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STANDARD OPERATING

PROCEDURES
TB Preventive Treatment: 3HR Regimen
Standard Operating Procedures TB Preventive Therapy: 3HR Regimen

CONTENTS

1. Purpose
2. Scope
3. Responsibility/Use of this SOP
4. Overview on 3HR
5. Implementation Procedures
5.1 Allocating 3HR Supply to Demonstration Sites
5.2 Conducting contact investigation
5.3 Identifying priority groups
5.4 Screening to Rule Out Active TB
5.5 Testing for TB Infection
5.6 Initiating Treatment for TB Infection
5.7 Monitoring of Treatment
6. Electronic Recording and Reporting
6.1 Recording
6.2 Reporting

ANNEXES

1. iNTP Demonstration Sites 3HR Allocation Table


2. List of Health Care Providers Trained with iNTP Module 2: 3HR Training
July 29 and 30, 2021 Batches
3. 3HR Allocation Table to Facilities Providing TB Services
4. Steps in Contact Investigation
5. TB Infection Cascade of Care
6. TST and IGRA Results Interpretation
7. TPT Treatment Initiation Algorithm
Figure 1: Algorithm for Children <5 y/o with HIV Negative or Unknown HIV Status Contacts of BC-TB (HH and
close contacts) and CD-TB cases
Figure 2: Algorithm for > 5 y/o with HIV Negative or Unknown HIV Status Contacts of BC-TB (HH and Close
Contacts)
Figure 3: Algorithm for Children 1-4 y/o with HIV Infection
Figure 4: Algorithm for > 5 y/o with HIV Infection
8. List of Preparations before starting 3HR
Table 1: Potential Adverse Events (AEs)
Table 2: Baseline Clinical Examinations
Table 3: Precautions
9. Electronic Recording and Reporting for the TPT: 3HR Implementation

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Standard Operating Procedures TB Preventive Therapy: 3HR Regimen

1 PURPOSE
This standard operating procedure (SOP) describes the procedure in the implementation of TB
Preventive Treatment using the 3-months of daily Isoniazid and Rifampicin (3HR)- a shorter oral TB
preventive treatment (TPT) course under the introducing New Tools Project (iNTP). The use of 3HR
will address barriers to TPT i.e., availability of fixed dose combinations to reduce pill burden, shorter
regimens, and child-friendly formulations. Further, it will ensure programmatic alignment of TPT
regimens for children < 15 years old regardless of HIV Status.

2 SCOPE
This SOP includes technical and operational protocol in allocating TPT courses to iNTP sites, conducting
contact investigation, identifying priority groups for TPT, screening to rule out active TB, testing for TB
infection, initiating treatment for TB infection, monitoring of treatment and its outcomes, recording, and
reporting, as well as other activities (e.g., use of VOT if available) to support treatment adherence and
success.

3 RESPONSIBILITY/USE OF THIS SOP


This procedure applies to the primary health care providers and all other healthcare workers who are
involved in contact investigation and provision of 3HR TPT.

4 OVERVIEW ON 3HR
Current efforts of finding missing cases of tuberculosis (TB) and treatment of active TB disease are
insufficient to achieve global and country targets in reducing TB burden by 2035, specifically reducing TB
incidence by 90%, mortality by 95%, and zero catastrophic cost. Globally, the rate of TB incidence needs
to accelerate to an average of 17% per year between 2025 and 2035. The only way to achieve this level
of decline in TB incidence is through introduction and rapid scale-up of new tools that can substantially
reduce the risk of developing active TB disease among approximately 1.7 billion people (equivalent to
around one-fourth of the world’s population) infected with TB. One of these tools is the provision of
short, effective and safe treatment for TB infection or TB preventive treatment (TPT).

In 2018, during the United Nations high level meeting on TB, member states committed to provide TPT
to at least 30 million people from 2018 to 2022 {6 million people living with HIV (PLHIV), 4 million
children below 5 years who are household contacts of patients with bacteriologically confirmed TB, and
20 million household contacts in older age groups}. The Updated Philippine Strategic TB Elimination Plan
(PhilSTEP1) 2020-2023 targets to provide TPT to at least 685,000 eligible individuals.

