Support for Adolescents Living With HIV in South Africa

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.

Conditions

• Human Immunodeficiency Virus
• HIV

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.

Sponsors & Collaborators

• University of KwaZulu

  collaborator OTHER

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Emory University

  lead OTHER

Principal Investigators

• Brian C Zanoni, MD, MPH · Emory University

• Mohendran Archary, MBchB · King Edward VIII Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-02

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• South Africa

Study Locations