UPDOs Program for HIV Prevention

(UPDOs Trial)

Overseen By Niasha Fray, MA, MSPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Under 18, Not Black, Not cisgender female

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an online program called UPDOs can enhance understanding and use of PrEP, a medicine that prevents HIV. The study focuses on Black cisgender women in the southeastern U.S. who may be at higher risk for HIV and have not had equal access to PrEP. Participants will either engage with UPDOs, which provides videos and telehealth services, or receive standard HIV prevention materials. The trial will also assess the program's effectiveness across different communities. Black cisgender women concerned about HIV and who have not used PrEP may find this trial suitable. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve access to and education about HIV prevention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on learning about and starting PrEP, so it's best to discuss your current medications with the study team.

What prior data suggests that the UPDOs program is safe for participants?

Research has shown that PrEP (pre-exposure prophylaxis) is a safe and effective method for preventing HIV. Studies indicate that when taken as directed, PrEP can reduce the risk of contracting HIV from sex by about 99%. Most individuals tolerate PrEP well, with no serious safety issues reported. Common side effects, such as nausea or headache, are typically mild and resolve on their own.

The UPDOs program employs a community-based approach to educate people about PrEP and facilitate its use. It aims to enhance accessibility and trust, particularly for those who may have lacked equal access previously. Although UPDOs is a new program, it builds on proven methods to increase PrEP use.

In summary, PrEP is considered safe for most people, and the UPDOs program is designed to make starting and continuing its use easier and more comfortable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Using PrEP, Doing it for Ourselves" (UPDOs) program because it offers a fresh approach to HIV prevention. Unlike the standard care, which mainly involves CDC educational materials, the UPDOs program uses "edutainment"—a mix of engaging videos, blogs, and vlogs—to educate and empower individuals. This approach aims to make learning about HIV prevention more relatable and accessible. By incorporating Q Care Plus, an online service for PrEP access, the program also emphasizes convenience and personal empowerment, potentially leading to better adherence and outcomes.

What evidence suggests that the UPDOs program is effective for increasing PrEP use?

Research has shown that PrEP, a medication taken before exposure, effectively prevents HIV when used correctly. Studies have found that PrEP can lower the chance of contracting HIV by about 92%. However, usage remains low in some communities, particularly among Black women. In this trial, participants in the "Using PrEP, Doing it for Ourselves (UPDOs)" intervention arm will receive engaging online content and telehealth services designed to facilitate learning about and starting PrEP. By offering these resources, UPDOs aims to build trust and understanding of PrEP, potentially increasing its use, especially among those at higher risk for HIV. ^{2 5 6 7 8}

Who Is on the Research Team?

Schenita Randolph, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for Black, cisgender females aged 18 and older in the southeastern U.S. who are at higher risk for HIV and have not had equal access to PrEP, a medication that prevents HIV.

Inclusion Criteria

I am a cisgender female.

I am Black.

I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the UPDOs intervention, including six weekly edutainment videos, blog discussions, and access to telehealth services through Q Care Plus

6 weeks

Weekly online engagement

Follow-up

Participants are monitored for PrEP uptake and effectiveness through surveys and telehealth services

52 weeks

Surveys at 6, 12, 24, 32, and 52 weeks

Implementation Evaluation

Examine barriers and facilitators of PrEP decision-making and implementation of UPDOs for future scalability

Ongoing throughout the study

What Are the Treatments Tested in This Trial?

Interventions

• Using PrEP, Doing it for Ourselves (UPDOs)

Trial Overview The study tests UPDOs Protective Styles, an online program with videos, blog discussions, and telehealth services versus standard CDC HIV prevention materials. It measures trust in PrEP and its uptake over time through surveys.

How Is the Trial Designed?

Group I: Using PrEP, Doing it for Ourselves (UPDOs) intervention Experimental Treatment 1 Intervention

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

Group II: Standard of Care Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06638892

NCT06638892 | Using PrEP, Doing It for Ourselves The Principal Investigator proposes an effectiveness-implementation type-I hybrid study to test the intervention Using PrEP, Doing it for Ourselves (UPDOs) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9472057/

Using PrEP and Doing it for Ourselves (UPDOs Protective ... Pre-exposure prophylaxis (PrEP), taken as prescribed, is an effective HIV prevention strategy, yet uptake remains low among populations at risk ...

3. reporter.nih.gov reporter.nih.gov/project-details/11166639

A Multilevel Intervention to Improve HIV Testing and PrEP ... We propose an effectiveness-implementation type I hybrid study to test an intervention, Using PrEP, Doing it for Ourselves (UPDOs) Protective Styles, and its ...

4. nursing.duke.edu nursing.duke.edu/theheeat/updos

UPDOS | Duke University School of Nursing PrEP is a pill that if taken daily reduces the risk of one contracting HIV. It has been proven to be 92% effective, however, less than 1% of Black women who are ...

5. researchgate.net researchgate.net/publication/361663526_UPDOs_Protective_Styles_Using_PrEP_and_Doing_it_for_Ourselves_a_web-based_salon_intervention_to_improve_uptake_of_pre-exposure_prophylaxis_PrEP_among_Black_women_Protocol_for_a_pilot_feasibility_study

Using PrEP and Doing it for Ourselves, a web-based salon ... This multilevel, mixed methods study uses a community-engagement approach to develop and pilot test a salon-based intervention.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36040785/

Using PrEP and Doing it for Ourselves (UPDOs ... - PubMed This multilevel, mixed methods study uses a community-engagement approach to develop and pilot test a salon-based intervention.

7. researchprotocols.org researchprotocols.org/2022/8/e34556/metrics

Using PrEP and Doing it for Ourselves (UPDOs Protective ... Data collection for phase 1 began in April 2022. Data collection for phase 2 ... HIV/AIDS/STI Prevention and Care (1023). Published on 30.Aug.2022 in Vol 11 ...

8. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0296080

Feasibility and acceptability of SEPA+PrEP: An HIV prevention ... PrEP is highly effective for preventing HIV, reducing the risk of acquiring HIV from sexual activity by about 99% when taken as prescribed [23].