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Clinical Trials/NCT03911024
NCT03911024
Completed
Not Applicable

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)

The University of Texas Health Science Center, Houston1 site in 1 country100 target enrollmentMay 20, 2019
ConditionsBehavior, Risk

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Behavior, Risk
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
100
Locations
1
Primary Endpoint
Effect on HIV risk as assessed by number of sexual partners
Status
Completed
Last Updated
6 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
May 20, 2019
End Date
August 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Diane Santa Maria

Associate Professor

The University of Texas Health Science Center, Houston

Eligibility 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)

Outcomes

Primary Outcomes

Effect on HIV risk as assessed by number of sexual partners

Time Frame: 6 weeks

Feasibility as assessed by number of participants who complete the study

Time Frame: 6 weeks

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 staff hours required

Time Frame: 6 weeks

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

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.

Feasibility as assessed by number of participants who damage or lose phones

Time Frame: 6 weeks

Effect on HIV risk behaviors as assessed by number of participants who use condoms

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 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

Study Sites (1)

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