HIV/AIDSNCT06741631
MyPEEPS LITE Trial
A study testing MyPEEPS Mobile in people with HIV/AIDS, run by Columbia University at 2 sites in United States.
Trial summary
This study will use community-informed advertisements and messages through electronic methods to recruit and retain a large (N=3,200), diverse national sample of high-risk young men who have sex with men (YMSM) and non-binary individuals that are assigned male sex at birth, 16-29 years of age to determine the efficacy… Read more about this study
- Who is it for?
- Ages 16 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- MyPEEPS Mobile
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,200 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jan 2025to 1 Dec 2028
- 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 29 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Be between 16-29 years of age;
- Sex assigned at birth is male and identify gender as male or non-binary;
- Understand and read English;
- Live within US and its territories;
- Own or have access to a smartphone;
- Self-report anal sex with someone who has a penis in the last 12 months; and
- Be HIV-negative or status unknown
Who cannot join
- Individuals who identify as transgender
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
- Recruiting
Columbia University
New York, New York, 10032
About this study
This study will use community-informed advertisements and messages through electronic methods to recruit and retain a large (N=3,200), diverse national sample of high-risk young men who have sex with men (YMSM) and non-binary individuals that are assigned male sex at birth, 16-29 years of age to determine the efficacy of the MyPEEPS Mobile intervention on reduced incident HIV infections in comparison to a standard of care condition and to examine the degree to which reduced incident HIV infections occurs in the context of potential multilevel moderators and conceptual mediators. This is key to advancing HIV prevention among HIV-negative US persons at extremely high-risk for HIV seroconversion.
Read the detailed description
In direct response to RFA-AI-21-018, Limited Interaction Targeted Epidemiology (LITE-2): To Advance HIV Prevention (UG3/UH3 Clinical Trial Optional), we proposed to harness innovative electronic methods to conduct a large, rigorous national study collecting and contextualizing epidemiological HIV incidence data in Young Men who have Sex with Men (YMSM) and testing the efficacy of MyPEEPS Mobile, an evidence-based, digitally delivered mHealth sexual risk reduction intervention on HIV incidence. We proposed to establish a large national cohort of 3,200 racially and ethnically diverse YMSM 16-29 years old, the age YMSM are most susceptible to HIV acquisition to identify theoretically-driven correlates of HIV seroconversion among a key population experiencing a disproportionate number of new HIV diagnoses.
Randomized controlled trials (RCTs) are considered the gold standard for estimating treatment efficacy because randomization mitigates risk of bias by balancing measured and unmeasured confounders across treatment groups. However, RCTs are costly, time-consuming, and can be challenging to conduct in certain context. We are therefore integrating the robust epidemiological data that we collected during the UG3 phase into the clinical trial design. That integration is a potentially appealing way to generate an external comparator cohort to increase the power of our RCT to estimate the effect of MyPEEPS Mobile on HIV incidence.
- Conditions
- HIV/AIDS
- Being tested
- MyPEEPS Mobile
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants randomized to the control arm will receive standard of care. This consists of HIV home testing every 6 months, 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. |
| Intervention | Experimental | Participants randomized to the intervention arm will have access to MyPEEPS Mobile for the next 6 months. MyPEEPS Mobile is a secure web app with content delivered through games, scenarios, and role-plays within 22 mobile activities (true/ false questions, multiple choice, matching, videos). Receives: Behavioral: MyPEEPS Mobile |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Incidence
OraQuick In-Home HIV Tests will be shipped to participants at baseline, 6 and 12 months.
Measured: Baseline, 6 month follow up, 12 month follow up.
Total Condomless Anal Sex Occurring in the Context of Insufficient PrEP Protection
Condomless anal sex acts not protected by PrEP, defined as condomless anal sex acts in the prior 6 months without protection via PrEP. We will measure sexual risk with the AIDS-Risk Behavior Assessment.
Measured: Baseline, 6 month follow up, 12 month follow up.
Secondary outcomes (1)
Self-Reported PrEP Initiation
Self reported PrEP initiation variables will be measured for the purposes of characterizing the uptake of PrEP over the course of the study. We will use a self-reported approach to capture the date of initiation of medication, current use, and most recent date the medication was taken.
