HIV/AIDSNCT06741618
MyPEEPS Mobile Plus: A Multi-Level HIV Prevention Intervention for Young MSM
A study testing MyPEEPS Mobile and Electronic PrEP peer navigation in people with HIV/AIDS, run by Columbia University at 1 site in United States.
Trial summary
MyPEEPS Mobile Plus, a multi-level intervention for improving HIV prevention outcomes in YMSM, is a novel and evidence-driven approach using mobile technology to deliver HIV prevention information specifically developed for YMSM. Read more about this study
- Who is it for?
- Ages 16 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- MyPEEPS Mobile and Electronic PrEP peer navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2026to 30 Jun 2029
- 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 16 to 25 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 16-25 years of age
- identify as male or non-binary
- male sex assigned at birth
- understand and read English
- own a smartphone
- report condomless anal sex with a male in the past year
- HIV-negative (OraQuick verified)
Who cannot join
- HIV Positive
- If study staff determine participant unable to consent due to obvious and severe cognitive impairment or under the influence of drugs or alcohol
- currently report consistent use of PrEP
- currently enrolled in another HIV prevention study
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, 1 recruiting
- Recruiting
Columbia University
New York, New York, 10032
Rebecca Schnall, 212-342-6886, rb897@cumc.columbia.edu
About this study
Official title: MyPEEPS Mobile Plus
MyPEEPS Mobile Plus, a multi-level intervention for improving HIV prevention outcomes in YMSM, is a novel and evidence-driven approach using mobile technology to deliver HIV prevention information specifically developed for YMSM. Building on strong preliminary work, the proposed research is the next logical step in a body of work designed to assess whether refinement of this mobile intervention used in combination with virtual PrEP Peer Navigation will result in improvements in PrEP uptake and a reduction in HIV-related behavior. This is key to advancing HIV prevention among HIV-negative US persons at extremely high-risk for HIV seroconversion.
Read the detailed description
This study expands MyPEEPS Mobile to develop MyPEEPS Mobile Plus, a multi-level intervention comprised of MyPEEPS Mobile with added PrEP content (based upon expert advisory and youth feedback) + PrEP E-Peer Navigation to overcome the challenges of PrEP initiation, adherence, and persistence among YMSM. Peer navigation is an evidence-based, widely recommended intervention for reaching youth and MSM for HIV-related care outcomes, with evidence of acceptability among racial/ethnic minority YMSM for PrEP. Peer navigation addresses common reasons for failing to begin or maintain PrEP use, including low perceived risk, structural or logistic barriers to care engagement, and anticipated side effects. Relative to in-person and group-based HIV prevention programs, behavioral interventions with digital and virtual components can have vast reach and present unique potential to rapidly scale delivery to very large and hidden groups. Therefore, the investigators propose to conduct a randomized controlled trial to test the efficacy of MyPEEPS Mobile Plus (a multi-level intervention comprised of MyPEEPS Mobile + PrEP E-Peer Navigation) for promoting initiation, adherence, and persistence of PrEP and decreased HIV risk behavior in YMSM. Building upon the team's demonstrated ability to enroll large numbers of young racially and ethnically diverse YMSM and extensive experience developing mobile health interventions, the proposed study will test the efficacy of this expanded, multi-level mobile HIV prevention intervention emphasizing PrEP. If efficacious, it will increase PrEP initiation, adherence, and persistence and decrease overall HIV risk in diverse YMSM in the US.
- Conditions
- HIV/AIDS
- Being tested
- MyPEEPS Mobile, Electronic PrEP peer navigation
- Keywords
- PrEP, care navigation
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyPEEPS MobileBehavioural
An evidence-based, digitally delivered mHealth sexual risk reduction intervention on HIV incidence
Electronic PrEP peer navigationBehavioural
Electronic peer navigation to PreP services
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants randomized to the control arm will receive standard of care information regarding sexual and other behaviors that potentiate one's risk for HIV infection, receipt of a fact sheet about PrEP and PEP, referrals to the local PrEP clinic, and referrals for local sexually transmitted disease testing, and will have access to the MyPEEPS Mobile App during the study. Receives: Behavioral: MyPEEPS Mobile |
| Intervention | Experimental | Participants randomized to the intervention arm will have access to the MyPEEPS mobile application and Electronic peer PrEP navigation for the entire 12-month study period. Receives: Behavioral: MyPEEPS Mobile; Behavioral: Electronic PrEP peer navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP Initiation:
Participants will self-report attending at least one PrEP-related care visit to asess medical eligibility for PrEP initiation.
Measured: Baseline, 6-month follow-up, 12-month follow-up
Secondary outcomes (2)
PrEP Adherence
Daily oral PrEP users will report PrEP use in the past 7-days.
Measured: Baseline, 6-month follow-up, 12-month follow-up
PrEP Persistence
Questions will be measure visit constancy, i.e., self-report at least 1 PrEP related care visit in the past 6 months.
