Support for Adolescents Living With HIV in South Africa

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HIV, Human Immunodeficiency Virus

Intervention / Treatment
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* Behavioral: In-person adolescent-friendly service (iPAS) intervention
* Behavioral: mHealth (InTSHA) intervention
* Behavioral: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In-person adolescent-friendly service (iPAS) intervention:<br>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<br>* 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.<br>|
| Experimental: mHealth (InTSHA) intervention<br>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<br>* 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.<br>|
| Active Comparator: Standard of Care/Delayed Intervention<br>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<br>* 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.<br>|
| No Intervention: Healthcare Providers<br>Healthcare providers working at one of study clinics, administering the study intervention selected for that clinic. | |
| No Intervention: Observational cohort<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Acceptability of Intervention Measure (AIM) Score | Acceptability of the intervention is assessed with the AIM questionnaire. The AIM questionnaire has 4 items asking respondents how much they agree with statements such as the intervention is appealing to me. Responses are given on a 5-point scale where completely disagree = 1 and completely agree = 5. Total scores range from 4 to 20 where higher scores indicate greater feelings of acceptability. | Baseline, After the 9 month intervention (Month 9 or Month 18) | 
| Change in Intervention Appropriateness Measure (IAM) Score | Appropriateness of the intervention is assessed with the IAM questionnaire. The IAM questionnaire has 4 items asking respondents how much they agree with statements such as the intervention seems applicable. Responses are given on a 5-point scale where completely disagree = 1 and completely agree = 5. Total scores range from 4 to 20 where higher scores indicate greater feelings that the intervention is appropriate. | Baseline, After the 9 month intervention (Month 9 or Month 18) | 
| Change in Feasibility of Intervention Measure (FIM) Score | Feasibility of the intervention is assessed with the FIM questionnaire. The FIM questionnaire has 4 items asking respondents how much they agree with statements such as the intervention seems possible. Responses are given on a 5-point scale where completely disagree = 1 and completely agree = 5. Total scores range from 4 to 20 where higher scores indicate greater feelings that the intervention is feasible. | Baseline, After the 9 month intervention (Month 9 or Month 18) | 
| Change in HIV Adolescent Readiness for Transition Scale (HARTS) Score | The HIV Adolescent Readiness for Transition Scale (HARTS) includes 16 items that are responded to on a 5-point scale where 0 = no, 1 = no, but I am learning, 2 = yes, a little bit, 3 = yes, almost always, and 4 = yes, always. Total scores range from 0 to 64 and higher scores indicate greater readiness to transition to adult care. | Baseline, Month 9, Month 18, Month 24 | 
| Change in Participation Rate | Adoption of the intervention is examined as the number of adolescent patients enrolling in the study. Adoption of the intervention is considered successful with a participation rate threshold of >70%. | Baseline, After the 9 month intervention (Month 9 or Month 18) | 
| Change in Intervention Fidelity | Healthcare providers will complete an intervention checklist monthly during the intervention. A threshold of >80% of intervention checklist items is considered to be fidelity to the intervention. | Up to Month 24 | 
| Cost of the Intervention | Cost of the intervention is assessed through time and motions studies. Time and motion studies involve counting the time a healthcare provider takes to prepare and deliver the intervention and how long (in hours) each session takes. | After the 9 month intervention (Month 9 or Month 18) | 
| Intervention Completion Rate | Completion of the intervention is examined as the number of adolescent participants who complete the study. | After the 9 month intervention (Month 9 or Month 18) | 
| Change in Percent of Clinic Visits Attended | Sustained effectiveness of the study is examined as the percentage of scheduled clinic appointments that are attended, post-transitioning to care through an adult clinic. Attending at least 80% of scheduled clinic appointments is considered successful retention-in-care. | Month 18, Month 24 | 
| Change in Percent of On Time Pharmacy Refills | Sustained effectiveness of the study is examined as the percentage of ART pharmacy refills that are filled within 7 days from the scheduled date, post-transitioning to care through an adult clinic. Refilling at least 80% of ART pharmacy on time (< 7 days past the scheduled date) is considered successful retention-in-care in terms of pharmacy refills. | Month 18, Month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transition of care, adolescent