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HIV PreventionUPDOsNCT06638892

Using PrEP, Doing It for Ourselves

A study testing Using PrEP, Doing it for Ourselves (UPDOs) in people with HIV Prevention and PrEP, run by Duke University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
HIV Prevention, PrEP
What is being tested?
Using PrEP, Doing it for Ourselves (UPDOs)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
1 siteUnited States
Study dates
13 Feb 2026to Jan 2030
Phase
Interventional
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
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Black
  • cisgender female
  • Ages 18+

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Niasha Fray, MA, MSPH contact

919-668-8325

Niasha.Fray@Duke.edu

Schenita Randolph, PhD contact

919-684-3786

schenita.randolph@duke.edu

United States1 site, 1 recruiting
  • Duke University School of Nursing

    Durham, North Carolina, 27710

    Niasha Fray, MA, MSPH, 9196688325, niasha.fray@duke.edu

    Schenita Randolph, PhD, MPH, RN, FAAN

    Recruiting

Other trials in United States

About this study

Official title: Cluster Randomized Controlled Trial of Using PrEP Doing It for Ourselves Protective Styles: A Multilevel Intervention to Improve HIV Testing and PrEP Uptake Among Southeastern U.S. At-risk Populations

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:

Read more

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.

Read the 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.

Recruitment is ongoing across participating salon sites. As of May 2026, a total of 42 participants have been enrolled toward the target sample size of 1,000 participants.

Based on current recruitment planning projections, the study anticipates reaching approximately 25% of target enrollment by October 30, 2026, 50% by January 31, 2027, 75% by April 30, 2027, and full enrollment (100%) by July 31, 2027. These projections are subject to change based on recruitment progress and site engagement.

Conditions
HIV Prevention, PrEP
Being tested
Using PrEP, Doing it for Ourselves (UPDOs), Standard of Care
Keywords
Black Women, Community-based Research

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Using PrEP, Doing it for Ourselves (UPDOs)Behavioural

    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 CareOther

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

Study groups in NCT06638892
Study groupRoleWhat they receive
Using PrEP, Doing it for Ourselves (UPDOs) interventionExperimentalThis group will receive the UPDOs intervention that includes "edutainment", e.g., videos, blogs, vlogs, and Q Care Plus.
Receives: Behavioral: Using PrEP, Doing it for Ourselves (UPDOs)
Standard of CareOtherThis group will receive CDC standard of care, e.g., CDC videos and website.
Receives: Other: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pre-exposure prophylaxis (PrEP) Contemplation Ladder total score

    The PrEP Contemplation Ladder is a 1-item survey designed to measure Motivational PrEP Cascade (MPC) stages of behavior change that represent one's PrEP intentions by a score of 1-10. Scores correspond to MPC stages. Lower numbers indicate PrEP is not being used to prevent HIV and the participant is not really thinking of ever starting to use PrEP. Higher numbers indicate that PrEP is being used daily and the participant is returning for provider checkups and HIV/STI testing every 3 months, as recommended.

    Measured: 12 weeks post-intervention

Secondary outcomes (3)
  1. Change in pre-exposure prophylaxis (PrEP) Contemplation Ladder total score - 12 to 24 weeks

    The PrEP Contemplation Ladder is a 1-item survey designed to measure Motivational PrEP Cascade (MPC) stages of behavior change that represent one's PrEP intentions by a score of 1-10. Scores correspond to MPC stages. Lower numbers indicate PrEP is not being used to prevent HIV and the participant is not really thinking of ever starting to use PrEP. Higher numbers indicate that PrEP is being used daily and the participant is returning for provider checkups and HIV/STI testing every 3 months, as recommended.

    Measured: 12 to 24 weeks post-intervention

  2. Change in pre-exposure prophylaxis (PrEP) Contemplation Ladder total score - 24 to 32 weeks

    The PrEP Contemplation Ladder is a 1-item survey designed to measure Motivational PrEP Cascade (MPC) stages of behavior change that represent one's PrEP intentions by a score of 1-10. Scores correspond to MPC stages. Lower numbers indicate PrEP is not being used to prevent HIV and the participant is not really thinking of ever starting to use PrEP. Higher numbers indicate that PrEP is being used daily and the participant is returning for provider checkups and HIV/STI testing every 3 months, as recommended.

    Measured: 24 to 32 weeks post-intervention

  3. Change in pre-exposure prophylaxis (PrEP) Contemplation Ladder total score - 32 to 52 weeks

    The PrEP Contemplation Ladder is a 1-item survey designed to measure Motivational PrEP Cascade (MPC) stages of behavior change that represent one's PrEP intentions by a score of 1-10. Scores correspond to MPC stages. Lower numbers indicate PrEP is not being used to prevent HIV and the participant is not really thinking of ever starting to use PrEP. Higher numbers indicate that PrEP is being used daily and the participant is returning for provider checkups and HIV/STI testing every 3 months, as recommended.

    Measured: 32 to 52 weeks post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start13 Feb 2026
  3. Primary completionJun 2029 (estimated)
  4. Study completionJan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06638892
Sponsor's protocol ID
Pro00116215
Other IDs
1R01NR021692
Acronym
UPDOs
Status last verified
Feb 2026
First submitted
9 Oct 2024
Last updated
28 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Only statistical information for primary and secondary outcomes will be shared. Individual participant data will not be shared.

Questions about this trial

What is this clinical trial studying?

A study testing Using PrEP, Doing it for Ourselves (UPDOs) in people with HIV Prevention and PrEP, run by Duke University 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?

The sponsor lists 3 inclusion and 3 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 28 Aug 2026. 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.

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?

Contact Niasha Fray, MA, MSPH (919-668-8325, Niasha.Fray@Duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pre-exposure prophylaxis (PrEP) Contemplation Ladder total score (time frame: 12 weeks post-intervention). 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 28 Aug 2026.

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