HIV InfectionsNCT03149757
Connecting Youth and Young Adults to Optimize ART Adherence: YouTHrive Efficacy Trial
A study testing YouTHrive in people with HIV Infections, run by University of Minnesota at 7 sites in United States.
Trial summary
YouTHrive (YT) is a two-arm randomized control trial (RCT) to test the efficacy of an adapted version of the Thrive With Me (TWM) intervention for youth living with HIV (YLWH). In the RCT, intervention participants will have access to the full YouTHrive (YT) website- a mobile-enhanced private social networking website… Read more about this study
- Who is it for?
- Ages 15 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- YouTHrive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 7 sitesUnited States
- Study dates
- 16 May 2017to 31 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 15-24 years of age at the enrollment visit;
- HIV-positive status;
- Residing in Chicago, Houston, NYC, Philadelphia, Atlanta, Tampa, or Raleigh/Durham/Chapel Hill areas and available to meet in-person or virtually with SRV staff for visits at baseline and 5-month follow-up assessment;
- English-speaking (since the intervention will be in English);
- Anticipated continuous internet access and SMS messaging for the intervention period (approximately 5 months);
- Not enrolled in another ART adherence intervention research study at the time of screening;
- Has or is willing to create an e-mail address to use during the study period;
- Did not attend an iTech Youth Advisory Board (YAB) or Youth Advisory Council (YAC) meeting where the YouTHrive study was presented or YouTHrive study materials were discussed.
Who cannot join
- Is younger than 15 years old or older than 24 years old at the enrollment visit;
- does not have an HIV-positive status;
- Does not reside in Chicago, Houston, NYC, Philadelphia, Atlanta, Tampa, or Raleigh/Durham/Chapel Hill areas and not available to meet with SRV staff for visits at baseline, and 5-month follow-up assessment;
- Does not speak English;
- Does not anticipate having continuous internet access and SMS messaging for the intervention period (approximately 5 months);
- Is enrolled in another ART adherence intervention research study at the time of screening;
Show all 9Show fewer
- Does not have or is not willing to create an e-mail address to use during the study period;
- Is a member of an iTech Youth Advisory Board (YAB) or Youth Advisory Council (YAC).
- Participants who are or become pregnant during the study period will not be excluded.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Emory University
Atlanta, Georgia, 30322
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Cook County Hospital and Health Systems CORE Center
Chicago, Illinois, 60612
Texas Children's Hospital
Houston, Texas, 77030
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of South Florida
Tampa, Florida, 33606
Montefiore Children's Hospital
The Bronx, New York, 10467
About this study
Official title: Connecting Youth and Young Adults to Optimize ART Adherence: Testing the Efficacy of the Youth Thrive Intervention
YouTHrive (YT) is a two-arm randomized control trial (RCT) to test the efficacy of an adapted version of the Thrive With Me (TWM) intervention for youth living with HIV (YLWH). In the RCT, intervention participants will have access to the full YouTHrive (YT) website- a mobile-enhanced private social networking website aimed at improving medication adherence for YLWH. The investigators will enroll up to 60 YLWH for formative work on YT, and 300 YLWH (15-24 years old) of all genders living in eight cities and randomize them to either the intervention condition or control condition. Assessments will be collected at baseline and 5-month follow-up.
Read the detailed description
Youth between the ages of 13 and 24 accounted for 22% of all new HIV infections in 2015. Less than half (44%) of youth living with HIV (YLWH) in the US are estimated to be virally suppressed, which is a well recognized critical factor in individual health and non-infectiousness. Given the high demands of social identity development during adolescence and early adulthood, as well as the increasing use of social media as important and influential communication channels, there is an ongoing need for innovative programs that leverage current communication channels to foster social support for ART adherence behaviors.
The investigators developed a program first called Thrive With Me (TWM) as an intervention that leverages enhanced peer-to-peer interaction, ART adherence reminders and self-monitoring, and ART and HIV informational content to improve ART adherence. Given youth's broad acceptance and adoption of many of the components of the TWM intervention, and the critical need for novel and scalable ART adherence interventions for this population, we have adapted TWM for a younger audience and all genders in a program called YouTHrive (YT).
Focus groups will provide insights into what features and functions of the current TWM study youth like and dislike to assist intervention adaptation. The investigators will conduct focus groups in three cities (Houston, Bronx, and Chicago) and will recruit up to 16 YLWH per city, and use the results to develop the YT intervention. Ahead of the RCT, the investigators will conduct usability testing on YT to gain feedback about the developed intervention. The investigators will recruit 12 YLWH in six cities to use the intervention for a two-week period for usability testing.
The randomized controlled efficacy trial will compare YT (N=150) to a control group (N=150). YLWH in the control arm will receive weekly static information-only emails, compared to daily use of the dynamic YT social network site for the intervention group. Participants will be recruited from eight cities: Atlanta, New York, Chapel Hill, Charlotte, Chicago, Houston, Philadelphia, and Tampa. Assessments will be collected at baseline and 5-month follow-up.
Specific Aims include:
Primary Objective: In a 2-arm RCT (n=300), assess the efficacy of YouTHrive(YT) to promote higher treatment success at month 5 among YLWH, compared to an HIV information-only control condition, as defined by higher self-reported ART adherence (primary), higher percent suppressed viral load (secondary), and higher HIV care attendance (secondary).
H1: Participants in the YT intervention arm than in the information-only control arm will report higher ART adherence at the 5-month follow-up time point.
H2: A higher proportion of participants in the YT intervention arm than in the information-only control arm will have suppressed viral load at the 5-month follow-up time point.
H3: Participants in the YT intervention arm than in the information-only control arm will report higher HIV care attendance at the 5-month follow-up time point.
H4: A higher proportion of participants in the YT intervention arm than in the information-only control arm will demonstrate treatment success on a composite variable of primary and secondary outcomes.
Secondary Objective 1: Assess whether YT has more HIV treatment benefits for substance-using than non-substance-using YLWH.
H5: Among YLWH in the YT intervention arm, a higher proportion of substance-using participants will demonstrate improvement on primary and secondary outcomes, and a composite variable of these outcomes, at the 5-month follow-up time point compared to non-substance-using participants.
Secondary Objective 2: Examine whether YT has positive impacts on mental health and social support.
H6: Participants in the YT intervention arm will report lower depression and anxiety and higher social support at the 5-month follow-up time point compared to those in an information-only control arm.
- Conditions
- HIV Infections
- Being tested
- YouTHrive, Information-only Control
- Keywords
- Treatment Adherence, Alcohol or Drugs, Behavioral, Internet, Adolescents, Young Adults, Social Support
- Medical subject headings
- HIV Infections, Treatment Adherence and Compliance, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YouTHriveBehavioural
Also called YT
The YT website is a mobile-enhanced private social networking website. Participants on the site are anonymous and choose alternate usernames and personalized profile features for a new online identity within YT. The investigators designed YouTHrive to encourage social support, reduce isolation, improve HIV medication adherence, and promote general well being. The study involves rolling recruitment so that new members are continuously entering the intervention. Participants use YT for five months before "graduating" from the program. The core components of YT are: 1) peer-to-peer interaction in a shared feed; 2) daily monitoring of HIV medication adherence and real-time mood; 3) daily mixed-media content with strategies to improve medication adherence' and 4) goal setting and monitoring.
