CRUSH-PrEP for Women Project

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 50
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Gilead Sciences; Lifelong Medical Care
• Last Updated: 2016-09-07

Criteria

Inclusion Criteria:

• Women who are over 18, able to provide consent in English and intending to reside in the study area for the next 15 months and meeting the eligibility criteria for PrEP per the American College of Obstetricians and Gynecologists 2014 recommendations will be enrolled and complete a baseline evaluation visit.

Eligibility criteria include: women not infected with HIV who are in one or more of the following risk groups:

1. have a male sexual partner who is HIV positive

2. 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,

3. have sexual partners of unknown HIV status with any of the factors previously listed.

Exclusion Criteria:

• Absolute Exclusion Criteria:

• Under the age of 18

• Inability to provide informed consent in English

• Intention to leave the study area within the following 15 months

• Insufficient renal function (estimated creatinine clearance less than 60 mL/min)

• HIV infected

• Breastfeeding

Potential Exclusion Criteria:

• High risk known or suspected exposure to HIV within 72 hours prior to presentation;

• Osteoporosis;

• History of pathological bone fractures not related to trauma;

• Ongoing therapy with a drug with significant nephrotoxic potential (other than over the counter non-steroidal anti-inflammatory drugs taken as directed);

• Concomitant participation in a clinical trial using investigational agents, including placebo-controlled clinical trials using such agents;

• Any other conditions that are deemed contraindications for PrEP by the NP/MD; or

• Any other condition that would preclude provision of informed consent; make participation in the project unsafe; complicate interpretation of outcome data; or otherwise interfere with achieving the project objectives, based on the opinion of the investigators and/or treating clinician.