22
AUGUST 2022
GUIDELINES IN THE IMPLEMENTATION OF DIFFERENTIATED HIV TESTING SERVICES
I. RATIONALE
The Philippines has maintained the Human Immunodeficiency Virus (HIV) prevalence rate at less than 1%, however, it has been noted that there has been a 207% increase in new HIV infections from 2010 to 2019, disproportionately affecting key populations. While 70% (78,921) from the estimated 111,400 people living with HIV (PLHIV) in the country have been diagnosed, 30% (33,109) were still undiagnosed as of December 2020 with limited testing options identified as one of the key issues in the diagnosis gap based on the 2019 HIV Joint Program Review (JPR).
To bridge the diagnosis gap, the Philippine Health Sector – HIV Strategic Plan (HSP) 2020 – 2022, deeply rooted in the Republic Act No. 11223 Universal Health Care Act and the DOH FOURmula ONE, HIV testing options made available at the primary care level as one of its key strategies to achieve its targets. This strategy which includes peer–led or community–based screening (CBS), health worker–led or facility–based testing, self–testing, social and sexual network testing (SSNT), and the intimate partner testing. These various approaches in HIV testing are underpinned by multi–sectoral action and empowered people and communities to ensure integration of HIV–related services into the primary care package.
Demonstration projects on self–screening have shown high uptake among males who have sex with males (MSM) and transgender women (TGW). In Metro Manila, it showed 8.04% reactivity rate of which 37.2% were first–time testers. In Western Visayas, a 9.2% reactivity rate was reported whereby 50% were first–time testers. Further, SSNT has high uptakes in four community centers with a 3% reactivity rate and an average of 1 recruiter to 30 key populations client referrals tested. This Administrative Order is developed to increase HIV diagnosis to 95% by reaching out to key populations.
II. OBJECTIVE
The Administrative Order is issued to
provide technical, programmatic, and operational guidance in the implementation
of HIV Testing Services in health facilities and guidance for HIV clients in
the Philippines.
III. SCOPE OF APPLICATION
This Order shall apply to DOH hospitals, Centers of Health Development (CHDs), Local Government Units (LGUs), and all service providers, coordinators, heads, or managers of facilities offering HTS in public and private settings, including community–based organizations (CBOs) or key population–led facilities.
In the case of Bangsamoro Autonomous
Region in Muslim Mindanao (BARMM), the adoption of this Order shall be in
accordance with R.A. 11054, otherwise known as Bangsamoro Organic Act and the
subsequent laws and issuances to be issued by the Bangsamoro Government.
IV. DEFINITION OF TERMS
A. Adverse event – refers to an incident that results in harm to the client or others because of their participation, including both intended and unintended cause of physical, economic, emotional, or psychosocial injury or hurt occurring before, during, or after HTS from one person to another, to oneself, and/or an institution to a person.
B. Children in Need of Special Protection – refers to children living alone, co–habitating, primary worker of the family, engaged in transactional sex, disowned due to discrimination based on their sexual orientation, gender identity and expression (SOGIE) and/or sexual characteristics, sexually active, or in other similar situations that expose them to risks of HIV infection.
C. Clinical reach – refers to the active participation of clinicians and other healthcare providers in the clinical setting to offer HTS.
D. Combination prevention – refers to the strategic use of different options for HIV prevention, which include but are not limited to non–occupational and occupational post–exposure prophylaxis (PEP), pre–exposure prophylaxis (PrEP), condoms and lubricants, substance–related harm reduction, safe needle, and syringe practices, and/or treatment of HIV–positive partners.
E. Community outreach – refers to testing activities that reach to many people, including those who live far from a testing facility or those who are working that may not have the time to visit a testing facility.
F. Community–based HIV Screening (CBS) – refers to a non–laboratory rapid HIV screening procedures performed by a trained healthcare provider or a member of community–based organization.
G. Facility–based HIV testing – refers to testing performed in accredited facilities to determine the presence of antigen and/or antibody against HIV. These facilities may include (1) laboratory facility–based testing (LFBT), in a licensed laboratory, which can either be certified rHIVda confirmatory laboratory (CrCL) or non–CrCL, and (2) non–laboratory facility–based testing (NLFBT), which refers to facilities other than licensed laboratories performed by other trained healthcare worker, which can include provider–initiated counselling and testing (PICT).
