Clinical trial NCT05929521: Centering Those Engaged in Transactional Sex: A PrEP Innovation for Getting To Zero
Official title: Centering Those Engaged in Transactional Sex: A PrEP Innovation for Getting To Zero
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Sex Work
Pre-Exposure Prophylaxis
Keywords: Group Care
Centering Healthcare
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2023-07-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Demographic Survey Questionnaire
timeFrame: Up to one year
measure: PrEP Medication Adherence
timeFrame: Through Study completion, an average of one year
measure: HIV Related Knowledge Survey
timeFrame: Through Study Completion, an average of one year
measure: PrEP - related knowledge survey
timeFrame: Through Study Completion, an average of one year
measure: HIV Treatment Self-Efficacy survey
timeFrame: Through Study Completion, an average of one year
measure: Intention to Adhere to PrEP Survey
timeFrame: Through Study Completion, an average of one year
measure: Behaviors: HIV - Risk Assessment for Sexual Partnerships (H-RASP)
timeFrame: Through Study Completion, an average of one year
measure: Patient Satisfaction Survey
timeFrame: Through Study Completion, an average of one year
measure: Acceptability Survey
timeFrame: Through Study Completion, an average of one year
measure: Appropriateness Survey
timeFrame: Through Study Completion, an average of one year
measure: Intervention Feasibility Survey
timeFrame: Through Study Completion, an average of one year
Secondary outcomes:
measure: Sustainability Survey
timeFrame: Through Study Completion, an average of one year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Randi B Singer, PhD
role: PRINCIPAL_INVESTIGATOR
References: