HIVLYPSNCT07438041
Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services
A study testing LYPS in people with HIV and PrEP, run by Westat at 4 sites in United States.
Trial summary
The LYPS intervention is a multi-level intervention that combines: a) structural-level delivery of PrEP and PrEP services by a community health professional (CHP) at a designated place in the community being offered by the SC where PrEP is not yet provided (e.g., participant's home, community partner location, or… Read more about this study
- Who is it for?
- Ages 13 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV, PrEP, PrEP Adherence
- What is being tested?
- LYPS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 Oct 2026to 15 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 13 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 13-24 years, inclusive;
- Reports anal or vaginal sex in the past year;
- Is not living with HIV;
- Weighs at least 35 kilograms (77 pounds);
- Willing to receive PrEP care from a provider at a participating SC either in the clinic or at one of the designated places in the community being offered by the SC SC;
- Has an Android-based smartphone or iPhone;
- Has fluency in English (able to read, speak, and understand English); and
- Willing to provide informed consent to participate in the study.
Who cannot join
- Has counter-indications for PrEP according to guidelines and approved local label;
- Has any clinically significant systemic disease (including but not limited to significant or uncontrolled liver disease, gastrointestinal disease, kidney disease, thyroid disease, osteoporosis, or bone disease) or diabetes;
- Any other medical, behavioral, or other conditions that, in the opinion of the SC project lead or designee, could interfere with adherence to study procedures or compromise interpretation of study results;
- Concurrent participation in ATN 166, ATN 170, or any other clinical trial providing HIV medications (PrEP, vaccine, etc.) or currently receiving any PrEP-adherence or persistence behavioral intervention; or
- Is currently incarcerated or pending incarceration.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Emory Atlanta Adolescent Consortium
Atlanta, Georgia, 30322
Kaylin Dance, (404) 727-5642, kaylin.dance@emory.edu
Andres Camacho-Gonzalez
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Jessica Coleman, 301-385-4868, jcolem52@jh.edu
Allison Agwu
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Litty Koshy, 832-822-1038, Litty.Koshy@bcm.edu
Mary Paul
- Recruiting
San Francisco Department of Public Health
San Francisco, California, 94102
Emily Schaeffer, 628-217-7456, emily.schaeffer@sfdph.org
Albert Liu
About this study
Official title: Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services (LYPS): An Innovative Mobile Delivery and Mobile Health (mHealth) Intervention to Optimize PrEP Adherence and Persistence
The LYPS intervention is a multi-level intervention that combines: a) structural-level delivery of PrEP and PrEP services by a community health professional (CHP) at a designated place in the community being offered by the SC where PrEP is not yet provided (e.g., participant's home, community partner location, or traveling mobile van), with b) an individual-level mobile application (app) to support PrEP adherence and persistence between CHP visits.
Read the detailed description
LYPS is a two-arm randomized controlled trial (RCT) to assess the efficacy of the LYPS intervention. Up to 272 participants will be randomized in a 1:1 ratio to receive either the LYPS intervention or enhanced standard of care (eSOC) (136 participants per arm). The eSOC control condition will consist of usual clinic-based PrEP care and access to a limited number of LYPS app components. Participants will complete four research assessments, at Enrollment and Weeks 12, 24, and 36, that include computer-assisted self-interviews (CASIs) and blood collection. CASIs will collect information including, but not limited to, demographics, PrEP adherence and persistence, PrEP clinic visit attendance, PrEP knowledge and attitudes, PrEP self-efficacy, PrEP stigma, and psychosocial variables, questions that evaluate components of the LYPS intervention, tailored for intervention and eSOC conditions. Blood (dried blood spot [DBS] and plasma) will be collected to evaluate PrEP drug concentrations and stored for additional study-related testing.
All participants will receive daily oral PrEP, oral PrEP taken using a 2-1-1 dosing strategy, or injectable PrEP based on their preference and in consultation with their PrEP provider. There is no randomization involved for PrEP provision and participants are allowed to switch between oral and injectable PrEP or vice versa during the study. PrEP care visits (quarterly for those on oral PrEP and two monthly injections followed by an injection every two months for those on injectable PrEP) will include clinical labs such as HIV and STI testing and focused physical exams for signs and symptoms of HIV infection. Other relevant clinical data collected as part of the participant's PrEP clinical care will also be collected.
- Conditions
- HIV, PrEP, PrEP Adherence
- Being tested
- LYPS, Enhanced Standard of Care
- Keywords
- PrEP, Adherence, Oral PrEP, Injectable cabotegravir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LYPSOther
The LYPS intervention combines the use of a CHP to deliver PrEP services at a designated place in the community being offered by the SC where PrEP is not yet provided (e.g., participant's home, community partner location, or traveling mobile van) with an android-based smartphone or iphone app to support PrEP use between CHP visits.
