Clinical trial NCT03149757: Connecting Youth and Young Adults to Optimize ART Adherence: YouTHrive Efficacy Trial
Official title: Connecting Youth and Young Adults to Optimize ART Adherence: Testing the Efficacy of the Youth Thrive Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Treatment Adherence
Alcohol or Drugs
Behavioral
Internet
Adolescents
Young Adults
Social Support
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: University of North Carolina
name: University of Michigan
name: Emory University
name: Children's Hospital of Philadelphia
name: Baylor College of Medicine
name: Cook County Hospital
name: Montefiore Medical Center
name: University of South Florida
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-05-11
Enrollment: 208
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Visual Analog Scale (VAS) of Self-Reported Antiretroviral Adherence
timeFrame: 5-month follow-up
Secondary outcomes:
measure: Percentage of Participants With Undetectable HIV Viral Load
timeFrame: 5-month follow-up
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Cook County Hospital and Health Systems CORE Center
state: Illinois
city: Bronx
country: United States
facility: Montefiore Children's Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: University of North Carolina
name: Lisa Hightow-Weidman, PhD
role: STUDY_CHAIR
affiliation: Emory University
name: Patrick S Sullivan, PhD
role: STUDY_CHAIR
affiliation: University of Minnesota
name: Keith J. Horvath, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: K. Rivet Amico, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.