Using PrEP, Doing It for Ourselves

NCT06638892 | Recruiting

• 2 other identifiers: Pro001162151R01NR021692
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Prevention; PrEP

Keywords

Black Women; Community-based Research

Outcome Measures

Primary Outcomes (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.

  12 weeks post-intervention

Secondary Outcomes (3)

• Change in pre-exposure prophylaxis (PrEP) Contemplation Ladder total score - 12 to 24 weeks

  12 to 24 weeks post-intervention

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

  24 to 32 weeks post-intervention

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

  32 to 52 weeks post-intervention

Study Arms (2)

Using PrEP, Doing it for Ourselves (UPDOs) intervention

EXPERIMENTAL

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

Behavioral: Using PrEP, Doing it for Ourselves (UPDOs)

Standard of Care

OTHER

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

Other: Standard of Care

Interventions

Using PrEP, Doing it for Ourselves (UPDOs) 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).

Using PrEP, Doing it for Ourselves (UPDOs) intervention

Standard of Care OTHER

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

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Black
• cisgender female
• Ages 18+

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• National Institute of Nursing Research (NINR): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Duke University School of Nursing

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Schenita Randolph, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Niasha Fray, MA, MSPH

CONTACT

919-668-8325; Niasha.Fray@Duke.edu

Schenita Randolph, PhD

CONTACT

919-684-3786; schenita.randolph@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: February 13, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)