Enhanced Standard of CareOther
Clinic-based PrEP services per usual standard of care (e.g., HIV and STI testing, clinical assessments for signs and symptoms of HIV and PrEP safety) with access to a limited number of LYPS app components, including basic PrEP adherence information and study visit reminders.
| Study group | Role | What they receive |
|---|---|---|
| LYPS Intervention | Experimental | PrEP and PrEP care will be delivered to youth in the communities where they live through a Community Health Professional (CHP) (e.g., a nurse or other qualified health care professional home, friend's home, community venue or clinic, mobile health clinic), supplemented by a mobile app to provide real-time intervention between CHP visits. Receives: Other: LYPS |
| Enhanced Standard of Care (eSOC) Control Condition | Active comparator | Usual standard of care clinic-based PrEP, enhanced with access to a limited number of LYPS app components, including basic PrEP adherence information and study visit reminders. Receives: Other: Enhanced Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP adherence at 6 months
Determine adherence outcomes as measured by blood will be tailored for oral PrEP modality (daily oral or 2-1-1) and target vs. non-target PrEP concentration thresholds (depending on regimen) will be examined. Adherence outcomes for participants on injectable PrEP will be determined by the timely (± 1 week for the second injection; ± 2 weeks for any subsequent injection) administration of injections.
Measured: 6 months
PrEP persistence at 6 months
Access persistence measures as based on 1) participant's self-report of currently taking PrEP (daily or 2-1-1) or having received last shot of injectable PrEP, and 2) has an active prescription for PrEP based on study records or drug level associated with use at 6 months.
Measured: 6 months
Secondary outcomes (2)
PrEP adherence at 9 months
Determine adherence outcomes as measured by blood will be tailored for oral PrEP modality (daily oral or 2-1-1) and target vs. non-target PrEP concentration thresholds (depending on regimen) will be examined. Adherence outcomes for participants on injectable PrEP will be determined by the timely (± 1 week for the second injection; ± 2 weeks for any subsequent injection) administration of injections.
Measured: 9 months
PrEP persistence at 9 months
Access persistence measures as based on 1) participant's self-report of currently taking PrEP (daily or 2-1-1) or having received last shot of injectable PrEP, and 2) has an active prescription for PrEP based on study records or drug level associated with use at 9 months.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start30 Oct 2026 (estimated)
- Primary completion15 Aug 2028 (estimated)
- Study completion15 Dec 2028 (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.
- 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
- Model description
- Participants will be randomized in a 1:1 ratio to receive either the LYPS intervention or eSOC. The LYPS intervention arm consists of structural-level delivery of PrEP and PrEP services by a community health professional (CHP) at a designated place in the community being offered by the SC where PrEP is not yet provided (e.g., participant's home, community partner location, or traveling mobile van) with an individual-level mobile application to support PrEP adherence and persistence between CHP visits. The eSOC control condition consists of usual clinic-based PrEP care and access to a limited number of LYPS app components.
- Masking
- None (open label)
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Westat
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institutes of Health (NIH), Florida State University, The Emmes Company, LLC
- Responsible party
- Sponsor
- Investigators
- Kate Muessig, Study chair, Florida State UniversityKeith Horvath, Study chair, San Diego State UniversityAudrey Pettifor, Study chair, UNC Chapel HillLisa Hightow-Weidman, MD, MPH, Principal investigator, Florida State UniversitySybil Hosek, PhD, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438041
- Sponsor's protocol ID
- ATN165
- Acronym
- LYPS
- Status last verified
- Oct 2026
- First submitted
- 20 Feb 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services (LYPS): An Innovative Mobile Delivery and Mobile Health (mHealth) Intervention to Optimize PrEP Adherence and Persistence
- ClinicalTrials.gov ID
- NCT07438041
- Acronym / sponsor ID
- LYPS / ATN165
- Conditions
- HIV, PrEP, PrEP Adherence
- Keywords
- PrEP, Adherence, Oral PrEP, Injectable cabotegravir
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- WestatUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institutes of Health (NIH), Florida State University, The Emmes Company, LLC
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 15 Aug 2028 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 27 Feb 2026 (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.
The LYPS intervention is a multi-level intervention that combines: a) structural-level delivery of PrEP and PrEP services by a community health professional (CHP) at a designated place in the community being offered by the SC where PrEP is not yet provided (e.g., participant's home, community partner location, or traveling mobile van), with b) an individual-level mobile application (app) to support PrEP adherence and persistence between CHP visits.
Detailed description
LYPS is a two-arm randomized controlled trial (RCT) to assess the efficacy of the LYPS intervention. Up to 272 participants will be randomized in a 1:1 ratio to receive either the LYPS intervention or enhanced standard of care (eSOC) (136 participants per arm). The eSOC control condition will consist of usual clinic-based PrEP care and access to a limited number of LYPS app components. Participants will complete four research assessments, at Enrollment and Weeks 12, 24, and 36, that include computer-assisted self-interviews (CASIs) and blood collection. CASIs will collect information including, but not limited to, demographics, PrEP adherence and persistence, PrEP clinic visit attendance, PrEP knowledge and attitudes, PrEP self-efficacy, PrEP stigma, and psychosocial variables, questions that evaluate components of the LYPS intervention, tailored for intervention and eSOC conditions. Blood (dried blood spot [DBS] and plasma) will be collected to evaluate PrEP drug concentrations and stored for additional study-related testing.
