Behavior, RiskNCT03911024
Development and Piloting of a Just-in-Time, Personalized HIV Prevention Intervention for Youth Experiencing Homelessness and Unstable Housing
A study testing HIV and General health in people with Behavior, Risk, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Behavior, Risk
- What is being tested?
- HIV and General health
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2019to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Below 6th grade reading level:determined by the Rapid Estimate of Adult Literacy in Medicine Short Form (REALM)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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)
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)
- Conditions
- Behavior, Risk
- Being tested
- HIV, General health
- Keywords
- HIV prevention, homeless
- Medical subject headings
- Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIVBehavioural
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 healthBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| HIV | Active comparator | Not described Receives: Behavioral: HIV |
| General Health | Placebo comparator | Not described Receives: Behavioral: General health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as assessed by number recruited
Number recruited is number of eligible youth minus number who refuse to participate.
Measured: baseline
Feasibility as assessed by number of participants who complete the study
Measured: 6 weeks
Feasibility as assessed by number of staff hours required
Measured: 6 weeks
Feasibility as assessed by number of participants who damage or lose phones
Measured: 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.
Measured: 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.
Measured: 6 weeks
Number of participants who complete greater than 80% of the Ecological Momentary Assessments (EMAs)
Measured: 6 weeks
Number of participants who read greater than 80% of Just-In-Time Adaptive Intervention (JITAI) messages
Measured: 6 weeks
Effect on HIV risk behaviors as assessed by number of participants who use condoms
Measured: 6 weeks
Effect on HIV risk as assessed by number who use substances before sex
Measured: 6 weeks
Effect on HIV risk as assessed by number of participants who have pre-exposure prophylaxis (PrEP) interest
Measured: 6 weeks
Effect on HIV risk as assessed by number of participants who undergo HIV or sexually transmitted infection (STI) testing
Measured: 6 weeks
Effect on HIV risk as assessed by number of sexual partners
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start20 May 2019
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behavior, RiskStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diane Santa Maria, The University of Texas Health Science Center, Houston
- Investigators
- Diane Santa Maria, DrPH, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911024
- Sponsor's protocol ID
- HSC-SN-18-0501
- Status last verified
- Oct 2019
- First submitted
- 8 Apr 2019
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Santa Maria D, Padhye N, Businelle M, Yang Y, Jones J, Sims A, Lightfoot M. Efficacy of a Just-in-Time Adaptive Intervention to Promote HIV Risk Reduction Behaviors Among Young Adults Experiencing Homelessness: Pilot Randomized Controlled Trial. J Med Internet Res. 2021 Jul 6;23(7):e26704. doi: 10.2196/26704.
PubMed 34255679
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03911024
- Acronym / sponsor ID
- HSC-SN-18-0501
- Conditions
- Behavior, Risk
- Keywords
- HIV prevention, homeless
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV | Active comparator | Behavioral: HIV |
| General Health | Placebo comparator | Behavioral: General health |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Below 6th grade reading level:determined by the Rapid Estimate of Adult Literacy in Medicine Short Form (REALM)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIVAt 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 | Behavioural | HIV |
| General healthParticipants 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. | Behavioural | General Health |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Derived from this study: PubMed 34255679Santa Maria D, Padhye N, Businelle M, Yang Y, Jones J, Sims A, Lightfoot M. Efficacy of a Just-in-Time Adaptive Intervention to Promote HIV Risk Reduction Behaviors Among Young Adults Experiencing Homelessness: Pilot Randomized Controlled Trial. J Med Internet Res. 2021 Jul 6;23(7):e26704. doi: 10.2196/26704.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane Santa Maria, DrPH principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV and General health in people with Behavior, Risk, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as assessed by number recruited (time frame: baseline). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03911024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2019.