Identification of the Pre-exposure Prophylaxis (PrEP) Cascade for Women.

NCT03705663 | Completed

• 1 other identifier: 2017-0870
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

Pre-exposure prophylaxis (PrEP) is a daily pill that greatly reduces the risk of transmission of human immunodeficiency virus (HIV), however the barriers to PrEP use for women are understudied and PrEP is underutilized by women. Partnering with the DC Department of Health and the DC Center for AIDS Research (DC-CFAR), the overarching goals are (1) to identify and populate the PrEP cascade for women, (2) to provide a blueprint for family planning providers to integrate HIV prevention into their practices and target evidence-based interventions to the women at highest risk for HIV in their communities, and (3) to evaluate the cost-effectiveness of this intervention. The overarching hypotheses are that (1) the timeline and roadmap to PrEP adoption and the PrEP cascade will be different for cis-gender women than that described for men who have sex with men (MSM) and transgender women, (2) women seeking family planning services will be eligible for and interested in PrEP and family planning providers are ideally situated to provide this care, and (3) provision of PrEP in the family planning setting will be cost-effective. This research proposes to evaluate (1) PrEP cascade of events for women (eligibility for PrEP, acceptability/interest in PrEP, access/linkage to a PrEP program, initiation of PrEP, retention, and adherence to PrEP) and (2) the integration of universal screening for PrEP and PrEP provision into a women's family planning clinic. This research will allow for targeted evidence-based interventions to reach women at high-risk for HIV and will provide a blueprint for the implementation of PrEP services in the family planning setting nationally.

Conditions

Pre-Exposure Prophylaxis

Keywords

HIV prevention, PrEP cascade, women

Outcome Measures

Primary Outcomes (1)

• PrEP cascade in cis-gender women

  We will be using a variety of measures to describe the "PrEP cascade" for women, specifically the proportion of women who initiate, continue, and adhere to PrEP and the timeline associated with the steps of the PrEP cascade.

  2 years

Secondary Outcomes (2)

• Implementation analysis of universal PrEP screening

  2 years

• Cost effectiveness analysis of universal PrEP screening

  2 years

Study Arms (1)

Women interested in HIV PrEP

Cis-gender women at high risk for HIV interested in or initiating HIV PrEP

Behavioral: PrEP initiation

Interventions

PrEP initiation BEHAVIORAL

Women who are interested in or who initiate PrEP will be followed in a prospective cohort to identify and populate the PrEP cascade for cis-gender, high risk women

Women interested in HIV PrEP

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cis-gender women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women at high risk for HIV interested in and/or initiating pre-exposure prophylaxis (PrEP)

You may qualify if:

• Cis-gender women
• Interested in PrEP and/or initiating PrEP

You may not qualify if:

• HIV positive
• Severe liver disease
• Severe renal (kidney) disease
• Signs/symptoms of acute HIV infection (such as fever, swollen lymph nodes, sore throat, skin rash, body aches)
• Do not speak English or Spanish
• No access to a telephone for follow-up
• Planning to leave the Washington, DC area in the next 6 months

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (2)

DC Health and Wellness Center

Washington D.C., District of Columbia, 20002, United States

Location

Rachel Scott

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (1)

• Scott RK, Deyarmond M, Marwitz S, Huang JC, Moriarty P, Visconti AJ, Beverley J, Elion R, Coleman M, Hull SJ. Implementation of an Educational Intervention to Improve HIV Pre-Exposure Prophylaxis Services for Women in an Urban Sexual Health Clinic. AIDS Patient Care STDS. 2023 Sep;37(9):447-457. doi: 10.1089/apc.2023.0107.

  PMID: 37713289 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Dried Blood Spots

Study Officials

• Rachel K Scott, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: October 15, 2018
• Study Start: July 1, 2018
• Primary Completion: March 15, 2020
• Study Completion: April 27, 2020
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Upon request.
• Access Criteria: Pending review of concept sheet.

Locations

US (2)