Development and Piloting of a Just-in-Time, Personalized HIV Prevention Intervention for Youth Experiencing Homelessness and Unstable Housing
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|ClinicalTrials.gov Identifier: NCT03911024|
Recruitment Status : Completed
First Posted : April 10, 2019
Last Update Posted : October 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Behavior, Risk||Behavioral: HIV Behavioral: General health||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||May 20, 2019|
|Actual Primary Completion Date :||August 1, 2019|
|Actual Study Completion Date :||August 1, 2019|
|Active Comparator: 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.
- Feasibility as assessed by number recruited [ Time Frame: baseline ]Number recruited is number of eligible youth minus number who refuse to participate.
- 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) [ Time Frame: 6 weeks ]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.
- Acceptability as assessed by score on the Mobile App Rating Scale (MARS) [ Time Frame: 6 weeks ]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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03911024
|United States, Texas|
|The University of Texas Health Science Center at Houston|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Diane Santa Maria, DrPH||The University of Texas Health Science Center, Houston|