Sex WorkEarly Phase 1C-PrEP+NCT05929521
Centering Those Engaged in Transactional Sex: A PrEP Innovation for Getting To Zero
A Early Phase 1 study testing C-PrEP+ in people with Sex Work and Pre-Exposure Prophylaxis, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sex Work, Pre-Exposure Prophylaxis
- What is being tested?
- C-PrEP+
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2024to 31 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Howard Brown Health personnel Inclusion Criteria:
- 18 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
Howard Brown Health personnel Exclusion Criteria:
- <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
Sex workers Inclusion Criteria:
- 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.
Sex Workers Exclusion Criteria:
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
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.
Read the detailed description
Chicago is an HIV epicenter, and Getting to Zero (GTZ) new HIV infections by 2030 is a public health priority. Sex workers (SW) are a priority population because their HIV prevalence is 12 times greater than the general population. Innovative prevention methods are needed. For high-risk HIV-negative sex workers, pre-exposure prophylaxis (PrEP) is an empowering HIV prevention method because it is user-controlled and requires no partner negotiation.Stigma, criminalization, and financial constraints are barriers preventing sex workers from accessing HIV/Sexually Transmitted infections (STI) prevention information, services, and treatment, including PrEP initiation and adherence. Community-empowered interventions are designed, implemented, and evaluated by the target community and have reduced HIV risk and improved health service delivery among sex workers. Centering Healthcare, an evidence-based community-empowered group healthcare model, has demonstrated benefits and well-defined core components that act together to improve health outcomes: health assessment, interactive learning, and community building. Rather than a one-on-one visit, a cohort of 8-12 patients meet with the same providers at each visit for regular health assessments, linkages to services, and 75-90 minutes of interactive learning and skill-building that centers patients' experiences. When conducted with pregnant women it was associated with increased condom use and decreased STI infections into the postpartum. This innovative and evidence-based approach to healthcare has great potential meet sex workers' HIV prevention needs, including optimal use of PrEP. Guided by the Exploration, Preparation, Implementation, Sustainment framework (EPIS), the objective of this research study is to assess the feasibility, acceptability, and potential sustainability of C-PrEP+ through an individually randomized pilot trial of C-PrEP+. Building on the skills acquired during the training component of the K23, the research study's specific aims are as follows:
Aim 1. Conduct an environmental scan to identify the most efficient implementation approach for integrating C-PrEP+ into health system. From clinic walk-throughs, observations, and interviews with Howard Brown Health (HBH) staff, providers, and leadership, document implementation determinants, structures, processes related to facilitation of C-PrEP+ into patient care at HBH to produce an implementation plan (Training aims 1,2,3).
Aim 2. Conduct a two-arm pilot randomized control trial (RCT, n=48) at HBH to examine feasibility (recruitment, retention, and treatment completion) and acceptability (patient evaluations) of the C-PrEP+ intervention and explore preliminary outcomes, namely PreP use at six months (primary) and PrEP knowledge, self-efficacy, and PrEP adherence intention (secondary). I hypothesize that a Centering group healthcare model (C-PrEP+) will increase rates of PrEP adherence among sex workers who decide to adopt PrEP. (Training Aims 2,3) Aim 3. Evaluate C-PrEP+ documenting implementation processes, barriers, and facilitators. Post-intervention qualitative interviews with C-PrEP+ participants, facilitators, stakeholders, and HBH staff and providers will reveal personal and structural determinants (barriers and facilitators) of adoption, acceptability, fidelity, appropriateness and sustainability (Training Aims 1,2,3).
- Conditions
- Sex Work, Pre-Exposure Prophylaxis
- Being tested
- C-PrEP+
- Keywords
- Group Care, Centering Healthcare
- Medical subject headings
- Sex Work
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-PrEP+Other
Also called Group PrEP Care
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
| Study group | Role | What they receive |
|---|---|---|
| C-PrEP+ | Experimental | Sex Workers engaged in group PrEP care. Receives: Other: C-PrEP+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Through Study Completion, an average of one year
PrEP - related knowledge survey
6-item yes/no and 1 (3 point) Likert scale question
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Through Study Completion, an average of one year
Secondary outcomes (1)
Sustainability Survey
Program Sustainability Assessment Tool (PSAT)
Measured: Through Study Completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start12 Dec 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sex WorkStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Randi Singer, University of Illinois Chicago
- Investigators
- Randi B Singer, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929521
- Sponsor's protocol ID
- 2022-0730
- Other IDs
- K23NR020445
- Acronym
- C-PrEP+
- Status last verified
- Sep 2025
- First submitted
- 14 Jun 2023
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Centering Those Engaged in Transactional Sex: A PrEP Innovation for Getting To Zero
- ClinicalTrials.gov ID
- NCT05929521
- Acronym / sponsor ID
- C-PrEP+ / 2022-0730
- Conditions
- Sex Work, Pre-Exposure Prophylaxis
- Keywords
- Group Care, Centering Healthcare
