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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
Sponsor:
Information provided by (Responsible Party):
Diane Santa Maria, The University of Texas Health Science Center, Houston

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)

Condition or disease Intervention/treatment Phase
Behavior, Risk Behavioral: HIV Behavioral: General health Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.




Primary Outcome Measures :
  1. Feasibility as assessed by number recruited [ Time Frame: baseline ]
    Number recruited is number of eligible youth minus number who refuse to participate.

  2. Feasibility as assessed by number of participants who complete the study [ Time Frame: 6 weeks ]
  3. Feasibility as assessed by number of staff hours required [ Time Frame: 6 weeks ]
  4. Feasibility as assessed by number of participants who damage or lose phones [ Time Frame: 6 weeks ]
  5. 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.

  6. 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.

  7. Number of participants who complete greater than 80% of the Ecological Momentary Assessments (EMAs) [ Time Frame: 6 weeks ]
  8. Number of participants who read greater than 80% of Just-In-Time Adaptive Intervention (JITAI) messages [ Time Frame: 6 weeks ]
  9. Effect on HIV risk behaviors as assessed by number of participants who use condoms [ Time Frame: 6 weeks ]
  10. Effect on HIV risk as assessed by number who use substances before sex [ Time Frame: 6 weeks ]
  11. Effect on HIV risk as assessed by number of participants who have pre-exposure prophylaxis (PrEP) interest [ Time Frame: 6 weeks ]
  12. Effect on HIV risk as assessed by number of participants who undergo HIV or sexually transmitted infection (STI) testing [ Time Frame: 6 weeks ]
  13. Effect on HIV risk as assessed by number of sexual partners [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Locations
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United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Diane Santa Maria, DrPH The University of Texas Health Science Center, Houston
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Diane Santa Maria, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03911024    
Other Study ID Numbers: HSC-SN-18-0501
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Diane Santa Maria, The University of Texas Health Science Center, Houston:
HIV prevention
homeless