Adolescent Behavior, Adolescent Development, Disclosure, HIV, Transition
Conditions
Brief summary
This study evaluates an adolescent transition package (ATP) to support HIV infected adolescents transitioning form pediatric/adolescent care to adult care. Ten clinics will receive the intervention and 10 will receive standard of care transition services.
Detailed description
The Adolescent Transition Package (ATP) will include two components. The validated Namibia comic book for disclosure (to be used with children over 10 years of age) and transition booklet Taking Charge developed by stakeholders in Kenya. The disclosure tool includes a cartoon book, readiness and tracking tools used in clinic and health care worker training material. The intervention progresses from incomplete to complete disclosure using a narrative about soldiers fighting the battle of infection as the rationale for taking medicine. This tool has been validated for use in Namibia. The adapted transition toolkit includes a transition booklet, tracking tools to be used by health care workers and a readiness assessment checklist to be completed by study staff. The booklet has 4 chapters addressing key areas to support adolescents gain the knowledge and skills they need in adult care. The 4 chapters are: HIV treatment literacy, self management, communication and support.
Interventions
BEHAVIORALAdolescent Transition Package
Clinic level intervention composed of an adolescent transition package with tools to support health care workers to disclose HIV status to adolescents and to track transition to adult care.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
An adolescent transition package composed of a disclosure booklet and transition tool
Eligibility
Sex/Gender
ALL
Age
10 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
* Facility leadership is willing to implement the intervention
Exclusion criteria
* Clinics already actively using transition or disclosure tools
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Support Readiness Score | 1 year | The scale name is the Taking Charge transition readiness assessment. The scale measures readiness to transition to adult care. The scale has questions measuring attainment of skills to navigate adult care systems. The higher the score the more prepared an adolescent is to transition to adult care. For this outcome we will sum scores from the HIV literacy domain (maximum score is 3, minimum 0). |
| Transition Readiness Score Overall | 1 year | The scale name is the Taking Charge transition readiness assessment. The scale measures readiness to transition to adult care. The scale has questions measuring attainment of knowledge and skills to navigate adult care systems. The scale is divided into 4 domains: HIV literacy (maximum score is 5, minimum 0), self-management (maximum score is 9, minimum 0), communication (maximum score is 5, minimum is 0) and support (maximum score 3, minimum is 0). The higher the score the more prepared an adolescent is to transition to adult care. For this outcome, scores across all domains will be summed to get a total readiness score (maximum score 22, minimum 0). |
| Treatment Literacy Readiness Score | 1 year | The scale name is the Taking Charge transition readiness assessment. The scale measures readiness to transition to adult care. The scale has questions measuring attainment of knowledge to navigate adult care systems. The higher the score the more prepared an adolescent is to transition to adult care. For this outcome we will sum scores from the HIV literacy domain (maximum score is 5, minimum 0). |
| Self Management Readiness Score | 1 year | The scale name is the Taking Charge transition readiness assessment. The scale measures readiness to transition to adult care. The scale has questions measuring attainment of knowledge and skills to navigate adult care systems. The higher the score the more prepared an adolescent is to transition to adult care. For this outcome we will sum scores from the HIV literacy domain (maximum score is 9, minimum 0). |
| Communication Readiness Score | 1 year | The scale name is the Taking Charge transition readiness assessment. The scale measures readiness to transition to adult care. The scale has questions measuring attainment of skills to navigate adult care systems. The higher the score the more prepared an adolescent is to transition to adult care. For this outcome we will sum scores from the HIV literacy domain (maximum score is 5, minimum 0). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Retention Among 10-24 Year Old Adolescents | 1 year | Proportion of 10-24 year old adolescents completing visits within 6 months of last visit |
| Number of Participants With Viral Suppression | 1 year | Comparisons of time to transition specific milestones between intervention and control |
Other
| Measure | Time frame | Description |
|---|---|---|
| Post-transition Retention | 1 year | completing and adult clinic visit day after transfer to adult services and at least 1 other visit within 6 months of the adult visit (total of 2 visits) |
| Disclosure | 1 year | Time to full disclosure |
| Adolescents With Full Disclosure by Age 10-12, 13-15 and 16-19 | 1 year | Proportions by age group with full disclosure |
Countries
Kenya
Participant flow
Pre-assignment details
Of 1095 enrolled, we have excluded 25 who did not meet age criteria for the intervention (15-24) or who withdrew consent.
