An interventional study of Pre Exposure Prophylaxis and Characteristics of women who enroll in Sexually Transmitted Diseases and HIV, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-11.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention
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.
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.
424 studies on the registry are indexed under Sexually Transmitted Diseases; 71 are open to participants now.
This study's enrollment of 30 is below the median of 470 across 346 interventional studies indexed under Sexually Transmitted Diseases.
Browse Sexually Transmitted Diseases studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
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Eligibility criteria include: women not infected with HIV who are in one or more of the following risk groups:
engage in sexual activity within a high HIV-prevalence area or social network, and who have one or more of the following risk factors:
Inconsistent or no condom use,
Diagnosis of sexually transmitted infections,
Exchange of sex for commodities,
Use of intravenous drugs or alcohol dependence or both,
Exclusion Criteria:
Absolute Exclusion Criteria:
Potential Exclusion Criteria:
Assess PrEP among women in the study. Assess the characteristics of women who enroll in the PrEP study. Assess the referral sources of women who enroll in the PrEP study
Other: Pre Exposure Prophylaxis · Behavioral: Characteristics of women who enroll · Behavioral: referral sources of women who enroll
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.
Also known as: PrEP
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.
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.
The proportion of women eligible for PrEP who choose to access PrEP.
Time frame: 1 year
Monitor adherence to PrEP through pharmacy pick up information. Self reported adherence and blood levels.
Pharmacy records will be accessed to monitor pick-up records. Self administered quantitative interviews will collect self reported adherence to PrEP. Dried blood spot tests are conducted to establish the amount of PrEP taken.
Time frame: 48 weeks
Plan to share: Yes — Access is restricted to those who successfully submit a protocol to the UCSF IRB.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Sexually Transmitted Diseases→
University of California, San Francisco