CRUSH-PrEP for Women Project

NCT02852226 | Completed

• 1 other identifier: 15-17574
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• The proportion of women eligible for PrEP who choose to access PrEP.

  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.

  48 weeks

Study Arms (1)

Study Intervention

EXPERIMENTAL

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

Interventions

Pre Exposure Prophylaxis OTHER

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

Study Intervention

Characteristics of women who enroll BEHAVIORAL

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.

Study Intervention

referral sources of women who enroll BEHAVIORAL

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.

Study Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• have a male sexual partner who is HIV positive
• 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,
• have sexual partners of unknown HIV status with any of the factors previously listed.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Gilead Sciences: collaborator
• Lifelong Medical Care: collaborator

Study Sites (1)

Lifelong Medical Care

Oakland, California, 94605, United States

Location

Related Publications (4)

• Eisingerich AB, Wheelock A, Gomez GB, Garnett GP, Dybul MR, Piot PK. Attitudes and acceptance of oral and parenteral HIV preexposure prophylaxis among potential user groups: a multinational study. PLoS One. 2012;7(1):e28238. doi: 10.1371/journal.pone.0028238. Epub 2012 Jan 11.

  PMID: 22247757 BACKGROUND

• Gupta N, Schmidt H, Buisker T, Dufour MS, Goldenson J, Myers J, Tulsky J. After the Fact: A Brief Educational Program on HIV Postexposure Prophylaxis for Female Detainees in a Local Jail. J Correct Health Care. 2015 Apr;21(2):140-51. doi: 10.1177/1078345815572335.

  PMID: 25788609 BACKGROUND

• Koester KA, Maiorana A, Vernon K, Myers J, Rose CD, Morin S. Implementation of HIV prevention interventions with people living with HIV/AIDS in clinical settings: challenges and lessons learned. AIDS Behav. 2007 Sep;11(5 Suppl):S17-29. doi: 10.1007/s10461-007-9233-8. Epub 2007 Apr 11.

  PMID: 17436072 BACKGROUND

• Auerbach JD, Kinsky S, Brown G, Charles V. Knowledge, attitudes, and likelihood of pre-exposure prophylaxis (PrEP) use among US women at risk of acquiring HIV. AIDS Patient Care STDS. 2015 Feb;29(2):102-10. doi: 10.1089/apc.2014.0142. Epub 2014 Dec 16.

  PMID: 25513954 RESULT

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Pre-Exposure Prophylaxis

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Janet Myers, PhD

  UCSF Center for AIDS Prevention

  PRINCIPAL INVESTIGATOR

• Mi-Suk Kang Dufour, PhD

  UCSF Center for AIDS Prevention

  PRINCIPAL INVESTIGATOR

• Kimberly A Koester, MA

  UCSF Center for AIDS Prevention

  PRINCIPAL INVESTIGATOR

• Rebecca Packard, BA

  UCSF Center for AIDS Prevention

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: August 2, 2016
• Study Start: May 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 11, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)