A Study To Learn About The Effects Of Pneumococcal Vaccine In People With HIV

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn about how well a vaccine (Prevnar 13, PCV13) works in preventing disease in adults with HIV. The diseases studied are pneumonia. Mostly the ones caused by the bacteria - pneumococcus. This study also evaluates the type of pneumonia that is spread into the bloodstream. All participants in the study will be identified in health care databases. Adults with HIV will be identified by looking for a medical diagnosis that has confirmed HIV from the databases. Vaccination will be identified in the databases by looking for vaccine administration or for PCV13. Participants will be followed in the databases to see if they have one of the diseases mentioned above or not. The number of vaccinated participants with the diseases will be compared to the number participants without the vaccines but with the diseases. This will help to understand how well the vaccine worked.

Official Title
-----------------
Assessment of 13-valent Pneumococcal Conjugate Vaccine Effectiveness Among People With HIV

Conditions
-----------------
HIV, Pneumonia, Infections, Pneumococcal

Intervention / Treatment
-----------------
* Biological: Vaccine Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infection defined as at least one inpatient or ≥2 outpatient codes related to HIV at least 30 days but no more than 730 days apart At least 18 years of age at the time of the first HIV-related code At least six months of continuous enrollment in medical and pharmacy plans after the first HIV-related code Exclusion Criteria: 1. Evidence of PCV13 vaccination before the first HIV-related code

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Persons living with HIV (PLWH)<br>Adults with HIV | Biological: Vaccine Administration<br>* PCV13 administration<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of invasive pneumococcal disease | Medical record for IPD diagnosed by ICD9 or ICD10 code | July,1 2014 - September 30, 2022 (duration of study) | 
| Incidence of all cause pneumonia | Incidence of all cause pneumonia diagnosed by ICD9 - ICD10 code | July 1, 2014 - September 30, 2022 (duration of study) | 
| Incidence of pneumococcal pneumonia | Diagnosis of pneumococcal pneumonia by ICD9 / ICD10 code | July 1, 2014 - September 30, 2022 (duration of study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pneumococcal pneumonia or unspecified pneumonia |  | July 1, 2014 - September 30, 2022 (timeframe of study) | 
| Incidence of pneumonia of unspecified causes |  | July 1, 2014 - September 30, 2022 (timeframe of study) |