About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Black

cisgender female

Ages 18+

Disqualifiers

Under 18 years of age

Does not identify as Black

Not a cisgender female

Trial design

Design model

Parallel

Treatments tested in this trial

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).
Standard of Care
Other intervention
CDC standard of care, e.g., CDC videos and website.

Treatment groups

1,000 Participants

are divided into 2 treatment groups

Group A: Using PrEP, Doing it for Ourselves (UPDOs) interventionExperimental treatment 1 intervention

Group B: Standard of CareOther 1 intervention

Trial outcomes

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.

Time frame

12 weeks post-intervention

Secondary outcomes

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.

Time frame

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.

Time frame

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.

Time frame

32 to 52 weeks post-intervention

Using PrEP, Doing It for Ourselves

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts