Life Steps for PrEP for Youth

NCT ID: NCT03805451

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-27
• Study Completion Date: 2022-11-15

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.

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.

Conditions

HIV; Pre-exposure Prophylaxis; Medication Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Life Steps for PrEP for Youth

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

University of North Carolina

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: collaborator

Cook County Hospital

OTHER

Sponsor Role: collaborator

Fenway Community Health

OTHER

Sponsor Role: lead

Responsible Party

Kenneth H. Mayer, MD

Medical Research Director, Co-Chair TFI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ken A Mayer, MD

Role: PRINCIPAL_INVESTIGATOR

The Fenway Institute

Christina Psaros, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School and Massachusetts General Hospital

Locations

PRISM Health

Atlanta, Georgia, United States

Core Center

Chicago, Illinois, United States

Fenway Health

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

ATN 158

Identifier Type: -

Identifier Source: org_study_id