Centering Those Engaged in Transactional Sex: A PrEP Innovation for Getting To Zero

NCT05929521 | Active Not Recruiting Early Phase 1 DMC

• 2 other identifiers: 2022-0730K23NR020445
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Using a participatory implementation science framework, I will test whether an adapted and community empowered group healthcare model, Centering PrEP+, is a feasible and acceptable health system intervention to improve the health of sex workers and their clients by increasing PrEP uptake and adherence. The conduct of this pilot study will provide an opportunity to gain experience with all aspects of intervention research, including recruitment, retention, implementing a randomization protocol, assessing measurement tools, delivering an intervention, and monitoring fidelity across two sites, tracking all metrics suggested by CONSORT, data collection and management of quantitative data from multiple sources (e.g., survey, laboratory), data analysis, and dissemination.

Conditions

Sex Work; Pre-Exposure Prophylaxis

Keywords

Group Care; Centering Healthcare

Outcome Measures

Primary Outcomes (11)

• Demographic Survey Questionnaire

  8-Item Center for Disease Control (CDC) Behavioral Risk Factor Surveillance System determining gender identity, age, race/ethnicity, education level and income

  Up to one year

• PrEP Medication Adherence

  Assessed from Dried Blood spot (DBS) detecting levels of tenofovir-containing PrEP reflecting use over the preceding 6-8 weeks

  Through Study completion, an average of one year

• HIV Related Knowledge Survey

  18-Item brief HIV knowledge true/false questionnaire; cronbach alpha of 0.75-0.95

  Through Study Completion, an average of one year

• PrEP - related knowledge survey

  6-item yes/no and 1 (3 point) Likert scale question

  Through Study Completion, an average of one year

• HIV Treatment Self-Efficacy survey

  12 - Item HIV Treatment Self-Efficacy Scale (HIV-ASES) cronbach alpha of 0.7-0.92 (PrEP adapted)

  Through Study Completion, an average of one year

• Intention to Adhere to PrEP Survey

  17-Item Intention to Adhere to HIV Treatment. Likert scale 1-6 cronbach alpha 0.81 (PrEP adapted)

  Through Study Completion, an average of one year

• Behaviors: HIV - Risk Assessment for Sexual Partnerships (H-RASP)

  6 questions about condom use, STI testing, and PrEP adherence (yes/no, don't know), Cronbach alpha 0.85 20-item HIV self-management Scale (3-point Likert) Cronbach alpha 0.78 (PrEP adapted)

  Through Study Completion, an average of one year

• Patient Satisfaction Survey

  8-Item Abbreviated Acceptability Rating Profile, 6-point Likert Scale from strongly disagree to strongly agree; cronbach alpha 0.97

  Through Study Completion, an average of one year

• Acceptability Survey

  4-Item Acceptability of Intervention Measure (AIM) with a 5 option response scale (completely disagree, disagree scale, neither agree nor disagree, agree, completely agree), score range 4-16

  Through Study Completion, an average of one year

• Appropriateness Survey

  4 item Intervention Appropriateness Measure (IAM; with a 5 option response scale (completely disagree, disagree scale, neither agree nor disagree, agree, completely agree), score range 4-16

  Through Study Completion, an average of one year

• Intervention Feasibility Survey

  4-item Feasibility of Intervention Measure (FIM; with a 5 option response scale (completely disagree, disagree scale, neither agree nor disagree, agree, completely agree), score range 4-16

  Through Study Completion, an average of one year

Secondary Outcomes (1)

• Sustainability Survey

  Through Study Completion, an average of one year

Study Arms (1)

C-PrEP+

EXPERIMENTAL

Sex Workers engaged in group PrEP care.

Other: C-PrEP+

Interventions

C-PrEP+ OTHER

Rather than a one-on-one PrEP care visit, a cohort of 8-12 patients meet with the same providers at each visit for individual health assessments, linkages to services, and 75-90 minutes of group interactive learning and skill-building that centers patients' experiences. This approach to healthcare has great potential meet sex workers' HIV prevention needs, including optimal use of PrEP

Also known as: Group PrEP Care

C-PrEP+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older;
• currently employed at Howard Brown Health
• are active in HIV prevention programs, epidemiology and/or GTZ 2030 projects;
• speak and understand English

You may not qualify if:

• \<18
• Not employed at Howard Brown Health
• Not active in HIV prevention programs, epidemiology and/or GTZ 2030 projects
• Does not speak and understand English
• Initiating PrEP at HBH
• ≥ 18 years of age;
• engaged in sex work, defined as the exchange of oral, vaginal, or anal sex for something of value, in the past 12 months;
• lives in Chicago area;
• speak/understand English.
• Not initiating PrEP at HBH
• \< 18 years of age;
• Identify as a victim of sex trafficking
• \) Not engaged in sex work, defined as the exchange of oral, vaginal, or anal sex for something of value, in the past 12 months; 4) Does NOT live in Chicago area; 5) Does NOT speak/understand English. 6) Does not/cannot provide informed consent.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Sex Work

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Officials

• Randi B Singer, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 1 arm pilot to determine feasibility, acceptability and effectiveness of group care for those who are engaged in transactional sex and taking PrEP for HIV prevention.

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: July 3, 2023
• Study Start: December 12, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

US (1)