Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06035445
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2023-09-06
Brief Title:
Support for Adolescents Living With HIV in South Africa
Sponsor:
Emory University
Organization:
Emory University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
InTSHA VIP
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 500000 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 320000 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 teenadherence 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 skillsself-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
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 teenadherence 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 skillsself-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01MH131434 | NIH | None | httpsreporternihgovquickSearch1R01MH131434 |