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| ID | Type | Description | Link |
|---|---|---|---|
| 1U19HD089881 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of North Carolina | OTHER |
| University of Michigan | OTHER |
| Emory University | OTHER |
| Children's Hospital of Philadelphia |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YouTHrive | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
Participants who are or become pregnant during the study period will not be excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Hightow-Weidman, PhD | University of North Carolina | Study Chair |
| Patrick S Sullivan, PhD | Emory University | Study Chair |
| Keith J. Horvath, PhD | University of Minnesota | Principal Investigator |
| K. Rivet Amico, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Tampa | Florida | 33606 | United States | ||
| Emory University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41675101 | Derived | 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. | |
| 31364601 | Derived | Horvath 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. |
| Label | URL |
|---|---|
| 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. | View source |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | YouTHrive | 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. YouTHrive: 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. |
| FG001 | Thrive Tips | Participants randomized to the control condition will receive a weekly email with static informational content about living with HIV and general well being. Information-only Control: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | YouTHrive | 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. YouTHrive: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Unit on a scale | 5-month follow-up |
|
5 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | YouTHrive | 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. YouTHrive: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keith Horvath | University of Minnesota | 619-594-3346 | khorvath@sdsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2021 | May 11, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 8, 2021 | May 11, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000074822 | Treatment Adherence and Compliance |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| OTHER |
| Baylor College of Medicine | OTHER |
| Cook County Hospital | OTHER |
| Montefiore Medical Center | OTHER |
| University of South Florida | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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|
|
| Information-only Control | Behavioral | 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. |
|
| 5-month follow-up |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Cook County Hospital and Health Systems CORE Center | Chicago | Illinois | 60612 | United States |
| Montefiore Children's Hospital | The Bronx | New York | 10467 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| BG001 | Thrive Tips | Participants randomized to the control condition will receive a weekly email with static informational content about living with HIV and general well being. Information-only Control: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Thrive Tips | Participants randomized to the control condition will receive a weekly email with static informational content about living with HIV and general well being. Information-only Control: 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. |
|
|
| Secondary | 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). | The number of participants on which the study team was able to collect HIV viral load measure on was lower than the number of participants who completed the self-report surveys. As such, the number reported on for HIV viral load is smaller than the number of participants available for the primary outcome measure. | Posted | Count of Participants | Participants | 5-month follow-up |
|
|
|
| 1 |
| 103 |
| 0 |
| 103 |
| 0 |
| 103 |
| EG001 | Thrive Tips | Participants randomized to the control condition will receive a weekly email with static informational content about living with HIV and general well being. Information-only Control: 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. | 0 | 105 | 0 | 105 | 0 | 105 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D015438 | Health Behavior |