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

Not Applicable

Completed

• Conditions: Adolescent Behavior; HIV-1-infection
• Interventions: Other: Standard of Care; Behavioral: Social Media Intervention

• Registration Number: NCT03624413
• Lead Sponsor: Emory University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-06-13
• Study First Submitted QC: 2018-08-08
• Study First Posted: 2018-08-10
• Study Start: 2021-04-15
• Primary Completion: 2022-08-04
• Study Completion: 2022-08-04
• Disposition First Submitted: 2023-08-03
• Status Verified: 2023-09
• Disposition First Posted: 2023-09-06
• Results First Submitted: 2023-09-27
• Results First Submitted QC: 2023-09-27
• Last Update Submitted: 2023-09-27
• Results First Posted: 2023-10-23
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	Adolescent HIV-positive participants receiving the standard of care.
Social Media Intervention	Social Media Intervention	Adolescent HIV-positive participants receiving the social media intervention.

Primary Outcome Measures

Name	Time	Method
Acceptability of Intervention Measure Score	Month 6	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.
Number of Participants Completing Intervention Sessions	Up to Month 6	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.

Secondary Outcome Measures

Name	Time	Method
Change in Child and Adolescent Social Support Scale (CASSS) Score	Baseline, Month 6	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.
Change in Connection to Clinic Score	Baseline, Month 6	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.
HIV Viral Suppression	Month 6	HIV-1 viral load is measured in copies per milliliter (mL) and viral suppression is considered \<200 copies/mL.
Number of Participants Retained in Care	Up to Month 6	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.

Trial Locations

Locations (1)

University of Kwazulu-Natal; 🇿🇦 Westville, South Africa