Pre-Exposure Prophylaxis Clinical Trial
— C-PrEP+Official title:
Centering Those Engaged in Transactional Sex: A PrEP Innovation for Getting To Zero
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.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | July 31, 2025 |
Est. primary completion date | May 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Howard Brown Health personnel Inclusion Criteria: 1. 18 years of age or older; 2. currently employed at Howard Brown Health 3. are active in HIV prevention programs, epidemiology and/or GTZ 2030 projects; 4. speak and understand English Howard Brown Health personnel Exclusion Criteria: 1. <18 2. Not employed at Howard Brown Health 3. Not active in HIV prevention programs, epidemiology and/or GTZ 2030 projects 4. Does not speak and understand English Sex workers Inclusion Criteria: 1. Initiating PrEP at HBH 2. = 18 years of age; 3. engaged in sex work, defined as the exchange of oral, vaginal, or anal sex for something of value, in the past 12 months; 4. lives in Chicago area; 5. speak/understand English. Sex Workers Exclusion Criteria: 1. Not initiating PrEP at HBH 2. < 18 years of age; 3. Identify as a victim of sex trafficking 3) 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Illinois at Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Chicago | National Institute of Nursing Research (NINR) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | PrEP - related knowledge survey | 6-item yes/no and 1 (3 point) Likert scale question | Through Study Completion, an average of one year | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Sustainability Survey | Program Sustainability Assessment Tool (PSAT) | Through Study Completion, an average of one year |
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