Clinical trial NCT06035445: Support for Adolescents Living With HIV in 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Human Immunodeficiency Virus
HIV
Keywords: transition of care
adolescent
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: University of KwaZulu
name: National Institute of Mental Health (NIMH)
First posted: 2023-09-13
Enrollment: 1000
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: This study uses a stepped-wedge, delayed implementation randomized clinical trial design, to measure the effectiveness of the interventions compared to standard of care.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: South Africa has the highest number of adolescents living with HIV in the world, yet adolescents are poorly prepared for transition from pediatric to adult services. For a large majority of South Africans living with HIV, antiretroviral therapy (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 efforts and improved access to ART in recent years, survivors of perinatal HIV infection are now reaching adolescence and beyond. As the wave of adolescents living with perinatally-acquired HIV 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. Although the mother-to-child HIV transmission rates in South Africa have decreased to less than 2%, thousands of infants are still being born with HIV each year ensuring that adolescent HIV will be an issue for many years. Currently, adolescents living with perinatally-acquired HIV enter adult care at variable ages and developmental stages, typically without necessary preparation or support through the process.

The transition from pediatric to adult services for adolescents living with HIV is a critically vulnerable time during which there is a high risk for disengagement from care and resultant morbidity and mortality. Despite an overall decrease in global HIV-related mortality, HIV remains the leading cause of death among adolescents living in South Africa where less than 50% of adolescents living with HIV are virally suppressed. Globally, disruptions related to transitioning from pediatric to adult care have been associated with high rates of HIV drug resistance, virologic failure, progression to AIDS and mortality. In South Africa, older adolescents (\>15 years old) had lower viral suppression rates than younger adolescents at the time of transfer to general clinics.

Studies of in-person adolescent support groups (teen/adherence clubs) and adolescent-friendly services have shown mixed results in mitigating the poor outcomes of adolescents living with HIV. In-person adherence clubs have improved long-term adherence to ART among adults. However, the adherence or teen club models among adolescents living with HIV have shown mixed results.

The delivery of healthcare through portable mobile devices (mHealth) interventions have potential to remedy the challenges along the HIV continuum of care faced by adolescents living with HIV but larger, adequately powered randomized trials are needed. Adolescents in South Africa commonly communicate via social media to gain social support and health information from their peers and the use of social media for health expanded during the coronavirus infection 2019 (COVID-19) pandemic. mHealth strategies thus provides the opportunity to reach adolescents regularly using a preferred format, which could be utilized to improve the reach and impact of adolescent-focused interventions.

The Social-ecological Model of Adolescent and Young Adult Readiness to Transition (SMART) highlights modifiable targets of intervention that can improve transition care for adolescents living with HIV. 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. 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. Using the SMART model, interventions delivered in-person or virtually can address the modifiable factors in the model to improve transition care for adolescents living with HIV but rigorous clinical trials are needed to prove effectiveness.

The researchers have developed and validated the first transition readiness assessment for adolescents living with HIV in South Africa and demonstrated its utility in predicting viral suppression in adult care. Through the development and validation of the HIV Adolescent Readiness to Transition Scale (HARTS) the researchers found that higher ratings reflecting HIV disclosure, healthcare navigation, self-advocacy, and health literacy were predictive of viral suppression after transition to adult care for adolescents living with HIV in South Africa. Using the HARTS in addition to demographic data associated with viral suppression after transition to adult care, the researchers created a transition readiness score to assist clinicians in determining which adolescents may benefit from additional services prior to transitioning to adult care.

Clinics in KwaZulu-Natal, South Africa are randomized to deliver an in-person adolescent-friendly service (iPAS) intervention, mHealth InTSHA intervention, or standard of care to adolescents receiving care at those clinics who score low or intermediate when screened for transition readiness. After the first 9 months of the study, the clinics randomized to deliver standard of care will begin delivering either the iPAS or InTSHA interventions for the next 9 month period. Adolescents participate in the intervention occurring at the clinic they attend for 9 months and complete surveys at baseline, after the 9 month intervention, and a final survey at the end of the study (15 or 24 months after enrollment). Adolescents with high scores when screened for transition readiness will comprise an observational cohort where data will be abstracted from medical records and they will complete questionnaires at 9, 18, and 24 months.

Eligibility criteria: Inclusion Criteria for Adolescent Participants:

* 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)

Inclusion Criteria for Healthcare Providers:

* Profession as a healthcare provider
* Working at one of the designated clinics
* Involvement with adolescents before, during or after transition to adult care

Exclusion Criteria for all participants:

* 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

Primary outcomes:
measure: Number of Participants Retained in Care
timeFrame: After the 9 month intervention (Month 9 or Month 18)
measure: Change in Number of Participants with Viral Suppression
timeFrame: Baseline, After the 9 month intervention (Month 9 or Month 18)
Secondary outcomes:
measure: Acceptability of Intervention Measure (AIM) Score
timeFrame: Baseline, After the 9 month intervention (Month 9 or Month 18)
measure: Intervention Appropriateness Measure (IAM) Score
timeFrame: Baseline, After the 9 month intervention (Month 9 or Month 18)
measure: Feasibility of Intervention Measure (FIM) Score
timeFrame: Baseline, After the 9 month intervention (Month 9 or Month 18)
measure: HIV Adolescent Readiness for Transition Scale (HARTS) Score
timeFrame: Baseline, Month 9, Month 18, Month 24
measure: Participation Rate
timeFrame: Baseline, After the 9 month intervention (Month 9 or Month 18)
measure: Intervention Fidelity
timeFrame: Up to Month 24
measure: Cost of the Intervention
timeFrame: After the 9 month intervention (Month 9 or Month 18)
measure: Intervention Completion Rate
timeFrame: After the 9 month intervention (Month 9 or Month 18)
measure: Percent of Clinic Visits Attended
timeFrame: Month 18, Month 24
measure: Percent of On Time Pharmacy Refills
timeFrame: Month 18, Month 24
Other outcomes:
measure: Child and Adolescent Social Support Scale (CASSS) Score
timeFrame: Baseline, After the 9 month intervention (Month 9 or Month 18)
measure: Rosenberg's Self-Esteem Scale Score
timeFrame: Baseline, After the 9 month intervention (Month 9 or Month 18)
measure: Patient Health Questionnaire (PHQ-9) Score
timeFrame: Baseline, After the 9 month intervention (Month 9 or Month 18)
measure: Internalized AIDS-Related Stigma Scale (IA-RSS) Score
timeFrame: Baseline, After the 9 month intervention (Month 9 or Month 18)
measure: Working Alliance Inventory (WAI) Score
timeFrame: Baseline, After the 9 month intervention (Month 9 or Month 18)
Locations:
city: Congella
country: South Africa
facility: King Edward VIII Hospital
Study officials:
affiliation: Emory University
name: Brian C Zanoni, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: King Edward VIII Hospital
name: Mohendran Archary, MBchB
role: PRINCIPAL_INVESTIGATOR
References: