25 March 2022
GUIDELINES ON TUBERCULOSIS – HUMAN IMMUNODEFICIENCY
VIRUS (TB – HIV) SERVICES INTEGRATION FOR UNIVERSAL HEALTH CARE (UHC)
IMPLEMENTATION
The collaborative approach of prevention and control of Tuberculosis (TB) and Human Immunodeficiency Virus (HIV) of the Department of Health (DOH) was catalyzed with the issuance of Administrative Order No. 2008 – 0022, entitled “Policies and Guidelines in the Collaborative Approach of TB and HIV Prevention and Control” and its further revision through Administrative Order No. 2014 – 0005. With the enactment of Republic Act No. 11223 or the Universal Health Care Act, TB and HIV are identified as flagship programs for integration in the UHC implementation.
The Philippine Health Sector HIV Strategic Plan 2020 – 2022 enumerates high impact prevention, testing, treatment, and adherence strategies targeting high risk key populations in high burden areas. Innovative and differentiated approaches for HIV treatment and adherence involve introducing safer treatment regimen, managing co–infections such as TB, enhancing case management, and scaling up viral load testing.
Similarly, the updated Philippine Strategic TB Elimination Plan 2020 – 2023 (PhilSTEP1) enumerates the strategies for screening, testing and diagnosis, treatment, and prevention that will contribute to the Global End TB objectives. Part of these strategies are integrated patient–centered care including TB – HIV collaboration.
This policy consolidates the key components of the above strategies and guidelines pertaining to TB and HIV with the goal of reducing the burden of TB among people living with HIV (PLHIV) and the burden of HIV among people with TB towards the attainment of goals of the UHC Act and FOURmula One Plus for Health (F1 Plus).
II. OBJECTIVE
This Order is issued to provide standards and mechanisms for collaboration between the National TB Control Program (NTP) and National AIDS and STI Prevention and Control program (NASPCP) for the provision of TB and HIV services under UHC.
III. SCOPE OF APPLICATION
These guidelines shall apply to all public and private health facilities providing TB and HIV services from screening, diagnosis, treatment, and prevention. In the case of the Bangsamoro Autonomous Region in Muslim Mindanao (BARMM), the adoption of these guidelines shall be in accordance with R.A. No. 11054 (Bangsamoro Organic Law) and the subsequent laws and issuances to be issued by the Bangsamoro government.
IV. DEFINITION OF TERMS
A. Active drug safety monitoring and management (aDSM) – refers to the reporting of all serious adverse events (SAE) and adverse events of special interests (AESI) among patients using new drugs and new treatment regimen.
B. Antiretroviral therapy (ART) – refers to lifelong treatment using a combination of three or more anti – retroviral (ARV) drugs to achieve viral suppression.
C. Nucleic acid amplification test (NAAT) – (e.g., GeneXpert test) refers to a semi–automated, molecular assay which permits rapid diagnosis through the detection of nucleic acid (DNA/RNA). It is used to detect TB, COVID, and other infectious diseases as well as determine the viral load among PLHIV.
D. Community–based treatment – refers to taking the TB medications in a designated location in the community, usually near the patient’s residence, with a health worker or community volunteer acting as treatment supporter.
E. Digital adherence technologies – refer to tools designed to support people with TB that allow them to take their medications at a place and time that is convenient to them, while remaining connected to their health care provider.
F. Health facilities – refer to an institution that has healthcare as its core service, function, or business. Health care pertains to the maintenance or improvement of the health of individuals or populations through the prevention, diagnosis, treatment, rehabilitation and chronic management of disease, illness, injury and other physical and mental ailments or impairments of human beings.
G. HIV testing – refers to any procedure used to identify the presence or absence of HIV in a person’s body which includes a test for triage or HIV screening, laboratory – based or facility–based testing, mobile procedures, and other approaches.
H. HIV testing services – refer to a broad range of services that shall be provided alongside HIV testing. These services include counselling, linkage to necessary and appropriate HIV prevention, treatment and care, and other clinical support services, as well as coordination with stakeholders to support quality assurance.
I. Home–based treatment – refers to taking the TB medications at home assisted by a family treatment supporter or using digital adherence technologies.
J. Key populations – refer to populations with high risk of contracting HIV but not limited to males who have sex with males, transgender women, people with multiple sex partners, and people who inject drugs.
K. Patient–centered care – refers to an approach to care that recognizes and respects the patient’s rights and values and considers the patient as an important partner who actively participates in decisions on diagnosis and treatment.
L. Differentiated service delivery – refers to a person – centered approach that simplifies and adapts HIV services across the cascade to reflect the preferences and expectations of various groups of PLHIV while reducing unnecessary burdens on the health system.
M. TB preventive treatment (TPT) – refers to treatment offered to individuals who are at risk of developing active TB disease to reduce that risk.
N. TB screening – refers to the systematic identification of presumptive TB in a predetermined target group, using examinations or other procedures that can be applied rapidly.
O. Young key populations – refer to populations within the age range of 15 – 24 years old with high risks or contracting HIV but not limited to males who have sex with males, people with multiple sexual partners, and people who inject drugs.
V. GENERAL GUIDELINES
A. Health facilities shall provide integrated TB and HIV services to all patients and ensure appropriate referral of cases within the health care provider network (HCPN).
B. The DOH and local government units (LGUs) shall ensure that adequate commodities for the provision of TB – HIV services.
C. Resources from the national and local governments, private sector, and partners shall be pooled and harmonized through the Special Health Fund to ensure efficient budgeting and to minimize catastrophic costs to patients and to avoid overlapping of provision of services and proper role delineation.
D. Health care workers shall be capacitated to provide both TB and HIV services according to standards.
E. Appropriate and timely TB and HIV treatment shall be given to all newly diagnosed TB or HIV patients.
F. A Data Sharing Agreement shall be issued to ensure that data captured on information systems related to TB and HIV will be rationally shared to better manage both programs while maintaining confidentiality and security of data as required by R.A. No. 10173 or the Data Privacy Act of 2012.
G. Infection prevention and control measures shall be strictly observed in the delivery of TB and HIV services.
VI. SPECIFIC GUIDELINES
A. Prevention
1. All PLHIV who do not have active TB shall receive TB preventive treatment.
2. All household and close contacts of diagnosed TB cases in whom TB have been ruled out shall be assessed for eligibility to TPT. TPT shall be offered for those found eligible. Please refer to the NTP Manual of Procedures (MOP), 6th Ed. (2020), page 70, Table 29 for TPT regimens, which can be accessed through https://tinyurl.com/NTPMOP-6th.
3. Education, counselling, and social communication on TB and HIV prevention shall be provided as part of the comprehensive care.
4. HIV prevention commodities such as condoms and lubricants shall be appropriately provided to TB and HIV patients.
5. Existing service delivery networks shall be maximized for advocacy, demand generation, service delivery, and implementation of other TB – HIV related activities.
B. Detection
1. Early identification of TB among PLHIV shall be done through careful assessment of signs and symptoms (fever, weight loss, cough, night sweats) at every visit and by doing chest X–ray upon diagnosis of HIV and at least annually. GeneXpert shall be done anytime a patient has TB signs and symptoms or chest X–ray findings suggestive of TB. Please refer to the NTP MOP, page 12, Figure 2, which can be access through https://tinyurl.com/NTPMOP-6th.
2. All patients consulting the health facility shall also be screened for TB according to algorithms in the NTP MOP, page 12, Figure 1, which can be accessed through https://tinyurl.com/NTPMOP-6th.
3. All TB patients aged at least 15 years old shall be offered HIV testing services.
4. The NAAT/GeneXpert shall be used as primary diagnostic tool for diagnosis of TB among presumptive TB and for point–of–care HIV viral load testing for PLHIV on Antiretroviral Therapy (ART).
5. A laboratory network analysis for TB and HIV shall be implemented to determine the optimal number and location of required NAAT machines based on testing targets and population served.