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chicago is an HIV epicenter, and Getting to Zero (GTZ) new HIV infections by 2030 is a public health priority. Sex workers (SW) are a priority population because their HIV prevalence is 12 times greater than the general population. Innovative prevention methods are needed. For high-risk HIV-negative sex workers, pre-exposure prophylaxis (PrEP) is an empowering HIV prevention method because it is user-controlled and requires no partner negotiation.Stigma, criminalization, and financial constraints are barriers preventing sex workers from accessing HIV/Sexually Transmitted infections (STI) prevention information, services, and treatment, including PrEP initiation and adherence. Community-empowered interventions are designed, implemented, and evaluated by the target community and have reduced HIV risk and improved health service delivery among sex workers. Centering Healthcare, an evidence-based community-empowered group healthcare model, has demonstrated benefits and well-defined core components that act together to improve health outcomes: health assessment, interactive learning, and community building. Rather than a one-on-one visit, a cohort of 8-12 patients meet with the same providers at each visit for regular health assessments, linkages to services, and 75-90 minutes of interactive learning and skill-building that centers patients' experiences. When conducted with pregnant women it was associated with increased condom use and decreased STI infections into the postpartum. This innovative and evidence-based approach to healthcare has great potential meet sex workers' HIV prevention needs, including optimal use of PrEP. Guided by the Exploration, Preparation, Implementation, Sustainment framework (EPIS), the objective of this research study is to assess the feasibility, acceptability, and potential sustainability of C-PrEP+ through an individually randomized pilot trial of C-PrEP+. Building on the skills acquired during the training component of the K23, the research study's specific aims are as follows:
Aim 1. Conduct an environmental scan to identify the most efficient implementation approach for integrating C-PrEP+ into health system. From clinic walk-throughs, observations, and interviews with Howard Brown Health (HBH) staff, providers, and leadership, document implementation determinants, structures, processes related to facilitation of C-PrEP+ into patient care at HBH to produce an implementation plan (Training aims 1,2,3).
Aim 2. Conduct a two-arm pilot randomized control trial (RCT, n=48) at HBH to examine feasibility (recruitment, retention, and treatment completion) and acceptability (patient evaluations) of the C-PrEP+ intervention and explore preliminary outcomes, namely PreP use at six months (primary) and PrEP knowledge, self-efficacy, and PrEP adherence intention (secondary). I hypothesize that a Centering group healthcare model (C-PrEP+) will increase rates of PrEP adherence among sex workers who decide to adopt PrEP. (Training Aims 2,3) Aim 3. Evaluate C-PrEP+ documenting implementation processes, barriers, and facilitators. Post-intervention qualitative interviews with C-PrEP+ participants, facilitators, stakeholders, and HBH staff and providers will reveal personal and structural determinants (barriers and facilitators) of adoption, acceptability, fidelity, appropriateness and sustainability (Training Aims 1,2,3).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| C-PrEP+ | Experimental | Other: C-PrEP+Sex Workers engaged in group PrEP care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-PrEP+Also: Group PrEP CareRather 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 | Other | C-PrEP+ |
Primary outcome
Demographic Survey Questionnaire
Time frame: Up to one year
8-Item Center for Disease Control (CDC) Behavioral Risk Factor Surveillance System determining gender identity, age, race/ethnicity, education level and income
PrEP Medication Adherence
Time frame: Through Study completion, an average of one year
Assessed from Dried Blood spot (DBS) detecting levels of tenofovir-containing PrEP reflecting use over the preceding 6-8 weeks
HIV Related Knowledge Survey
Time frame: Through Study Completion, an average of one year
18-Item brief HIV knowledge true/false questionnaire; cronbach alpha of 0.75-0.95
PrEP - related knowledge survey
Time frame: Through Study Completion, an average of one year
6-item yes/no and 1 (3 point) Likert scale question
HIV Treatment Self-Efficacy survey
Time frame: Through Study Completion, an average of one year
12 - Item HIV Treatment Self-Efficacy Scale (HIV-ASES) cronbach alpha of 0.7-0.92 (PrEP adapted)
Intention to Adhere to PrEP Survey
Time frame: Through Study Completion, an average of one year
17-Item Intention to Adhere to HIV Treatment. Likert scale 1-6 cronbach alpha 0.81 (PrEP adapted)
Behaviors: HIV - Risk Assessment for Sexual Partnerships (H-RASP)
Time frame: Through Study Completion, an average of one year
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)
Patient Satisfaction Survey
Time frame: Through Study Completion, an average of one year
8-Item Abbreviated Acceptability Rating Profile, 6-point Likert Scale from strongly disagree to strongly agree; cronbach alpha 0.97
Acceptability Survey
Time frame: Through Study Completion, an average of one year
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
Appropriateness Survey
Time frame: Through Study Completion, an average of one year
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
Intervention Feasibility Survey
Time frame: Through Study Completion, an average of one year
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
1 secondary outcome
Sustainability Survey
Time frame: Through Study Completion, an average of one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randi B Singer, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing C-PrEP+ in people with Sex Work and Pre-Exposure Prophylaxis, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic Survey Questionnaire (time frame: Up to one year). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.