In 2020, the World Health Organization (WHO) recommended several TPT regimen options regardless
of HIV status including 6 or 9 months of daily isoniazid (6H or 9H), 3-months of weekly rifapentine plus
isoniazid (3HP), 1-month of daily rifapentine plus isoniazid (1HP), 4 months of daily rifampicin (4R) and 3

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Standard Operating Procedures TB Preventive Therapy: 3HR Regimen

months of daily isoniazid and rifampicin (3HR). The choice of regimen depends on availability of
appropriate formulations and considerations of age, safety, potential drug–drug interactions, and
adherence.

In collaboration with the Stop TB Partnership and the United States Agency for International
Development (USAID), the Philippines is one among six (6) countries under the Introducing New Tools
Project (iNTP) to receive a package of new tools to address the issues and challenges across the TB
continuum of care. In coordination with the National TB Control Program (NTP), these tools will be
introduced in six (6) selected sites in the country under programmatic conditions.
One of the new tools in the iNTP package to improve coverage of TPT is the 3 months daily isoniazid
and rifampicin regimen (3HR).

In the Philippines, 6 iNTP demonstration sites were identified to implement the 3HR regimen. These are
Bataan and Tarlac Provinces in Region III, Valenzuela City in NCR, Laguna Province in Region IV-A, Cebu
Province in Region VII and South Cotabato Province in Region XII.

5 IMPLEMENTATION PROCEDURES

5.1 Allocation of 3HR Supply for Demonstration Sites

5.1.1 iNTP-PMT prepares allocation table on all demonstration sites (Annex 1) based
on the site’s 2020 accomplishment on TB notification and with the following
assumptions: 4 household (HH) contacts per index BC-TB case, 1 child HH contact <5
years old per index CD-TB case, at least 70% of the HH contacts will complete the
screening procedures, at least 50% of those screened will be eligible for TPT, and with 3
months buffer. 78% were allotted for adults while 22% for children.
5.1.2 iNTP-PMT requests demonstration sites to identify public and private facilities with
trained staff to rollout 3HR (Annex 2)
5.1.3 PHO/CHO prepares distribution list detailing allocation of adult and
children's doses per facility and submits a copy to iNTP-PMT (Annex 3)

5.2 Conduct contact investigation

5.2.1 Contact Investigation is the important first step for TPT, an entry point for
systematic screening for active TB through identification of people with TB disease and
contacts of patients with TB who are eligible for TPT.
5.2.2. Contacts should be evaluated within 7 days from treatment initiation of the index
case and must follow the steps on effective contact investigation as shown on Annex 4.
5.2.3 TPT is offered to individuals who are at risk of developing active TB disease to
reduce that risk.

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Standard Operating Procedures TB Preventive Therapy: 3HR Regimen

5.3 Identifying priority groups

5.3.1 Household contacts, close contacts, PLHIV and other high risk clinical
groups (undergoing dialysis, preparing for organ/hematologic transplantation,
patients initiating anti-TNF or with silicosis) are people at-risk for TPT.
5.3.2 TPT Eligibility for At-risk Populations:

Household Contacts Close PLHIV


Contacts
At least 1 year old regardless of
All HH Contacts of BC DS- All CC of BC whether a contact of a TB Case
TB index DS-TB index or not
0-4 years old HH contacts of Less than 1 year old and a HH
CD DS-TB index contact of a known TB Case

5.3.3 Contacts of patients with known DR-TB have a high risk of infection
with drug-resistant organism and there is limited evidence on an optimal
approach for TPT on contacts of patients with DR-TB (no standard regimen).

5.4 Screening to Rule Out Active TB

5.4.1 ADULT: 4-symptom screening lasting 2 weeks or more with any


of the following symptoms: Cough; Unexplained weight loss;
Drenching night sweats; and unexplained fever.
5.4.2 PLHIV: 4-symptom screening regardless of duration with any of
the following symptoms: Cough; Unexplained weight loss; Drenching
night sweats; and unexplained fever.
5.4.3 CHILDREN: Symptom screening lasting for 2 weeks or more
with any of the following symptoms: Coughing/Wheezing; Unexplained
weight loss or failure to thrive; and unexplained fever. If the child is a
contact of a TB Case, also ask for the presence of fatigue, reduced
playfulness, decreased activity or anorexia.
5.4.4 If no sign and symptoms of TB, perform CXR except amongst
below 5 years of age contacts. Findings suggestive of TB should be
evaluated to rule out active TB Disease. Unavailability of CXR is not a
barrier to TPT as physicians may offer TPT later but should not contain
rifamycin.

