Clinical trial NCT03805451: Life Steps for PrEP for Youth
Official title: Life Steps for PrEP for Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Pre-exposure Prophylaxis
Medication Adherence
Lead sponsor: Fenway Community Health
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: University of North Carolina
name: Emory University
name: Brown University
name: Cook County Hospital
First posted: 2019-01-15
Enrollment: 32
Sex: MALE
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Pre-Exposure Prophylaxis (PrEP) Adherence at 3 months post PrEP initiation
timeFrame: Blood sample collected at 3 month visit post baseline
measure: Pre-Exposure Prophylaxis (PrEP) Adherence at 6 months post PrEP initiation
timeFrame: blood sample collected at 6 month visit post baseline
Secondary outcomes:
measure: Retention in Pre-Exposure Prophylaxis (PrEP) care and prevention services
timeFrame: 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
measure: LifeSteps for PrEP for Youth Intervention Acceptability
timeFrame: Measured at each study visit (3 and 6 months post baseline)
measure: LifeSteps for PrEP for Youth Intervention Satisfaction
timeFrame: Measured at each study visit (3 and 6 months post baseline)
Other outcomes:
measure: 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)
timeFrame: one time qualitative interviews will be conducted
Locations:
city: Atlanta
country: United States
facility: PRISM Health
state: Georgia
city: Chicago
country: United States
facility: Core Center
state: Illinois
city: Boston
country: United States
facility: Fenway Health
state: Massachusetts
Study officials:
affiliation: The Fenway Institute
name: Ken A Mayer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard Medical School and Massachusetts General Hospital
name: Christina Psaros, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: