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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
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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.
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
5.1.1 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)
5.2.1 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
5.3.1 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:
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).
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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.
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
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
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Standard Operating Procedures TB Preventive Therapy: 3HR Regimen
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Standard Operating Procedures TB Preventive Therapy: 3HR Regimen
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
*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
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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
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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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Standard Operating Procedures TB Preventive Therapy: 3HR Regimen
Annex 4
Steps in Contact Investigation
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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
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
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Standard Operating Procedures TB Preventive Therapy: 3HR Regimen
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
Annex 8
List of Preparations before starting 3HR
Suspected Culprit
Known AEs Rare AEs
Anti-TB Drugs
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Standard Operating Procedures TB Preventive Therapy: 3HR Regimen
Table 3: Precautions
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Standard Operating Procedures TB Preventive Therapy: 3HR Regimen
Annex 9
Recording and Reporting Forms for the TPT: 3HR Implementation
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