Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
HIV disclosure rate |
Structured and caregiver-centered and culturally-relevant disclosure intervention will be delivered by an adherence and disclosure specialist to the caregiver. After one year, the rate of disclosure of the HIV status of the children will be assessed. |
1 year after intervention |
|
Secondary |
Change in Antiretroviral medication adherence |
Medication adherence will be assessed with the AIDS Clinical Trials Group (ACTG) Adherence Questionnaire self-report questionnaire. This will be assessed every 3 months up until end of study. This measures provides a ratio of adherence to antiviral medication requirements. A score of 1 equals perfect adherence and 0 represents no adherence. |
5 year |
|
Secondary |
Antiretroviral medication adherence - Pharmacy refill measurement |
The pharmacy-based time-to-refill measure adherence is calculated as the number of months for which antiretroviral therapy claims were submitted to the pharmacy, divided by the number of complete months during the period under consideration, and the results multiplied by 100 |
5 year |
|
Secondary |
Antiretroviral medication adherence - HIV-1 RNA |
HIV-1 RNA is calculated by |
5 year |
|
Secondary |
Immunologic health |
The immunologic staging of their disease according to both the U.S. CDC and WHO classification criteria will be used to determine immunologic health using patient's medical chart. |
5 year |
|
Secondary |
Behavioral health - CBCL child version |
Children health will be measured by using the Child Behavior checklist-child version (CBCL). For each item on the CBCL, the respondent is asked to choose from a three-point response scale indicating whether a problem behavioral description is "not true" (= 0), "somewhat or sometimes true" (= 1), or "very true or often true" (= 2) of the child |
5 year |
|
Secondary |
Behavioral health - CBCL parent version |
Children health will be measured by using the Child Behavior checklist-child version (CBCL). For each item on the CBCL, the respondent is asked to choose from a three-point response scale indicating whether a problem behavioral description is "not true" (= 0), "somewhat or sometimes true" (= 1), or "very true or often true" (= 2) of the child |
5 year |
|
Secondary |
Child Depression Inventory (CDI) |
The CDI is an 27 item questionnaire on a three-point scale to assess depression symptoms. The cumulative score will be calculated |
5 year |
|
Secondary |
Beck Depression Inventory |
The Caregiver's psychosocial health will be measured with the 21-item Beck Depression Inventory (BDI). The Beck Depression Inventory (BDI) is a 21-item, multiple-choice inventory. Respondents are asked to rate each item based on four response choices according to the severity of the symptoms, ranging from the absence of a symptom to an intense level, during the past week. BDI scores from 0 through 9 indicate no or minimal depression; scores from 10 through 18 indicate mild to moderate depression; scores from 19 through 29 indicate moderate to severe depression; and scores from 30 through 63 indicate severe depression. |
5 year |
|
Secondary |
Implementation - Retention |
Proportion of subjects retained throughout the implementation phase. This will be reported >90%, 60-90%, and <60%) |
5 year |
|
Secondary |
Implementation - Caregiver 6-month log |
The caregivers' 6-month surveys (e.g., caregivers' experience summarized into 3 categories: 1=Not Satisfactory, 2=Satisfactory, 3=Very Satisfactory). will be used to characterize a composite outcome for implementation success: 1= successful, 2= intermediate, 3= problematic |
6 month |
|
Secondary |
Incremental cost-effectiveness ratio |
The incremental cost effectiveness ratio (ICER) will be used to compare pediatric intervention relative to the standard of care to assess cost-effectiveness. The 1 year ratio will provide directly observed near term economic impact of disclosure. |
5 year |
|
Secondary |
Change in HIV -1 RNA Viral Load |
The HIV-1 RNA viral load will be measured every 6 months to determine the change over 5 years. |
5 years |
|