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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Care Provider)
  • Study Primary Completion Date: July 1, 2020

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.

Interventions

  • Behavioral: 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.

Arms, Groups and Cohorts

  • No Intervention: PrEP Standard of Care
    • PrEP standard of care, administered through the Baltimore City Health Department
  • Experimental: PrEP standard of care+behavioral intervention
    • PrEP standard of care, administered through the Baltimore City Health Department, and the behavioral intervention.

Clinical Trial Outcome Measures

Primary Measures

  • Change over time to adherence to PrEP using plasma
    • Time Frame: 3 and 6 months
    • Adherence as the biological outcome, measured by the use of plasma to see concentration of tenofovir (ng/mL), to examine the pilot study’s impact on adherence and inform metrics and outcomes of a future R01.
  • Change over time to adherence to PrEP using dried blood spots
    • Time Frame: 3 and 6 months
    • Adherence as the biological outcome, measured by the use of dried blood spots to see concentration of tenofovir (fmol/punch), to examine the pilot study’s impact on adherence and inform metrics and outcomes of a future R01.

Secondary Measures

  • Behavioral outcomes change over time
    • Time Frame: 3 and 6 months
    • unsafe syringe use, unsafe sex, measured by survey. No scales for these, just individual questions about behavior. Syringe use are binary yes/no questions, condom use is frequency of condom use during vaginal, oral, and anal sex (separately).
  • Social outcomes change over time
    • Time Frame: 3 and 6 months
    • Social support, measured by survey. Social support: Moser, A., Stuck, A. E., Silliman, R. A., Ganz, P. A., & Clough-Gorr, K. M. (2012). The eight-item modified Medical Outcomes Study Social Support Survey: psychometric evaluation showed excellent performance. Journal of clinical epidemiology, 65(10), 1107-1116. Possible range is 0-32, higher score indicates better outcome
  • Structural vulnerabilities change over time
    • Time Frame: 3 and 6 months
    • housing, access to healthcare, measured by survey. Access to healthcare partially measured by: modified Kalichman, S. C., Catz, S., and Ramachandran, B. (1999). Barriers to HIV/AIDS treatment and adherence among African-American adults with disadvantaged education. Journal of the National Medical Association, 91, 439-446. Higher # endorsed means greater barriers to care
  • Individual health change over time
    • Time Frame: 3 and 6 months
    • PrEP uptake, awareness and knowledge, measured by survey. Adapted from the ACTG Adherence Questionnaire The AIDS Clinical Trials Group (ACTG) (2009). ACTG Adherence Questionnaires. Retrieved at: https://prevention.ucsf.edu/sites/prevention.ucsf.edu/files/uploads/tools/surveys/pdf/2098.4188.pdf Independently developed self-report questions to measure PrEP uptake, knowledge, and perceived barriers and facilitators
  • Individual PrEP change over time
    • Time Frame: weekly, from baseline visit to last study visit (six months from baseline)
    • PrEP adherence, measured by mHealth. Survey question: How many times in the past week have you taken your medication? Please respond with 0-7.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Currently identify as a woman or female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Johns Hopkins Bloomberg School of Public Health
  • Collaborator
    • Baltimore City Health Department
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Susan Sherman, PhD, Principal Investigator, Johns Hopkins Bloomberg School of Public Health

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