NCT03705663: PrEP

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

Completed Last updated 15 December 2022

What this trial tests

trial testing PrEP initiation in Pre-Exposure Prophylaxis in 25 participants. Completed in 27 April 2020.

Timeline

1 July 2018

Primary endpoint
15 March 2020

27 April 2020

Quick facts

Lead sponsor	Medstar Health Research Institute
Status	Completed
Study type	OBSERVATIONAL
Enrollment	25
Start date	1 July 2018
Primary completion	15 March 2020
Estimated completion	27 April 2020
Sites	2 locations across United States

Drugs / interventions tested

• PrEP initiation

Conditions studied

• Pre-Exposure Prophylaxis — all drugs for Pre-Exposure Prophylaxis →

Sponsor

Medstar Health Research Institute

Who can join

18 and older, female only, with Pre-Exposure Prophylaxis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Implementation of an Educational Intervention to Improve HIV Pre-Exposure Prophylaxis Services for Women in an Urban Sexual Health Clinic.
   Scott RK, Deyarmond M, Marwitz S, Huang JC, et al · · 2023 · cited 14× · PMID 37713289 · DOI 10.1089/apc.2023.0107