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NCT Number: NCT03911024

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

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)

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Key information

Conditions

Behavior, Risk Behavior Risk-Taking

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

HIV

Behavioral

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

General health

Behavioral

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study 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)

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 10, 2019
Registry last updated
Oct 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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