Information-only ControlBehavioural
Participants will receive 21 emails, once per week, for five months. The emails will include static informational content relatable to YLWH, but informational content will not be focused on ART medication adherence.
| Study group | Role | What they receive |
|---|---|---|
| YouTHrive | Experimental | YouTHrive is a five-month technology-based intervention that uses peer-to-peer interaction, daily self-monitoring, and tailored content to address barriers to HIV medication adherence. Receives: Behavioral: YouTHrive |
| Thrive Tips | Active comparator | Participants randomized to the control condition will receive a weekly email with static informational content about living with HIV and general well being. Receives: Behavioral: Information-only Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) of Self-Reported Antiretroviral Adherence
Participants were presented with a visual analog scale (VAS) of the percentage of antiretroviral therapy (ART) adherence in the past 30 days on a scale from 0% to 100% (with 10% increments as response options) and asked to choose the level of ART adherence they achieved in the past 30 days. The mean percentage of ART adherence across all participants was calculated.
Measured: 5-month follow-up
Secondary outcomes (1)
Percentage of Participants With Undetectable HIV Viral Load
HIV viral load was abstracted from participants' medical records or a blood draw as part of research protocols (if no recent viral load measure was available from the medical record). A participant was recorded as having an undetectable HIV viral load if the level of HIV was so low that the test used by that clinic did not detect HIV in the participant (between <20 and <50 HIV copies depending on the clinic's viral load test).
Measured: 5-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start16 May 2017
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, University of Michigan, Emory University, Children's Hospital of Philadelphia, Baylor College of Medicine, Cook County Hospital, Montefiore Medical Center, University of South Florida, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Lisa Hightow-Weidman, PhD, Study chair, University of North CarolinaPatrick S Sullivan, PhD, Study chair, Emory UniversityKeith J. Horvath, PhD, Principal investigator, University of MinnesotaK. Rivet Amico, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149757
- Sponsor's protocol ID
- 16-3136
- Other IDs
- 1U19HD089881
- Status last verified
- Jun 2023
- First submitted
- 9 May 2017
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will assure the timely release and sharing of data two years after the publication of the main trial findings from the final dataset. Study variables will be available; however, the investigators will protect the rights and privacy of human subjects by redacting all identifiers from the data set. The de-identified data from this project will be available through individual requests directed to the Principal Investigator.
Publications
Horvath KJ, Miller-Perusse M, MacLehose R, Sullivan PS, Hightow-Weidman LL, Amico KR. The results of a web-based randomized controlled intervention trial to improve antiretroviral therapy (ART) adherence among Youth with HIV (YouTHrive, ATN 135) during the COVID-19 pandemic. Mhealth. 2026 Jan 20;12:5. doi: 10.21037/mhealth-25-47. eCollection 2026.
PubMed 41675101Horvath KJ, MacLehose RF, Martinka A, DeWitt J, Hightow-Weidman L, Sullivan P, Amico KR. Connecting Youth and Young Adults to Optimize Antiretroviral Therapy Adherence (YouTHrive): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Jul 30;8(7):e11502. doi: 10.2196/11502.
PubMed 31364601
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connecting Youth and Young Adults to Optimize ART Adherence: Testing the Efficacy of the Youth Thrive Intervention
- ClinicalTrials.gov ID
- NCT03149757
- Acronym / sponsor ID
- 16-3136
- Conditions
- HIV Infections
- Keywords
- Treatment Adherence, Alcohol or Drugs, Behavioral, Internet, Adolescents, Young Adults, Social Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- University of North Carolina, University of Michigan, Emory University, Children's Hospital of Philadelphia, Baylor College of Medicine, Cook County Hospital, Montefiore Medical Center, University of South Florida, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 16 May 2017 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 11 May 2017 (actual)
- Results
- Posted 3 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
YouTHrive (YT) is a two-arm randomized control trial (RCT) to test the efficacy of an adapted version of the Thrive With Me (TWM) intervention for youth living with HIV (YLWH). In the RCT, intervention participants will have access to the full YouTHrive (YT) website- a mobile-enhanced private social networking website aimed at improving medication adherence for YLWH. The investigators will enroll up to 60 YLWH for formative work on YT, and 300 YLWH (15-24 years old) of all genders living in eight cities and randomize them to either the intervention condition or control condition. Assessments will be collected at baseline and 5-month follow-up.