H. HIV Self Testing – refers to a process in which a person collects their own specimen, often in a private setting, either assisted or unassisted, then performs a test using DOH FDA–registered HIV test kits and interprets the result.
I. HIV Testing – refers to any procedure used to identify the presence or absence of HIV infection, which includes test for triage or HIV screening, laboratory facility– based testing, mobile procedures, and other approaches.
J. HIV Testing Services – refers to a broad range of services that shall be provided alongside HIV testing, including counselling, linkage to necessary and appropriate HIV prevention, treatment, and care, and other clinical support services and coordination with stakeholders to support quality assurance.
K. Index client – refers to a diagnosed PLHIV, who is enrolled or returning in HIV care services.
L. Index Testing (IT) – refers to offering HTS to sexual partners, injecting partners, and biological children and parents of known PLHIV.
M. In–reach – refers to offering HTS to partners and peers, colleagues, networks, and communities with common interests.
N. Key population – refers to sex workers, men who have sex with men, transgender women, people who inject drugs, and people in prison and other enclosed settings.
O. Mature Minor Doctrine – refers to the legal principle that recognizes the capacity of some minors to consent independently to medical procedures if they have been assessed by qualified health professionals to understand the nature of procedures and their consequences and to decide on their own.
P. Sexual and social network Testing (SSNT) – refers to a process where a trained provider asks a PLHIV or key population client who tested negative but with continuous substantial risk for HIV to motivate and invite other people in their sexual or social networks to engage in voluntary HIV testing.
Q. Social Network – refers to a group of people brought together by a similar characteristic, set of relationships, or behaviours, including sexual and drug – injecting/using partners.
R. Testing for Triage (T0) – refers to initial screening tests done outside CrCL using Department of Health (DOH) Food and Drug Administration (FDA)–registered rapid diagnostic kits which can be performed by oneself and/or by a trained and supervised healthcare worker or lay person.
S. Virtual
reach
– refers to the use of digital platforms to increase efficiency of HTS through
providing approaches simulated online.
V. GENERAL GUIDELINES
A. Provision of HTS shall observe the fundamental principles of human rights as it relates to universal health care and gender equality which includes but not limited to:
1. Right
to self–determination
2. Right
to informed consent
3. Right
to privacy and confidentiality
4. Right
to information
5. Right
to choose a health provider
6. Right to be informed of patient rights and obligations
B. Conduct of HTS shall be based on the Philippine HIV and AIDS Policy Act (R.A. 11166), Universal Health Care Act (R.A. 11223), Data Privacy Act of 2012 (R.A. 10173), Responsible Parenthood and Reproductive Health Act of 2012 (R.A. 10354), and Special Protection of Children Against Abuse, Exploitation and Discrimination Act (R.A. 7610), and subsequent related issuances.
C. Integration of multiple approaches of HTS (see Annex A) shall be based on the capacity of service providers, facilities, or organizations.
D. Informed
consent shall be obtained form all HTS clients through written, electronic, or
recorded means.
VI. SPECIFIC GUIDELINES
A. Demand Generation
1. Healthcare workers, CBOs, volunteers, public and private health facilities, including key population–led service facilities shall work closely to promote knowledge sharing and improve the awareness of KPs and their access to testing modalities that fit their needs.
2. All communication platforms shall be explored to identify demand and educate key populations on the available HTS in the country, specifically emphasizing the importance of knowing HIV status.
3. The HCWs, CBOs and volunteers shall work with key population–led health services, reproductive health, and wellness centers (RHWC) and other HIV treatment facilities to ensure access of key population clients to HTS.
4. In every circumstance, proper counselling shall be conducted by a social worker, a healthcare provider, or other health care professional accredited by the DOH or the DSWD.
B. Informed Consent
1. Consent for HIV testing shall be obtained from the client 15 years old and above through written or electronic consent (see Annex C.1).
