← Back to Search

Cognitive Behavioral Therapy

Life Steps for PrEP for Youth for HIV/AIDS (LSPY Trial)

N/A
Waitlist Available
Led By Ken A Mayer, MD
Research Sponsored by Fenway Community Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at each study visit (3 and 6 months post baseline)
Awards & highlights

LSPY Trial Summary

This trial is designed to test the feasibility, acceptability, and preliminary efficacy of Life-Steps for PrEP among high-risk young men who have sex with men (YMSM) and young transgender women who have sex with men (YTWSM).

Eligible Conditions
  • HIV/AIDS
  • Medication Adherence
  • Pre-Exposure Prophylaxis

LSPY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at each study visit (3 and 6 months post baseline)
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at each study visit (3 and 6 months post baseline) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pre-Exposure Prophylaxis (PrEP) Adherence at 3 months post PrEP initiation
Pre-Exposure Prophylaxis (PrEP) Adherence at 6 months post PrEP initiation
Secondary outcome measures
LifeSteps for PrEP for Youth Intervention Acceptability
LifeSteps for PrEP for Youth Intervention Satisfaction
Retention in Pre-Exposure Prophylaxis (PrEP) care and prevention services
Other outcome measures
Adapt Life-Steps for PrEP to be appropriate for at-risk young men who have sex with men (YMSM) and young transgender women who have sex with men (YTWSM)

LSPY Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Life Steps for PrEP for YouthExperimental Treatment1 Intervention
Life Steps for PrEP for Youth was derived from our prior PrEP work supported by the National Institute of Mental Health and will be tailored for YMSM/TWSM based on the findings from 20 qualitative interviews with YMSM and TWSM and 10 qualitative interviews with key informants. It will likely consist of four weekly sessions at the time of PrEP initiation and two booster sessions, which occur two and three months after PrEP initiation. Overall, the core components of the intervention will focus on medication adherence, sexual behavior, and problem solving barriers to adherence, using motivational interviewing when needed.
Group II: Standard of CareActive Control1 Intervention
After being prescribed PrEP, participants will receive standard-of-care adherence support for PrEP. They will have blood collected for medication adherence measures and will complete computer assisted behavioral surveys during study visits. Participants in this arm will also be followed for 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Life Steps for PrEP for Youth
2019
N/A
~40

Find a Location

Who is running the clinical trial?

University of North CarolinaOTHER
166 Previous Clinical Trials
1,449,575 Total Patients Enrolled
Massachusetts General HospitalOTHER
2,928 Previous Clinical Trials
13,198,323 Total Patients Enrolled
Emory UniversityOTHER
1,636 Previous Clinical Trials
2,560,541 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Life Steps for PrEP for Youth
Kenneth H. Mayer, MD 2019. "Life Steps for PrEP for Youth". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03805451.
~6 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top