Support for Adolescents Living With HIV in South Africa

HIV Clinical Trial

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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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06035445
• Other study ID #: STUDY00004803
• Secondary ID: 1R01MH131434
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2024
• Source: Emory University
• Contact: Brian C Zanoni, MD, MPH
• Phone: 404-727-0284
• Email: brian.christopher.zanoni[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV
• HIV Infections
• Human Immunodeficiency Virus

Intervention

Behavioral:
• In-person adolescent-friendly service (iPAS) intervention
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.
• mHealth (InTSHA) intervention
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.
• Standard of Care
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.

Locations

Country	Name	City	State
South Africa	King Edward VIII Hospital	Congella

Sponsors (3)

Lead Sponsor	Collaborator
Emory University	National Institute of Mental Health (NIMH), University of KwaZulu

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Child and Adolescent Social Support Scale (CASSS) Score	Social support from peers is assessed using 10 items of the Child and Adolescent Social Support Scale (friend support subscale). Responses are given on a 6-point scale where 1 = never and 6 = always. Total scores range from 10 to 60, where higher scores represent greater social support from peers.	Baseline, After the 9 month intervention (Month 9 or Month 18)
Other	Change in Rosenberg's Self-Esteem Scale Score	The Rosenberg's Self-Esteem Scale is a 10-item instrument assessing self-esteem. Responses are given on a 4-point scale where 0 = strongly disagree and 3 = strongly agree. Total scores range 0 to 30 and higher scores indicate greater self-esteem.	Baseline, After the 9 month intervention (Month 9 or Month 18)
Other	Change in Patient Health Questionnaire (PHQ-9) Score	The PHQ-9 is a 9-item self-report questionnaire developed to identify patients at risk for depression. Participants report how often they have been bothered by specific symptoms of depression on a scale of 0 (not at all) to 3 (nearly every day). Higher scores indicate greater symptoms of depression. A score of = 9 indicates clinically significant symptoms.	Baseline, After the 9 month intervention (Month 9 or Month 18)
Other	Change in Internalized AIDS-Related Stigma Scale (IA-RSS) Score	The IA-RSS assesses several dimensions of stigma concerning HIV status. The instrument includes 6 items adapted form the AIDS-Related Stigma scale. Statements about hesitancy to disclose HIV status and feelings of shame are responded to as 0 = Disagree and 1 = Agree. Total scores range from 0 to 6 with higher scores indicating increased internalized stigma.	Baseline, After the 9 month intervention (Month 9 or Month 18)
Other	Change in Working Alliance Inventory (WAI) Score	connection to clinic (Working Alliance Inventory) A modified version of the Working Alliance Inventory is used to measure how connected participants feel to the clinical staff and medical team. Ten items are responded to on a 4-point scale where 0 = strongly disagree and 3 = strongly agree. Total scores range from 0 to 30 where higher scores indicate increased feelings of connection with clinical staff.	Baseline, After the 9 month intervention (Month 9 or Month 18)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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