ClinicalTrials.gg
Not yet recruitingNCT07535346Updated Sep 22, 2026

Integrating Supports to Promote PrEP for Black Adolescents Working With Apps- Atlanta

An interventional study of Health MPowerment App in HIV Infections, sponsored by Emory University. Not yet recruiting at 1 site in United States. Open to participants aged 14 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Emory University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
14 Years to 21 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 19 studies in HIV Infections by Emory University — 4 open to participants now, 6 under way, none of them phase 3. HIV Infections · Emory University.

Planned enrollment
17th of 17
10 · median 63
Started
2027
the only one that year
No phase
9 of 19
3 open now
Registered
19th of 19
by date

Among the 19 studies in HIV Infections by Emory University, this one is the 17th largest by planned enrollment of the 17 interventional ones that give a count, is the only one that started in 2027, is one of 9 with no phase, and was the 19th registered.

HIV Infections

4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.

Browse HIV Infections studies →

Open to participants now

4 of the 19 studies in HIV Infections by Emory University are open now, in 3 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Who these studies take

Of the 158 HIV Infections studies recruiting now, 104 (66%) set no upper age limit and 41 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.

This study: 14 Years to 21 Years · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 19 studies in HIV Infections by Emory University, or all of them as a file.
02

Study 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 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 metro Atlanta, Georgia, where AYAs (ages 13-24) account for 21% 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 four counties in metro Atlanta (Cobb, DeKalb, Fulton, and Gwinnett) as geographic hotspots, emphasizing the need for patient-centered interventions to reduce HIV incidence.

03

Conditions studied

  • HIV Infections

Keywords

  • medication adherence
  • PrEP
04

Who can participate

Ages eligible
14 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • African Americans
  • Living in metropolitan Atlanta counties- Cobb, DeKalb, Fulton, Gwinnett
  • Have a PrEP indication (e.g., sex with a partner living with , condomless sex, sex with multiple partners, engagement in transactional sex, or at least one sexually transmitted infection in the past 6 months)
  • Support Person:
  • self-reported provision of instrumental, informational, or emotional support for a Black AYA 14-21 years old

Exclusion criteria

Exclusion Criteria:

positive Inability to provide consent

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    AYA group

    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 be 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

    Behavioral: Health MPowerment App

Interventions

  • BehavioralHealth MPowerment App

    A mobile health app designed to facilitate increased PrEP use and adherence among AYAs

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 month, 3 months, and 6 months

  2. 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.

    Time frame: 1 month, 3 months, and 6 months

Secondary outcomes

  1. 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)

    Time frame: 1 month, 3 months, and 6 months

  2. 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)

    Time frame: 1 month, 3 months, and 6 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — The following data will be shared: Data acceptability and feasibility measures as analyzed via interviews and surveys, and data app usage

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: May 2027 onwards

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2027; primary completion for Apr 2027, 0 months later.

Of 393 non-industry interventional studies with no phase under HIV Infections, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's planned 0 months is below that.

Counting every sponsor, half of 402 studies reached it within 28 months; a quarter within 16 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 10, 2026
First posted
Apr 17, 2026
StartEst.
Apr 2027
Primary completionEst.
Apr 2027
CompletionEst.
Apr 2027
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07535346
Lead sponsor
Emory University
Responsible party
Samantha Hill (Assistant Professor, Emory University) — Principal investigator
First posted
Apr 17, 2026
Start date
Apr 2027 (estimated)
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Sep 22, 2026

Study contacts

Samantha Hill, MD, MPH
Contact
samantha.veronica.hill@emory.edu
404-778-1537
Jacob Aiello, MPH
Contact
jacob.aiello@emory.edu
404-712-9344
Samantha Hill, MD, MPH
principal investigator · Emory University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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