Women Project is a 16month demonstration project designed to evaluate and assess the adherence of PrEP within a community based clinic. The specific aims of the project are as follows:

Aim 1. Assess uptake and adherence to PrEP among women in the study: 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. Because the effective dose of PrEP is less well characterized for women, only blood concentration levels consistent with daily use will be considered effective use for this analysis. After the supply of study provided medication is ended at 12 months, participants will be followed for an additional 3 months to determine the proportion who continued on PrEP. The investigators will describe patterns of use and the barriers and facilitators to continued use beyond one year. The investigators will look at demographic, and psychosocial and risk factors that may be associated with less than daily adherence to medication, and describe reasons for early discontinuation of PrEP among any women who choose to stop taking medication prior to the end of the first 12 months. Factors associated with discontinuation at the end of the 12-month study provided supply of medication will also be described. Although these analyses will be exploratory, the investigators hypothesize that changes in relationships and pregnancy intentions will be related to changes in PrEP use.

Aim 2. Assess the characteristics of women who enroll in the PrEP study: For Aim 2, 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 our 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.

Aim 3: Assess the referral sources of women who enroll in the PrEP study: Process data will capture the outreach efforts made to recruit participants for this study. At the time of baseline visit, the source of referral for each woman screened will be captured, 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. ;

Related Conditions & MeSH terms

• HIV
• Sexually Transmitted Diseases

• NCT number: NCT02852226
• Study type: Interventional
• Source: University of California, San Francisco
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Completion date: August 2017