HIV-1-infectionInTSHANCT03624413
InTSHA: Interactive Transition Support for HIV-infected Adolescents Using Social Media
A study testing Social Media Intervention in people with HIV-1-infection and Adolescent Behavior, run by Emory University at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 19 years
- Conditions the study is for
- HIV-1-infection, Adolescent Behavior
- What is being tested?
- Social Media Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Africa
- Study dates
- 15 Apr 2021to 4 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 15 to 19 years
- Perinatally HIV-infected
- Receiving ART for at least 6 months
- Fully aware of their HIV status
Who cannot join
- Inability to read and/or speak English or Zulu
- Severe mental or physical illness preventing informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- HIV-1-infection, Adolescent Behavior
- Being tested
- Social Media Intervention, Standard of Care
- Keywords
- Adolescent, HIV, Transition care, Mobile health, Social media, South Africa
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Media InterventionBehavioural
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.
Standard of CareOther
Standard of care transition from pediatric to adult care for HIV.
| Study group | Role | What they receive |
|---|---|---|
| Social Media Intervention | Experimental | Adolescent HIV-positive participants receiving the social media intervention. Receives: Behavioral: Social Media Intervention |
| Standard of Care | Active comparator | Adolescent HIV-positive participants receiving the standard of care. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 6
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.
Measured: Up to Month 6
Secondary outcomes (4)
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.
Measured: Baseline, Month 6
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.
Measured: Baseline, Month 6
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.
Measured: Up to Month 6
HIV Viral Suppression
HIV-1 viral load is measured in copies per milliliter (mL) and viral suppression is considered <200 copies/mL.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start15 Apr 2021
- Primary completion4 Aug 2022
- Study completion4 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pilot randomized controlled trial with 40 adolescents receiving a social media intervention and 40 adolescents receiving standard of care.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- University of KwaZulu, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Brian Zanoni, Emory University
- Investigators
- Brian C Zanoni, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624413
- Sponsor's protocol ID
- IRB00116921
- Other IDs
- K23MH114771
- Acronym
- InTSHA
- Status last verified
- Sep 2023
- First submitted
- 13 Jun 2018
- Last updated
- 23 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data will be available on request and will include demographic data, age, sex, baseline cluster of differentiation 4 (CD4), viral load, results of baseline and end of study questionnaires on transition readiness, self-esteem, social support, connection to clinic and end points of acceptability, feasibility, retention in care and viral suppression.
Publications
Zanoni BC, Archary M, Sibaya T, Goldstein M, Bergam S, Denton D, Cordero V, Peng C, Psaros C, Marconi VC, Haberer JE. Mobile Phone-Based Intervention Among Adolescents Living With Perinatally Acquired HIV Transitioning from Pediatric to Adult Care: Protocol for the Interactive Transition Support for Adolescents Living With HIV using Social Media (InTSHA) Study. JMIR Res Protoc. 2022 Jan 21;11(1):e35455. doi: 10.2196/35455.
PubMed 35060907
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InTSHA: Interactive Transition Support for HIV-infected Adolescents Using Social Media
- ClinicalTrials.gov ID
- NCT03624413
- Acronym / sponsor ID
- InTSHA / IRB00116921
- Conditions
- HIV-1-infection, Adolescent Behavior
- Keywords
- Adolescent, HIV, Transition care, Mobile health, Social media, South Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- University of KwaZulu, National Institute of Mental Health (NIMH)
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 4 Aug 2022 (actual)
- Study completion
- 4 Aug 2022 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Posted 23 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A pilot randomized controlled trial with 40 adolescents receiving a social media intervention and 40 adolescents receiving standard of care.
| Arm | Type | Receives |
|---|---|---|
| Social Media Intervention | Experimental | Behavioral: Social Media InterventionAdolescent HIV-positive participants receiving the social media intervention. |
| Standard of Care | Active comparator | Other: Standard of CareAdolescent HIV-positive participants receiving the standard of care. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Aged 15 to 19 years
- Perinatally HIV-infected
- Receiving ART for at least 6 months
- Fully aware of their HIV status
Key exclusion criteria (2 listed)
- Inability to read and/or speak English or Zulu
- Severe mental or physical illness preventing informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Media InterventionThe 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. | Behavioural | Social Media Intervention |
| Standard of CareStandard of care transition from pediatric to adult care for HIV. | Other | Standard of Care |
Primary outcome
Acceptability of Intervention Measure Score
Time frame: 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
Time frame: 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.
4 secondary outcomes
Change in Child and Adolescent Social Support Scale (CASSS) Score
Time frame: Baseline, Month 6
Change in Connection to Clinic Score
Time frame: Baseline, Month 6
Number of Participants Retained in Care
Time frame: Up to Month 6
HIV Viral Suppression
Time frame: Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35060907Zanoni BC, Archary M, Sibaya T, Goldstein M, Bergam S, Denton D, Cordero V, Peng C, Psaros C, Marconi VC, Haberer JE. Mobile Phone-Based Intervention Among Adolescents Living With Perinatally Acquired HIV Transitioning from Pediatric to Adult Care: Protocol for the Interactive Transition Support for Adolescents Living With HIV using Social Media (InTSHA) Study. JMIR Res Protoc. 2022 Jan 21;11(1):e35455. doi: 10.2196/35455.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data will be available on request and will include demographic data, age, sex, baseline cluster of differentiation 4 (CD4), viral load, results of baseline and end of study questionnaires on transition readiness, self-esteem, social support, connection to clinic and end points of acceptability, feasibility, retention in care and viral suppression.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian C Zanoni, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Media Intervention in people with HIV-1-infection and Adolescent Behavior, run by Emory University at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention Measure Score (time frame: Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03624413, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.