Detailed description
Youth between the ages of 13 and 24 accounted for 22% of all new HIV infections in 2015. Less than half (44%) of youth living with HIV (YLWH) in the US are estimated to be virally suppressed, which is a well recognized critical factor in individual health and non-infectiousness. Given the high demands of social identity development during adolescence and early adulthood, as well as the increasing use of social media as important and influential communication channels, there is an ongoing need for innovative programs that leverage current communication channels to foster social support for ART adherence behaviors.
The investigators developed a program first called Thrive With Me (TWM) as an intervention that leverages enhanced peer-to-peer interaction, ART adherence reminders and self-monitoring, and ART and HIV informational content to improve ART adherence. Given youth's broad acceptance and adoption of many of the components of the TWM intervention, and the critical need for novel and scalable ART adherence interventions for this population, we have adapted TWM for a younger audience and all genders in a program called YouTHrive (YT).
Focus groups will provide insights into what features and functions of the current TWM study youth like and dislike to assist intervention adaptation. The investigators will conduct focus groups in three cities (Houston, Bronx, and Chicago) and will recruit up to 16 YLWH per city, and use the results to develop the YT intervention. Ahead of the RCT, the investigators will conduct usability testing on YT to gain feedback about the developed intervention. The investigators will recruit 12 YLWH in six cities to use the intervention for a two-week period for usability testing.
The randomized controlled efficacy trial will compare YT (N=150) to a control group (N=150). YLWH in the control arm will receive weekly static information-only emails, compared to daily use of the dynamic YT social network site for the intervention group. Participants will be recruited from eight cities: Atlanta, New York, Chapel Hill, Charlotte, Chicago, Houston, Philadelphia, and Tampa. Assessments will be collected at baseline and 5-month follow-up.
Specific Aims include:
Primary Objective: In a 2-arm RCT (n=300), assess the efficacy of YouTHrive(YT) to promote higher treatment success at month 5 among YLWH, compared to an HIV information-only control condition, as defined by higher self-reported ART adherence (primary), higher percent suppressed viral load (secondary), and higher HIV care attendance (secondary).
H1: Participants in the YT intervention arm than in the information-only control arm will report higher ART adherence at the 5-month follow-up time point.
H2: A higher proportion of participants in the YT intervention arm than in the information-only control arm will have suppressed viral load at the 5-month follow-up time point.
H3: Participants in the YT intervention arm than in the information-only control arm will report higher HIV care attendance at the 5-month follow-up time point.
H4: A higher proportion of participants in the YT intervention arm than in the information-only control arm will demonstrate treatment success on a composite variable of primary and secondary outcomes.
Secondary Objective 1: Assess whether YT has more HIV treatment benefits for substance-using than non-substance-using YLWH.
H5: Among YLWH in the YT intervention arm, a higher proportion of substance-using participants will demonstrate improvement on primary and secondary outcomes, and a composite variable of these outcomes, at the 5-month follow-up time point compared to non-substance-using participants.
Secondary Objective 2: Examine whether YT has positive impacts on mental health and social support.
