Support for Adolescents Living with HIV in South Africa
- Conditions
- HIVHuman Immunodeficiency Virus
- Interventions
- Behavioral: Standard of CareBehavioral: In-person adolescent-friendly service (iPAS) interventionBehavioral: mHealth (InTSHA) intervention
- Registration Number
- NCT06035445
- Lead Sponsor
- Emory University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care/Delayed Intervention Standard of Care 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. In-person adolescent-friendly service (iPAS) intervention: 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. mHealth (InTSHA) intervention 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.
- Primary Outcome Measures
Name Time Method Number of Participants Retained in Care 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 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.
- Secondary Outcome Measures
Name Time Method Acceptability of Intervention Measure (AIM) Score Baseline, After the 9 month intervention (Month 9 or Month 18) 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.
Intervention Appropriateness Measure (IAM) Score Baseline, After the 9 month intervention (Month 9 or Month 18) 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.
Feasibility of Intervention Measure (FIM) Score Baseline, After the 9 month intervention (Month 9 or Month 18) 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.
HIV Adolescent Readiness for Transition Scale (HARTS) Score Baseline, Month 9, Month 18, Month 24 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.
Participation Rate Baseline, After the 9 month intervention (Month 9 or Month 18) 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%.
Intervention Fidelity Up to Month 24 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.
Cost of the Intervention After the 9 month intervention (Month 9 or Month 18) 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.
Intervention Completion Rate After the 9 month intervention (Month 9 or Month 18) Completion of the intervention is examined as the number of adolescent participants who complete the study.
Percent of Clinic Visits Attended Month 18, Month 24 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.
Percent of On Time Pharmacy Refills Month 18, Month 24 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.
Trial Locations
- Locations (1)
King Edward VIII Hospital
🇿🇦Congella, South Africa