Form 3 Attachment C1 - Medical_Record_Abstraction_long.xlsm

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Overview

Instructions
List of HIV Medicines
Data Abstraction Tool - LONG

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Sheet 1: Instructions

		Public Burden Statement: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is 0915-xxxx. Public reporting burden for this collection of information is estimated to average xx hours per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 14N136B, Rockville, Maryland, 20857.
DATA TYPE SUMMARY	DATA TYPE	INSTRUCTIONS
Abstractor and Site Information	Name	The name of the person doing chart abstraction/data collection
	Date	The date of data collection/medical chart abstraction
	Type 1 Site ID	The Type 1 provider side ID
	Type 2 Site ID	The Type 2 provider side ID
Demographic information	Client Identifier	Client's eUCI or encrypted client identifier*
	Age	Client's current age*
	Gender	Client's current gender*
Initial HIV diagnosis	Month and year of initial HIV diagnosis	Indicate month and year, if known, of initial HIV diagnosis
Outpatient medical visit	Dates of all medical visits.	Record dates of all outpatient medical visits for client in 2018. Medical visits are defined as the provision of professional diagnostic and therapeutic services rendered by a licensed physician, physician's assistant, clinical nurse specialist, or nurse practitioner in an outpatient setting (not a hospital, hospital emergency room, or any other type of inpatient treatment center), consistent with HHS guidelines and including access to antiretroviral and other drug therapies, including prophylaxis and treatment of opportunistic infections and combination antiretroviral therapies. Allowable services include: Diagnostic testing • Early intervention and risk assessment, • Preventive care and screening • Practitioner examination, medical history taking, diagnosis and treatment of common physical and mental conditions • Prescribing and managing of medication therapy • Education and counseling on health issues • Well-baby care • Continuing care and management of chronic conditions • Referral to and provision of HIV-related specialty care (includes all medical subspecialties even ophthalmic and optometric services)
	Medical visit data source	Indicate whether the information found in the medical record regarding the client's medical visits is a primary or secondary source
Prescription of ART	Dates of ART prescriptions	Enter dates of all ART prescriptions in 2018.
	Type of ART prescriptions	Select brand or generic name of all ART medications prescribed. See list of HIV medicines approved by FDA.
	ART prescription data source	Indicate whether the information found in the medical record regarding the client's ART prescription is a primary or secondary source
Viral load suppression	Dates of viral load lab tests	Enter dates of all viral load lab tests ordered in 2018.
	Results of viral load lab tests	Indicate results (in copies/ml) of all lab tests.
	Viral load data source	Indicate whether the information found in the client's medical record regarding the viral load test is a primary or secondary source
* This value will be pre-populated from the 2017 RSR.

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Sheet 2: List of HIV Medicines