H6: Participants in the YT intervention arm will report lower depression and anxiety and higher social support at the 5-month follow-up time point compared to those in an information-only control arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YouTHrive | Experimental | Behavioral: YouTHriveYouTHrive is a five-month technology-based intervention that uses peer-to-peer interaction, daily self-monitoring, and tailored content to address barriers to HIV medication adherence. |
| Thrive Tips | Active comparator | Behavioral: Information-only ControlParticipants randomized to the control condition will receive a weekly email with static informational content about living with HIV and general well being. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 15-24 years of age at the enrollment visit;
- HIV-positive status;
- Residing in Chicago, Houston, NYC, Philadelphia, Atlanta, Tampa, or Raleigh/Durham/Chapel Hill areas and available to meet in-person or virtually with SRV staff for visits at baseline and 5-month follow-up assessment;
- English-speaking (since the intervention will be in English);
- Anticipated continuous internet access and SMS messaging for the intervention period (approximately 5 months);
Key exclusion criteria (9 listed)
- Is younger than 15 years old or older than 24 years old at the enrollment visit;
- does not have an HIV-positive status;
- Does not reside in Chicago, Houston, NYC, Philadelphia, Atlanta, Tampa, or Raleigh/Durham/Chapel Hill areas and not available to meet with SRV staff for visits at baseline, and 5-month follow-up assessment;
- Does not speak English;
- Does not anticipate having continuous internet access and SMS messaging for the intervention period (approximately 5 months);
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 |
|---|---|---|
| YouTHriveAlso: YTThe YT website is a mobile-enhanced private social networking website. Participants on the site are anonymous and choose alternate usernames and personalized profile features for a new online identity within YT. The investigators designed YouTHrive to encourage social support, reduce isolation, improve HIV medication adherence, and promote general well being. The study involves rolling recruitment so that new members are continuously entering the intervention. Participants use YT for five months before "graduating" from the program. The core components of YT are: 1) peer-to-peer interaction in a shared feed; 2) daily monitoring of HIV medication adherence and real-time mood; 3) daily mixed-media content with strategies to improve medication adherence' and 4) goal setting and monitoring. | Behavioural | YouTHrive |
| Information-only ControlParticipants will receive 21 emails, once per week, for five months. The emails will include static informational content relatable to YLWH, but informational content will not be focused on ART medication adherence. | Behavioural | Thrive Tips |
Primary outcome
Visual Analog Scale (VAS) of Self-Reported Antiretroviral Adherence
Time frame: 5-month follow-up
Participants were presented with a visual analog scale (VAS) of the percentage of antiretroviral therapy (ART) adherence in the past 30 days on a scale from 0% to 100% (with 10% increments as response options) and asked to choose the level of ART adherence they achieved in the past 30 days. The mean percentage of ART adherence across all participants was calculated.
1 secondary outcome
Percentage of Participants With Undetectable HIV Viral Load
Time frame: 5-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41675101Horvath KJ, Miller-Perusse M, MacLehose R, Sullivan PS, Hightow-Weidman LL, Amico KR. The results of a web-based randomized controlled intervention trial to improve antiretroviral therapy (ART) adherence among Youth with HIV (YouTHrive, ATN 135) during the COVID-19 pandemic. Mhealth. 2026 Jan 20;12:5. doi: 10.21037/mhealth-25-47. eCollection 2026.
- Derived from this study: PubMed 31364601Horvath KJ, MacLehose RF, Martinka A, DeWitt J, Hightow-Weidman L, Sullivan P, Amico KR. Connecting Youth and Young Adults to Optimize Antiretroviral Therapy Adherence (YouTHrive): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Jul 30;8(7):e11502. doi: 10.2196/11502.
- YouThrive is part of the Adolescent Trials Network. To learn more about the study, or others in the iTECH network, please visit the iTECH website.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The investigators will assure the timely release and sharing of data two years after the publication of the main trial findings from the final dataset. Study variables will be available; however, the investigators will protect the rights and privacy of human subjects by redacting all identifiers from the data set. The de-identified data from this project will be available through individual requests directed to the Principal Investigator.
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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.
Lisa Hightow-Weidman, PhD study chair
University of North Carolina
Patrick S Sullivan, PhD study chair
Emory University
Keith J. Horvath, PhD principal investigator
University of Minnesota
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YouTHrive in people with HIV Infections, run by University of Minnesota at 7 sites 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 8 inclusion and 9 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 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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. 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?
Yes. Results are posted in the registry (first posted 3 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Analog Scale (VAS) of Self-Reported Antiretroviral Adherence (time frame: 5-month follow-up). 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 NCT03149757, which also lists 2 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 3 Jul 2023.