5.5 Testing for TB Infection

5.5.1 WHO recommends either a Tuberculin Skin Test (TST) or Interferon-


Gamma Release Assay (IGRA) test to determine TB infection though neither
is considered as gold standard test.
5.5.2 TST or IGRA is not mandatory or required for all contacts prior to
initiation of TPT. Eligibility of Risk Groups for TPT using TST can be seen on

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Standard Operating Procedures TB Preventive Therapy: 3HR Regimen

the table below. For TST and IGRA result interpretation, please refer to
Annex 6.

TST NOT TST REQUIRED NOT


REQUIRED (Eligible ONLY if ELIGIBLE
(Eligible for TPT) positive) for TPT
<5 y/o, BC-TB index <5 y/o, CD-TB index ----------
HH
contacts
>5 y/o, BC-TB index, >5 y/o, BC-TB index, no >5 y/o, CD-TB
with TB risk* TB risk index

Close All ages, CD-TB


contacts ---------- All ages, BC-TB index index

Age <1 y/o


PLHIV Ages >1 y/o ---------- (If not contact
of a person with
TB)

Patients receiving
dialysis,
Other • Patients preparing
Risk ---------- for an organ or ----------
Groups hematological
transplantation
• Patients initiating
anti-TNF
treatment
• Patients with
silicosis
*TB Risk are those PLHIV, DM, smokers, with immune-suppressive medical
conditions, malnourished, with multiple people with TB in same household.

5.6 Initiating Treatment for TB Infection

5.6.1 TPT should be considered only after TB Disease is ruled out and after a
careful risk assessment of risk factor for TB Infection, positive test on TB
infection (if TST/IGRA is required) and potential toxicity of treatment. To
properly guide the health care providers, please see Annex 7 for the
algorithm of TPT Treatment initiation. (Figures 1-4)

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Standard Operating Procedures TB Preventive Therapy: 3HR Regimen

5.6.2 Preparations before starting 3HR Treatment includes counselling,


identifying potential adverse events, baseline clinical examination and
laboratory tests (if required), precautions for women of reproductive age and
for PLHIV. See Annex 8 for the List of Preparations before starting 3HR.
5.6.3 Provide the appropriate dosage for children and adults and use the
routine NTP TPT Treatment Card upon initiation of 3HR treatment regimen.
It is best to educate about TB infection and TPT and counsel on the
adherence plan.

Appropriate Dosage on 3HR Regimen

Children:
Weight 4-7 kg 8-11 kg 12-15 kg 16-24 kg > 25 kg
Band
HR Use adult
50/75mg 1 2 3 4 formulation
FDC

Adults:
Weight Band 25-37 kg 38-54 kg 55-70 kg > 70 kg
HR
75/150mg 2 3 4 5
FDC

5.7 Monitoring of Treatment

5.7.1 Conduct regular follow-ups and monitoring of AEs through


counselling, IECs and follow-up plan. Education and counseling
are crucial to capacitate and empower the clients to take
responsibility for their health. Remember that those with a
high risk of hepatotoxicity need monthly liver function
tests. Potential AEs and Management Strategies are as follows:

Adverse Event Suggested Management


• Advice to stay hydrated
• Give Paracetamol 500mg (adult) every 4 hours, as
Flu-like Signs and needed
Symptoms • If severe and not tolerated, consider switching to
the alternate regimen (6H)

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Standard Operating Procedures TB Preventive Therapy: 3HR Regimen

• Advice to stay hydrated


• Advice to avoid spicy and greasy foods
• Provide Oral Rehydration Solutions (ORS) if there
Nausea and is a mild dehydration
Vomiting • Give Metoclopramide 10mg (adult) every 8 hours
(TID), as needed
• If AST and/or ALT results are >3 but <5 times ULN
without signs and symptoms of hepatitis, continue
3HR and repeat ALT and AST weekly
Hepatotoxicity • If AST and/or ALT results are >3 times ULN with
signs and symptoms of hepatitis or if AST and/or
ALT >5 times ULN with or without signs of
hepatitis, stop 3HR and do not reintroduce

