Adolescent Behavior, HIV-1-infection
Conditions
Keywords
Adolescent, HIV, Transition care, Mobile health, Social media, South Africa
Brief summary
The goal of this study is to develop and evaluate a social media behavioral intervention based on the Social-ecological Model of Adolescent and Young Adult Readiness to Transition (SMART) to improve transition care for adolescents living with HIV in South Africa. Participants will be randomized to receive the social media intervention or the standard of care.
Detailed description
South Africa has the highest burden of adolescents living with HIV in the world and adolescents are poorly prepared for transition from pediatric to adult services. For a large majority of South Africans living with HIV, 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 and improved access to ART in recent years, survivors of perinatal HIV infection are now reaching adolescence and beyond. As the wave of perinatally HIV-infected adolescents 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. Currently, perinatally HIV-infected adolescents enter adult care at variable ages and developmental stages, without necessary preparation or support through the process. This study will develop and evaluate an innovative intervention designed to address this critical problem. 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. Qualitative studies with adolescents and clinicians from sub-Saharan Africa suggest that peer support, collaboration with health providers, and communication between adult and pediatric providers might assist in transition to adult services. 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.The social media intervention for this study incorporates these stakeholders and addresses the modifiable factors in the SMART model to improve transition care for adolescents living with HIV. Social media is defined as internet-based applications that allow the creation and exchange of user generated content. A recent meta-analysis found that social support was the most common reason for patients to use social media for health purposes. Social media has also been used to improve the relationship between caregivers and patients when switching caregivers, a major barrier to transition for adolescents in South Africa. Although results vary in different settings, a recent meta-analysis has shown overall improved adherence and viral suppression among adults living with HIV using social media based health services technology. Social media can address the modifiable variables in the SMART model such as knowledge, self-efficacy, goals, relationships, peer and social support, which could ultimately improve virologic suppression and retention in care during the transition to adult services. The researchers will perform a pilot randomized controlled trial with 40 adolescents receiving the social media intervention and 40 adolescents receiving standard of care. In-depth interviews and quantitative surveys with adolescents living with HIV will be used to assess the acceptability and feasibility of the intervention. The secondary outcomes of peer support, connection to clinical staff, retention in care, and viral suppression will also be examined at baseline and 6 months after randomization.
Interventions
BEHAVIORALSocial Media Intervention
The social media intervention is a behavioral intervention developed by the study investigators and is delivered via mobile phones. The intervention uses the Social-ecological Model of Adolescent and Young Adult Readiness to Transition (SMART) model, highlighting modifiable targets of intervention that can be addressed through a social media platform. 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. 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. The intervention is designed to overcome barriers and enhance facilitators to transitioning care among adolescents living with HIV who are transitioning to adult care in South Africa.
OTHERStandard of Care
Standard of care transition from pediatric to adult care for HIV.
Sponsors
University of KwaZulu
National Institute of Mental Health (NIMH)
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
A pilot randomized controlled trial with 40 adolescents receiving a social media intervention and 40 adolescents receiving standard of care.
Eligibility
Sex/Gender
ALL
Age
15 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
* Aged 15 to 19 years * Perinatally HIV-infected * Receiving ART for at least 6 months * Fully aware of their HIV status
Exclusion criteria
* Inability to read and/or speak English or Zulu * Severe mental or physical illness preventing informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Intervention Measure Score | Month 6 | The acceptability score is based on a validated acceptability questionnaire, the Acceptability of Intervention Measure (Proctor et al., 2011). Acceptability of the intervention is assessed with 4 questions rated on a 5-point scale, where 1 = completely disagree and 5 = completely agree. The total score is the average of item scores and ranges from 1 to 5 with higher scores indicating greater acceptability of the InTSHA intervention. |
| Number of Participants Completing Intervention Sessions | Up to Month 6 | Feasibility of the intervention is reported as the number of participants randomized to the InTSHA intervention who participated in 8 to 10 sessions, 5 to 7 sessions, or fewer than 5 sessions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Connection to Clinic Score | Baseline, Month 6 | 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. The change from baseline is calculated as the Month 6 score minus the baseline score. A positive value means that the scores at Month 6 increased from what they were at baseline. |
| HIV Viral Suppression | Month 6 | HIV-1 viral load is measured in copies per milliliter (mL) and viral suppression is considered \<200 copies/mL. |
| Number of Participants Retained in Care | Up to Month 6 | Retention in care is assessed as a composite outcome of missing any pharmacy refills of antiretroviral medication and/or missing any clinic visits in the last 6 months. Participants are considered as retained in care if they did not miss any pharmacy refills or clinic visits. |
| Change in Child and Adolescent Social Support Scale (CASSS) Score | Baseline, Month 6 | 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. The change from baseline is calculated as the Month 6 score minus the Baseline score. A positive value means that the scores at Month 6 increased from what they were at Baseline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Rosenberg's Self-Esteem Scale Score | Baseline, Month 6 | 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. The change in score is the Month 6 score subtracted by the Baseline score. A positive values indicates that the self-esteem score increased by the end of the study. |
| Change in HIV Adolescent Readiness for Transition Scale (HARTS) Score | Baseline, Month 6 | 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. The change from baseline is calculated as the Month 6 score minus the Baseline score. A positive value means that the scores at Month 6 increased from what they were at Baseline. |
Countries
South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| InTSHA Social Media Intervention Adolescent HIV-positive participants receiving the InTSHA social media intervention. | 40 |
| Standard of Care Adolescent HIV-positive participants receiving the standard of care. | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Standard of Care | Total | InTSHA Social Media Intervention |
|---|---|---|---|
| Age, Continuous | 17.0 years STANDARD_DEVIATION 1.3 | 16.9 years STANDARD_DEVIATION 1.3 | 16.9 years STANDARD_DEVIATION 1.2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment South Africa | 40 participants | 80 participants | 40 participants |
| Sex: Female, Male Female | 18 Participants | 37 Participants | 19 Participants |
| Sex: Female, Male Male | 22 Participants | 43 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Acceptability of Intervention Measure Score
The acceptability score is based on a validated acceptability questionnaire, the Acceptability of Intervention Measure (Proctor et al., 2011). Acceptability of the intervention is assessed with 4 questions rated on a 5-point scale, where 1 = completely disagree and 5 = completely agree. The total score is the average of item scores and ranges from 1 to 5 with higher scores indicating greater acceptability of the InTSHA intervention.
