Life Steps for PrEP for Youth

HIV Clinical Trial

— LSPY  

Official title:

Life Steps for PrEP for Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03805451
• Other study ID #: ATN 158
• Status: Completed
• Phase: N/A
• Start date: September 27, 2019
• Est. completion date: November 15, 2022

Study information

• Verified date: March 2023
• Source: Fenway Community Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 15, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 16 Years to 24 Years

Eligibility

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)

Related Conditions & MeSH terms

• HIV
• Medication Adherence
• Pre-exposure Prophylaxis

Intervention

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.

Locations

Country	Name	City	State
United States	PRISM Health	Atlanta	Georgia
United States	Fenway Health	Boston	Massachusetts
United States	Core Center	Chicago	Illinois

Sponsors (6)

Lead Sponsor	Collaborator
Fenway Community Health	Brown University, Cook County Hospital, Emory University, Massachusetts General Hospital, University of North Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	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
Primary	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
Primary	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	Retention in Pre-Exposure Prophylaxis (PrEP) care and prevention services	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
Secondary	LifeSteps for PrEP for Youth Intervention Acceptability	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)
Secondary	LifeSteps for PrEP for Youth Intervention Satisfaction	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)