Measured: Baseline, 6-month follow-up, 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start20 Apr 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago, Callen-Lorde Community Health Center, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Rebecca Schnall, RN, MPH, PhD, Columbia University
- Investigators
- Robert Garofalo, MD, MPH, Principal investigator, Ann & Robert H Lurie Children's Hospital of ChicagoLisa Kuhns, PhD, MPH, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741618
- Sponsor's protocol ID
- AAAU8894
- Other IDs
- R01MD019181
- Status last verified
- Jun 2026
- First submitted
- 15 Dec 2024
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyPEEPS Mobile Plus
- ClinicalTrials.gov ID
- NCT06741618
- Acronym / sponsor ID
- AAAU8894
- Conditions
- HIV/AIDS
- Keywords
- PrEP, care navigation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago, Callen-Lorde Community Health Center, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 19 Dec 2024 (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.
MyPEEPS Mobile Plus, a multi-level intervention for improving HIV prevention outcomes in YMSM, is a novel and evidence-driven approach using mobile technology to deliver HIV prevention information specifically developed for YMSM. Building on strong preliminary work, the proposed research is the next logical step in a body of work designed to assess whether refinement of this mobile intervention used in combination with virtual PrEP Peer Navigation will result in improvements in PrEP uptake and a reduction in HIV-related behavior. This is key to advancing HIV prevention among HIV-negative US persons at extremely high-risk for HIV seroconversion.
Detailed description
This study expands MyPEEPS Mobile to develop MyPEEPS Mobile Plus, a multi-level intervention comprised of MyPEEPS Mobile with added PrEP content (based upon expert advisory and youth feedback) + PrEP E-Peer Navigation to overcome the challenges of PrEP initiation, adherence, and persistence among YMSM. Peer navigation is an evidence-based, widely recommended intervention for reaching youth and MSM for HIV-related care outcomes, with evidence of acceptability among racial/ethnic minority YMSM for PrEP. Peer navigation addresses common reasons for failing to begin or maintain PrEP use, including low perceived risk, structural or logistic barriers to care engagement, and anticipated side effects. Relative to in-person and group-based HIV prevention programs, behavioral interventions with digital and virtual components can have vast reach and present unique potential to rapidly scale delivery to very large and hidden groups. Therefore, the investigators propose to conduct a randomized controlled trial to test the efficacy of MyPEEPS Mobile Plus (a multi-level intervention comprised of MyPEEPS Mobile + PrEP E-Peer Navigation) for promoting initiation, adherence, and persistence of PrEP and decreased HIV risk behavior in YMSM. Building upon the team's demonstrated ability to enroll large numbers of young racially and ethnically diverse YMSM and extensive experience developing mobile health interventions, the proposed study will test the efficacy of this expanded, multi-level mobile HIV prevention intervention emphasizing PrEP. If efficacious, it will increase PrEP initiation, adherence, and persistence and decrease overall HIV risk in diverse YMSM in the US.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: MyPEEPS MobileParticipants randomized to the control arm will receive standard of care information regarding sexual and other behaviors that potentiate one's risk for HIV infection, receipt of a fact sheet about PrEP and PEP, referrals to the local PrEP clinic, and referrals for local sexually transmitted disease testing, and will have access to the MyPEEPS Mobile App during the study. |
| Intervention | Experimental | Behavioral: MyPEEPS Mobile, Behavioral: Electronic PrEP peer navigationParticipants randomized to the intervention arm will have access to the MyPEEPS mobile application and Electronic peer PrEP navigation for the entire 12-month study period. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 16-25 years of age
- identify as male or non-binary
- male sex assigned at birth
- understand and read English
- own a smartphone
Key exclusion criteria (4 listed)
- HIV Positive
- If study staff determine participant unable to consent due to obvious and severe cognitive impairment or under the influence of drugs or alcohol
- currently report consistent use of PrEP
- currently enrolled in another HIV prevention study
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 |
|---|---|---|
| MyPEEPS MobileAn evidence-based, digitally delivered mHealth sexual risk reduction intervention on HIV incidence | Behavioural | Control, Intervention |
| Electronic PrEP peer navigationElectronic peer navigation to PreP services | Behavioural | Intervention |
Primary outcome
PrEP Initiation:
Time frame: Baseline, 6-month follow-up, 12-month follow-up
Participants will self-report attending at least one PrEP-related care visit to asess medical eligibility for PrEP initiation.
2 secondary outcomes
PrEP Adherence
Time frame: Baseline, 6-month follow-up, 12-month follow-up
PrEP Persistence
Time frame: Baseline, 6-month follow-up, 12-month follow-up
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 26 Jun 2026.
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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.
Robert Garofalo, MD, MPH principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
Lisa Kuhns, PhD, MPH principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyPEEPS Mobile and Electronic PrEP peer navigation in people with HIV/AIDS, run by Columbia 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 7 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: looking for participants now, as of the sponsor's last update on 26 Jun 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 Rebecca Schnall, PhD, MPH (212-342-6886, rb897@columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP Initiation: (time frame: Baseline, 6-month follow-up, 12-month follow-up). 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 26 Jun 2026.