6. The LGUs shall coordinate with the Centers for Health Development (CHDs) to ensure that the recommended laboratory sites for both TB and HIV are within the regional laboratory network and referral system among laboratories in the HCPN in their respective regions.
7. Existing specimen transport systems shall be optimized for both TB (sputum) and HIV viral load testing (blood) and shall also be utilized for transport of the results.
8. All public and private providers are mandated to report to the DOH all diagnosed TB and HIV patients using available platforms (e.g., Integrated TB Information System or ITIS, and One HIV, AIDS, and STI Information System or OHASIS) as part of the strengthening disease surveillance.
C. Infection Prevention and Control
1. Minimum public health standards shall be implemented in all health facilities.
2. All health facilities providing TB and HIV services shall implement administrative controls, engineering controls and use of personal protective equipment based on a facility risk assessment.
D. Treatment
1. Standard regimens for drug–susceptible and drug–resistant TB shall be used based on eligibility criteria. Please refer to the NTP MOP, page 35, Figure 6 and page 45, Table 18, which can be accessed through https://tinyurl.com/NTPMOP-6th.
2. Antiretroviral therapy (ART) shall be initiated within the same day upon recognition of HIV infection, whenever possible, regardless of clinical and immunologic status.
3. Persons with TB – HIV co–infection shall be given both TB and HIV treatment based on DOH guidelines.
4. Patients with TB – HIV co–infection shall also be managed for prevention of other opportunistic infections (OIs). For the list of OIs, please refer to the DOH Department Memorandum (DM) No. 2020 – 0338, entitled “Adoption of PSMID Clinical Practice Guidelines on the Prevention, Diagnosis and Treatment of Opportunistic Infections in HIV Infected Adults and Adolescents in the Philippines,” which be accessed through https://tinyurl.com/OI-Guidelines.
5. Treatment adherence support and counselling shall be given to all patients with TB, HIV and TB – HIV co–infection.
6. Patient–centered care and differentiated service delivery through home–based and community–based treatment shall be practiced.
7. When available, digital adherence technologies shall be used.
8. Active drug safety monitoring and management (aDSM) shall be implemented for novel drugs and treatment regimens by reporting severe adverse events (SAE) and adverse events of special interest (AESI).
E. Provision of Commodities
The DOH and LGU shall ensure adequate commodities for the provision of TB – HIV services.
1. The following commodities shall be procured by the DOH – Disease Prevention and Control Bureau and transitioned to the LGUs based on the DOH–approved Devolution Transition Plan as aligned with the UHC.
a. Cartridges for Xpert TB test
b. HIV point of care Viral Load (VL) cartridges
c. HIV testing kits
d. CD4 cartridges
e. First–line anti–TB drugs for susceptible TB for adults, and children.
f. Selected second line anti–TB drugs for drug resistant TB (Bedaquiline and Delamanid). Other second line anti–TB
drugs will be provided by the Global Fund. As part of the sustainability
measure, the government will continuously increase its commitment to provide
these commodities annually.
g. Drugs for antiretroviral therapy (ART)
h. Drugs for TB preventive treatment
(1) Isoniazid for 6 months (6H)
(2) Isoniazid + Rifampicin combination for 3 months (3HR)
(3) Isoniazid + Rifapentine combination for 12 weekly doses (3HP)
(4) Rifampicin for 4 months (4R)
i. Trimethoprim – Sulfamethoxazole (Cotrimoxazole) for prophylaxis or
treatment of Pneumocystis pneumonia.