Participants by arm
| Arm | Count |
|---|---|
| Adolescent Transition Package Baseline characteristics of participants in intervention arm | 578 |
| Standard of Care Baseline characteristics of participants in control arm | 488 |
| Total | 1,066 |
Baseline characteristics
| Characteristic | Standard of Care | Adolescent Transition Package | Total |
|---|---|---|---|
| Age, Continuous | 19.7 years | 21.1 years | 20.5 years |
| Baseline readiness score (Communication) | 3.8 score on a scale STANDARD_DEVIATION 1.1 | 3.9 score on a scale STANDARD_DEVIATION 1 | 3.9 score on a scale STANDARD_DEVIATION 1.1 |
| Baseline readiness score (HIV literacy) | 2.3 score on a scale STANDARD_DEVIATION 1.5 | 2.6 score on a scale STANDARD_DEVIATION 1.5 | 2.5 score on a scale STANDARD_DEVIATION 1.5 |
| Baseline readiness score (Self-management) | 3.8 score on a scale STANDARD_DEVIATION 1.1 | 3.9 score on a scale STANDARD_DEVIATION 1 | 3.9 score on a scale STANDARD_DEVIATION 1 |
| Baseline readiness score (Support) | 1.6 score on a scale STANDARD_DEVIATION 1 | 1.7 score on a scale STANDARD_DEVIATION 1 | 1.6 score on a scale STANDARD_DEVIATION 1.1 |
| Baseline Transition readiness score (overall) | 11.4 score on a scale STANDARD_DEVIATION 3.7 | 12.1 score on a scale STANDARD_DEVIATION 3.4 | 11.8 score on a scale STANDARD_DEVIATION 3.6 |
| Entry point HIV clinic | 344 Participants | 367 Participants | 711 Participants |
| Entry point missing | 0 Participants | 1 Participants | 1 Participants |
| Entry point Other | 15 Participants | 9 Participants | 24 Participants |
| Entry point PMTCT clinics | 129 Participants | 201 Participants | 330 Participants |
| Months since disclosure of HIV status | 45 months | 34 months | 42 months |
| Primary caregiver Grand parent | 43 Participants | 31 Participants | 74 Participants |
| Primary caregiver Other | 73 Participants | 69 Participants | 142 Participants |
| Primary caregiver Parent | 241 Participants | 227 Participants | 468 Participants |
| Primary caregiver Sibling | 28 Participants | 49 Participants | 77 Participants |
| Primary caregiver Spouse | 103 Participants | 202 Participants | 305 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 488 Participants | 578 Participants | 1066 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Kenya | 488 participants | 578 participants | 1066 participants |
| Sex: Female, Male Female | 338 Participants | 432 Participants | 770 Participants |
| Sex: Female, Male Male | 150 Participants | 146 Participants | 296 Participants |
| Viral suppression at baseline | 326 Participants | 382 Participants | 708 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 578 | 1 / 488 |
| other Total, other adverse events | 0 / 578 | 0 / 488 |
| serious Total, serious adverse events | 0 / 578 | 0 / 488 |
Outcome results
Primary
Communication Readiness Score
The scale name is the Taking Charge transition readiness assessment. The scale measures readiness to transition to adult care. The scale has questions measuring attainment of skills to navigate adult care systems. The higher the score the more prepared an adolescent is to transition to adult care. For this outcome we will sum scores from the HIV literacy domain (maximum score is 5, minimum 0).
Time frame: 1 year
Population: The number of participants at month 12 are less than the number enrolled due to losses to follow-up, deaths or unanswered question items
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adolescent Transition Package | Communication Readiness Score | 4.7 score on a scale | Standard Deviation 0.5 |
| Standard of Care | Communication Readiness Score | 4.4 score on a scale | Standard Deviation 0.8 |
Primary
Self Management Readiness Score
The scale name is the Taking Charge transition readiness assessment. The scale measures readiness to transition to adult care. The scale has questions measuring attainment of knowledge and skills to navigate adult care systems. The higher the score the more prepared an adolescent is to transition to adult care. For this outcome we will sum scores from the HIV literacy domain (maximum score is 9, minimum 0).
