Trial Outcomes & Findings for InTSHA: Interactive Transition Support for HIV-infected Adolescents Using Social Media (NCT NCT03624413)
NCT ID: NCT03624413
Last Updated: 2023-10-23
Results Overview
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.
COMPLETED
NA
80 participants
Month 6
2023-10-23
Participant Flow
Participant milestones
| Measure |
InTSHA Social Media Intervention
Adolescent HIV-positive participants receiving the InTSHA social media intervention.
Social Media Intervention: The InTSHA 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.
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Standard of Care
Adolescent HIV-positive participants receiving the standard of care.
Standard of Care: Standard of care transition from pediatric to adult care for HIV.
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|---|---|---|
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Overall Study
STARTED
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40
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40
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Overall Study
COMPLETED
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40
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40
|
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
InTSHA Social Media Intervention
n=40 Participants
Adolescent HIV-positive participants receiving the InTSHA social media intervention.
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Standard of Care
n=40 Participants
Adolescent HIV-positive participants receiving the standard of care.
|
Total
n=80 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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16.9 years
STANDARD_DEVIATION 1.2 • n=40 Participants
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17.0 years
STANDARD_DEVIATION 1.3 • n=40 Participants
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16.9 years
STANDARD_DEVIATION 1.3 • n=80 Participants
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Sex: Female, Male
Female
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19 Participants
n=40 Participants
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18 Participants
n=40 Participants
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37 Participants
n=80 Participants
|
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Sex: Female, Male
Male
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21 Participants
n=40 Participants
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22 Participants
n=40 Participants
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43 Participants
n=80 Participants
|
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Race and Ethnicity Not Collected
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—
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—
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0 Participants
Race and Ethnicity were not collected from any participant.
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Region of Enrollment
South Africa
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40 participants
n=40 Participants
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40 participants
n=40 Participants
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80 participants
n=80 Participants
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PRIMARY outcome
Timeframe: Month 6The 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.
Outcome measures
| Measure |
InTSHA Social Media Intervention
n=40 Participants
Adolescent HIV-positive participants receiving the InTSHA social media intervention.
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Standard of Care
Adolescent HIV-positive participants receiving the standard of care.
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|---|---|---|
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Acceptability of Intervention Measure Score
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4.1 score on a scale
Interval 2.38 to 5.0
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—
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PRIMARY outcome
Timeframe: Up to Month 6Feasibility 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.
Outcome measures
| Measure |
InTSHA Social Media Intervention
n=40 Participants
Adolescent HIV-positive participants receiving the InTSHA social media intervention.
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Standard of Care
Adolescent HIV-positive participants receiving the standard of care.
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|---|---|---|
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Number of Participants Completing Intervention Sessions
Participated in 8 to 10 sessions
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15 Participants
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—
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Number of Participants Completing Intervention Sessions
Participated in 5 to 7 sessions
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9 Participants
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—
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Number of Participants Completing Intervention Sessions
Participated in less than 5 sessions
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16 Participants
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—
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SECONDARY outcome
Timeframe: Baseline, Month 6Social 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.
Outcome measures
| Measure |
InTSHA Social Media Intervention
n=36 Participants
Adolescent HIV-positive participants receiving the InTSHA social media intervention.
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Standard of Care
n=38 Participants
Adolescent HIV-positive participants receiving the standard of care.
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|---|---|---|
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Change in Child and Adolescent Social Support Scale (CASSS) Score
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3.31 score on a scale
Standard Deviation 9.37
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1.74 score on a scale
Standard Deviation 12.36
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SECONDARY outcome
Timeframe: Baseline, Month 6A 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.
Outcome measures
| Measure |
InTSHA Social Media Intervention
n=36 Participants
Adolescent HIV-positive participants receiving the InTSHA social media intervention.
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Standard of Care
n=38 Participants
Adolescent HIV-positive participants receiving the standard of care.
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|---|---|---|
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Change in Connection to Clinic Score
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0.44 score on a scale
Standard Deviation 6.35
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0.42 score on a scale
Standard Deviation 5.42
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SECONDARY outcome
Timeframe: Up to Month 6Retention 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.
Outcome measures
| Measure |
InTSHA Social Media Intervention
n=40 Participants
Adolescent HIV-positive participants receiving the InTSHA social media intervention.
|
Standard of Care
n=40 Participants
Adolescent HIV-positive participants receiving the standard of care.
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|---|---|---|
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Number of Participants Retained in Care
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39 Participants
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35 Participants
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SECONDARY outcome
Timeframe: Month 6HIV-1 viral load is measured in copies per milliliter (mL) and viral suppression is considered \<200 copies/mL.
Outcome measures
| Measure |
InTSHA Social Media Intervention
n=40 Participants
Adolescent HIV-positive participants receiving the InTSHA social media intervention.
|
Standard of Care
n=40 Participants
Adolescent HIV-positive participants receiving the standard of care.
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|---|---|---|
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HIV Viral Suppression
No viral suppression (>200 copies/mL)
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5 Participants
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4 Participants
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HIV Viral Suppression
Viral suppression (<200 copies/mL)
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35 Participants
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36 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Month 6The 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.
Outcome measures
| Measure |
InTSHA Social Media Intervention
n=39 Participants
Adolescent HIV-positive participants receiving the InTSHA social media intervention.
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Standard of Care
n=38 Participants
Adolescent HIV-positive participants receiving the standard of care.
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|---|---|---|
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Change in Rosenberg's Self-Esteem Scale Score
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0.51 score on a scale
Standard Deviation 5.22
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-0.39 score on a scale
Standard Deviation 5.38
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Month 6The 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.
Outcome measures
| Measure |
InTSHA Social Media Intervention
n=39 Participants
Adolescent HIV-positive participants receiving the InTSHA social media intervention.
|
Standard of Care
n=38 Participants
Adolescent HIV-positive participants receiving the standard of care.
|
|---|---|---|
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Change in HIV Adolescent Readiness for Transition Scale (HARTS) Score
|
0.46 score on a scale
Standard Deviation 0.79
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0.30 score on a scale
Standard Deviation 0.91
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Adverse Events
InTSHA Social Media Intervention
Standard of Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place