j. Azithromycin for Mycobacterium avium complex prophylaxis (Note: for
devolution in 2023)
k. Condoms and lubricants
l. Personal protective equipment (PPE)
2. LGUs shall be responsible for providing or procuring the following:
a. Chest X–ray for TB screening (provisions or referral)
b. Specimen containers (sputum cups and blood collection vials)
c. Glass slides
d. Staining kits for direct sputum smear microscopy
e. Purified protein derivative (for Tuberculin skin test)
f. Cartridges for Xpert TB test (augmentation)
g. HIV testing kits (augmentation)
h. HIV point of care VL cartridges (augmentation)
i. CD4 cartridges (augmentation)
j. Azithromycin for Mycobacterium avium complex (prophylaxis (Note: for
devolution in 2023)
k. Condoms and lubricants (augmentation)
l. PPE (augmentation)
3. Health facilities through PhilHealth Outpatient HIV/AID Treatment (OHAT) package:
a. Consumables for HIV VL testing (EDTA tubes, cryovials)
b. Point of care HIV VL cartridges
c. CD4 cartridges
F. Capacity Building
1. Health workers in hospitals, health centers/rural health units, TB facilities, and HIV treatment facilities including barangay health workers and community volunteers shall be trained in TB and HIV care, particularly on the following:
a. NTP Manual of Procedures, 6th Ed.
b. HIV counselling, testing, and treatment
c. Use of GeneXpert for TB diagnosis and HIV viral load testing
d. Integrated TB Information System (ITIS) and One HIV, AIDS, and STI
Information System (OHASIS)
e. Procurement and supply management
VII. MONITORING AND EVALUATION
A. Standard indicators shall be used to monitor TB and HIV program performance:
1. No. of TB patients with known HIV status (tested for HIV)
2. No. of PLHIV screened for TB
3. No. of patients with TB – HIV co–infection
4. No. of PLHIV given TB preventive treatment
5. Treatment outcome of patients placed on TB treatment and TB preventive treatment.
B. Other TB and HIV indicators not directly related to TB – HIV integration shall continue to be monitored.
C. Data for the standard indicators shall be reported by all health facilities following regular program reporting through ITIS and OHASIS.
D. Data sharing between ITIS and OHASIS shall be implemented for harmonization of TB – HIV indicators.
E. Integrated monitoring and program implementation reviews shall be done for both TB and HIV.
F. The TB – HIV Integration Technical working group shall convene to monitor
program implementation and perform other functions as stated in DOH A.O. No.
2014 – 0005.
VIII. ROLES AND RESPONSIBILITIES
A. The Disease Prevention and Control Bureau (DPCB) shall:
1. Develop the plan for implementation of the TB – HIV integration.
2. Ensure adequate commodities for TB and HIV.
3. Develop capacity–building tool for TB – HIV integration.
4. Provide technical assistance to CHDs in implementation of the TB – HIV
integration guidelines.
5. Monitor and evaluate implementation of TB – HIV service integration and
provide regular feedback to the Public Health Services Team (PHST).
6. Develop additional policies and guidelines, as necessary.
B. The Epidemiology Bureau (EB) shall:
1. Maintain and update surveillance systems that capture TB – HIV data and monitor TB – HIV indicators.
2. Collect and validate required data from facilities providing HIV services.
3. Provide monthly updates on TB – HIV–related strategic information to the DPCB, partners, and other stakeholders.
4. Develop and maintain the OHASIS and ensure availability to its end users.
5. Maintain the electronic recording and reporting system of HIV including providers and facilities databases.
C. The Health Promotion Bureau (HPB) shall:
1. Ensure the promotion of integrated TB – HIV as part of the DOH Campaign for Primary Care such as KosulTayo, and in coordination with the Presidential Communications Operations Office (PCOD) for information dissemination.
2. Develop Social Behavior Change Communication (SBCC) plan and its corresponding materials in different platforms.
3. Monitor the implementation of the SBCC.
4. Evaluate the impact of the integrated TB – HIV SBCC to target individuals/populations.
D. The Knowledge Management and Information Technology Service (KMITS) shall:
1. Develop and maintain the Integrated TB Information System (ITIS) and ensure availability to its end users.
2. Maintain the electronic recording and reporting system of TB including providers and facilities databases.
3. Ensure data privacy of patient’s personal information.
E. The Centers for Health Development (CHDs) and Ministry of Health – Bangsamoro Autonomous Region in Muslim Mindanao (MOH – BARMM) shall:
1. Lead capacity building of LGU health facilities in TB – HIV integration.
2. Coordinate with LGUs in the distribution and procurement of necessary commodities for implementation.
3. Collaborate with LGUs to develop the referral system for the TB and HIV laboratory network including, but not limited to the referral procedure for HIV VL testing.
