InTSHA: Interactive Transition Support for HIV-infected Adolescents Using Social Media

NCT03624413 | Completed Results DMC

• 2 other identifiers: IRB00116921K23MH114771
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to develop and evaluate a social media behavioral intervention based on the Social-ecological Model of Adolescent and Young Adult Readiness to Transition (SMART) to improve transition care for adolescents living with HIV in South Africa. Participants will be randomized to receive the social media intervention or the standard of care.

Conditions

HIV-1-infection; Adolescent Behavior

Keywords

Adolescent; HIV; Transition care; Mobile health; Social media; South Africa

Outcome Measures

Primary Outcomes (2)

• Acceptability of Intervention Measure Score

  The acceptability score is based on a validated acceptability questionnaire, the Acceptability of Intervention Measure (Proctor et al., 2011). Acceptability of the intervention is assessed with 4 questions rated on a 5-point scale, where 1 = completely disagree and 5 = completely agree. The total score is the average of item scores and ranges from 1 to 5 with higher scores indicating greater acceptability of the InTSHA intervention.

  Month 6

• Number of Participants Completing Intervention Sessions

  Feasibility of the intervention is reported as the number of participants randomized to the InTSHA intervention who participated in 8 to 10 sessions, 5 to 7 sessions, or fewer than 5 sessions.

  Up to Month 6

Secondary Outcomes (4)

• Change in Child and Adolescent Social Support Scale (CASSS) Score

  Baseline, Month 6

• Change in Connection to Clinic Score

  Baseline, Month 6

• Number of Participants Retained in Care

  Up to Month 6

• HIV Viral Suppression

  Month 6

Other Outcomes (2)

• Change in Rosenberg's Self-Esteem Scale Score

  Baseline, Month 6

• Change in HIV Adolescent Readiness for Transition Scale (HARTS) Score

  Baseline, Month 6

Study Arms (2)

Social Media Intervention

EXPERIMENTAL

Adolescent HIV-positive participants receiving the social media intervention.

Behavioral: Social Media Intervention

Standard of Care

ACTIVE COMPARATOR

Adolescent HIV-positive participants receiving the standard of care.

Other: Standard of Care

Interventions

Social Media Intervention BEHAVIORAL

The social media intervention is a behavioral intervention developed by the study investigators and is delivered via mobile phones. The intervention uses the Social-ecological Model of Adolescent and Young Adult Readiness to Transition (SMART) model, highlighting modifiable targets of intervention that can be addressed through a social media platform. The SMART model incorporates modifiable factors such as knowledge, skills/self-efficacy, relationships and social support that can be targets of interventions to improve transition care. The SMART model emphasizes eight modifiable factors, three key stakeholders (adolescents, caregivers, and clinicians) and their interconnected relationship in influencing successful transition to adult care. The intervention is designed to overcome barriers and enhance facilitators to transitioning care among adolescents living with HIV who are transitioning to adult care in South Africa.

Social Media Intervention

Standard of Care OTHER

Standard of care transition from pediatric to adult care for HIV.

Standard of Care

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged 15 to 19 years
• Perinatally HIV-infected
• Receiving ART for at least 6 months
• Fully aware of their HIV status

You may not qualify if:

• Inability to read and/or speak English or Zulu
• Severe mental or physical illness preventing informed consent

Sponsors & Collaborators

• Emory University: lead
• University of KwaZulu: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Kwazulu-Natal

Westville, South Africa

Location

Related Publications (1)

• Zanoni BC, Archary M, Sibaya T, Goldstein M, Bergam S, Denton D, Cordero V, Peng C, Psaros C, Marconi VC, Haberer JE. Mobile Phone-Based Intervention Among Adolescents Living With Perinatally Acquired HIV Transitioning from Pediatric to Adult Care: Protocol for the Interactive Transition Support for Adolescents Living With HIV using Social Media (InTSHA) Study. JMIR Res Protoc. 2022 Jan 21;11(1):e35455. doi: 10.2196/35455.

  PMID: 35060907 DERIVED

MeSH Terms

Conditions

Adolescent Behavior

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Brian C. Zanoni, MD
• Organization: Emory University

brian.christopher.zanoni@emory.edu

404-727-0284

Study Officials

• Brian C Zanoni, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A pilot randomized controlled trial with 40 adolescents receiving a social media intervention and 40 adolescents receiving standard of care.

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: August 10, 2018
• Study Start: April 15, 2021
• Primary Completion: August 4, 2022
• Study Completion: August 4, 2022
• Last Updated: October 23, 2023
• Results First Posted: October 23, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Individual participant data will be made available for sharing beginning after publication of this study, with no end date.
• Access Criteria: Requests for sharing the data are made by contacting Dr. Zanoni. A data sharing agreement is required before data can be accessed.

Locations

ZA (1)