Development and Piloting of a Just-in-Time, Personalized HIV Prevention Intervention for Youth Experiencing Homelessness and Unstable Housing

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)

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)

Study Overview

• Status: Completed
• Conditions: Behavior, Risk
• Intervention / Treatment: Behavioral: HIV; Behavioral: General health

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HIV	Behavioral: HIV; At the completion of each EMA, participants in the intervention group (n=50) will receive messages that address:1) unsafe sexual behaviors, 2) alcohol/drug use, 3) PrEP interest, and 4) HIV testing. In addition, participants will have access to a button in the app that will link them to resources when/if they are the victim of sexual assault. Finally, intervention arm youth will be asked to set a behavioral goal related to HIV prevention during this session. Those goals will include increasing condom use, PrEP use, non-occupational post-exposure prophylaxis (nPEP) use, reducing number of sexual partners, not having sex with using drugs or drinking alcohol, avoiding IV drug use, getting testing for HIV, and testing and treating sexually transmitted infections (STIs) as needed
Placebo Comparator: General Health	Behavioral: General health; Participants in the attention control condition (n=50) will answer the same EMA items as the Intervention group. However, the intervention messages will contain content related to nutrition, physical activity, sleep hygiene, and tobacco use. Finally, control arm youth will be asked to set a behavioral goal related to general health during this session.Those goals will include getting 7+ hours of sleep, eating >= 5 servings of fruits or vegetables, not using tobacco products, exercising at least 60 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility as assessed by number recruited	Number recruited is number of eligible youth minus number who refuse to participate.	baseline
Feasibility as assessed by number of participants who complete the study		6 weeks
Feasibility as assessed by number of staff hours required		6 weeks
Feasibility as assessed by number of participants who damage or lose phones		6 weeks
Acceptability as assessed by score on the System Usability Scale (SUS)	The System Usability Scale (SUS) consists of 10 items on a 5-point (0-4) Likert scale and is designed to assess acceptability of a product. Overall score ranges from 0 to 100, with higher scores indicating greater acceptability.	6 weeks
Acceptability as assessed by score on the Mobile App Rating Scale (MARS)	The Mobile App Rating Scale (MARS) consists of 23 items on a 5-point (1-5) scale is designed to score apps on the criteria of engagement, functionality, aesthetics, and information quality (sub-scales). Total score is determined by calculating the mean of each sub-scale and an overall mean score. High mean scores indicate a higher quality app.	6 weeks
Number of participants who complete greater than 80% of the Ecological Momentary Assessments (EMAs)		6 weeks
Number of participants who read greater than 80% of Just-In-Time Adaptive Intervention (JITAI) messages		6 weeks
Effect on HIV risk behaviors as assessed by number of participants who use condoms		6 weeks
Effect on HIV risk as assessed by number who use substances before sex		6 weeks
Effect on HIV risk as assessed by number of participants who have pre-exposure prophylaxis (PrEP) interest		6 weeks
Effect on HIV risk as assessed by number of participants who undergo HIV or sexually transmitted infection (STI) testing		6 weeks
Effect on HIV risk as assessed by number of sexual partners		6 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (Actual): April 10, 2019

Study Record Updates

• Last Update Posted (Actual): October 17, 2019
• Last Update Submitted That Met QC Criteria: October 16, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: HIV prevention; homeless
• Other Study ID Numbers: HSC-SN-18-0501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No