Developing a PrEP Adherence Intervention Targeting At-Risk and Substance Using Women
NCT ID: NCT04396678
Last Updated: 2021-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2019-06-12
2020-12-01
Brief Summary
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Detailed Description
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The intervention includes three main components: 1) group PrEP engagement sessions, which include four educational sessions that situate PrEP in a broader framework of access and barriers to care, provider/patient communication, sexual health, HIV/sexually transmitted infection (STI) education, harm reduction around drug use, stigma, risk compensation and safe sex, and health/science literacy; 2) peer navigation, which aims to help women navigate healthcare engagement with the SPARC nurse practitioner and other providers; and 3) an mHealth component, consisting of a two-way text messaging system through which women will receive automated daily messages and weekly messages requesting adherence reports.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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PrEP Standard of Care
PrEP standard of care, administered through the Baltimore City Health Department
No interventions assigned to this group
PrEP standard of care+behavioral intervention
PrEP standard of care, administered through the Baltimore City Health Department, and the behavioral intervention.
PrEP standard of care+behavioral intervention
The intervention includes three main components: 1) group PrEP engagement sessions, which include four educational sessions that situate PrEP in a broader framework of access and barriers to care, provider/patient communication, sexual health, HIV/STI education, harm reduction around drug use, stigma, risk compensation and safe sex, and health/science literacy; 2) peer navigation, which aims to help women navigate healthcare engagement with the SPARC nurse practitioner and other providers; and 3) an mHealth component, consisting of a two-way text messaging system through which women will receive automated daily messages and weekly messages requesting adherence reports.
Interventions
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PrEP standard of care+behavioral intervention
The intervention includes three main components: 1) group PrEP engagement sessions, which include four educational sessions that situate PrEP in a broader framework of access and barriers to care, provider/patient communication, sexual health, HIV/STI education, harm reduction around drug use, stigma, risk compensation and safe sex, and health/science literacy; 2) peer navigation, which aims to help women navigate healthcare engagement with the SPARC nurse practitioner and other providers; and 3) an mHealth component, consisting of a two-way text messaging system through which women will receive automated daily messages and weekly messages requesting adherence reports.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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Baltimore City Health Department
OTHER
Johns Hopkins Bloomberg School of Public Health
OTHER
Responsible Party
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Principal Investigators
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Susan Sherman, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Locations
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SPARC Center
Baltimore, Maryland, United States
Countries
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Other Identifiers
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126993
Identifier Type: -
Identifier Source: org_study_id
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