• Use Brief Peripheral Neuropathy Screening (BPNS)


to screen and assess the severity of Peripheral
Neuropathy
Peripheral • If mild: give 100-150 mg of Vit B6 to adults and
Neuropathy 50mg in children
• If not better or worsens with an increased Vit B6
dose: Stop 3HR and consider switching to 4R

• Give calamine lotion or topical steroid preparation


twice a day (BID) on the affected area
• Provide Chlorpheniramine 8mg BID or TID orally
Skin • Desensitize by starting with a low dose once
Hypersensitivity hypersensitivity reaction is resolved.
Reaction • If with Steven-Johnson Syndrome, consult with
regional TB MAC and/or specialist and follow their
advice.
• Do a drug rechallenge and:
o If due to Isoniazid – switch to 4R
o If due to Rifampicin – switch to 6H
• If with itchiness, generalized rashes, swelling of
nose tips or lips, with or without fever, withhold
3HR

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Standard Operating Procedures TB Preventive Therapy: 3HR Regimen

Orange-red • Reassure that it is just a staining from a drug in the


Discoloration of regimen and is harmless
Body Fluids (Tears, • Advise to continue 3HR
Saliva, Urine, Milk)

• Investigate for active TB disease or other diseases


Any Occurrence of and:
TB Signs and o If no active TB Disease, continue 3HR
Symptoms o If active TB Disease, stop 3HR provide
DS-TB or DR-TB treatment

5.7.2 Do not reintroduce 3HR if there is a major ADR requiring need to


discontinue 3HR.
5.7.3 Reporting of serious adverse events (SAEs) and adverse events of special
interest (AESIs) is highly encouraged. Use the Food and Drug Administration’s
(FDA) suspected adverse reaction form. Report can be sent via email to
pharmacovigilance@fda.gov.ph, adsm@doh.gov.ph, and
ntp.pharmacovigilance@gmail.com
5.7.4 Dispense a whole course of 3HR Supply to ensure continuous drug supply.
This can be delivered through treatment supporters such as barangay health
workers (BHWs), community volunteers, health facility staff, family members, or
to the client themselves assisted by digital adherence technology such as Video
Observed Treatment (VOT), 99DOTS and smart pill box.
5.7.5 Advised client to take the missed dose when remembered and continue
longer to make up for the required doses within the maximum extended
duration of the regimen that the client is taking. Extension of treatment
duration to make up for missed doses should not be more than 1 month.
5.7.6 Defining treatment outcomes are based on the client's treatment
adherence towards the whole treatment duration.

Outcome Definition
An individual who has completed the prescribed treatment
Completed duration and remains well or asymptomatic during the entire
period
Lost to An individual who interrupted TPT for 2 consecutive months
follow-up or more
Died Individual who dies for any reason during treatment
Failed An individual who developed active TB Disease anytime whilst
on TPT

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Standard Operating Procedures TB Preventive Therapy: 3HR Regimen

An individual who has been transferred to another health


facility with proper referral slip the continuation of TPT and
Not whose treatment outcome is not known; include here
Evaluated discontinued by a physician because the patient cannot tolerate
(e.g., severe ADRs) or those who refused to continue

6 RECORDING AND REPORTING


6.1 Recording
During the implementation, HCPs shall implement electronic recording through the ITIS
web version (Annex 9). ITIS Web shall serve as the primary recording and reporting
system throughout the duration of the project. Other digital platforms like ITIS Mobile
and the Care TB App can also be used for TPT notification once they are launched.

6.1.1. Log-in via https://itis.doh.gov.ph using your username and password.


6.1.2. Click Case Management then choose Add New Patient and add client for TPT.
Thereafter, make sure to add TB Record fill out all the information asked.
6.1.3. Add TST result (if done or available) and encode all diagnosis information
required. Also, remember to add patient’s contact in the contact investigation window.
6.1.4. Add treatment information and indicate 3HR under TPT regimen type.

*Note: Do not leave any blanks. Indicate “NA” if not applicable to patient or
patient is ineligible, “ND” if the patient is eligible but activity was not done,
“none” or “0’ if nothing, and “Unk” if unknown by health staff or patient,
accordingly.

