HIVNCT06876324
Integrating Supports to Promote PrEP for Black Adolescents Working With Apps- Alabama
A study testing HealthMPowerment App in people with HIV, run by Emory University at 1 site in United States.
Trial summary
This study applies Social Cognitive Theory to develop behavioral interventions promoting PrEP adherence. It seeks to adapt and test the enhanced HMP app for feasibility and acceptability among Black adolescents and young adults (AYAs) and adult supports. Read more about this study
- Who is it for?
- Ages 14 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- HealthMPowerment App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to 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 14 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- African Americans
- Living in the state of Alabama
- Have a PrEP indication (e.g. sex with a partner living with HIV, condomless sex, sex with multiple partners, engagement in transactional sex, or at least one sexually transmitted infection in the past 6 months)
- Support Person:
- >21 years old
- self-reported provision of instrumental, informational, or emotional support for a Black AYA 14-21 years old
Who cannot join
- HIV positive
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama
Birmingham, Alabama, 25294-0111
Stephenie Wallace, MD, (205) 638-9345, stepheni@uab.edu
Stephanie Wallace, MD
About this study
Official title: Adolescent SPEAKS Study: Integrating Supports to Promote PrEP for Black Adolescents Working With Apps
This study applies Social Cognitive Theory to develop behavioral interventions promoting PrEP adherence. It seeks to adapt and test the enhanced HMP app for feasibility and acceptability among Black adolescents and young adults (AYAs) and adult supports.
Read the detailed description
HIV pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV infections, reducing the risk by over 90%. However, adherence among AYAs remains suboptimal, with only 34% maintaining adherence at 48 weeks. Studies suggest that adult support can improve adherence in pediatric HIV treatment, but this approach has not been systematically evaluated for PrEP use in AYAs. Prior research indicates that Black AYAs and their families are open to incorporating adult support for PrEP adherence.
Given the success of mobile health (mHealth) interventions in promoting sexual health, this study aims to enhance the HealthMPowerment (HMP) app-an existing mHealth platform designed for HIV prevention-to facilitate dyadic communication between Black AYAs and trusted adult support persons.
The study addresses the high rates of HIV among Black adolescents and young adults (AYAs) in Alabama, where AYAs (ages 13-24) account for 31% of new HIV diagnoses, with Black gay and bisexual males, transgender individuals, and heterosexual young women being disproportionately affected. Nearly half of new infections occur in rural areas. The U.S. Department of Health and Human Services Ending the HIV Epidemic initiative prioritizes Alabama as a geographic hotspot, emphasizing the need for patient-centered interventions to reduce HIV incidence.
- Conditions
- HIV
- Being tested
- HealthMPowerment App
- Keywords
- Medication Adherence, PrEP
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealthMPowerment AppBehavioural
A mobile health app designed to facilitate increased PrEP use and adherence among AYAs
| Study group | Role | What they receive |
|---|---|---|
| AYA group | Experimental | All enrolled participants (AYAs and support persons) will receive a demonstration of the app including all of its features. All participants will use the app for 6 months. Each dyad of participants will instructed to use the app to communicate with each other and AYAs will be instructed to use the app to keep track of their PrEP. Data from the medication tracker will be collected at 1-, 3-, and 6-months Receives: Behavioral: HealthMPowerment App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability/Usability
The study evaluates an app's impact through post-intervention interviews, focusing on user experience, ethical concerns, and future usage intentions. It explores burden, satisfaction, attitudes, and how the app influences communication and adherence. Sekhon's Theoretical Framework of Acceptability will be utilized to measure this outcome.
Measured: 1 month, 3 months, and 6 months
Feasibility: Communication
Communication between adolescents and young adults (AYA) and support person (i.e., Experience using chat features; Experience using forums). A modified version of Structured Assessment of FEasibility (SAFE) will be utilized to measure this outcome.
