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

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 Overview

• Status: Completed
• Conditions: HIV/AIDS
• Intervention / Treatment: Behavioral: PrEP standard of care+behavioral intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21230
      • SPARC Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change over time to adherence to PrEP using plasma	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.	3 and 6 months
Change over time to adherence to PrEP using dried blood spots	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.	3 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral outcomes change over time	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).	3 and 6 months
Social outcomes change over time	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	3 and 6 months
Structural vulnerabilities change over time	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	3 and 6 months
Individual health change over time	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	3 and 6 months
Individual PrEP change over time	PrEP adherence, measured by mHealth. Survey question: How many times in the past week have you taken your medication? Please respond with 0-7.	weekly, from baseline visit to last study visit (six months from baseline)

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: Baltimore City Health Department
• Investigators: Principal Investigator: Susan Sherman, PhD, Johns Hopkins Bloomberg School of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2019
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: May 15, 2020
• First Posted (Actual): May 20, 2020

Study Record Updates

• Last Update Posted (Actual): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 126993

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to share data outside of the research plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No