Life Steps for PrEP for Youth (LSPY)

March 21, 2023 updated by: Kenneth H. Mayer, MD, Fenway Community Health

This is a formative study, designed to provide information required to tailor Life-Steps for Pre-Exposure Prophylaxis (PrEP), an evidence-based cognitive behavioral adherence intervention, to enhance PrEP uptake and adherence in high risk young men who have sex with men (YMSM) and young transgender women who have sex with men (YTWSM).

Life-Steps for Pre-exposure prophylaxis (PrEP) is a manualized modular adherence intervention based on principles of cognitive-behavioral therapy (CBT), that allows for recipients of the intervention to focus on the greatest challenges that they perceive in maintaining optimal adherence to PrEP.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Aim 1:

To adapt Life-Steps for Pre-Exposure Prophylaxis (PrEP) to be culturally relevant and appropriate for at-risk young men who have sex with men (YMSM) and transgender women who have sex with men (TWSM). The investigators will conduct in-depth qualitative interviews with up to 20 HIV-uninfected, at risk YMSM/TWSM at Fenway Health, an Adolescent Trials Network (ATN) clinical center. The investigators will also conduct in-depth, individual qualitative interviews with up to 10 key informants, including PrEP providers and staff at community-based organizations that work with YMSM/TWSM. Through these interviews, perceived facilitators and barriers to initiating and adhering to PrEP will be identified, and potential strategies to optimize adherence to PrEP for YMSM/TWSM. The investigators will explore youth perspectives on the use of nurses to deliver health messages and weekly text messages. YMSM/TWSM will be recruited at various points in the PrEP continuum of care, including those have opted not to initiate PrEP despite recommendations from clinicians, those who are using PrEP who report high levels of adherence and those who report adherence challenges through clinician referrals and direct recruitment in clinic waiting areas. Interviews will last approximately 60 minutes and will be digitally-recorded. Recordings will be transcribed and analyzed rapidly to inform the design of the youth-tailored Life-Steps for PrEP for YMSM/TWSM that we will test in Aim 2.

Aim 2:

To conduct a 2-arm pilot randomized control trial (RCT) to assess feasibility and acceptability of the Life-Steps for PrEP for youth intervention and preliminary efficacy of the intervention to improve PrEP adherence and retention in PrEP care compared to the standard of PrEP care at three different clinical sites. Investigators will enroll 50 YMSM/TWSM in the RCT (randomized 1:1 to the 2 arms) across the 3 sites. The primary efficacy outcomes will be PrEP adherence-as measured by dried blood spot testing -and retention in PrEP care-as measured by attendance at quarterly clinic appointments-at 3 and 6 months post baseline. Secondary outcomes include changes in sexual behaviors, retention in prevention services, and acceptability of the interventions which will be assessed at each major visit. Investigators will also conduct a brief, 15-minute semi-structured exit interview with participants in the Life-Steps for PrEP for youth intervention arm to provide an opportunity for more in-depth (open-ended) feedback on intervention satisfaction and acceptability. These data will be used to finalize the intervention manual to enhance participant acceptability.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • PRISM Health
    • Illinois
      • Chicago, Illinois, United States, 60612
        • CORE Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Fenway Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • age 16-24
  • HIV-uninfected by self-report
  • Assigned male sex at birth
  • self-identify as a man who has sex with men or a trans woman who has sex with men
  • able to understand English

Self-reported HIV risk is defined as meeting at least one of the following criteria:

  • At least one episode of unprotected anal intercourse with an HIV-positive partner with a penis or a partner with a penis of unknown HIV status during the last 6 months;
  • Anal intercourse with 3 or more partners with a penis during the last 6 months;
  • Exchange of money, gifts, shelter or drugs for anal sex with a partner with a penis during the last 6 months;
  • Sex with a partner with a penis and has had an STI(sexually transmitted infection) during the last 6 months;
  • Sexual partner of an HIV-positive person with a penis with whom condoms were not consistently used in the last 6 months; or
  • At least one episode of anal intercourse where the condom broke or slipped off during the last 6 months