Measured: 1 month, 3 months, and 6 months
Secondary outcomes (2)
Medication Adherence Tracker
This will be measured by analyzing the percent of dates with data entered into the medication tracker and correlating that data with reasons why participants did not take their medication (when applicable)
Measured: 1 month, 3 months, and 6 months
Data Usage
This will be measured by comparing the amount of time (minutes) spent using distinct features of the app (e.g. forums, educational resources, avatars, side effect trackers, chat features)
Measured: 1 month, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study startNov 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- AYAs will be paired with an adult who has identified as a support person and will use the app to facilitate dyadic communication to improve PrEP use among Black AYAs. Participants will be enrolled for 6 months. All participants will participate in the intervention
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Samantha Hill, Emory University
- Investigators
- Samantha Hill, MD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876324
- Sponsor's protocol ID
- STUDY00007320
- Other IDs
- 7K23MH128128-03, 2024P007023
- Status last verified
- Sep 2026
- First submitted
- 10 Mar 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results in the article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent SPEAKS Study: Integrating Supports to Promote PrEP for Black Adolescents Working With Apps
- ClinicalTrials.gov ID
- NCT06876324
- Acronym / sponsor ID
- STUDY00007320
- Conditions
- HIV
- Keywords
- Medication Adherence, PrEP
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 14 Mar 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 study applies Social Cognitive Theory to develop behavioral interventions promoting PrEP adherence. It seeks to adapt and test the enhanced HMP app for feasibility and acceptability among Black adolescents and young adults (AYAs) and adult supports.
Detailed description
HIV pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV infections, reducing the risk by over 90%. However, adherence among AYAs remains suboptimal, with only 34% maintaining adherence at 48 weeks. Studies suggest that adult support can improve adherence in pediatric HIV treatment, but this approach has not been systematically evaluated for PrEP use in AYAs. Prior research indicates that Black AYAs and their families are open to incorporating adult support for PrEP adherence.
Given the success of mobile health (mHealth) interventions in promoting sexual health, this study aims to enhance the HealthMPowerment (HMP) app-an existing mHealth platform designed for HIV prevention-to facilitate dyadic communication between Black AYAs and trusted adult support persons.
The study addresses the high rates of HIV among Black adolescents and young adults (AYAs) in Alabama, where AYAs (ages 13-24) account for 31% of new HIV diagnoses, with Black gay and bisexual males, transgender individuals, and heterosexual young women being disproportionately affected. Nearly half of new infections occur in rural areas. The U.S. Department of Health and Human Services Ending the HIV Epidemic initiative prioritizes Alabama as a geographic hotspot, emphasizing the need for patient-centered interventions to reduce HIV incidence.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- AYAs will be paired with an adult who has identified as a support person and will use the app to facilitate dyadic communication to improve PrEP use among Black AYAs. Participants will be enrolled for 6 months. All participants will participate in the intervention
| Arm | Type | Receives |
|---|---|---|
| AYA group | Experimental | Behavioral: HealthMPowerment AppAll enrolled participants (AYAs and support persons) will receive a demonstration of the app including all of its features. All participants will use the app for 6 months. Each dyad of participants will instructed to use the app to communicate with each other and AYAs will be instructed to use the app to keep track of their PrEP. Data from the medication tracker will be collected at 1-, 3-, and 6-months |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- African Americans
- Living in the state of Alabama
- Have a PrEP indication (e.g. sex with a partner living with HIV, condomless sex, sex with multiple partners, engagement in transactional sex, or at least one sexually transmitted infection in the past 6 months)
- Support Person:
Key exclusion criteria (2 listed)
- HIV positive
- Inability to provide informed consent
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 |
|---|---|---|
| HealthMPowerment AppA mobile health app designed to facilitate increased PrEP use and adherence among AYAs | Behavioural | AYA group |
Primary outcome
Acceptability/Usability
Time frame: 1 month, 3 months, and 6 months
The study evaluates an app's impact through post-intervention interviews, focusing on user experience, ethical concerns, and future usage intentions. It explores burden, satisfaction, attitudes, and how the app influences communication and adherence. Sekhon's Theoretical Framework of Acceptability will be utilized to measure this outcome.
Feasibility: Communication
Time frame: 1 month, 3 months, and 6 months
Communication between adolescents and young adults (AYA) and support person (i.e., Experience using chat features; Experience using forums). A modified version of Structured Assessment of FEasibility (SAFE) will be utilized to measure this outcome.
2 secondary outcomes
Medication Adherence Tracker
Time frame: 1 month, 3 months, and 6 months
Data Usage
Time frame: 1 month, 3 months, and 6 months
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 21 Sep 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results in the article, after deidentification (text, tables, figures, and appendices).
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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.
Samantha Hill, MD, MPH principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HealthMPowerment App in people with HIV, run by Emory University 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 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: opening soon, as of the sponsor's last update on 21 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 Samantha Hill, MD, MPH (404-778-1537, svhill2@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability/Usability (time frame: 1 month, 3 months, and 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 21 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.