2. Consent will be allowed either written or electronically complied.
3. Any young person below fifteen (15) years who is pregnant or has engaged in high–risk behaviour shall be eligible for HIV counselling and testing with the assistance of a licensed and trained social worker of health worker and consent shall be obtained from the person without the need for consent from a parent or guardian, based on the R.A. 11166.
a. In all other cases not covered above, consent to HIV testing for minors shall be obtained from the parents or legal guardians of infants or children born to HIV positive mothers, persons below 15 years old, or is mentally incapacitated.
b. Proxy consent shall be obtained from the licensed and trained social worker or health worker in cases when:
(1) The child parent or legal guardian cannot be located despite seven (7) working days of reasonable efforts or refused to give consent pursuant to Section 29 of Republic Act No. 11166.
(2) The child has been voluntarily or involuntarily under the protective custody of the Department of Social Welfare and Development (DSWD).
(3) The child has been living with the family, guardians, or relatives but with admission of abuse, neglect, and/or exploitation from any member of the family/household.
(4) The child is categorized under Children in Need of Special Protection by R.A. 7610.
(5) Assent of the minor shall be required prior to any HTS procedure to protect their best interest and consider their evolving capacity.
4. Although verbal consent from clients 15 years old and above is adequate in CBS and ST, securing written or electronic consent shall be preferred.
C. Differentiated Approaches in HIV Testing Services
1. Facility–based HIV Testing (FBT)
a. Any client who initiates accessing the following services shall be routinely offered HTS:
(1) Antenatal
and Postnatal Care
(2) Tuberculosis
Management and care
(3) HIV
prevention for key populations
(4) People
in closed settings, including people deprived of liberty.
(5) STI
and HIV diagnosis and management
(6) Reproductive
health and wellness
(7) Viral
hepatitis
(8) Adolescent clinics
b. Adults, adolescents, and children with symptoms or apparent presence of indicator conditions (See Annex C.2) suggesting HIV infection, or those with risky behaviours, shall be offered HTS through provider–initiated counselling and testing (PICT) in clinical settings. PICT can be provided by trained healthcare providers, which include but are not limited to Physicians, Nurses, and Midwives.
c. All HIV–exposed infants shall be tested for HIV in accordance with A.O. 2018 – 0024: Revised Policies and Guidelines on the Use of Antiretroviral Therapy (ART) among People Living with Human Immunodeficiency Virus (HIV) and HIV–exposed infants.
d. HIV proficiency training is no longer required for HIV testing, but identified rHIVda training requirement remains for CrCL [refer to A.O. 2019 – 0001: Guidelines on the Implementation of Rapid HIV Diagnostic Algorithm (rHIVda)]
e. See Annex D for the detailed FBT guidelines.
2. Community–based HIV Screening (CBS)
a. This service shall be provided to key populations at the community or closed settings and shall be implemented based on the Department Memorandum (DM) 2020 – 0276, or the Interim Guidelines on Community–based HIV Screening. Additional information on provision of CBS is indicated in (Annex E).
3. Self–Testing (ST)
a. This service shall be offered to high-risk key population clients who would not otherwise access HTS in the community or facility settings and who would prefer to collect specimens, perform the tests, and interpret the result either alone (unassisted) or with a trained provider or peer (assisted).
b. Results of unassisted and assisted self–testing will be consolidated and will be referred to a treatment hub or rHIVda site for repeat and confirmatory testing, care, and treatment if reactive, refer to combinations prevention if non–reactive and advise re–testing.
c. Additional information on provision and access to ST are detailed in Annex F.
4. Index Testing (IT)
a. This service shall be offered and shall be made voluntary to the sexual partner(s) of PLHIV considering the needs and safety of the index client and their partner(s).
b. Biological infants and young children of PLHIV and whose HIV status is unknown shall be offered HTS through provider–assisted index testing.
c. The PLHIV shall be assured of continued HIV services regardless of their decision to participate.
d. All providers offering IT shall adhere to minimum safety and ethical standard requirements for the conduct of IT.
e. See Annex G for detailed guidelines.
5. Social and Sexual Network Testing (SSNT)
a. This service shall be offered to all persons, regardless of HIV status, coming from networks with substantial risk for HIV to motivate and invite other people in their sexual or social networks to engage in voluntary HIV testing.
b. SSNT shall be integrated in other services like STIs, Tuberculosis, and Hepatitis B and C.
c. Safety and privacy of clients shall be ensured when offering SSNT.
d. See Annex H for detailed SSNT guidelines.
