PrEP UptakeNCT07024745
PrEP US NoW: PrEP Utilization Through Increasing Social Capital Among YBMSM Networks With Women
A study testing Intervention Group in people with PrEP Uptake, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This project is a randomized intervention looking at PrEP uptake among young, black men who identify as gay, bisexual, or same gender loving, utilizing black females within the community to help deliver study related topics. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- PrEP Uptake
- What is being tested?
- Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Female Facilitators: 1) Black/African American; 2) age 18-80 years old; 3) Female; 4) able to lead weekly sessions with participants; 5) able to download the Us*Now mHealth app
- Participants: 1) Black/African American; 2) age 18-29 years old; 3) Male; 4) Identifies as gay, bisexual, or same gender loving; 5) able to download the Us*Now mHealth app
Who cannot join
- Female Facilitators: 1) does not identify as Black/African American; 2) not Female; 3) not able to lead the weekly sessions or attend the study training
- Participants: 1) does not identify as Black/African American; 2) age 30 years or older; 3) Identifies as Straight or Heterosexual; 4) not able to download the Us*Now mHealth app
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35222
About this study
This project is a randomized intervention looking at PrEP uptake among young, black men who identify as gay, bisexual, or same gender loving, utilizing black females within the community to help deliver study related topics. All participants will download the Us*Now mHealth app that was created specifically for this project. Participants randomized to the Intervention arm will interact with the Us*Now mHealth app and will be invited to attend 4 weekly sessions led by a black female facilitator where the topic are pre-selected by the study team. Participants randomized to the Control arm will interact with the Us*Now mHealth app only.
- Conditions
- PrEP Uptake
- Being tested
- Intervention Group, Control (Standard treatment)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupBehavioural
The Intervention is 1) interact with the Us*Now mHealth app for 1 month; 2) participate in 4 weekly sessions with other group members and led by a Female Facilitator. Each week will cover a different topic - Week 1: Intersectional Stigma, Week 2: Sexual Health, Week 3: HIV Prevention, Week 4: Engagement in PrEP Care.
Control (Standard treatment)Behavioural
The Control group will be asked to interact with the Us*Now mHealth app for 1 month.
| Study group | Role | What they receive |
|---|---|---|
| Female Facilitator | Other | Not described Receives: Behavioral: Intervention Group |
| Control Participants | Other | Not described Receives: Behavioral: Control (Standard treatment) |
| Intervention Participants | Other | Not described Receives: Behavioral: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Feasibility and Acceptability
Participants will complete the Feasibility of Intervention Measure (FIM), Acceptability of Intervention Measure (AIM), and Intervention Appropriateness Measure (IAM) at T1 (1 month post Intervention) and T3 (3 month after T1) surveys. All measures are 4 questions, scaled responses from Completely Disagree to Completely Agree
Measured: 6 months
Change in Social Capital and Internalized Homonegativity
Participants will complete the Personal Social Capital Scale and Internalized Homophobia Scale at T0 (baseline), T1 (1 month after Intervention), and T3 (3 months after T1) surveys. The Personal Social Capital Scale a 10 question measure, responses range from 1 (all/Alot) to 5 (None). The Internalized Homophobia Scale is a 12 question measure with True, False, and Don't Know responses.
Measured: 6 months
Secondary outcomes (2)
PrEP uptake
Participants will be asked if they are on PrEP at T0 (baseline), T1 (1 month after Intervention), and T3 (3 months after T1) surveys.
Measured: 6 months
Change in sexual practices
Participants will be asked a Sexual Behavior Assessment at T0 (baseline), T1 (1 month after Intervention), and T3 (3 months after T1) surveys. This is a 4 question measure asking if they have had sex in past 3 months, and if it was condomless sex
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start9 May 2024
- Primary completion30 Nov 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrEP UptakeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Michael J Mugavero, MD, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024745
- Sponsor's protocol ID
- IRB-300007813
- Other IDs
- R34MH128072
- Status last verified
- Jan 2026
- First submitted
- 22 May 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sohail M, Hussen SA, Dougherty Sheff S, Mugavero M, Schneider J, Hightow-Weidman L, Turan JM, Lynam M, Elopre L. An mHealth App-Based Social Capital Intervention (PrEP US NoW) to Improve Sexual Health and Uptake of Pre-Exposure Prophylaxis Among Young, Black, Sexual Minority Men: Protocol for Intervention Development and a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 18;14:e66326. doi: 10.2196/66326.