Drug Class	Generic Name	Brand Name	FDA Approval Date
	(Other names and acronyms)
Nucleoside Reverse Transcriptase Inhibitors (NRTIs) (N = 5)
NRTIs block reverse transcriptase, an enzyme HIV needs to make copies of itself.	abacavir	Ziagen	17-Dec-98
	(abacavir sulfate, ABC)
	emtricitabine	Emtriva	2-Jul-03
	(FTC)
	lamivudine	Epivir	17-Nov-95
	(3TC)
	tenofovir disoproxil	Viread	26-Oct-01
	fumarate
	(tenofovir DF, TDF)
	zidovudine	Retrovir	19-Mar-87
	(azidothymidine, AZT, ZDV)
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) (N = 5)
NNRTIs bind to and later alter reverse transcriptase, an enzyme HIV needs to make copies of itself.	doravirine	Pifeltro	30-Aug-18
	(DOR)
	efavirenz	Sustiva	17-Sep-98
	(EFV)
	etravirine	Intelence	18-Jan-08
	(ETR)
	nevirapine	Viramune	21-Jun-96
	(extended-release nevirapine, NVP)	Viramune XR (extended release)	25-Mar-11
	rilpivirine	Edurant	20-May-11
	(rilpivirine hydrochloride, RPV)
Protease Inhibitors (PIs) (N = 6)
PIs block HIV protease, an enzyme HIV needs to make copies of itself.	atazanavir	Reyataz	20-Jun-03
	(atazanavir sulfate, ATV)
	darunavir	Prezista	23-Jun-06
	(darunavir ethanolate, DRV)
	fosamprenavir	Lexiva	20-Oct-03
	(fosamprenavir calcium, FOS-APV, FPV)
	ritonavir	Norvir	1-Mar-96
	(RTV)
	*Although ritonavir is a PI, it is generally used as a pharmacokinetic enhancer as recommended in the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.
	saquinavir	Invirase	6-Dec-95
	(saquinavir mesylate, SQV)
	tipranavir	Aptivus	22-Jun-05
	(TPV)
Fusion Inhibitors (N 1)
Fusion inhibitors block HIV from entering the CD4 cells of the immune system.	enfuvirtide	Fuzeon	13-Mar-03
	(T-20)
CCR5 Antagonists (N=1)
CCR5 antagonists block CCR5 coreceptors on the surface of certain immune cells that HIV needs to enter the cells.	maraviroc	Selzentry	6-Aug-07
	(MVC)
Integrase Inhibitors (N= 2)
Integrase inhibitors block HIV integrase, an enzyme HIV needs to make copies of itself.	dolutegravir	Tivicay	August 13, 2013
	(DTG, dolutegravir sodium)
	raltegravir	Isentress	12-Oct-07
	(raltegravir potassium, RAL)	Isentress HD	May 26, 2017
Post-Attachment Inhibitors (N = 1)
Post-attachment inhibitors block CD4 receptors on the surface of certain immune cells that HIV needs to enter the cells.	ibalizumab	Trogarzo	6-Mar-18
	(Hu5A8, IBA, Ibalizumab-uiyk, TMB-355, TNX-355)
Pharmacokinetic Enhancers (N = 1)
Pharmacokinetic enhancers are used in HIV treatment to increase the effectiveness of an HIV medicine included in an HIV regimen.	cobicistat	Tybost	24-Sep-14
	(COBI)
Combination HIV Medicines (N = 21)
Combination HIV medicines contain two or more HIV medicines from one or more drug classes.	abacavir and lamivudine	Epzicom	2-Aug-04
	(abacavir sulfate / lamivudine, ABC / 3TC)
	abacavir, dolutegravir, and lamivudine	Triumeq	22-Aug-14
	(abacavir sulfate / dolutegravir sodium / lamivudine, ABC / DTG / 3TC)
	abacavir, lamivudine, and zidovudine	Trizivir	14-Nov-00
	(abacavir sulfate / lamivudine / zidovudine, ABC / 3TC / ZDV)
	atazanavir and cobicistat	Evotaz	29-Jan-15
	(atazanavir sulfate / cobicistat, ATV / COBI)
	bictegravir, emtricitabine, and tenofovir alafenamide	Biktarvy	7-Feb-18
	(bictegravir sodium / emtricitabine / tenofovir alafenamide fumarate, BIC / FTC / TAF)
	darunavir and cobicistat	Prezcobix	29-Jan-15
	(darunavir ethanolate / cobicistat, DRV / COBI)
	darunavir, cobicistat, emtricitabine, and tenofovir alafenamide	Symtuza	July 17, 2018
	(darunavir ethanolate / cobicistat / emtricitabine / tenofovir AF, darunavir ethanolate / cobicistat / emtricitabine / tenofovir alafenamide, darunavir / cobicistat / emtricitabine / tenofovir AF, darunavir / cobicistat / emtricitabine / tenofovir alafenamide fumarate,  DRV / COBI / FTC / TAF)
	dolutegravir and rilpivirine	Juluca	21-Nov-17
	(dolutegravir sodium / rilpivirine hydrochloride, DTG / RPV)
	doravirine, lamivudine, and tenofovir disoproxil fumarate	Delstrigo	30-Aug-18
	(doravirine / lamivudine / TDF, doravirine / lamivudine / tenofovir DF, DOR / 3TC / TDF)
	efavirenz, emtricitabine, and tenofovir disoproxil fumarate	Atripla	12-Jul-06
	(efavirenz / emtricitabine / tenofovir DF, EFV / FTC / TDF)
	efavirenz, lamivudine, and tenofovir disoproxil fumarate	Symfi	22-Mar-18
	(EFV / 3TC / TDF)
	efavirenz, lamivudine, and tenofovir disoproxil fumarate	Symfi Lo	5-Feb-18
	(EFV / 3TC / TDF)
	elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide	Genvoya	5-Nov-15
	(elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide fumarate, EVG / COBI / FTC / TAF)
	elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate	Stribild	27-Aug-12
	(QUAD, EVG / COBI / FTC / TDF)
	emtricitabine, rilpivirine, and tenofovir alafenamide	Odefsey	1-Mar-16
	(emtricitabine / rilpivirine / tenofovir AF, emtricitabine / rilpivirine / tenofovir alafenamide fumarate, emtricitabine / rilpivirine hydrochloride / tenofovir AF, emtricitabine / rilpivirine hydrochloride / tenofovir alafenamide, emtricitabine / rilpivirine hydrochloride / tenofovir alafenamide fumarate, FTC / RPV / TAF)
	emtricitabine, rilpivirine, and tenofovir disoproxil fumarate	Complera	10-Aug-11
	(emtricitabine / rilpivirine hydrochloride / tenofovir disoproxil fumarate, emtricitabine / rilpivirine / tenofovir, FTC / RPV / TDF)
	emtricitabine and tenofovir alafenamide	Descovy	4-Apr-16
	(emtricitabine / tenofovir AF, emtricitabine / tenofovir alafenamide fumarate, FTC / TAF)
	emtricitabine and tenofovir disoproxil fumarate	Truvada	2-Aug-04
	(emtricitabine / tenofovir DF, FTC / TDF)
	lamivudine and tenofovir disoproxil fumarate	Cimduo	28-Feb-18
	(Temixys, 3TC / TDF)
	lamivudine and zidovudine	Combivir	27-Sep-97
	(3TC / ZDV)
	lopinavir and ritonavir	Kaletra	15-Sep-00
	(ritonavir-boosted lopinavir, LPV/r, LPV / RTV)
https://aidsinfo.nih.gov/understanding-hiv-aids/fact-sheets/21/58/fda-approved-hiv-medicines/

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Sheet 3: Data Abstraction Tool - LONG

Public Burden Statement: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is 0915-xxxx. Public reporting burden for this collection of information is estimated to average xx hours per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 14N136B, Rockville, Maryland, 20857.

OMB NUMBER: 0915-XXXX EXPIRATION DATE: XX/XX/20XX

Abstractor and provider information

Demograhic information (for validation of record)

Initial HIV diagnosis

HIV medical visits

Prescription of ART

Viral load tests and results

Notes

Abstractor name

Abstraction date

Type 1 provider encrypted ID

Type 2 provider encrypted ID

Client encrypted ID (eUCI)

Client age

Client gender (current)

Month and year of initial HIV diagnosis

Dates of outpatient medical visits (see definition)

Medical visit data source

Dates of ART prescriptions

Types of ART prescribed

ART prescription data source

Dates of viral load lab tests

Results of viral load lab tests

Viral load data source

Additional Information from the Abstractor