4. Provide technical assistance to LGUs and facilities, both public and private, in the implementation of the guidelines.
5. Monitor and evaluate implementation.
6. Provide feedback and quarterly program reports to DPCB to guide policy revision or development.
F. The Local Government Units (Provincial, City, and Municipal Levels) shall:
1. Co–lead in capacity–building activities related to TB and HIV and procurement and supply management.
2. Implement the guidelines on TB and HIV integration.
3. Implement awareness and demand generation activities at the local level.
4. Establish the referral system including, but not limited to a laboratory network.
5. Ensure adequate supply of commodities for TB – HIV.
6. Provide feedback and quarterly program reports to CHDs and participate in monitoring and review activities.
7. Provide and ensure access to transport mechanisms for patients.
G. The Health Facilities shall:
1. Provide TB and HIV services in accordance with DOH guidelines.
2. Ensure mechanisms and standards are in place for provision of TB and HIV services.
H. Reference Laboratories
1. The Research Institute for Tropical Medicine – National Tuberculosis Reference Laboratory (RITM – NTRL) shall:
a. Provide technical guidance on CBNAAT machine (e.g., GeneXpert) placement, installation, capacity building and operations.
b. Monitor and provide recommendations on operations of GeneXpert laboratory.
c. Conduct EQA in the use of CBNAAT.
d. Conduct Training of Trainers for the use of CBNAAT.
2. The National Reference Laboratory – San Lazaro Hospital STD AIDS Cooperative Central Laboratory (NRL – SLH/SACCL) shall:
a. Provide External Quality Assessment Schemes (EQAS) for Serology to HIV testing facilities and GeneXpert sites performing HIV Viral Load testing.
b. Conduct of Training of Trainers of the Regional HIV – TB Coordinators on Laboratory Quality Management System, Referral Networking and Monitoring and Evaluation.
c. Conduct Kit Evaluation for the registration of test kits to be used in the HIV testing facilities.
d. Resolve laboratory discrepancies and concerns regarding HIV testing.
I. Non–government/Community–based/ Civil Society Organizations shall:
1. Advocate for political support and resource mobilization for TB – HIV program.
2. Provide support to patients in detection and treatment for both TB and HIV.
3. Provide support to LGUs in terms of TB and HIV awareness.
4. Actively engage in community–led monitoring of TB – HIV.
5. Coordinate with local authorities for appropriate delivery of TB and HIV services.
6. Engage in consultations for policy and guidelines development.
J. Development and other external partners shall:
1. Provide technical assistance in planning, implementing, capacity building, monitoring, and evaluation.
2. Provide support for TB – HIV commodities and activities.
IX. FUNDING
The DPCB shall allocate funding through the Communicable Disease Budget line item for implementation of these guidelines.
X. SEPARABILITY CLAUSE
If any clause, sentence, or provision of this Order shall be declared invalid, unconstitutional, illegal, or unenforceable, the other provisions not acted thereby shall remain, vital, valid, and effective.
XI. REPEALING CLAUSE
The DOH A.O. No. 2008 – 0022 entitled “Policies and Guidelines in the Collaborative Approach of TB and HIV Prevention and Control,” and A.O. No. 2014 – 0005 entitled “Revised Policies and Guidelines in the Collaborative Approach of TB and HIV Prevention and Control” and other issuances, rules, and regulations inconsistent with or contrary to this A.O. are hereby repealed, amended, or modified accordingly.
XII. EFFECTIVITY
This Administrative Order shall take effect after fifteen (15) days following its publication in a newspaper of general circulation.
FRANCISCO T. DUQUE III, MD,
Msc
Secretary of Health
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