6.2. Reporting

6.2.1. Quarterly reporting shall follow the guidelines as stipulated in NTP’s Manual of
Procedures.
6.2.2. Report 3 (Quarterly Report on TB and TB Preventive notification and Treatment)
and Report 5 (Quarterly Report on TB and TB Preventive Treatment Outcomes) shall
be accomplished and submitted every quarter.

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Standard Operating Procedures TB Preventive Therapy: 3HR Regimen

Annex 1
iNTP Demonstration Sites 3HR Allocation Table

Region Province/ Final Equivalent Qty in Equivalent Qty in Date of


City Allocation Number of Tablets Number of Tablets Delivery
Patients Patients
(Adults) (Children)
Tarlac 3,974 3,100 1,041,600 874 293,664 Aug. 26,
Region 2021
III Bataan 2,430 1,896 637,056 534 179,424 Sept 01,
2021
NCR Valenzuela 2,144 1,672 561,792 472 158,592 Aug. 31,
2021
Region Laguna 8,288 6,464 2,171,904 1,824 612,864 Aug. 25,
IV-A 2021
Region Cebu 6,036 4,708 1,581,888 1,328 446,208 Sept. 02,
VII Province 2021
Region South 3,208 2,502 840,672 706 237,216 Sept. 13,
XII Cotabato 2021

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Standard Operating Procedures TB Preventive Therapy: 3HR Regimen

Annex 2
List of Health Care Providers Trained with iNTP Module 2:
3HR Training
July 29 and 30, 2021 Batches
Name of Staff Name of Facility Name of Staff Name of Facility
Abigail Morales-Co Beng Valenzuela City Health Office Benny Maypa norala district hospital
Alberto L. Guinto Valenzuela City Health Office Bhryan Bacasmas Batucan Borbon RHU
Alicia P. Antonio San Clemente RHU Brenda G. Paredes LGU - RHU1 Minglanilla
Allen Ray P. Cruz Valenzuela Health Office Camille P. Fugio DOH-CHD XII
Benilda D. Evangelista Valenzuela Health Office Catherine C. Relator,RN Norala District Hospital
Benilinda Jane Cay-an Karuhatan Health Station Catherine D. Cabatuan ALOGUINSAN RHU
Cris Albert Pidot Ramos Rural Health Unit Ceba Marie Bayno Badian District Hospital
CEBU PROVINCIAL HOSPITAL-
Dave Renz Beltrano Valenzuela Health Office CHARIE MAE E. LOBITANA BOGO CITY
Editha Marie Urbano Elysian Health Center Charise R. Valendez Borbon Rural Health Unit
GEN. T. DE LEON 1 HEALTH CEBU PROVINCIAL HOSPITAL-
EDUARDO DALAGAN STATION CHARITY I. PILAPIL III BOGO CITY
Edward Angelo Velasco Valenzuela Health Office Chelsea Daine Mariveles RHU SURALLAH
CENTRAL LUZON DOCTORS'
ELMAN HOWELL D. TAGUBA HOSPITAL Christine Ann E. Castillo SANTA FE RURAL HEALTH UNIT
Isidro C. Kintanar Memorial
Engracia F. Almazan Pinalagad Health Center Christine Vismanos (ICKMH-Argao) Hospital-Argao
Glodel De Lara Valenzuela Medical Center Clare Angelie Barbon San Fernando RHU
Gubatan, Glenn Alfred Valenzuela Health Office Consuelo A. Lu Consuelo A. Lu children 's clinic
Hannah Joy Lumibao Valenzuela Health Office Corazon Dotillos Borbon RHU
Honeyvee R. Tan-Guzman Valenzuela Health Office Corazon Vergara Borbon Rural Health Unit
JANET ABUELA SAN AGUSTIN LINGUNAN 3S HEALTH CENTER Cresilda Cases DOH-CENTRAL VISAYAS
Cebu Provincial Hospital-Carcar
Jerome Senen Valenzuela Medical Center DAISY LOU C. ABARQUEZ, MD City
SOGOD DISTRICT HOSPITAL/
Joan Alvarez Valenzuela Medical Center DEANNA MARIE B. TAMPUS,RN CEBU
Joan Leyson-Saligumba, MD 3S Maysan Health Stations Divina Inso PORO RHU
Joann Suba DOH CLCHD 3 GEMMA SANCHEZ Santa Fe RHU
Dr.Jose Ma.V.Borromeo Memorial
John Philip Tiongco Valenzuela Health Office Glendale Taguiam District Hospital
Julie Ann Bautista Valenzuela Health Office Gracel Rose S. Perez Cebu Provincial Health Office
GREGORIA MACIMILIANA T.
Juvy Anne Munsayac Valenzuela Health Office DIEZ BADIAN DISTRICT HOSPITAL
Kaycelyn Alegre Valenzuela Medical Center Gwen Aban Balamban Rural Health Unit 1
CEBU PROVINCIAL HOSPITAL-
Leah B. Gato Valenzuela Medical Center GWYLLYN O. GULANE, MD BOGO CITY
Maricel Abarico Valenzuela Health Office Hazel Ramos PHO- South Cotabato
Marie Joy M. Sebastian DOH-MM CHD hilda s. tolentino ALOGUINSAN RHU

