Support for Adolescents Living With HIV in South Africa

NCT06035445 | Active Not Recruiting DMC

• 3 other identifiers: STUDY000048031R01MH1314342023P006373
• Study Type: interventional
• Target: 570
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

transition of care; adolescent

Outcome Measures

Primary Outcomes (2)

• Number of Participants Retained in Care

  Clinic patients are considered to be retained in care if 80% of ART pharmacy refills are filled on time (\< 7days from scheduled date) and 80% of scheduled clinic appointments are attended.

  After the 9 month intervention (Month 9 or Month 18)

• Change in Number of Participants with Viral Suppression

  HIV-1 viral load is measured in viral copies per milliliter (mL) of blood and viral suppression is defined as \<200 copies/ml.

  Baseline, After the 9 month intervention (Month 9 or Month 18)

Secondary Outcomes (10)

• Acceptability of Intervention Measure (AIM) Score

  Baseline, After the 9 month intervention (Month 9 or Month 18)

• Intervention Appropriateness Measure (IAM) Score

  Baseline, After the 9 month intervention (Month 9 or Month 18)

• Feasibility of Intervention Measure (FIM) Score

  Baseline, After the 9 month intervention (Month 9 or Month 18)

• HIV Adolescent Readiness for Transition Scale (HARTS) Score

  Baseline, Month 9, Month 18, Month 24

• Participation Rate

  Baseline, After the 9 month intervention (Month 9 or Month 18)

Other Outcomes (5)

• Child and Adolescent Social Support Scale (CASSS) Score

  Baseline, After the 9 month intervention (Month 9 or Month 18)

• Rosenberg's Self-Esteem Scale Score

  Baseline, After the 9 month intervention (Month 9 or Month 18)

• Patient Health Questionnaire (PHQ-9) Score

  Baseline, After the 9 month intervention (Month 9 or Month 18)

Study Arms (5)

In-person adolescent-friendly service (iPAS) intervention:

EXPERIMENTAL

Adolescents at study clinics who score low or intermediate on transition readiness during screening will be invited to enroll in the study. Adolescents attending clinics randomized to the in-person supported adolescent friendly services will attend their clinic after school hours on a designated day or on weekends dedicated for adolescent care monthly for 9 months.

Behavioral: In-person adolescent-friendly service (iPAS) intervention

mHealth (InTSHA) intervention

EXPERIMENTAL

Adolescents at study clinics who score low or intermediate on transition readiness during screening will be invited to enroll in the study. Adolescents attending clinics randomized to the mHealth intervention will receive the InTSHA intervention based in the Got Transition elements and the SMART model for 9 months.

Behavioral: mHealth (InTSHA) intervention

Standard of Care/Delayed Intervention

ACTIVE COMPARATOR

Adolescents at study clinics who score low or intermediate on transition readiness during screening will be invited to enroll in the study. Adolescents attending clinics randomized to deliver the standard of care before transitioning to adult care in their standard local adult clinic. Participants will be invited to receive the intervention the clinic is randomized to deliver when the 9 month period of administering the standard of care is complete.

Behavioral: Standard of Care

Healthcare Providers

NO INTERVENTION

Healthcare providers working at one of study clinics, administering the study intervention selected for that clinic.

Observational cohort

NO INTERVENTION

Adolescents at study clinics who score high on transition readiness during screening will not be invited to enroll in the study but will be asked for their consent to have their clinic records reviewed for medical records, retention data and transition readiness data. They will also complete a questionnaire at Months 9, 18, and 24.

Interventions

In-person adolescent-friendly service (iPAS) intervention BEHAVIORAL

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.

In-person adolescent-friendly service (iPAS) intervention:

mHealth (InTSHA) intervention BEHAVIORAL

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.

mHealth (InTSHA) intervention

Standard of Care BEHAVIORAL

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.

Standard of Care/Delayed Intervention

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged 15 to 19 years at enrollment
• Living with perinatally-acquired HIV
• Receiving ART for at least 6 months
• Aware of their HIV status
• Scoring low to intermediate on transition readiness assessment (intervention cohort only)
• Profession as a healthcare provider
• Working at one of the designated clinics
• Involvement with adolescents before, during or after transition to adult care

You may not qualify if:

• Inability to read and/or speak English or Zulu
• Severe mental or physical illness preventing participation in informed consent activities
• Anticipated move out of clinic area in the next 12 months

Sponsors & Collaborators

• Emory University: lead
• University of KwaZulu: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

King Edward VIII Hospital

KwaKhangela, South Africa

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Methods; Telemedicine; Standard of Care

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques; Delivery of Health Care; Patient Care Management; Health Services Administration; Quality Indicators, Health Care; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Brian C Zanoni, MD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

• Mohendran Archary, MBchB

  King Edward VIII Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study uses a stepped-wedge, delayed implementation randomized clinical trial design, to measure the effectiveness of the interventions compared to standard of care.

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 13, 2023
• Study Start: February 2, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be made available for sharing following publication of results from this study.
• Access Criteria: Data will be made available for sharing through the Emory Dataverse. The Dataverse website can be accessed by any researcher for secondary analyses.

Locations

ZA (1)