Using PrEP, Doing It for Ourselves

NCT ID: NCT06638892

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2030-01-31

Brief Summary

The goal of this clinical trial is to test a new online program called UPDOs Protective Styles to help people in the southeastern United States learn about and start using PrEP (pre-exposure prophylaxis), a medicine that helps prevent HIV. The study focuses on people who may be at higher risk for HIV and have not had equal access to PrEP.

The main questions it aims to answer are:

Does UPDOs help more people trust and understand PrEP? Does UPDOs increase the number of people who start and continue using PrEP?

Researchers will compare two groups:

One group will use UPDOs, which includes six weekly videos, blog discussions, and access to telehealth services through Q Care Plus. The other group will receive standard HIV prevention materials from the CDC.

Participants will:

Be recruited from 32 beauty salons in areas with high HIV rates. Complete surveys at the start of the study and again at 6, 12, 24, 32, and 52 weeks.

Have access to HIV testing and PrEP prescriptions through Q Care Plus.

This study will also look at how well the program works in different communities and how easy it is to use and share.

Detailed Description

HIV disproportionately affects people living in the United States Southeast, threatening progress toward the Ending the HIV Epidemic (EHE) initiative's 2030 goals. Therefore, interventions that consider the lived experiences and needs of this at-risk population are urgently needed to support individuals in these geographic areas from medication precontemplation to uptake to maintenance.

Under the leadership of the Principal Investigator and in partnership with communities, an established Community Advisory Council (CAC), an online telehealth platform (Q Care Plus), and beauty salon stylists, the research team co-developed Using PrEP, Doing it for Ourselves (UPDOs) Protective Styles, an e-Health intervention that strongly considers the unique needs of at-risk individuals. This intervention consists of training for stylists to become opinion leaders (trusted gatekeepers who share health information in the community) in HIV prevention (i.e., PrEP), and a 6-week web-based edutainment video series (six 20-minute episodes), structured debrief blogs, and telehealth service access. The CAC was invaluable in this development process, having collaborated with the research team across sexual health-based projects that informed and contributed to UPDOs preliminary research.

UPDOs web content shares core concepts by telling the stories of at-risk individuals in the US Southeast from various backgrounds and role-plays the PrEP decision-making process. Pilot research conducted by the research team found UPDOs acceptable, improved PrEP trust, increased knowledge-for both PrEP-aware and PrEP-unaware participants-and decreased perceptions of PrEP stigma within personal relationships. This proposed effectiveness-implementation type-I hybrid study will test UPDOs effectiveness in a larger, more geographically diverse sample using a cluster-randomized control trial and examine implementation determinants of UPDOs. In collaboration with Q Care Plus, a secure online platform to access telehealth services for home-delivered HIV testing and PrEP prescriptions, the research team will track how many at-risk individuals within counties of increased HIV infections reach out to a provider, get HIV testing, start PrEP, and maintain PrEP as prescribed.

A cohort of 32 beauty salons will be randomized to either an intervention group (n=16) or control group (n=16). Salons (1 salon = 1 cluster) will be randomized to UPDOs (edutainment videos + blogs + Q Care Plus) or usual care (CDC videos + website) conditions. Once salons are randomized, the recruitment and enrollment period of customers will occur over 24 months. Study participation will include data collection at baseline with follow-up measures at 6, 12, 24, 32, and 52 weeks. To assess implementation outcomes and context, the UPDOs Protective Styles research team will perform a mixed methods approach guided by the Consolidated Framework for Implementation Research (CFIR).

Although pre-exposure prophylaxis [PrEP] (an oral or injectable medication that is effective in preventing HIV) has been effective in decreasing HIV acquisition, PrEP uptake for increasingly at-risk populations in the US Southeast remains low. PrEP uptake is as low as 2% for some at-risk communities due to factors influencing decision-making to take PrEP, such as lack of awareness, distrust, stigma, and access. There is an urgent need to provide specific strategies to improve PrEP uptake in ways that are acceptable and feasible for individuals in the US Southeast. Engaging non-traditional settings, such as beauty salons, is one promising strategy. Additionally, engaging communities of interest is effective in reducing HIV for difficult-to-reach at-risk populations and should be prioritized.