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 start10 Jan 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2028 (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
- 3,200 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, Northwestern University, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Rebecca Schnall, RN, MPH, PhD, Columbia University
- Investigators
- Rebecca Schnall, PhD, MPH, Principal investigator, Columbia UniversityRobert Garofalo, MD, MPH, Principal investigator, Ann & Robert H Lurie Children's Hospital of ChicagoDustin Duncan, ScD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741631
- Sponsor's protocol ID
- AAAV4619
- Other IDs
- UH3AI169658
- Status last verified
- Feb 2026
- First submitted
- 15 Dec 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyPEEPS LITE Trial
- ClinicalTrials.gov ID
- NCT06741631
- Acronym / sponsor ID
- AAAV4619
- Conditions
- HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,200 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago, Northwestern University, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2028 (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.
This study will use community-informed advertisements and messages through electronic methods to recruit and retain a large (N=3,200), diverse national sample of high-risk young men who have sex with men (YMSM) and non-binary individuals that are assigned male sex at birth, 16-29 years of age to determine the efficacy of the MyPEEPS Mobile intervention on reduced incident HIV infections in comparison to a standard of care condition and to examine the degree to which reduced incident HIV infections occurs in the context of potential multilevel moderators and conceptual mediators. This is key to advancing HIV prevention among HIV-negative US persons at extremely high-risk for HIV seroconversion.
Detailed description
In direct response to RFA-AI-21-018, Limited Interaction Targeted Epidemiology (LITE-2): To Advance HIV Prevention (UG3/UH3 Clinical Trial Optional), we proposed to harness innovative electronic methods to conduct a large, rigorous national study collecting and contextualizing epidemiological HIV incidence data in Young Men who have Sex with Men (YMSM) and testing the efficacy of MyPEEPS Mobile, an evidence-based, digitally delivered mHealth sexual risk reduction intervention on HIV incidence. We proposed to establish a large national cohort of 3,200 racially and ethnically diverse YMSM 16-29 years old, the age YMSM are most susceptible to HIV acquisition to identify theoretically-driven correlates of HIV seroconversion among a key population experiencing a disproportionate number of new HIV diagnoses.
Randomized controlled trials (RCTs) are considered the gold standard for estimating treatment efficacy because randomization mitigates risk of bias by balancing measured and unmeasured confounders across treatment groups. However, RCTs are costly, time-consuming, and can be challenging to conduct in certain context. We are therefore integrating the robust epidemiological data that we collected during the UG3 phase into the clinical trial design. That integration is a potentially appealing way to generate an external comparator cohort to increase the power of our RCT to estimate the effect of MyPEEPS Mobile on HIV incidence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants randomized to the control arm will receive standard of care. This consists of HIV home testing every 6 months, 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. |
| Intervention | Experimental | Behavioral: MyPEEPS MobileParticipants randomized to the intervention arm will have access to MyPEEPS Mobile for the next 6 months. MyPEEPS Mobile is a secure web app with content delivered through games, scenarios, and role-plays within 22 mobile activities (true/ false questions, multiple choice, matching, videos). |
Who may qualify
- Ages
- 16 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Be between 16-29 years of age;
- Sex assigned at birth is male and identify gender as male or non-binary;
- Understand and read English;
- Live within US and its territories;
- Own or have access to a smartphone;
Key exclusion criteria (1 listed)
- Individuals who identify as transgender
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 | Intervention |
Primary outcome
HIV Incidence
Time frame: Baseline, 6 month follow up, 12 month follow up.
OraQuick In-Home HIV Tests will be shipped to participants at baseline, 6 and 12 months.
Total Condomless Anal Sex Occurring in the Context of Insufficient PrEP Protection
Time frame: Baseline, 6 month follow up, 12 month follow up.
Condomless anal sex acts not protected by PrEP, defined as condomless anal sex acts in the prior 6 months without protection via PrEP. We will measure sexual risk with the AIDS-Risk Behavior Assessment.
1 secondary outcome
Self-Reported PrEP Initiation
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 27 Feb 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.
Rebecca Schnall, PhD, MPH principal investigator
Columbia University
Robert Garofalo, MD, MPH principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
Dustin Duncan, ScD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyPEEPS Mobile in people with HIV/AIDS, run by Columbia University at 2 sites 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 1 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 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
HIV Incidence (time frame: Baseline, 6 month follow up, 12 month follow up.). 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 27 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.