Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-01 @ 8:33 AM
Study NCT ID:
NCT03805451
Status:
COMPLETED
Last Update Posted:
2023-03-22
First Post:
2018-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Life Steps for PrEP for Youth
Sponsor:
Fenway Community Health
Organization:
Study Overview
Official Title:
Life Steps for PrEP for Youth
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LSPY
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: