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: June 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
  • Overall Contact(s)
    • Susan Sherman, PhD, 410-614-3518, ssherma1@jhu.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.