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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

80 participants

Primary outcome timeframe

Month 6

Results posted on

2023-10-23

Participant Flow

Participant milestones

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.
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.
Overall Study
STARTED
40
40
Overall Study
COMPLETED
40
40
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
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.
Total
n=80 Participants
Total of all reporting groups
Age, Continuous
16.9 years
STANDARD_DEVIATION 1.2 • n=40 Participants
17.0 years
STANDARD_DEVIATION 1.3 • n=40 Participants
16.9 years
STANDARD_DEVIATION 1.3 • n=80 Participants
Sex: Female, Male
Female
19 Participants
n=40 Participants
18 Participants
n=40 Participants
37 Participants
n=80 Participants
Sex: Female, Male
Male
21 Participants
n=40 Participants
22 Participants
n=40 Participants
43 Participants
n=80 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
South Africa
40 participants
n=40 Participants
40 participants
n=40 Participants
80 participants
n=80 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
InTSHA Social Media Intervention
n=40 Participants
Adolescent HIV-positive participants receiving the InTSHA social media intervention.
Standard of Care
Adolescent HIV-positive participants receiving the standard of care.
Acceptability of Intervention Measure Score
4.1 score on a scale
Interval 2.38 to 5.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
InTSHA Social Media Intervention
n=40 Participants
Adolescent HIV-positive participants receiving the InTSHA social media intervention.
Standard of Care
Adolescent HIV-positive participants receiving the standard of care.
Number of Participants Completing Intervention Sessions
Participated in 8 to 10 sessions
15 Participants
Number of Participants Completing Intervention Sessions
Participated in 5 to 7 sessions
9 Participants
Number of Participants Completing Intervention Sessions
Participated in less than 5 sessions
16 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
InTSHA Social Media Intervention
n=36 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.
Change in Child and Adolescent Social Support Scale (CASSS) Score
3.31 score on a scale
Standard Deviation 9.37
1.74 score on a scale
Standard Deviation 12.36

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
InTSHA Social Media Intervention
n=36 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.
Change in Connection to Clinic Score
0.44 score on a scale
Standard Deviation 6.35
0.42 score on a scale
Standard Deviation 5.42

SECONDARY outcome

Timeframe: 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.

Outcome measures

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.
Number of Participants Retained in Care
39 Participants
35 Participants

SECONDARY outcome

Timeframe: Month 6

HIV-1 viral load is measured in copies per milliliter (mL) and viral suppression is considered \<200 copies/mL.

Outcome measures

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.
HIV Viral Suppression
No viral suppression (>200 copies/mL)
5 Participants
4 Participants
HIV Viral Suppression
Viral suppression (<200 copies/mL)
35 Participants
36 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

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.
Change in Rosenberg's Self-Esteem Scale Score
0.51 score on a scale
Standard Deviation 5.22
-0.39 score on a scale
Standard Deviation 5.38

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

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.
Change in HIV Adolescent Readiness for Transition Scale (HARTS) Score
0.46 score on a scale
Standard Deviation 0.79
0.30 score on a scale
Standard Deviation 0.91

Adverse Events

InTSHA Social Media Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brian C. Zanoni, MD

Emory University

Phone: 404-727-0284

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place