Time frame: 1 year
Population: The number of participants at month 12 are less than the number enrolled due to losses to follow-up, deaths or unanswered question items
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adolescent Transition Package | Self Management Readiness Score | 4.7 score on a scale | Standard Deviation 0.4 |
| Standard of Care | Self Management Readiness Score | 4.4 score on a scale | Standard Deviation 0.8 |
Primary
Support Readiness Score
The scale name is the Taking Charge transition readiness assessment. The scale measures readiness to transition to adult care. The scale has questions measuring attainment of skills to navigate adult care systems. The higher the score the more prepared an adolescent is to transition to adult care. For this outcome we will sum scores from the HIV literacy domain (maximum score is 3, minimum 0).
Time frame: 1 year
Population: The number of participants at month 12 are less than the number enrolled due to losses to follow-up, deaths or unanswered question items
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adolescent Transition Package | Support Readiness Score | 2.3 score on a scale | Standard Deviation 0.8 |
| Standard of Care | Support Readiness Score | 2.1 score on a scale | Standard Deviation 1 |
Primary
Transition Readiness Score Overall
The scale name is the Taking Charge transition readiness assessment. The scale measures readiness to transition to adult care. The scale has questions measuring attainment of knowledge and skills to navigate adult care systems. The scale is divided into 4 domains: HIV literacy (maximum score is 5, minimum 0), self-management (maximum score is 9, minimum 0), communication (maximum score is 5, minimum is 0) and support (maximum score 3, minimum is 0). The higher the score the more prepared an adolescent is to transition to adult care. For this outcome, scores across all domains will be summed to get a total readiness score (maximum score 22, minimum 0).
Time frame: 1 year
Population: The number of participants at month 12 are less than the number enrolled due to losses to follow-up, deaths or unanswered question items
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adolescent Transition Package | Transition Readiness Score Overall | 15.7 score on a scale | Standard Deviation 1.8 |
| Standard of Care | Transition Readiness Score Overall | 13.9 score on a scale | Standard Deviation 3.3 |
Primary
Treatment Literacy Readiness Score
The scale name is the Taking Charge transition readiness assessment. The scale measures readiness to transition to adult care. The scale has questions measuring attainment of knowledge to navigate adult care systems. The higher the score the more prepared an adolescent is to transition to adult care. For this outcome we will sum scores from the HIV literacy domain (maximum score is 5, minimum 0).
Time frame: 1 year
Population: The number of participants at month 12 are less than the number enrolled due to losses to follow-up, deaths or unanswered question items
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adolescent Transition Package | Treatment Literacy Readiness Score | 4.0 score on a scale | Standard Deviation 1 |
| Standard of Care | Treatment Literacy Readiness Score | 3.0 score on a scale | Standard Deviation 1.5 |
Secondary
Number of Participants With Viral Suppression
Comparisons of time to transition specific milestones between intervention and control
Time frame: 1 year
Population: The number of participants at month 12 are less than the number enrolled due to losses to follow-up, deaths or unavailable program level data on viral suppression
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adolescent Transition Package | Number of Participants With Viral Suppression | 249 Participants |
| Standard of Care | Number of Participants With Viral Suppression | 255 Participants |
Secondary
Overall Retention Among 10-24 Year Old Adolescents
Proportion of 10-24 year old adolescents completing visits within 6 months of last visit
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adolescent Transition Package | Overall Retention Among 10-24 Year Old Adolescents | 506 Participants |
| Standard of Care | Overall Retention Among 10-24 Year Old Adolescents | 440 Participants |
Other Pre-specified
Adolescents With Full Disclosure by Age 10-12, 13-15 and 16-19
Proportions by age group with full disclosure
Time frame: 1 year
Other Pre-specified
Disclosure
Time to full disclosure
Time frame: 1 year
Other Pre-specified
Post-transition Retention
completing and adult clinic visit day after transfer to adult services and at least 1 other visit within 6 months of the adult visit (total of 2 visits)
Time frame: 1 year