Clinical trial NCT03911024: Development and Piloting of a Just-in-Time, Personalized HIV Prevention Intervention for Youth Experiencing Homelessness and Unstable Housing
Official title: Development and Piloting of a Just-in-Time, Personalized HIV Prevention Intervention for Youth Experiencing Homelessness (YEH) and Unstable Housing (Study Alias: HIV Prevention Messaging Intervention for YEH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior, Risk
Keywords: HIV prevention
homeless
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is develop and pilot test a personalized HIV intervention with youth experiencing homelessness by creating and field testing prevention messages that address real-time predictors (e.g., sexual urge, use to use drugs, and substance use) of HIV risk behaviors,to evaluate the feasibility and acceptability of the intervention and to evaluate the intervention outcome effects on HIV risk behaviors (e.g., condomless sex, number of sexual partners, pre-exposure prophylaxis(PrEP) awareness, substance use during sex,Intravenous(IV)drug use)


Eligibility criteria: Inclusion Criteria:

* English speaking
* HIV high risk: IV drug user or sexually active youth (sex in the past 3 months) who reports at least one of the following: condomless sex, concurrent sexual partners within 2 weeks,sex with a partner of unknown HIV status, or a bacterial STI in the last 6 months.
* Homelessness: staying on the streets or in a place not meant for human habitation, a shelter,hotel/motel, or some place they cannot stay for more than 30 days

Exclusion Criteria:

* Below 6th grade reading level:determined by the Rapid Estimate of Adult Literacy in Medicine Short Form (REALM)

Primary outcomes:
measure: Feasibility as assessed by number recruited
timeFrame: baseline
measure: Feasibility as assessed by number of participants who complete the study
timeFrame: 6 weeks
measure: Feasibility as assessed by number of staff hours required
timeFrame: 6 weeks
measure: Feasibility as assessed by number of participants who damage or lose phones
timeFrame: 6 weeks
measure: Acceptability as assessed by score on the System Usability Scale (SUS)
timeFrame: 6 weeks
measure: Acceptability as assessed by score on the Mobile App Rating Scale (MARS)
timeFrame: 6 weeks
measure: Number of participants who complete greater than 80% of the Ecological Momentary Assessments (EMAs)
timeFrame: 6 weeks
measure: Number of participants who read greater than 80% of Just-In-Time Adaptive Intervention (JITAI) messages
timeFrame: 6 weeks
measure: Effect on HIV risk behaviors as assessed by number of participants who use condoms
timeFrame: 6 weeks
measure: Effect on HIV risk as assessed by number who use substances before sex
timeFrame: 6 weeks
measure: Effect on HIV risk as assessed by number of participants who have pre-exposure prophylaxis (PrEP) interest
timeFrame: 6 weeks
measure: Effect on HIV risk as assessed by number of participants who undergo HIV or sexually transmitted infection (STI) testing
timeFrame: 6 weeks
measure: Effect on HIV risk as assessed by number of sexual partners
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Diane Santa Maria, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Santa Maria D, Padhye N, Businelle M, Yang Y, Jones J, Sims A, Lightfoot M. Efficacy of a Just-in-Time Adaptive Intervention to Promote HIV Risk Reduction Behaviors Among Young Adults Experiencing Homelessness: Pilot Randomized Controlled Trial. J Med Internet Res. 2021 Jul 6;23(7):e26704. doi: 10.2196/26704.