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

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.

Study Overview

• Status: Completed
• Conditions: HIV-1-infection; Adolescent Behavior
• Intervention / Treatment: Behavioral: Social Media Intervention; Other: Standard of Care

Detailed Description

South Africa has the highest burden of adolescents living with HIV in the world and adolescents are poorly prepared for transition from pediatric to adult services. For a large majority of South Africans living with HIV, ART was not available until 2004. This delay contributed to nearly 500,000 perinatal HIV infections in the late 1990s and early 2000s. With large scale-up and improved access to ART in recent years, survivors of perinatal HIV infection are now reaching adolescence and beyond. As the wave of perinatally HIV-infected adolescents matures, an estimated 320,000 adolescents will transfer from pediatric- or adolescent-based clinics to adult services in the next 10 years in South Africa. Currently, perinatally HIV-infected adolescents enter adult care at variable ages and developmental stages, without necessary preparation or support through the process. This study will develop and evaluate an innovative intervention designed to address this critical problem.

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. Medical care during adolescence is typically complicated by increased risk-taking behavior, as well as decreased caregiver involvement, which occur during a time of rapid physical, emotional, and cognitive development. When adolescents transition to adult care, they often do not receive the coordinated services that they received under pediatric care. Qualitative studies with adolescents and clinicians from sub-Saharan Africa suggest that peer support, collaboration with health providers, and communication between adult and pediatric providers might assist in transition to adult services. 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 social media intervention for this study incorporates these stakeholders and addresses the modifiable factors in the SMART model to improve transition care for adolescents living with HIV.

Social media is defined as internet-based applications that allow the creation and exchange of user generated content. A recent meta-analysis found that social support was the most common reason for patients to use social media for health purposes. Social media has also been used to improve the relationship between caregivers and patients when switching caregivers, a major barrier to transition for adolescents in South Africa. Although results vary in different settings, a recent meta-analysis has shown overall improved adherence and viral suppression among adults living with HIV using social media based health services technology. Social media can address the modifiable variables in the SMART model such as knowledge, self-efficacy, goals, relationships, peer and social support, which could ultimately improve virologic suppression and retention in care during the transition to adult services.

The researchers will perform a pilot randomized controlled trial with 40 adolescents receiving the social media intervention and 40 adolescents receiving standard of care. In-depth interviews and quantitative surveys with adolescents living with HIV will be used to assess the acceptability and feasibility of the intervention. The secondary outcomes of peer support, connection to clinical staff, retention in care, and viral suppression will also be examined at baseline and 6 months after randomization.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Westville, South Africa
    • University of KwaZulu-Natal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Social Media Intervention; Adolescent HIV-positive participants receiving the social media intervention.	Behavioral: Social Media Intervention; 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.
Active Comparator: Standard of Care; Adolescent HIV-positive participants receiving the standard of care.	Other: Standard of Care; Standard of care transition from pediatric to adult care for HIV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Child and Adolescent Social Support Scale (CASSS) Score	Social support from peers is assessed using 10 items of the Child and Adolescent Social Support Scale (friend support subscale). Responses are given on a 6-point scale where 1 = never and 6 = always. Total scores range from 10 to 60, where higher scores represent greater social support from peers. The change from baseline is calculated as the Month 6 score minus the Baseline score. A positive value means that the scores at Month 6 increased from what they were at Baseline.	Baseline, Month 6
Change in Connection to Clinic Score	A modified version of the Working Alliance Inventory is used to measure how connected participants feel to the clinical staff and medical team. Ten items are responded to on a 4-point scale where 0 = strongly disagree and 3 = strongly agree. Total scores range from 0 to 30 where higher scores indicate increased feelings of connection with clinical staff. The change from baseline is calculated as the Month 6 score minus the baseline score. A positive value means that the scores at Month 6 increased from what they were at baseline.	Baseline, Month 6
Number of Participants Retained in Care	Retention in care is assessed as a composite outcome of missing any pharmacy refills of antiretroviral medication and/or missing any clinic visits in the last 6 months. Participants are considered as retained in care if they did not miss any pharmacy refills or clinic visits.	Up to Month 6
HIV Viral Suppression	HIV-1 viral load is measured in copies per milliliter (mL) and viral suppression is considered <200 copies/mL.	Month 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Rosenberg's Self-Esteem Scale Score	The Rosenberg's Self-Esteem Scale is a 10-item instrument assessing self-esteem. Responses are given on a 4-point scale where 0 = strongly disagree and 3 = strongly agree. Total scores range 0 to 30 and higher scores indicate greater self-esteem. The change in score is the Month 6 score subtracted by the Baseline score. A positive values indicates that the self-esteem score increased by the end of the study.	Baseline, Month 6
Change in HIV Adolescent Readiness for Transition Scale (HARTS) Score	The HIV Adolescent Readiness for Transition Scale (HARTS) includes 16 items that are responded to on a 5-point scale where 0 = no, 1 = no, but I am learning, 2 = yes, a little bit, 3 = yes, almost always, and 4 = yes, always. Total scores range from 0 to 64 and higher scores indicate greater readiness to transition to adult care. The change from baseline is calculated as the Month 6 score minus the Baseline score. A positive value means that the scores at Month 6 increased from what they were at Baseline.	Baseline, Month 6

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Mental Health (NIMH); University of KwaZulu
• Investigators: Principal Investigator: Brian C Zanoni, MD, Emory University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Actual): August 4, 2022
• Study Completion (Actual): August 4, 2022

Study Registration Dates

• First Submitted: June 13, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Adolescent; HIV; South Africa; Social media; Mobile health; Transition care
• Other Study ID Numbers: IRB00116921; K23MH114771 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data will be available on request and will include demographic data, age, sex, baseline cluster of differentiation 4 (CD4), viral load, results of baseline and end of study questionnaires on transition readiness, self-esteem, social support, connection to clinic and end points of acceptability, feasibility, retention in care and viral suppression.
• IPD Sharing Time Frame: Individual participant data will be made available for sharing beginning after publication of this study, with no end date.
• IPD Sharing Access Criteria: Requests for sharing the data are made by contacting Dr. Zanoni. A data sharing agreement is required before data can be accessed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No