EMPOWERTelehealth Intervention to Improve PrEP Uptake in African American Women
EMPOWER
Prevention Study
Summary
Study start date: August 1, 2026
Actual date on which the first participant was enrolled.This study aims to help African American women in the southern United States make informed choices about preventing HIV by testing a new telehealth program called EMPOWER. This program builds upon an existing approach, POWER, which focuses on improving emotional well-being and relationships through mindfulness and cognitive behavioral therapy techniques. The goal is to increase the use and continuation of pre-exposure prophylaxis (PrEP), a medication that helps prevent HIV, among Black women. This is important because it could lead to better health outcomes and empower women to take charge of their sexual health. Participants will be part of a randomized trial where they will be divided into groups and receive the EMPOWER intervention over six sessions. This will be done through a crossover design, meaning some participants will start with the intervention, while others will begin with the usual care and later receive the intervention. The study will measure how many women start and continue using PrEP by checking levels of the medication in their blood at the start, after three months, and after six months. The study will also evaluate how feasible, acceptable, and user-friendly the intervention is compared to the standard care, which is an opt-out PrEP offering at the study site.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.80 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location