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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD089850-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adolescent transition package | Experimental | Adolescent transition package |
|
| Standard of care | No Intervention | Standard of care adolescent services |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adolescent Transition Package | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 1 year |
| 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). | 1 year |
| 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). | 1 year |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Retention Among 10-24 Year Old Adolescents | Proportion of 10-24 year old adolescents completing visits within 6 months of last visit | 1 year |
| Number of Participants With Viral Suppression |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 year |
| Disclosure | Time to full disclosure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grace John-Stewart, MD, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 20 HIV clinics in Nairobi, Homabay, Nakuru and Kajiado counties | Nairobi | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37580836 | Derived | Mangale DI, Onyango A, Mugo C, Mburu C, Chhun N, Wamalwa D, Njuguna I, Means AR, John-Stewart G, Weiner BJ, Beima-Sofie K. Characterizing provider-led adaptations to mobile phone delivery of the Adolescent Transition Package (ATP) in Kenya using the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS): a mixed methods approach. Implement Sci Commun. 2023 Aug 14;4(1):95. doi: 10.1186/s43058-023-00446-y. | |
| 37432311 |
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Of 1095 enrolled, we have excluded 25 who did not meet age criteria for the intervention (15-24) or who withdrew consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adolescent Transition Package | Received the study intervention |
| FG001 | Standard of Care | Did not receive study intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adolescent Transition Package | Baseline characteristics of participants in intervention arm |
| BG001 | Standard of Care | Baseline characteristics of participants in control arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | The number of participants at month 12 are less than the number enrolled due to losses to follow-up, deaths or unanswered question items | Posted | Mean | Standard Deviation | score on a scale | 1 year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adolescent Transition Package | Proportion with adverse event | 8 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Irene Njuguna | University of Washington | 2065191275 | irenen@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 29, 2020 | Jan 31, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000294 | Adolescent Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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An adolescent transition package composed of a disclosure booklet and transition tool
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| 1 year |
| 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). | 1 year |
Comparisons of time to transition specific milestones between intervention and control
| 1 year |
| 1 year |
| Adolescents With Full Disclosure by Age 10-12, 13-15 and 16-19 | Proportions by age group with full disclosure | 1 year |
| Mburu C, Njuguna I, Neary J, Mugo C, Moraa H, Beima-Sofie K, Onyango A, Oyiengo L, Richardson BA, John-Stewart G, Wamalwa D. Mortality and Loss to Follow-Up Among Adolescents and Young Adults Attending HIV Care Programs in Kenya. AIDS Patient Care STDS. 2023 Jul;37(7):323-331. doi: 10.1089/apc.2023.0019. |
| 36309040 | Derived | Njuguna IN, Beima-Sofie K, Mburu CW, Mugo C, Itindi J, Onyango A, Neary J, Richardson BA, Oyiengo L, Wamalwa D, John-Stewart G. Transition to independent care for youth living with HIV: a cluster randomised clinical trial. Lancet HIV. 2022 Dec;9(12):e828-e837. doi: 10.1016/S2352-3018(22)00244-2. Epub 2022 Oct 26. |
| 33268417 | Derived | Njuguna IN, Beima-Sofie K, Mburu CW, Mugo C, Neary J, Itindi J, Onyango A, Richardson BA, Rubin Means A, Sharma M, Weiner BJ, Wagner AD, Oyiengo L, Wamalwa D, John-Stewart G. Adolescent transition to adult care for HIV-infected adolescents in Kenya (ATTACH): study protocol for a hybrid effectiveness-implementation cluster randomised trial. BMJ Open. 2020 Dec 2;10(12):e039972. doi: 10.1136/bmjopen-2020-039972. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Primary caregiver | Count of Participants | Participants |
|
| Entry point | Count of Participants | Participants |
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| Months since disclosure of HIV status | Median | Inter-Quartile Range | months |
|
| Baseline Transition readiness score (overall) | Total scale score was 18, the higher the score the better the outcome | Scores are aggregate of total domain scores. Some participants did not respond to all the questions in the score. | Mean | Standard Deviation | score on a scale |
|
| Baseline readiness score (HIV literacy) | The total score was 5, the higher the score the better the outcome | Some participants did not respond to some of the questions that comprise the score. | Mean | Standard Deviation | score on a scale |
|
| Baseline readiness score (Self-management) | The total score was 5, the higher the score the better the outcome | Some participants did not respond to some of the questions that comprise the score | Mean | Standard Deviation | score on a scale |
|
| Baseline readiness score (Communication) | The total score was 5, the higher the score the better the outcome | Some participants did not respond to some of the questions that comprise the score | Mean | Standard Deviation | score on a scale |
|
| Baseline readiness score (Support) | The total score was 3, the higher the score the better the outcome | Some participants did not respond to some of the questions that comprise the score | Mean | Standard Deviation | score on a scale |
|
| Viral suppression at baseline | Viral load data not available for all enrolled participants | Count of Participants | Participants |
|
Month 12 transition readiness score (Total score)
| OG001 | Standard of Care | Month 12 transition readiness score (Total score) |
|
|
| 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). | The number of participants at month 12 are less than the number enrolled due to losses to follow-up, deaths or unanswered question items | Posted | Mean | Standard Deviation | score on a scale | 1 year |
|
|
|
| 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). | The number of participants at month 12 are less than the number enrolled due to losses to follow-up, deaths or unanswered question items | Posted | Mean | Standard Deviation | score on a scale | 1 year |
|
|
|
| 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). | The number of participants at month 12 are less than the number enrolled due to losses to follow-up, deaths or unanswered question items | Posted | Mean | Standard Deviation | score on a scale | 1 year |
|
|
|
| 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). | The number of participants at month 12 are less than the number enrolled due to losses to follow-up, deaths or unanswered question items | Posted | Mean | Standard Deviation | score on a scale | 1 year |
|
|
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| Secondary | Overall Retention Among 10-24 Year Old Adolescents | Proportion of 10-24 year old adolescents completing visits within 6 months of last visit | Posted | Count of Participants | Participants | 1 year |
|
|
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| Secondary | Number of Participants With Viral Suppression | Comparisons of time to transition specific milestones between intervention and control | 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 | Posted | Count of Participants | Participants | 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) | Not Posted | 1 year | Participants |
| Other Pre-specified | Disclosure | Time to full disclosure | Not Posted | 1 year | Participants |
| Other Pre-specified | Adolescents With Full Disclosure by Age 10-12, 13-15 and 16-19 | Proportions by age group with full disclosure | Not Posted | 1 year | Participants |
| 578 |
| 0 |
| 578 |
| 0 |
| 578 |
| EG001 | Standard of Care | Proportion with adverse event | 1 | 488 | 0 | 488 | 0 | 488 |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Grand parent |
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| Spouse |
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| Other |
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| Other |
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| missing |
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