HIV Pre-exposure ProphylaxisEMPOWERNCT07173816
Optimizing PrEP Uptake for African American Women in the South by Empowering Women to Make Informed HIV Prevention and Sexual Health Choices
A study testing EMPOWER in people with HIV Pre-exposure Prophylaxis, run by University of Georgia at 1 site in United States.
Trial summary
Pilot testing of EMPOWER, a group sexual health intervention, to increase uptake and persistence of PrEP Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Pre-exposure Prophylaxis
- What is being tested?
- EMPOWER
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
- Able to speak and read English; and
- No plans to leave the Atlanta, GA area during the duration of study participation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Pilot testing of EMPOWER, a group sexual health intervention, to increase uptake and persistence of PrEP
Read the detailed description
This study will pilot test the telehealth intervention EMPOWER (Enhancing and Motivating PrEP Options among Women through Empowerment and Resilience) by adapting an evidence-informed intervention, POWER (Progressing Our Well-Being, Emotions, and Relationships) based on mindfulness and cognitive behavioral therapy, to improve PrEP uptake and persistence by Black women in the South.
Conduct a waitlist-controlled, randomized pilot trial of the 6-session group intervention using a crossover design with 80 Black women. Clinical outcomes will be the PrEP uptake and PrEP persistence measured by TDF via the dried blood spot at baseline, 3- and 6-months post-intervention. We will also assess the intervention's feasibility, acceptability, and usability. The outcomes will be compared with the usual standard of care (opt-out PrEP) at the intervention site.
- Conditions
- HIV Pre-exposure Prophylaxis
- Being tested
- EMPOWER
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMPOWERBehavioural
EMPOWER, a group-based 6 sessions telehealth behavioral intervention, will comprise sexual health goals and values elicitation, sexual health plan development, and motivational enhancement skills will be used to promote effective HIV prevention decision-making within the relationship context, incorporating the sexual values of each participant. This will allow each participant to develop a personalized, tailored sexual health plan that includes PrEP deliberation to enhance PrEP decision-making, uptake and persistence within a culturally congruent and empowering program that aims to reduce stigma around HIV and barriers to access.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Active comparator | This arm will receive the intervention first. Receives: Behavioral: EMPOWER |
| Waitlist Control | Active comparator | This arm will receve the intervention after the wait period Receives: Behavioral: EMPOWER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of EMPOWER Intervention
Enrollment rate will be used an indicator of the feasibility of the intervention
Measured: From enrollment to the end of data collection and analysis at 6 months
Acceptability of EMPOWER Intervention
Acceptability of the intervention based on participant satisfaction using the Client Satisfaction Questionnaire scores
Measured: From enrollment to the end of data collection and analysis at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Oct 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Pre-exposure ProphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Investigators will recruit 80 Black women from HIV testing sites who have engaged in HIV risk behavior in the prior three months and randomly assign them to either the EMPOWER intervention condition (n=40) or a standard of care control condition (n=40). Standard of care includes provision of opt-out PrEP. Both conditions will receive EMPOWER. However, the standard of care control condition will receive the intervention after the 3-month follow-up assessment. The active intervention period will last 9 weeks (5 weekly sessions and a booster session after 4 weeks).
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Mohammad Rifat Haider, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173816
- Sponsor's protocol ID
- R34MH137775
- Other IDs
- R34MH137775
- Acronym
- EMPOWER
- Status last verified
- Aug 2026
- First submitted
- 1 Sep 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Investigators will not share the IPD of the participants of this study with others because the investigaotrs will only report the aggregated results of the study.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing PrEP Uptake for African American Women in the South by Empowering Women to Make Informed HIV Prevention and Sexual Health Choices
- ClinicalTrials.gov ID
- NCT07173816
- Acronym / sponsor ID
- EMPOWER / R34MH137775
- Conditions
- HIV Pre-exposure Prophylaxis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilot testing of EMPOWER, a group sexual health intervention, to increase uptake and persistence of PrEP
Detailed description
This study will pilot test the telehealth intervention EMPOWER (Enhancing and Motivating PrEP Options among Women through Empowerment and Resilience) by adapting an evidence-informed intervention, POWER (Progressing Our Well-Being, Emotions, and Relationships) based on mindfulness and cognitive behavioral therapy, to improve PrEP uptake and persistence by Black women in the South.
Conduct a waitlist-controlled, randomized pilot trial of the 6-session group intervention using a crossover design with 80 Black women. Clinical outcomes will be the PrEP uptake and PrEP persistence measured by TDF via the dried blood spot at baseline, 3- and 6-months post-intervention. We will also assess the intervention's feasibility, acceptability, and usability. The outcomes will be compared with the usual standard of care (opt-out PrEP) at the intervention site.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Investigators will recruit 80 Black women from HIV testing sites who have engaged in HIV risk behavior in the prior three months and randomly assign them to either the EMPOWER intervention condition (n=40) or a standard of care control condition (n=40). Standard of care includes provision of opt-out PrEP. Both conditions will receive EMPOWER. However, the standard of care control condition will receive the intervention after the 3-month follow-up assessment. The active intervention period will last 9 weeks (5 weekly sessions and a booster session after 4 weeks).
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Active comparator | Behavioral: EMPOWERThis arm will receive the intervention first. |
| Waitlist Control | Active comparator | Behavioral: EMPOWERThis arm will receve the intervention after the wait period |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
- Able to speak and read English; and
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMPOWEREMPOWER, a group-based 6 sessions telehealth behavioral intervention, will comprise sexual health goals and values elicitation, sexual health plan development, and motivational enhancement skills will be used to promote effective HIV prevention decision-making within the relationship context, incorporating the sexual values of each participant. This will allow each participant to develop a personalized, tailored sexual health plan that includes PrEP deliberation to enhance PrEP decision-making, uptake and persistence within a culturally congruent and empowering program that aims to reduce stigma around HIV and barriers to access. | Behavioural | Intervention Arm, Waitlist Control |
Primary outcome
Feasibility of EMPOWER Intervention
Time frame: From enrollment to the end of data collection and analysis at 6 months
Enrollment rate will be used an indicator of the feasibility of the intervention
Acceptability of EMPOWER Intervention
Time frame: From enrollment to the end of data collection and analysis at 6 months
Acceptability of the intervention based on participant satisfaction using the Client Satisfaction Questionnaire scores
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No. Investigators will not share the IPD of the participants of this study with others because the investigaotrs will only report the aggregated results of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMPOWER in people with HIV Pre-exposure Prophylaxis, run by University of Georgia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Rifat Haider, Ph.D. (803-477-4289, haider@uga.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of EMPOWER Intervention (time frame: From enrollment to the end of data collection and analysis at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.