Clinical trial NCT03624413: InTSHA: Interactive Transition Support for HIV-infected Adolescents Using Social Media
Official title: InTSHA: Interactive Transition Support for HIV-infected Adolescents Using Social Media
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV-1-infection
Adolescent Behavior
Keywords: Adolescent
HIV
Transition care
Mobile health
Social media
South Africa
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: University of KwaZulu
name: National Institute of Mental Health (NIMH)
First posted: 2018-08-10
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pilot randomized controlled trial with 40 adolescents receiving a social media intervention and 40 adolescents receiving standard of care.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of Intervention Measure Score
timeFrame: Month 6
measure: Number of Participants Completing Intervention Sessions
timeFrame: Up to Month 6
Secondary outcomes:
measure: Change in Child and Adolescent Social Support Scale (CASSS) Score
timeFrame: Baseline, Month 6
measure: Change in Connection to Clinic Score
timeFrame: Baseline, Month 6
measure: Number of Participants Retained in Care
timeFrame: Up to Month 6
measure: HIV Viral Suppression
timeFrame: Month 6
Other outcomes:
measure: Change in Rosenberg's Self-Esteem Scale Score
timeFrame: Baseline, Month 6
measure: Change in HIV Adolescent Readiness for Transition Scale (HARTS) Score
timeFrame: Baseline, Month 6
Locations:
city: Westville
country: South Africa
facility: University of Kwazulu-Natal
Study officials:
affiliation: Emory University
name: Brian C Zanoni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.