An interventional study of HIV and General health in Behavior, Risk, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2019-10-17.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Prevention
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)
The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: HIV
Behavioral: General health
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
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.
Feasibility as assessed by number recruited
Number recruited is number of eligible youth minus number who refuse to participate.
Time frame: baseline
Feasibility as assessed by number of participants who complete the study
Time frame: 6 weeks
Feasibility as assessed by number of staff hours required
Time frame: 6 weeks
Feasibility as assessed by number of participants who damage or lose phones
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks
Number of participants who complete greater than 80% of the Ecological Momentary Assessments (EMAs)
Time frame: 6 weeks
Number of participants who read greater than 80% of Just-In-Time Adaptive Intervention (JITAI) messages
Time frame: 6 weeks
Effect on HIV risk behaviors as assessed by number of participants who use condoms
Time frame: 6 weeks
Effect on HIV risk as assessed by number who use substances before sex
Time frame: 6 weeks
Effect on HIV risk as assessed by number of participants who have pre-exposure prophylaxis (PrEP) interest
Time frame: 6 weeks
Effect on HIV risk as assessed by number of participants who undergo HIV or sexually transmitted infection (STI) testing
Time frame: 6 weeks
Effect on HIV risk as assessed by number of sexual partners
Time frame: 6 weeks
Plan to share: No
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center, Houston