All participants will receive daily oral PrEP, oral PrEP taken using a 2-1-1 dosing strategy, or injectable PrEP based on their preference and in consultation with their PrEP provider. There is no randomization involved for PrEP provision and participants are allowed to switch between oral and injectable PrEP or vice versa during the study. PrEP care visits (quarterly for those on oral PrEP and two monthly injections followed by an injection every two months for those on injectable PrEP) will include clinical labs such as HIV and STI testing and focused physical exams for signs and symptoms of HIV infection. Other relevant clinical data collected as part of the participant's PrEP clinical care will also be collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive either the LYPS intervention or eSOC. The LYPS intervention arm consists of structural-level delivery of PrEP and PrEP services by a community health professional (CHP) at a designated place in the community being offered by the SC where PrEP is not yet provided (e.g., participant's home, community partner location, or traveling mobile van) with an individual-level mobile application to support PrEP adherence and persistence between CHP visits. The eSOC control condition consists of usual clinic-based PrEP care and access to a limited number of LYPS app components.
| Arm | Type | Receives |
|---|---|---|
| LYPS Intervention | Experimental | Other: LYPSPrEP and PrEP care will be delivered to youth in the communities where they live through a Community Health Professional (CHP) (e.g., a nurse or other qualified health care professional home, friend's home, community venue or clinic, mobile health clinic), supplemented by a mobile app to provide real-time intervention between CHP visits. |
| Enhanced Standard of Care (eSOC) Control Condition | Active comparator | Other: Enhanced Standard of CareUsual standard of care clinic-based PrEP, enhanced with access to a limited number of LYPS app components, including basic PrEP adherence information and study visit reminders. |
Who may qualify
- Ages
- 13 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age 13-24 years, inclusive;
- Reports anal or vaginal sex in the past year;
- Is not living with HIV;
- Weighs at least 35 kilograms (77 pounds);
- Willing to receive PrEP care from a provider at a participating SC either in the clinic or at one of the designated places in the community being offered by the SC SC;
Key exclusion criteria (5 listed)
- Has counter-indications for PrEP according to guidelines and approved local label;
- Has any clinically significant systemic disease (including but not limited to significant or uncontrolled liver disease, gastrointestinal disease, kidney disease, thyroid disease, osteoporosis, or bone disease) or diabetes;
- Any other medical, behavioral, or other conditions that, in the opinion of the SC project lead or designee, could interfere with adherence to study procedures or compromise interpretation of study results;
- Concurrent participation in ATN 166, ATN 170, or any other clinical trial providing HIV medications (PrEP, vaccine, etc.) or currently receiving any PrEP-adherence or persistence behavioral intervention; or
- Is currently incarcerated or pending incarceration.
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 |
|---|---|---|
| LYPSThe LYPS intervention combines the use of a CHP to deliver PrEP services at a designated place in the community being offered by the SC where PrEP is not yet provided (e.g., participant's home, community partner location, or traveling mobile van) with an android-based smartphone or iphone app to support PrEP use between CHP visits. | Other | LYPS Intervention |
| Enhanced Standard of CareClinic-based PrEP services per usual standard of care (e.g., HIV and STI testing, clinical assessments for signs and symptoms of HIV and PrEP safety) with access to a limited number of LYPS app components, including basic PrEP adherence information and study visit reminders. | Other | Enhanced Standard of Care (eSOC) Control Condition |
Primary outcome
PrEP adherence at 6 months
Time frame: 6 months
Determine adherence outcomes as measured by blood will be tailored for oral PrEP modality (daily oral or 2-1-1) and target vs. non-target PrEP concentration thresholds (depending on regimen) will be examined. Adherence outcomes for participants on injectable PrEP will be determined by the timely (± 1 week for the second injection; ± 2 weeks for any subsequent injection) administration of injections.
PrEP persistence at 6 months
Time frame: 6 months
Access persistence measures as based on 1) participant's self-report of currently taking PrEP (daily or 2-1-1) or having received last shot of injectable PrEP, and 2) has an active prescription for PrEP based on study records or drug level associated with use at 6 months.
2 secondary outcomes
PrEP adherence at 9 months
Time frame: 9 months
PrEP persistence at 9 months
Time frame: 9 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 16 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Kate Muessig study chair
Florida State University
Keith Horvath study chair
San Diego State University
Audrey Pettifor study chair
UNC Chapel Hill
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LYPS in people with HIV and PrEP, run by Westat at 4 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 8 inclusion and 5 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 Nancy Liu (718-980-3937, NancyLiu@westat.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP adherence at 6 months (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?
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 16 Oct 2026.