Time frame: Month 6
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| InTSHA Social Media Intervention | Acceptability of Intervention Measure Score | 4.1 score on a scale |
Primary
Number of Participants Completing Intervention Sessions
Feasibility of the intervention is reported as the number of participants randomized to the InTSHA intervention who participated in 8 to 10 sessions, 5 to 7 sessions, or fewer than 5 sessions.
Time frame: Up to Month 6
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| InTSHA Social Media Intervention | Number of Participants Completing Intervention Sessions | Participated in 8 to 10 sessions | 15 Participants |
| InTSHA Social Media Intervention | Number of Participants Completing Intervention Sessions | Participated in 5 to 7 sessions | 9 Participants |
| InTSHA Social Media Intervention | Number of Participants Completing Intervention Sessions | Participated in less than 5 sessions | 16 Participants |
Secondary
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. The change from baseline is calculated as the Month 6 score minus the Baseline score. A positive value means that the scores at Month 6 increased from what they were at Baseline.
Time frame: Baseline, Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| InTSHA Social Media Intervention | Change in Child and Adolescent Social Support Scale (CASSS) Score | 3.31 score on a scale | Standard Deviation 9.37 |
| Standard of Care | Change in Child and Adolescent Social Support Scale (CASSS) Score | 1.74 score on a scale | Standard Deviation 12.36 |
Secondary
Change in Connection to Clinic Score
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. The change from baseline is calculated as the Month 6 score minus the baseline score. A positive value means that the scores at Month 6 increased from what they were at baseline.
Time frame: Baseline, Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| InTSHA Social Media Intervention | Change in Connection to Clinic Score | 0.44 score on a scale | Standard Deviation 6.35 |
| Standard of Care | Change in Connection to Clinic Score | 0.42 score on a scale | Standard Deviation 5.42 |
Secondary
HIV Viral Suppression
HIV-1 viral load is measured in copies per milliliter (mL) and viral suppression is considered \<200 copies/mL.
Time frame: Month 6
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| InTSHA Social Media Intervention | HIV Viral Suppression | No viral suppression (>200 copies/mL) | 5 Participants |
| InTSHA Social Media Intervention | HIV Viral Suppression | Viral suppression (<200 copies/mL) | 35 Participants |
| Standard of Care | HIV Viral Suppression | No viral suppression (>200 copies/mL) | 4 Participants |
| Standard of Care | HIV Viral Suppression | Viral suppression (<200 copies/mL) | 36 Participants |
Secondary
Number of Participants Retained in Care
Retention in care is assessed as a composite outcome of missing any pharmacy refills of antiretroviral medication and/or missing any clinic visits in the last 6 months. Participants are considered as retained in care if they did not miss any pharmacy refills or clinic visits.
Time frame: Up to Month 6
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| InTSHA Social Media Intervention | Number of Participants Retained in Care | 39 Participants |
| Standard of Care | Number of Participants Retained in Care | 35 Participants |
Other Pre-specified
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. The change from baseline is calculated as the Month 6 score minus the Baseline score. A positive value means that the scores at Month 6 increased from what they were at Baseline.
Time frame: Baseline, Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| InTSHA Social Media Intervention | Change in HIV Adolescent Readiness for Transition Scale (HARTS) Score | 0.46 score on a scale | Standard Deviation 0.79 |
| Standard of Care | Change in HIV Adolescent Readiness for Transition Scale (HARTS) Score | 0.30 score on a scale | Standard Deviation 0.91 |
Other Pre-specified
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. The change in score is the Month 6 score subtracted by the Baseline score. A positive values indicates that the self-esteem score increased by the end of the study.
Time frame: Baseline, Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| InTSHA Social Media Intervention | Change in Rosenberg's Self-Esteem Scale Score | 0.51 score on a scale | Standard Deviation 5.22 |
| Standard of Care | Change in Rosenberg's Self-Esteem Scale Score | -0.39 score on a scale | Standard Deviation 5.38 |