SEPA+PrEP for HIV Prevention
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a program called SEPA+PrEP-Women to determine if it helps women begin using PrEP (pre-exposure prophylaxis), a medication that can prevent HIV. The study will compare women who participate in the program immediately with those who start after three months. Women who are HIV-negative or unaware of their HIV status, have had sex with a male partner in the last six months, and have at least one risk factor for HIV may be suitable for this trial. Participants will join group sessions on Zoom to learn about health, education, prevention, and self-care. As an unphased trial, this study provides a unique opportunity to contribute to significant research on HIV prevention strategies for women.
What prior data suggests that the SEPA+PrEP-Women intervention is safe?
Research has shown that the SEPA+PrEP-Women program is easy to follow and well-liked by participants. In past studies, 94.5% of participants completed the program, and 94.2% expressed satisfaction and willingness to recommend it to others.
PrEP, a component of this program, has already proven highly effective in preventing HIV. When taken correctly, it can reduce the risk of contracting HIV from sex by about 99%. This effectiveness is significant due to its strong track record in HIV prevention.
Overall, these findings suggest that participants generally tolerate the SEPA+PrEP-Women program well. The studies reviewed reported no major side effects, which is encouraging for those considering joining a related clinical trial.12345Why are researchers excited about this trial?
Researchers are excited about the SEPA+PrEP-Women intervention for HIV prevention because it offers a unique blend of social and medical support. Unlike traditional approaches that focus solely on medication, this intervention combines PrEP (pre-exposure prophylaxis) with group sessions delivered via Zoom. These sessions aim to empower women by providing education and social support, potentially enhancing adherence to PrEP and improving overall prevention outcomes. This holistic approach could make HIV prevention more accessible and effective, particularly for women, by addressing both the medical and social aspects of HIV prevention.
What evidence suggests that SEPA+PrEP-Women could be effective for HIV prevention?
Research has shown that PrEP (pre-exposure prophylaxis) effectively prevents HIV, reducing the risk of contracting the virus from sex by about 99% when taken correctly. In this trial, participants in the SEPA+PrEP-Women Intervention arm will receive the SEPA+PrEP-Women program. Early results indicate that participants find the program easy to use and well-liked. Studies found that 94.5% of participants remained in the program, and 94.2% expressed satisfaction with the content. The program also improves understanding of PrEP, making it a promising method to encourage more women to use PrEP. This combination of education and medication could significantly enhance efforts to prevent HIV.12456
Who Is on the Research Team?
Joseph De Santis, PhD
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
This trial is for women who are at risk of getting HIV. Participants must be willing to attend study visits and take part in group sessions about health, education, prevention, and self-care related to HIV.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive the SEPA+PrEP-Women intervention, consisting of three weekly group sessions delivered via Zoom, each lasting approximately 2 hours
Follow-up
Participants are monitored for PrEP uptake and safe sex behavior at 1 month and 3 months post-intervention
What Are the Treatments Tested in This Trial?
Interventions
- SEPA+PrEP Women
Trial Overview
The study is testing whether a program combining group education (SEPA) with information and support for starting PrEP (a daily pill to prevent HIV) helps more women begin using PrEP compared to those who get the program later.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive the the SEPA+PrEP-Women intervention, consisting of three weekly group sessions delivered via Zoom. Each session lasting approximately 2 hours.
Participants assigned to this arm will complete baseline, 1-month, and 3-month follow-up assessments and will not receive the SEPA+PrEP-Women intervention during the 3-month study period. After completing the 3-month follow-up assessment, participants will be offered the SEPA+PrEP-Women intervention, which consists of three weekly group sessions delivered via Zoom, with each session lasting approximately 2 hours.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
Citations
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%. To respond to this
Feasibility and acceptability of SEPA+PrEP: An HIV prevention ...
Overall, study results suggest that SEPA+PrEP is an acceptable and feasible intervention to prevent HIV among HW, with a focus on PrEP knowledge ...
SEPA+PrEP-BW intervention: A feasible and acceptable HIV ...
Results demonstrated high feasibility (94.5% retention rate), strong acceptability (94.2% satisfaction with content), and unanimous willingness ...
4.
theconversation.com
theconversation.com/hispanic-women-are-less-likely-to-get-prep-treatment-new-intervention-could-change-that-233176Hispanic women are less likely to get PrEP treatment
Overall, SEPA+PrEP was found to be an acceptable and feasible way to teach Hispanic women about PrEP and other forms of HIV prevention, such as ...
SEPA+PrEP-BW intervention: A feasible and acceptable ...
Results demonstrated high feasibility (94.5% retention rate), strong acceptability (94.2% satisfaction with content), and unanimous willingness to recommend ...
SEPA+PrEP-BW intervention: A feasible and acceptable HIV ...
Results demonstrated high feasibility (94.5% retention rate), strong acceptability (94.2% satisfaction with content), and unanimous willingness ...
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