Clinical trial NCT04396678: Developing a PrEP Adherence Intervention Targeting At-Risk and Substance Using Women
Official title: Developing a PrEP Adherence Intervention Targeting At-Risk and Substance Using Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Baltimore City Health Department
First posted: 2020-05-20
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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-exposure prophylaxis (PrEP) engagement among street-based female sex workers (FSW) in Baltimore, Maryland.

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-reported PrEP adherence as well as biological adherence indicators.

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change over time to adherence to PrEP using plasma
timeFrame: 3 and 6 months
measure: Change over time to adherence to PrEP using dried blood spots
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Behavioral outcomes change over time
timeFrame: 3 and 6 months
measure: Social outcomes change over time
timeFrame: 3 and 6 months
measure: Structural vulnerabilities change over time
timeFrame: 3 and 6 months
measure: Individual health change over time
timeFrame: 3 and 6 months
measure: Individual PrEP change over time
timeFrame: weekly, from baseline visit to last study visit (six months from baseline)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: SPARC Center
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Susan Sherman, PhD
role: PRINCIPAL_INVESTIGATOR
References: