Recruiting soon

EMPOWERTelehealth Intervention to Improve PrEP Uptake in African American Women

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What is being tested

EMPOWER

Behavioral
Who is being recruted

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: August 2026
See protocol details

Summary

Principal SponsorUniversity of Georgia
Study ContactMohammad Rifat Haider, Ph.D.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleOptimizing PrEP Uptake for African American Women in the South by Empowering Women to Make Informed HIV Prevention and Sexual Health Choices
NCT07173816
Principal SponsorUniversity of Georgia
Study ContactMohammad Rifat Haider, Ph.D.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

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

6 inclusion criteria required to participate
Identification as cis-gendered Black woman;

Age 18 and older;

Engaging in risky sexual behavior in prior 3 months (condomless vaginal or anal sex with a non-main partner, or a partner with known or suspected risk behavior such as injection drug use or HIV/STI, multiple sex partners, transactional sex);

Access to a device with a screen, a web browser, and adequate internet speed (e.g., smartphone, computer) for videoconferencing;

Show More Criteria

4 exclusion criteria prevent from participating
Cognitive or mental health condition that limits the ability to provide informed consent;

Self-reported use of PrEP or PEP medication in the past three months;

Unable to speak and read English; and

Currently living with HIV.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
This arm will receive the intervention first.

Group II

Active Comparator
This arm will receve the intervention after the wait period

Study 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

Suspended

Empowerment Resource Center

Atlanta, United StatesOpen Empowerment Resource Center in Google Maps
Recruiting soonOne Study Center