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

Johns Hopkins Bloomberg School of Public Health

Status: Completed

Conditions: HIV/AIDS

Treatments: Behavioral: PrEP standard of care+behavioral intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04396678

126993

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 2 patient groups

PrEP Standard of Care

No Intervention group

Description:

PrEP standard of care, administered through the Baltimore City Health Department

PrEP standard of care+behavioral intervention

Experimental group

Description:

PrEP standard of care, administered through the Baltimore City Health Department, and the behavioral intervention.

Treatment:

Behavioral: PrEP standard of care+behavioral intervention