Connecting Youth and Young Adults to Optimize ART Adherence: YouTHrive Efficacy Trial

• ClinicalTrials.gov Identifier: NCT03149757
• Recruitment Status: Completed
• First Posted: May 11, 2017
• Last Update Posted: June 8, 2022
• Sponsor: University of Minnesota
• 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)
• Information provided by (Responsible Party): University of Minnesota

Study Description

Brief 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 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.

Condition or disease	Intervention/treatment	Phase
HIV Infections	Behavioral: YouTHrive; Behavioral: Information-only Control	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 205 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Connecting Youth and Young Adults to Optimize ART Adherence: Testing the Efficacy of the Youth Thrive Intervention
• Actual Study Start Date: May 16, 2017
• Actual Primary Completion Date: May 31, 2022
• Actual Study Completion Date: May 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Behavioral: 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.; Other Name: YT
Active Comparator: 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.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

1. Participants with Self-Reported ART Adherence [ Time Frame: Baseline and 5-month follow-up time points ]
   The investigators will test the efficacy of the YT intervention to elicit higher self-reported ART adherence among youth living with HIV (YLWH) at the 5-month follow-up time point compared to an HIV information-only control condition. Self-reported ART adherence will be assessed at baseline and 5-months.

Secondary Outcome Measures :

1. Participants with Viral Load [ Time Frame: Baseline and 5-month follow-up time points ]
   The investigators will test the efficacy of the YT intervention to suppress viral load (VL) among youth living with HIV (YLWH) at the 5-month follow-up time point compared to an HIV information-only control condition. Viral load will be assessed at baseline and 5-months.
2. Participants with HIV Care Attendance [ Time Frame: Baseline and 5-month follow-up time points ]
   The investigators will test the efficacy of the YT intervention to elicit higher HIV care attendance among youth living with HIV (YLWH) at the 5-month follow-up time point compared to an HIV information-only control condition. HIV care attendance will be assessed at baseline and 5-months.
3. Substance-Using Participants with Outcome Measures [ Time Frame: Baseline and 5-month follow-up time points ]
   Among the YT intervention participants, the investigators will assess whether a different proportion of substance-using youth demonstrate improvement on primary (Outcome 1) and secondary outcomes (Outcomes 2 and 3) at the 5-month follow-up timepoints compared to non-substance using participants.
4. Participants with Mental Health and Social Support [ Time Frame: Baseline and 5-month follow-up time points ]
   Among the YT intervention participants, the investigators will assess whether intervention participants report lower depression and anxiety scores, and higher social support at the 5-month follow-up time point compared to an HIV information-only control condition.

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 24 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. 15-24 years of age at the enrollment visit;
2. HIV-positive status;
3. 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;
4. English-speaking (since the intervention will be in English);
5. Anticipated continuous internet access and SMS messaging for the intervention period (approximately 5 months);
6. Not enrolled in another ART adherence intervention research study at the time of screening;
7. Has or is willing to create an e-mail address to use during the study period;
8. 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.

Exclusion Criteria:

1. Is younger than 15 years old or older than 24 years old at the enrollment visit;
2. does not have an HIV-positive status;
3. 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;
4. Does not speak English;
5. Does not anticipate having continuous internet access and SMS messaging for the intervention period (approximately 5 months);
6. Is enrolled in another ART adherence intervention research study at the time of screening;
7. Does not have or is not willing to create an e-mail address to use during the study period;
8. 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.

Contacts and Locations

Locations

United States, Florida

University of South Florida

Tampa, Florida, United States, 33606

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30322

United States, Illinois

Cook County Hospital and Health Systems CORE Center

Chicago, Illinois, United States, 60612

United States, New York

Montefiore Children's Hospital

Bronx, New York, United States, 10467

United States, North Carolina

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27514

United States, Pennsylvania

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

United States, Texas

Texas Children's Hospital

Houston, Texas, United States, 77030

Sponsors and Collaborators

University of Minnesota

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)

Investigators

• Study Chair: Lisa Hightow-Weidman, PhD; University of North Carolina
• Study Chair: Patrick S Sullivan, PhD; Emory University
• Principal Investigator: Keith J. Horvath, PhD; University of Minnesota
• Principal Investigator: K. Rivet Amico, PhD; University of Michigan

More Information

Additional Information:

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. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT03149757
• Other Study ID Numbers: 16-3136; 1U19HD089881 ( U.S. NIH Grant/Contract )
• First Posted: May 11, 2017
• Last Update Posted: June 8, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Minnesota:

Treatment Adherence; Alcohol or Drugs; Behavioral; Internet; Adolescents; Young Adults; Social Support

Additional relevant MeSH terms:

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases