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ACTIVE NOT RECRUITING
NCT06035445
NA

Support for Adolescents Living With HIV in South Africa

Sponsor: Emory University

View on ClinicalTrials.gov

Summary

This is a cluster randomized controlled trial determining the effectiveness of in-person or mHealth-based adolescent-friendly transition interventions compared to standard care on retention in care and viral suppression among adolescents living with HIV who have low transition readiness. Participants are adolescents living with HIV ages 15 to 19 years old in KwaZulu-Natal, South Africa.

Official title: Interactive Transition Support for Adolescents Living With HIV Comparing Virtual and In-person Delivery Through a Stepped-wedge Cluster Randomized Clinical Trial in South Africa

Key Details

Gender

All

Age Range

15 Years - 19 Years

Study Type

INTERVENTIONAL

Enrollment

570

Start Date

2024-02-02

Completion Date

2027-12-31

Last Updated

2026-03-09

Healthy Volunteers

No

Interventions

BEHAVIORAL

In-person adolescent-friendly service (iPAS) intervention

Monthly visits take place in a group setting with sessions led by peer educators. Clinical staff and peer educators are trained in care of adolescents using the Right to Care training materials. During their clinic visit, adolescents are evaluated individually by a healthcare provider and receive their supply of ART. In addition, adolescents participate in scheduled group team-building activities including dancing, sports, music and receive group counseling facilitated by peer educators. Nine group counseling sessions will discuss the topics of: HIV disclosure, alcohol and substance abuse, HIV knowledge, ART adherence and HIV resistance, goal setting and career planning, sexual and reproductive health, HIV stigma, healthcare navigation and self-advocacy, and healthy relationships. The half-day sessions will end with the provision of a meal. After completion of the 9-month intervention, adolescents will transition to adult care in their standard local adult clinic.

BEHAVIORAL

mHealth (InTSHA) intervention

The InTSHA intervention is based on Got Transition elements (two-way messaging between adolescents and healthcare providers) and the SMART model. The SMART model focuses on modifiable factors of transition preparation through content delivery, facilitated discussions, online meet ups and consultation with the healthcare team. The intervention consists of 9 modules delivered monthly by group chat. The topics of the modules are: HIV disclosure, alcohol and substance abuse, HIV knowledge, ART adherence and HIV resistance, goal setting and career planning, sexual and reproductive health, HIV stigma, healthcare navigation and self-advocacy, and healthy relationships. Outside of scheduled group chat sessions, adolescents have access to the chat group to check in with members, review content of the sessions, or to comment or ask additional questions. After completion of the 9-month intervention, adolescents will transition to adult care in their standard local adult clinic.

BEHAVIORAL

Standard of Care

Adolescents in standard of care are seen every three months by clinicians and collect medication monthly at an on-site pharmacy during regular weekdays. Individual counseling delivered by counselors or social workers is available when necessary. Staff at all clinics receive training in adolescent-friendly services (AFS) through the Right to Care training materials.

Locations (1)

King Edward VIII Hospital

KwaKhangela, South Africa