PrEPwise for HIV Prevention
(PrEPwise Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new tool called PrEPwise to help Black women in the Southern U.S. learn about and decide if PrEP, a medicine that prevents HIV, suits them. Many Black women face higher HIV risks but may not know about PrEP or find it hard to access. Community health workers, who understand the community's needs, will use this decision tool to provide better guidance during HIV testing. The trial involves two groups: one receiving usual care and the other using PrEPwise. Black women seeking HIV testing who are eligible for PrEP and willing to participate for three months may be a good fit for this trial. As an unphased trial, this study offers participants the chance to contribute to important research that could improve HIV prevention strategies in their community.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are already using PrEP, you cannot participate in this trial.
What prior data suggests that the PrEPwise decision aid is safe and effective?
Research has shown that PrEP (pre-exposure prophylaxis) is safe and effective for preventing HIV. Studies have found that PrEP can reduce the risk of contracting HIV by up to 99% when used correctly. Clinical trials indicate that the benefits of taking PrEP outweigh the risks. The FDA has approved PrEP for HIV prevention, indicating it is generally well-tolerated.
The trial under consideration is testing a tool called PrEPwise. This tool helps individuals understand and decide if PrEP is right for them. It is not a medicine but a way to make informed choices about using PrEP.
Overall, research strongly supports the safety of PrEP, and PrEPwise aims to make this safe treatment more accessible.12345Why are researchers excited about this trial?
Researchers are excited about PrEPwise for HIV prevention because it introduces a new behavioral intervention as a decision aid, rather than a medication or medical device. Unlike standard care, which typically includes HIV testing and information about pre-exposure prophylaxis (PrEP), PrEPwise aims to empower individuals by helping them make informed decisions regarding their HIV prevention strategies. This approach could potentially increase the adoption and effective use of PrEP among those at risk, making it a promising addition to existing prevention methods.
What evidence suggests that PrEPwise is effective for helping Black women decide on PrEP for HIV prevention?
Research shows that taking pre-exposure prophylaxis (PrEP) as directed can prevent HIV by 99%. This medicine effectively lowers the risk of contracting HIV from sex or injection drug use. Studies have found that PrEP significantly reduces new HIV infections. In this trial, PrEPwise is a tool designed to help Black women determine if PrEP suits them. It aims to simplify learning about PrEP and its benefits, especially in higher-risk communities. Participants in this trial will receive either usual care or the PrEPwise intervention to assess its effectiveness.16789
Who Is on the Research Team?
Sylvia Shangani, PhD
Principal Investigator
Boston University
Are You a Good Fit for This Trial?
This trial is for Black women in Eastern Virginia at high risk of HIV, aiming to help them learn about and decide on using PrEP, a medication that's highly effective in preventing HIV. Participants should be from the community where CHWs operate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Visit
Informed consent process, collection of demographic information, and administration of baseline survey
Intervention Delivery
Randomization and delivery of either enhanced or standard HIV prevention information
3-Month Follow-up
Assessment of effectiveness outcomes, including PrEP initiation status and persistence
Qualitative Interviews
Interviews with a subsample of participants to explore perspectives about intervention acceptability and barriers
What Are the Treatments Tested in This Trial?
Interventions
- PrEPwise
Trial Overview
The study tests 'PrEPwise', a decision aid tool adapted for Black women to understand their options regarding PrEP for HIV prevention, compared with usual care without this specialized tool.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants randomized to this arm who are HIV negative will receive the behavioral intervention PrEPwise at the HIV testing clinic.
Participants randomized to this arm will receive usual care including standard HIV testing, general HIV information, prep information and information about other available services.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston University
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator
Citations
Study Details | NCT07398482 | PrEPwise-Pilot Clinical Trial
Pre-exposure prophylaxis (PrEP), a medicine if taken as recommended by a clinician can prevent HIV almost completely (99% effective).
PrEPwise Pilot Among Black Women in Eastern Virginia
Pre-exposure prophylaxis (PrEP), a medicine if taken as recommended by a clinician can prevent HIV almost completely (99% effective). The ...
The Evolution of HIV Pre-Exposure Prophylaxis and Future ...
The FTC/TDF group showed a 44% reduction in new HIV infections compared to the placebo group. Subsequent studies, such as the TDF2 study in Botswana and the ...
Progress Toward UNAIDS Global HIV Pre-Exposure ...
Oral pre-exposure prophylaxis (PrEP) reduces HIV acquisition from sex by 99% and from injection drug use by ≥74% when taken as recommended (1).
Preexposure Prophylaxis (PrEP) for HIV
This regimen was effective at preventing HIV infection in a randomized clinical trial of 400 MSM; the incidence of HIV infection was 0.91 per ...
PrEP Ring Safety Data in Adolescent Girls and Youth ...
This slide deck presents emerging evidence to support conversations on expanding pre-exposure prophylaxis (PrEP) ring access for adolescent girls and young ...
Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns
PrEP as an intervention to reduce HIV transmission appears to have a safe benefit-risk profile in clinical trials.
Clinical Guidance for PrEP | HIV Nexus
... data suggest that PrEP is safe and effective for HIV prevention among adolescent patients.35. Daily oral F/TDF and F/TAF are FDA-approved ...
9.
hiv.gov
hiv.gov/hiv-basics/hiv-prevention/using-hiv-medication-to-reduce-risk/pre-exposure-prophylaxisPre-Exposure Prophylaxis (PrEP)
Pre-exposure prophylaxis, also called PrEP, is a safe, effective prescription medicine that can reduce the risk of getting HIV by as much as 99%.
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