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

Study Overview
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Brief Summary
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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)

Official Title
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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)

Conditions
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Behavior, Risk

Intervention / Treatment
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* Behavioral: HIV
* Behavioral: General health


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HIV<br> | Behavioral: HIV<br>* 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<br>|
| Placebo Comparator: General Health<br> | Behavioral: General health<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV prevention, homeless