HIV/AIDS and InfectionsNCT03368456
Preventing HIV/STI in Urban Adolescents Via an mHealth Primary Care Intervention
A study testing S4E in people with HIV/AIDS and Infections and Drug Abuse, run by University of Michigan at 1 site in United States.
Trial summary
The study evaluates the preliminary efficacy of an innovative mobile-health (mHealth) intervention (hereon referred to as S4E) to improve human immunodeficiency virus and sexually transmitted infection testing and reduce HIV/STI risk behaviors in a clinic sample (n=100) of at-risk youth ages 14-21 living in Southeast… Read more about this study
- Who is it for?
- Ages 14 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS and Infections, Drug Abuse, Adolescent Behavior
- What is being tested?
- S4E
- Type of treatment
- 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
- 1 May 2018to 12 Aug 2020
- 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 14 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female or male youth 14-21 years of age
- Sexually active
- Live in Southeast Michigan
- Have access to a smartphone or tablet
- Youth must see an enrolled clinician to participate in the study.
Who cannot join
- Report of prior psychiatric hospitalization by adolescent
- Visible cognitive impairment due to drug use
- Adolescent reports (tentative or firm) plans to move out of the Southeast Michigan area during the study
Trial locations and contacts
1 site in 1 country.
About this study
The study evaluates the preliminary efficacy of an innovative mobile-health (mHealth) intervention (hereon referred to as S4E) to improve human immunodeficiency virus and sexually transmitted infection testing and reduce HIV/STI risk behaviors in a clinic sample (n=100) of at-risk youth ages 14-21 living in Southeast Michigan. A Stage I randomized control trial will be conducted to examine the preliminary efficacy of S4E, relative to Usual Care (UC), over a period of six months.
Read the detailed description
HIV/STI and drug abuse remain significant public health priorities in the US and youth are disproportionately affected. Youth between the ages of 15 - 24 constitute 25% of the sexually experienced population, yet account for 46% and 50% of HIV infections and new STIs, respectively. National surveillance data indicate that youth disproportionately engage in HIV/STI risk behaviors, including condomless sex and licit and illicit drug use, which increase their risk for HIV/STI infection. Despite the disproportionately high rates of HIV/STI infection and risk behaviors in youth, fewer than 14% report having ever been tested for HIV and many are not routinely screened for asymptomatic STIs as recommended by the Center for Disease Control. In Southeast Michigan, HIV/STI are disproportionately high. To address these significant public health concerns, a mobile-health (mHealth) intervention was developed for health clinic settings. The proposed research aims to develop a cross-platform and universal version of S4E. The cross-platform and universal version of S4E will be compatible with both IOS and Android operating systems, and multiple mobile devices, aimed at providing adolescents with ongoing access to the intervention once they leave the clinic. The proposed research will also evaluate the preliminary efficacy of S4E to improve HIV/STI testing and reduce HIV/STI risk behaviors in a clinic sample (n=100) of at-risk youth ages 14-21 living in Southeast Michigan by conducting a Stage I RCT to examine the preliminary efficacy of S4E, relative to Usual Care, among a sample of 100 at-risk youth over six months.
- Conditions
- HIV/AIDS and Infections, Drug Abuse, Adolescent Behavior, Drug Usage
- Being tested
- S4E, Usual Care
- Keywords
- mhealth, preventive intervention, primary health care
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Infections, Substance-Related Disorders, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S4EBehavioural
S4E application was developed in collaboration with youth in Southeast Michigan. S4E aims to prevent and reduce HIV/STI risk behaviors, including drug use and sexual risk behaviors, and increase HIV/STI testing among youth. Content produced for the application is based on scientific prevention principles in conjunction with youth input. To date, we have developed modules focused on youth alcohol \& drug use, HIV \& STIs and a forthcoming module on tobacco prevention and cessation.
Usual CareBehavioural
Participants in Usual Care (i.e., Control Condition) will not receive the S4E intervention from the study staff. The Clinic's usual care includes a standard risk behaviors intake form, pamphlets highlighting resources, and reproductive and healthcare services.
| Study group | Role | What they receive |
|---|---|---|
| S4E App Intervention | Experimental | Participants in the S4E condition will first receive the intervention in the waiting area via iPads provided for them. Content includes the theoretically driven components of Storytelling for Empowerment: (a) Storytelling scenarios, (b) drug use and HIV/STI knowledge development, (c) interactive activities, (d) increasing self-efficacy to prevent/reduce sexual risk and drug use behaviors, and increase HIV/STI testing, (e) clinician-youth communication, and (f) highlighting prevention principles Receives: Behavioral: S4E |
| Usual Care Condition | Placebo comparator | Participants in Usual Care (i.e., Control Condition) will not receive the S4E intervention. The Clinic's usual care includes a standard risk behaviors intake form, pamphlets highlighting resources, and reproductive and healthcare services. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adolescent HIV Testing
Post-intervention, we will assess whether youths requested to receive HIV testing at the clinic, and at 3 and 6 months post-baseline (yes/no).