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Standard Operating Procedures TB Preventive Therapy: 3HR Regimen

Marilou B. Lebardo Tarlac PHO IRISH B. DURIMAN IPHO - SOUTH COTABATO


Valenzuela City Social Hygiene CEBU PROVINCIAL HEALTH
Mark Anthony A. Manaois Clinic JANET T. RAMOS OFFICE
CEBU PROVINCIAL HOSPITAL-
Mark laureen salvio Valenzuela Health Office JANYN VERGARA SARSONAS CARCAR CITY
Matty H. Torres Valenzuela Health Office Jasmen B. Pasco RHU BOLJOON
May Ronalee M. Mallari Valenzuela Health Office Jayne Pamela N. Te CPH-Carcar Cebu
Odielon Filomeno DOH-MM CHD Jennifer Estan Cebu Provincial Hospital Balamban
Patricia Carmela De Vega Tagalag HC jennifer sayson ALOGUINSAN RHU
Paul Ryan G. Macanas DOH CLCHD 3 JERLAE COMETA LUCERO COMPOSTELA RHU
paula bianca celso ugong 3s health station JOHN ARLO M. CODILLA IPHO- SOUTH COTABATO
Robin Erick Pascual Valenzuela Health Office John Lou Ducay SANTA FE RHU
Romella carag Bagbaguin Health Station Josiah Hans R. Samilin IPHO South Cotabato
Sharmaine Bataycan Valenzuela Health Office Joverson S. Bejic Pinamungajan RHU
Sharon Isturis Valenzuela Health Office Kamlon J. Usman Jr. DOH Region 12 CHD
Cebu Provincial Health Office /
Tedjesse B Orlino Valenzuela Medical Center Kenver Aaron D. Sabornido PBSP
Venjieleen esquivel Concepcion health station Kimverly Onajon IPHO South Cotabato
Venus Agullo Valenzuela Medical Center Lucille mae Potoy Carcar city health office
Xylene Sangco DOH-MM CHD Lux Ann Lirazan Cebu Provincial Health Office
Daanbantayan District Hospital-
Zadel bonilla BSPT , RN Valenzuela Health Office Lyka A. Sacapaño Cebu Province
Glorie A.Occeño Valenzuela Health Office MA. ANGELICA R. TOLOSA RHU SURALLAH
David John D. Faustino Valenzuela Health Office Ma. Arlene D. Castro Tuburan District Hospital
Edle Jay C Balunan Lawang Bato Health Center mae batoctoy Minglanilla District Hospital
Elizabeth D. Constantino Pasolo Health Station Maria Caracena Barili Rural Health Unit 1
Cherry Go-Frondarina Purok 4 HC Maria Fe C.Managaytay RHU- Pinamungajan
Ivy Rose De Guzman MABOLO HEALTH STATION Marian Melody S. Rabaca TUBURAN RHU
Jean Karen Reyes Valenzuela Health Office Marie Blanche A. Vazquez RHU Boljoon
Joshua James D. Reyes Valenzuela Health Office Mark Anthony Sangre Balamban Rural Health Unit 2
Rural Health Unit of Compostela,
Khristine G. Sy GTDL 3S health Center Mary Anne Q. Dungog Cebu
CEBU PROVINCIAL HOSPITAL -
Leah Dizon Pasolo Health Station Mary Grace Ypil DANAO
Lemon Jane Baltazar Parada 3s Health Station Mary Rose Therese C Cabillon Badian RHU
lilian lee partosa Valenzuela Health Office Melvin Saragena Alcoy rhu
Lombard Saligumba, MD Gen. T. De Leon Health Station Michelle Anne Recto Dagoy,MD Barili Rural Health Unit 1
lovelina o. maderazo Valenzuela Health Office Mitchell Tan Rural Health Unit II Dalaguete
MA EILEEN RAMONES-SIANGHIO,
MD Valenzuela Medical Center Nanette L. Torralba Cebu Provincial Hospital-Danao
Ma. Lorraine Martin Bonilla Valenzuela Health Office nathaniel b. alejado carcar city health office
Maria Kristina Crisostomo Sanchez Valenzuela Health Office Neillie Violon Aquino Minglanilla Rural Health Unit 1 IDots
Maria Ruth P Giron Valenzuela Health Office Nelivit Mandal Verdida LGU-San Remigio
Raquel E. Contreras Valenzuela Health Office Philip Balogo Borbon RHU
Rosalina B. Angeles Isla Health Station Philip Ponce Liloan Rhu
Rosanna De Vera Valenzuela Health Office Raiza Batomalaque Balamban Rural Health Unit 3
susan reyes Valenzuela Health Office Renne B. Ciano RHU SANTANDER

