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
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 570
- 试验地点
- 1
- 主要终点
- Number of Participants Retained in Care
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 19 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
In-person adolescent-friendly service (iPAS) intervention:
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.
干预措施: In-person adolescent-friendly service (iPAS) intervention (Behavioral)
mHealth (InTSHA) intervention
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.
干预措施: mHealth (InTSHA) intervention (Behavioral)
Standard of Care/Delayed Intervention
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.
干预措施: Standard of Care (Behavioral)
Healthcare Providers
Healthcare providers working at one of study clinics, administering the study intervention selected for that clinic.
Observational cohort
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.
结局指标
主要结局
Number of Participants Retained in Care
时间窗: After the 9 month intervention (Month 9 or Month 18)
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.
Change in Number of Participants with Viral Suppression
时间窗: Baseline, After the 9 month intervention (Month 9 or Month 18)
HIV-1 viral load is measured in viral copies per milliliter (mL) of blood and viral suppression is defined as \<200 copies/ml.
次要结局
- 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))
- Intervention Fidelity(Up to Month 24)
- Cost of the Intervention(After the 9 month intervention (Month 9 or Month 18))
- Intervention Completion Rate(After the 9 month intervention (Month 9 or Month 18))
- Percent of Clinic Visits Attended(Month 18, Month 24)
- Percent of On Time Pharmacy Refills(Month 18, Month 24)
研究者
Brian Zanoni
Associate Professor
Emory University