Measured: baseline, 3 and 6 month post-baseline
Secondary outcomes (2)
Change in condomless sex behaviors
Adolescent unsafe sexual behavior will be measured (time points 1-3) using items extracted from Jemmott, Jemmott, and Fong's Sexual Behavior instrument. This gated instrument will assess the adolescent's past 90-day condom use, number of sexual partners, and contraceptive use (non-condom).
Measured: 3 and 6 month post-baseline
Change in drug use behaviors
Licit and illicit drug use behaviors will be assessed (time points 1-3) using items from the Monitoring the Future Study. Youth will be asked whether or not they have used licit or illicit drugs in their lifetime and the past 90 days. Youth who report "Yes" to past 90-day sex will be asked to report the frequency of drug use before sex. These measures have been used in our formative research.
Measured: baseline, 3 and 6 month post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start1 May 2018
- Primary completion12 Aug 2020
- Study completion12 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDS and InfectionsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Model description
- To test the preliminary efficacy of S4E, we will conduct a Stage I RCT and use a mixed between/within-subjects design with two levels of intervention (S4E and Usual Care) as the between-subjects factor and three repeated measures assessments (Baseline, 3-, and 6-months post-Baseline) as the within-subjects factor.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Cordova, University of Michigan
- Investigators
- David Cordova, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368456
- Sponsor's protocol ID
- HUM00158089
- Other IDs
- Previous HUM00118704
- Status last verified
- Aug 2022
- First submitted
- 20 Nov 2017
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cordova D, Alers-Rojas F, Lua FM, Bauermeister J, Nurenberg R, Ovadje L, Fessler K, Delva J, Salas-Wright CP, Council YL. The Usability and Acceptability of an Adolescent mHealth HIV/STI and Drug Abuse Preventive Intervention in Primary Care. Behav Med. 2018 Jan-Mar;44(1):36-47. doi: 10.1080/08964289.2016.1189396. Epub 2016 Jul 15.
PubMed 27223646Cordova D, Bauermeister JA, Fessler K, Delva J, Nelson A, Nurenberg R, Mendoza Lua F, Alers-Rojas F, Salas-Wright CP; Youth Leadership Council. A Community-Engaged Approach to Developing an mHealth HIV/STI and Drug Abuse Preventive Intervention for Primary Care: A Qualitative Study. JMIR Mhealth Uhealth. 2015 Dec 18;3(4):e106. doi: 10.2196/mhealth.4620.
PubMed 26685288Cordova D, Bauermeister JA, Warner S; Youth Leadership Council; Wells P, MacLeod J, Neilands TB, Mendoza Lua F, Delva J, Fessler KB, Smith V Jr, Khreizat S, Boyer C. Efficacy of a Digital Health Preventive Intervention for Adolescents With HIV or Sexually Transmitted Infections and Substance Use Disorder: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Feb 19;13:e47216. doi: 10.2196/47216.
PubMed 38373025
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing HIV/STI in Urban Adolescents Via an mHealth Primary Care Intervention
- ClinicalTrials.gov ID
- NCT03368456
- Acronym / sponsor ID
- HUM00158089
- Conditions
- HIV/AIDS and Infections, Drug Abuse, Adolescent Behavior, Drug Usage
- Keywords
- mhealth, preventive intervention, primary health care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 12 Aug 2020 (actual)
- Study completion
- 12 Aug 2020 (actual)
- First posted
- 11 Dec 2017 (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 study evaluates the preliminary efficacy of an innovative mobile-health (mHealth) intervention (hereon referred to as S4E) to improve human immunodeficiency virus and sexually transmitted infection testing and reduce HIV/STI risk behaviors in a clinic sample (n=100) of at-risk youth ages 14-21 living in Southeast Michigan. A Stage I randomized control trial will be conducted to examine the preliminary efficacy of S4E, relative to Usual Care (UC), over a period of six months.
Detailed description
HIV/STI and drug abuse remain significant public health priorities in the US and youth are disproportionately affected. Youth between the ages of 15 - 24 constitute 25% of the sexually experienced population, yet account for 46% and 50% of HIV infections and new STIs, respectively. National surveillance data indicate that youth disproportionately engage in HIV/STI risk behaviors, including condomless sex and licit and illicit drug use, which increase their risk for HIV/STI infection. Despite the disproportionately high rates of HIV/STI infection and risk behaviors in youth, fewer than 14% report having ever been tested for HIV and many are not routinely screened for asymptomatic STIs as recommended by the Center for Disease Control. In Southeast Michigan, HIV/STI are disproportionately high. To address these significant public health concerns, a mobile-health (mHealth) intervention was developed for health clinic settings. The proposed research aims to develop a cross-platform and universal version of S4E. The cross-platform and universal version of S4E will be compatible with both IOS and Android operating systems, and multiple mobile devices, aimed at providing adolescents with ongoing access to the intervention once they leave the clinic. The proposed research will also evaluate the preliminary efficacy of S4E to improve HIV/STI testing and reduce HIV/STI risk behaviors in a clinic sample (n=100) of at-risk youth ages 14-21 living in Southeast Michigan by conducting a Stage I RCT to examine the preliminary efficacy of S4E, relative to Usual Care, among a sample of 100 at-risk youth over six months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To test the preliminary efficacy of S4E, we will conduct a Stage I RCT and use a mixed between/within-subjects design with two levels of intervention (S4E and Usual Care) as the between-subjects factor and three repeated measures assessments (Baseline, 3-, and 6-months post-Baseline) as the within-subjects factor.