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Standard Operating Procedures TB Preventive Therapy: 3HR Regimen

William R. Altobar Valenzuela Health Office Roda C. Camay San Remigio RHU I & II
ABIGAIL MONTEROLA SAN REMIGIO RHU Rodeliz K. Reyes Dumanjug Rural Health Unit
CEBU PROVINCIAL HOSPITAL-
Ace Climaco Balamban Rural Health Unit 3 RODELO THOMAS BALAGTAS JR. BOGO CITY
ailyn g. buenavista barili rhu Romelyn G. Tinga Bantayan District Hospital
Aimee Carumba RHU-2 Dalaguete Ronalyn Otarra Barili District Hospital
Aimee F. Apolinario RHU SANTANDER Roselyn S.Gako Dumanjug Rhu
Pilar Municipal Health Office And
Al Christy A. Catong Carcar City Health Office Steve Silagan Cuering Lying-In Clinic
Alcestis Donna Azul RHU San Fernando Thelma Arzadon-Lemente, RN. IPHO South Cotabato
Angiela May Cabinatan Cebu PHO Tomomi N. Abe, MD RHU Pinamungajan
Ann Lyka Liston Barili Rural Health Unit 1 VICK P. CABAHUG LILOAN RHU
Astrid Fariolen Santa Fe Rural Health Unit Vivian L. Awe RHU BOLJOON
BEN AMUS A. TAGALOG SOGOD DISTRICT HOSPITAL

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Standard Operating Procedures TB Preventive Therapy: 3HR Regimen

Annex 3
3HR Allocation Table to Facilities Providing TB Services

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Annex 4
Steps in Contact Investigation

LIST AND RECORD: Ask for


INTERVIEW: Once a case is
the name of all HH and close REQUEST: Request index case
registered for treatment,
contacts, regardless of ag, and to interview HH and Close
interview the index case and
list all of them in the DS-TB Contacts, and offer options on
explain the importance of
Treatment Card and how they will be interviewed.
contact investigation
Presumptive Masterlist

TEST: Test contacts for active


TB (Rapid TB Diagnostic Test) OFFER: Offer CXR if available
or TB Infection (TST or IGRA - to all contacts who are 5 years
INTERVIEW: Interview each
not mandatory to all contacts) old and above. If not, perform
of the contacts for s/sx of TB
depending on results of symptom screening including
symptom and/or CXR those under 5 years of age
Screening

PROVIDE: Provide results to MANAGE: Perform baseline


COUNSEL: Counsel contacts
contacts and discuss clinical evaluation and
prior to initiating TB
appropriate management laboratory tests and provide
Treatment or TPT
based on results appropriate management

UPDATE: Update patient


records, and facility forms and
registers

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Standard Operating Procedures TB Preventive Therapy: 3HR Regimen