PubMed 40966683
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrEP US NoW: PrEP Utilization Through Increasing Social Capital Among YBMSM Networks With Women
- ClinicalTrials.gov ID
- NCT07024745
- Acronym / sponsor ID
- IRB-300007813
- Conditions
- PrEP Uptake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 9 May 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 17 Jun 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.
This project is a randomized intervention looking at PrEP uptake among young, black men who identify as gay, bisexual, or same gender loving, utilizing black females within the community to help deliver study related topics. All participants will download the Us*Now mHealth app that was created specifically for this project. Participants randomized to the Intervention arm will interact with the Us*Now mHealth app and will be invited to attend 4 weekly sessions led by a black female facilitator where the topic are pre-selected by the study team. Participants randomized to the Control arm will interact with the Us*Now mHealth app only.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Female Facilitator | Other | Behavioral: Intervention Group |
| Control Participants | Other | Behavioral: Control (Standard treatment) |
| Intervention Participants | Other | Behavioral: Intervention Group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Female Facilitators: 1) Black/African American; 2) age 18-80 years old; 3) Female; 4) able to lead weekly sessions with participants; 5) able to download the Us*Now mHealth app
- Participants: 1) Black/African American; 2) age 18-29 years old; 3) Male; 4) Identifies as gay, bisexual, or same gender loving; 5) able to download the Us*Now mHealth app
Key exclusion criteria (2 listed)
- Female Facilitators: 1) does not identify as Black/African American; 2) not Female; 3) not able to lead the weekly sessions or attend the study training
- Participants: 1) does not identify as Black/African American; 2) age 30 years or older; 3) Identifies as Straight or Heterosexual; 4) not able to download the Us*Now mHealth app
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 |
|---|---|---|
| Intervention GroupThe Intervention is 1) interact with the Us*Now mHealth app for 1 month; 2) participate in 4 weekly sessions with other group members and led by a Female Facilitator. Each week will cover a different topic - Week 1: Intersectional Stigma, Week 2: Sexual Health, Week 3: HIV Prevention, Week 4: Engagement in PrEP Care. | Behavioural | Female Facilitator, Intervention Participants |
| Control (Standard treatment)The Control group will be asked to interact with the Us*Now mHealth app for 1 month. | Behavioural | Control Participants |
Primary outcome
Intervention Feasibility and Acceptability
Time frame: 6 months
Participants will complete the Feasibility of Intervention Measure (FIM), Acceptability of Intervention Measure (AIM), and Intervention Appropriateness Measure (IAM) at T1 (1 month post Intervention) and T3 (3 month after T1) surveys. All measures are 4 questions, scaled responses from Completely Disagree to Completely Agree
Change in Social Capital and Internalized Homonegativity
Time frame: 6 months
Participants will complete the Personal Social Capital Scale and Internalized Homophobia Scale at T0 (baseline), T1 (1 month after Intervention), and T3 (3 months after T1) surveys. The Personal Social Capital Scale a 10 question measure, responses range from 1 (all/Alot) to 5 (None). The Internalized Homophobia Scale is a 12 question measure with True, False, and Don't Know responses.
2 secondary outcomes
PrEP uptake
Time frame: 6 months
Change in sexual practices
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Derived from this study: PubMed 40966683Sohail M, Hussen SA, Dougherty Sheff S, Mugavero M, Schneider J, Hightow-Weidman L, Turan JM, Lynam M, Elopre L. An mHealth App-Based Social Capital Intervention (PrEP US NoW) to Improve Sexual Health and Uptake of Pre-Exposure Prophylaxis Among Young, Black, Sexual Minority Men: Protocol for Intervention Development and a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 18;14:e66326. doi: 10.2196/66326.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with PrEP Uptake, run by University of Alabama at Birmingham 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 26 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Feasibility and Acceptability (time frame: 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?
On the ClinicalTrials.gov record for NCT07024745, which also lists 1 linked publication.
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 26 Jan 2026.