| Arm | Type | Receives |
|---|---|---|
| S4E App Intervention | Experimental | Behavioral: S4EParticipants in the S4E condition will first receive the intervention in the waiting area via iPads provided for them. Content includes the theoretically driven components of Storytelling for Empowerment: (a) Storytelling scenarios, (b) drug use and HIV/STI knowledge development, (c) interactive activities, (d) increasing self-efficacy to prevent/reduce sexual risk and drug use behaviors, and increase HIV/STI testing, (e) clinician-youth communication, and (f) highlighting prevention principles |
| Usual Care Condition | Placebo comparator | Behavioral: Usual CareParticipants in Usual Care (i.e., Control Condition) will not receive the S4E intervention. The Clinic's usual care includes a standard risk behaviors intake form, pamphlets highlighting resources, and reproductive and healthcare services. |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Female or male youth 14-21 years of age
- Sexually active
- Live in Southeast Michigan
- Have access to a smartphone or tablet
- Youth must see an enrolled clinician to participate in the study.
Key exclusion criteria (3 listed)
- Report of prior psychiatric hospitalization by adolescent
- Visible cognitive impairment due to drug use
- Adolescent reports (tentative or firm) plans to move out of the Southeast Michigan area during the study
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 |
|---|---|---|
| S4ES4E application was developed in collaboration with youth in Southeast Michigan. S4E aims to prevent and reduce HIV/STI risk behaviors, including drug use and sexual risk behaviors, and increase HIV/STI testing among youth. Content produced for the application is based on scientific prevention principles in conjunction with youth input. To date, we have developed modules focused on youth alcohol \& drug use, HIV \& STIs and a forthcoming module on tobacco prevention and cessation. | Behavioural | S4E App Intervention |
| Usual CareParticipants in Usual Care (i.e., Control Condition) will not receive the S4E intervention from the study staff. The Clinic's usual care includes a standard risk behaviors intake form, pamphlets highlighting resources, and reproductive and healthcare services. | Behavioural | Usual Care Condition |
Primary outcome
Change in Adolescent HIV Testing
Time frame: baseline, 3 and 6 month post-baseline
Post-intervention, we will assess whether youths requested to receive HIV testing at the clinic, and at 3 and 6 months post-baseline (yes/no).
2 secondary outcomes
Change in condomless sex behaviors
Time frame: 3 and 6 month post-baseline
Change in drug use behaviors
Time frame: baseline, 3 and 6 month post-baseline
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 31 Aug 2022.
- Background: PubMed 27223646Cordova D, Alers-Rojas F, Lua FM, Bauermeister J, Nurenberg R, Ovadje L, Fessler K, Delva J, Salas-Wright CP, Council YL. The Usability and Acceptability of an Adolescent mHealth HIV/STI and Drug Abuse Preventive Intervention in Primary Care. Behav Med. 2018 Jan-Mar;44(1):36-47. doi: 10.1080/08964289.2016.1189396. Epub 2016 Jul 15.
- Background: PubMed 26685288Cordova D, Bauermeister JA, Fessler K, Delva J, Nelson A, Nurenberg R, Mendoza Lua F, Alers-Rojas F, Salas-Wright CP; Youth Leadership Council. A Community-Engaged Approach to Developing an mHealth HIV/STI and Drug Abuse Preventive Intervention for Primary Care: A Qualitative Study. JMIR Mhealth Uhealth. 2015 Dec 18;3(4):e106. doi: 10.2196/mhealth.4620.
- Derived from this study: PubMed 38373025Cordova D, Bauermeister JA, Warner S; Youth Leadership Council; Wells P, MacLeod J, Neilands TB, Mendoza Lua F, Delva J, Fessler KB, Smith V Jr, Khreizat S, Boyer C. Efficacy of a Digital Health Preventive Intervention for Adolescents With HIV or Sexually Transmitted Infections and Substance Use Disorder: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Feb 19;13:e47216. doi: 10.2196/47216.
- 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.
David Cordova, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S4E in people with HIV/AIDS and Infections and Drug Abuse, run by University of Michigan 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 5 inclusion and 3 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 31 Aug 2022. 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?
Change in Adolescent HIV Testing (time frame: baseline, 3 and 6 month post-baseline). 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 NCT03368456, which also lists 3 linked publications.
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 31 Aug 2022.