Status:

COMPLETED

Developing a PrEP Adherence Intervention Targeting At-Risk and Substance Using Women

Lead Sponsor:

Johns Hopkins Bloomberg School of Public Health

Collaborating Sponsors:

Baltimore City Health Department

Conditions:

HIV/AIDS

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief Summary

The purpose of this study is to develop and assess the feasibility, acceptability, and preliminary efficacy on adherence of a community-informed intervention for tenofovir/emtricitabine (TDF/FTC) pre-...

Detailed Description

This study is a prospective two-group trial comparing the efficacy of a comprehensive PrEP adherence program compared to PrEP standard of care among FSW. Outcomes will be assessed through self-reporte...

Eligibility Criteria

Inclusion

  • Age 18 or older
  • Assigned female at birth and identify as a woman
  • Traded sex for money or drugs at least three times in the past three months
  • HIV negative
  • Willing to initiate PrEP
  • Not knowingly pregnant or planning to become pregnant during the following 6 months.

Exclusion

  • Currently taking PrEP for HIV prevention
  • Inability to provide informed consent in English
  • Women who are determined as too high or drunk
  • Women who are cognitively impaired
  • Does not agree to data sharing with the Baltimore City Health Department

Key Trial Info

Start Date :

June 12 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2020

Estimated Enrollment :

39 Patients enrolled

Trial Details

Trial ID

NCT04396678

Start Date

June 12 2019

End Date

December 1 2020

Last Update

August 31 2021

Active Locations (1)

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1

SPARC Center

Baltimore, Maryland, United States, 21230