Exclusion Criteria:

  • Currently enrolled in another PrEP adherence study*
  • Prior enrollment in an HIV vaccine trial with receipt of experimental vaccine product.*
  • Enrollment in earlier phase of Life Steps for PrEP for Youth*
  • Unable to give informed consent/assent due to severe mental or physical illness/substance intoxication at baseline visit
  • Has severe cognitive limitation that would limit their ability to comprehend the informed consent or assent
  • Presence of an active (i.e. untreated) and interfering psychiatric disorder (e.g., bipolar disorder, schizophrenia, substance abuse)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Life Steps for PrEP for Youth
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.
Behavioral: Life Steps for PrEP for Youth
Life-Steps is a modular adherence intervention based on principles of cognitive-behavioral therapy (CBT), that allows for recipients of the intervention to focus on the greatest challenges that they perceive in maintaining optimal adherence to pre-exposure prophylaxis.
No Intervention: Standard of Care
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pre-Exposure Prophylaxis (PrEP) Adherence at 3 months post PrEP initiation
Time Frame: Blood sample collected at 3 month visit post baseline
Measured by dried blood spot (DBS) testing of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP)
Blood sample collected at 3 month visit post baseline
Pre-Exposure Prophylaxis (PrEP) Adherence at 6 months post PrEP initiation
Time Frame: blood sample collected at 6 month visit post baseline
Measured by dried blood spot (DBS) testing of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP)
blood sample collected at 6 month visit post baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Retention in Pre-Exposure Prophylaxis (PrEP) care and prevention services
Time Frame: Records will be abstracted at the end of the study period for each participant to determine if they attended a clinic appointment at 3 and 6 months post baseline
Attendance at quarterly clinic appointments obtained through medical record abstraction
Records will be abstracted at the end of the study period for each participant to determine if they attended a clinic appointment at 3 and 6 months post baseline
LifeSteps for PrEP for Youth Intervention Acceptability
Time Frame: Measured at each study visit (3 and 6 months post baseline)
To measure acceptability, participants will be asked to self-report the degree to which they find the intervention appropriate and useful using Likert-type agreement scales.
Measured at each study visit (3 and 6 months post baseline)
LifeSteps for PrEP for Youth Intervention Satisfaction
Time Frame: Measured at each study visit (3 and 6 months post baseline)

Satisfaction will be measured with the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item, easily scored and administered measurement designed to measure client satisfaction with services.

The CSQ-8 has been extensively studied, and while it is not necessarily a measure of a client's perceptions of gain from treatment, or outcome, it does elicit the client's perspective on the value of services received. The CSQ-8 seems to operate about the same across all ethnic groups.

The CSQ-8 is scored by summing the item scores to produce a range of 8 to 32, with high scores indicating greater satisfaction.

Larsen, D.L., Attkisson, C.C., Hargreaves, W.A., and Nguyen, T.D. (1979). Assessment of client/patient satisfaction: Development of a general scale, Evaluation and Program Planning, 2, 197-207. Instrument reproduced with permission of C. Clifford Attkisson. Attkisson, C. C., & Greenfield, T. K. (1994). Client Satisfaction Questionnaire-8 and Service Satisfaction Scale-30.
Measured at each study visit (3 and 6 months post baseline)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Time Frame: one time qualitative interviews will be conducted
Study Investigators will conduct qualitative interviews with up to 20 HIV-uninfected YMSM/TWSM at Fenway Health and with up to 10 key informants, including PrEP providers and staff at community-based organizations that work with YMSM/TWSM. Interviews will be transcribed and analyzed using content analysis to identify changes that should be made to the Life-Steps intervention.
one time qualitative interviews will be conducted

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fenway Community Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Massachusetts General Hospital
Brown University
Emory University
University of North Carolina
Cook County Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ken A Mayer, MD, The Fenway Institute
  • Principal Investigator: Christina Psaros, Ph.D., Harvard Medical School and Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 27, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ATN 158

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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