In component two, over 6 weeks, customers will view six edutainment videos that use stories, humor, and drama to highlight relevant messages that include HIV/PrEP. Debrief video blogs will follow each episode to highlight key points. Educational media designed to entertain have been effective in improving HIV prevention messaging.

The long-term goal of the Principal Investigator is to implement a real-world, sustainable intervention that will improve PrEP uptake and be scalable across the US South, where HIV inequalities are pronounced (51%) compared to other regions. For example, new diagnosis rates in North Carolina counties-Cumberland, Durham, Forsyth, Guilford, Mecklenburg, and Wake-where this study will take place, were higher than the state average. Thus, the aims of this study are:

• Aim 1:To test the effectiveness of the UPDOs intervention to improve PrEP uptake for at-risk individuals in the US Southeast using the Motivational PrEP Cascade framework within a community-engaged cluster-randomized controlled trial of intervention (UPDOs; N=16) and control (CDC information; N=16) salon clusters.

Hypothesis: Compared to control salons, salon customers in UPDOs (stylist opinion leaders, edutainment videos + blogs, and Q Care Plus) will have higher PrEP uptake.

• Aim 2: To examine the barriers and facilitators underlying PrEP decision-making among a subsample in both intervention (n=20) and control groups (n=20) using quantitative surveys and qualitative individual interviews.
• Aim 3: To understand the facilitators influencing implementation of UPDOs for future scalability using quantitative surveys and qualitative interviews grounded in the CFIR framework.

This proposed study has the potential to significantly advance EHE goals through an efficacious and cost-effective intervention for individuals in the US Southeast that can be scaled quickly throughout the US South.

The Principal Investigator proposes an effectiveness-implementation type-I hybrid study to test the intervention Using PrEP, Doing it for Ourselves (UPDOs) Protective Styles and its effectiveness to improve PrEP uptake among at-risk communities in the US Southeast using a cluster-randomized control trial and examining implementation determinants of UPDOs for scalability across the US South. Project activities will be delivered by an interdisciplinary research team advised by an external advisory panel and established community advisory council and implemented across six North Carolina counties with high concentrations of HIV incidences: Cumberland, Durham, Forsyth, Guilford, Mecklenburg, and Wake. At the conclusion of the funded project, the Principal Investigator and research team will have rigorously evaluated the intervention, ready for scale-up across the US South, with potential to significantly advance EHE goals for at-risk populations unreached by past HIV prevention efforts.

Conditions

HIV Prevention; PrEP

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Using PrEP, Doing it for Ourselves (UPDOs) intervention

This group will receive the UPDOs intervention that includes "edutainment", e.g., videos, blogs, vlogs, and Q Care Plus.

Group Type: EXPERIMENTAL

Using PrEP, Doing it for Ourselves (UPDOs)

Intervention Type: BEHAVIORAL

An e-Health intervention that considers women's lived experiences and uses three components: beauty salons and stylists as opinion leaders (trusted gatekeepers who share health information in the community), theory driven edutainment videos and blogs, and a secure online platform for accessing pre-exposure prophylaxis (PrEP).

Standard of Care

This group will receive CDC standard of care, e.g., CDC videos and website.

Group Type: OTHER

Standard of Care

Intervention Type: OTHER

CDC standard of care, e.g., CDC videos and website.

Interventions

Using PrEP, Doing it for Ourselves (UPDOs)

An e-Health intervention that considers women's lived experiences and uses three components: beauty salons and stylists as opinion leaders (trusted gatekeepers who share health information in the community), theory driven edutainment videos and blogs, and a secure online platform for accessing pre-exposure prophylaxis (PrEP).

Intervention Type: BEHAVIORAL

Standard of Care

CDC standard of care, e.g., CDC videos and website.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Black
• cisgender female
• Ages 18+

Exclusion Criteria

• Under 18 years of age
• Does not identify as Black
• Not a cisgender female

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Schenita Randolph, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University School of Nursing

Durham, North Carolina, United States

Countries

United States

Central Contacts

Niasha Fray, MA, MSPH

Role: CONTACT

Niasha.Fray@Duke.edu

919-668-8325

Schenita Randolph, PhD

Role: CONTACT

schenita.randolph@duke.edu

919-684-3786

Facility Contacts

Niasha Fray, MA, MSPH

Role: primary

niasha.fray@duke.edu

9196688325

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01NR021692

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00116215

Identifier Type: -

Identifier Source: org_study_id