Annex 5
TB Infection Cascade of Care

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Standard Operating Procedures TB Preventive Therapy: 3HR Regimen

Annex 6
TST and IGRA Results Interpretation

Type of Test Testing Method Lead Time Results

Positive:
At least 10mm
induration regardles
of BCG Vaccination
5 mm in
TST 0.1ml of PPD, ID 48-72 hours immunocompromise
route d children

Negative:
<9mm induration on
site

Positve: suggest that


TB infection is likely
Negative: suggest
IGRA In-vitro blood test 8-30 hours after TB infection is
using ELISA fresh blood unlikely
collection Indeterminate:
suggests for further
evaluation or repeat
testing

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Annex 7
TPT Treatment Initiation Algorithm
Figure 1: Algorithm for Children <5 y/o with HIV Negative or Unknown HIV Status
Contacts of BC-TB (HH and close contacts) and CD-TB cases

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Standard Operating Procedures TB Preventive Therapy: 3HR Regimen

Figure 2: Algorithm for > 5 y/o with HIV Negative or Unknown HIV Status Contacts of
BC-TB (HH and Close Contacts)

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Standard Operating Procedures TB Preventive Therapy: 3HR Regimen

Figure 3: Algorithm for Children 1-4 y/o with HIV Infection

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Standard Operating Procedures TB Preventive Therapy: 3HR Regimen

Figure 4: Algorithm for > 5 y/o with HIV Infection

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Standard Operating Procedures TB Preventive Therapy: 3HR Regimen

Annex 8
List of Preparations before starting 3HR

Table 1: Potential Adverse Events (AEs)

Suspected Culprit
Known AEs Rare AEs
Anti-TB Drugs

·Asymptomatic elevation of serum liver enzyme ·Convulsions


·Hepatitis ·Pellagra
Isoniazid ·Peripheral neuropathy ·Arthralgia
·Skin rash ·Anemia
·Sleepiness and lethargy ·Lupoid reactions
·Gastrointestinal reactions (abdominal pain, ·Osteomalacia
nausea, vomiting) ·Pseudomembranous colitis
·Hepatitis ·Pseudo adrenal crisis
Rifampicin
·Generalized cutaneous reactions ·Acute renal failure
·Thrombocytopenic purpura ·Shock
·Discoloration of body fluids ·Hemolytic anemia

Table 2: Baseline Clinical Examinations

Risk Factor for AE Action if Risk Factor is Present


Flu-like signs and symptoms:
Defer TPT until symptoms resolve
Fever, headache, runny nose, and joint pain
Increased risk of hepatotoxicity:
History of liver disease
Do a liver function test (AST and ALT)
Regular use of alcohol
Do not give TPT if AST and ALT are >3 times
Chronic liver disease
ULN
Pregnancy / Within 3 months postpartum
Age >60 years
Give pyridoxine (vitamin B6) prophylaxis.
Increased risk of peripheral neuropathy:
Adults and children >1 year old: 10 to 25 mg/day in
Malnourished
adults including pregnant and lactating women, and
Diabetes
people with other risk factors (depending on which
PLHIV
formulary is available)
Chronic alcoholic
For infants: 5 to 10 mg/day (including infants of
Renal insufficiency
lactating women who are taking isoniazid containing
Pregnancy and lactation
TPT regimen should receive vitamin B6 even if the
Infant
infant is not on TPT)

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Table 3: Precautions

1. Perform pregnancy when in doubt (missed period)


Women of 2. Ask if any contraceptive is being taken
Reproductive Age 3. Advise if receiving oral contraceptives containing ESTROGEN to
(14-54 y/o) take an oral contraceptive pill containing a higher dose of estrogen
(50 mcg) or use another form of contraception following a
consultation with a clinician
• Ask if PLHIV are on Anti-retroviral Therapy (ART) or not and
which ART drugs are being taken and adjust if required:

PLHIV ARTs Can Co-Administer with


3HR?
Efavirenz Yes
Protease inhibitors (Lopinavir, No, use 6H instead
Ritonavir) and Nevirapine
Raltegravir and Dolutegravir Yes, but increase dose

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Annex 9
Recording and Reporting Forms for the TPT: 3HR Implementation

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