NCT03805451

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable hiv

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2018

Completed
8 months until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

September 27, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

2.7 years

First QC Date

May 8, 2018

Last Update Submit

March 21, 2023

Conditions

HIVPre-exposure ProphylaxisMedication Adherence

Outcome Measures

Primary Outcomes (2)

  • Pre-Exposure Prophylaxis (PrEP) Adherence at 3 months post PrEP initiation

    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

    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 Outcomes (3)

  • Retention in Pre-Exposure Prophylaxis (PrEP) care and prevention services

    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

    Measured at each study visit (3 and 6 months post baseline)

  • LifeSteps for PrEP for Youth Intervention Satisfaction

    Measured at each study visit (3 and 6 months post baseline)

Other Outcomes (1)

  • 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)

    one time qualitative interviews will be conducted

Study Arms (2)

Life Steps for PrEP for Youth

EXPERIMENTAL

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

Standard of Care

NO 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.

Interventions

Life Steps for PrEP for YouthBEHAVIORAL

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.

Life Steps for PrEP for Youth

Eligibility Criteria

Age16 Years - 24 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

PRISM Health

Atlanta, Georgia, 30322, United States

Location

Core Center

Chicago, Illinois, 60612, United States

Location

Fenway Health

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Ken A Mayer, MD

    The Fenway Institute

    PRINCIPAL INVESTIGATOR

  • Christina Psaros, Ph.D.

    Harvard Medical School and Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Research Director, Co-Chair TFI

Study Record Dates

First Submitted

May 8, 2018

First Posted

January 15, 2019

Study Start

September 27, 2019

Primary Completion

May 31, 2022

Study Completion

November 15, 2022

Last Updated

March 22, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)