D. Conduct of HIV Testing Services
1. The conduct of HTS shall include the following components: (a) mobilization; (b) testing; and (c) linkage to appropriate services. For the HTS framework, see Annex A.
2. Mobilize through different forms of reach, which include in–reach (through SSNT and IT), community outreach (through ST and CBS), clinical reach (through FBT), and virtual reach as entry points for HTS.
3. Testing for triage (T0) through FBT, CBS, or ST, or T1 if in CrCl shall ensure provision of pre–test information and obtaining consent prior to testing.
a. Each approach shall follow procedures based on their respective specific guidelines (For FBT, see Annex D; for CBS, see DM 2020 – 0276: Interim Guidelines on Community Based Screening; and for ST, Annex F).
b. Post–test counselling (Annex I) shall be provided and linkage to appropriate services shall be ensured once the result is available.
c. Official copy of non–reactive T0 written results (T1, if CrCL) shall only be available in LFBT duly signed by a registered medical technologist who performed the test and validated by a Pathologist. For RHWC and TB Services facilities without a Pathologist, the supervising Physician shall review, validate, and countersign the result.
d. Unofficial reactive T0 results can be provided in FBT upon client’s request; however, it shall be indicated that this is not a confirmed HIV diagnosis and confirmatory testing is yet to be performed.
4. Link clients to appropriate services based on the result to T0
a. Clients with non–reactive T0 results shall be referred to appropriate services including retesting, SSNT, combination prevention services, and other ancillary services based on the needs of the client.
b. Clients with reactive T0 results shall be referred to an HIV treatment facility for linkage to confirmatory testing and care using an official referral form (Annex C.3) or by accompanying the client, if applicable.
(1) The HIV treatment facility which receives referred clients with initial reactive results shall repeat HIV testing within one week for the purpose of validation. Specimens shall be sent immediately to its designated CrCL or NRL – SLH/SACCL for confirmatory testing only if it has not been previously sent. If not done timely, the specimen shall be refrigerated and sent within one week of extraction.
(2) In cases when treatment facilities receive clients with confirmed positive results, the facility may repeat HIV testing if deemed necessary before initiating ART.
(3) The receiving HIV treatment facility shall perform clinical assessment and further management despite pending confirmatory results; clients shall be linked to treatment and care services, which include immediate initiation of ART, preferably same–day ART (in accordance with the national HIV treatment guidelines), effective and appropriate follow – up, case management, and continuous adherence counselling.
(4) The official confirmatory test results shall only be released to the referring facility by the CrCL or by the NRL – SLH/SACCL to ensure that the release of HIV confirmatory tests is accompanied by post–test counselling (see Annex I).
(5) Once the confirmatory test results are available, it is an ethical obligation of the treatment facility provider to check the test result is consistent with the label on the envelope and with that of the identified client. Upon verification of the result, they shall contact the client for further counselling and release of confirmatory test results.
(6) The treatment facility provider shall release the official copy of the confirmatory test results informing the client of the result simply, clearly and in an objective manner, and provide ample time to allow them to absorb the information via print or secured email.
(7) Provide further counselling (Annex I) and appropriate services based on the confirmatory test results:
· If confirmatory test is positive:
(a) CrCl and NRL – SLH/SACCL are required to report HIV positive results to the EB of the DOH.
(b) Continue medical management consistent with the national HIV treatment guidelines, case management, and counselling.
(c) Offer IT and/or SSNT
· If the confirmatory test is negative, the treatment facility shall perform the recommendations from the confirmatory laboratory as indicated in the confirmatory result, if there is any.
· If the confirmatory test is inconclusive, in cases that confirmatory laboratories will release such test results to the referring facility, the latter shall perform either (1) the recommendations of the national reference laboratory as indicated in the confirmatory result or (2) recommendations of Annex 1 of A.O. 2019 – 0001.
c. For clients with invalid or inconclusive T0 results, further services shall be provided based on the specific guidelines of FBT (Annex D), CBS (Annex E) and ST (Annex F).
d. All clients shall be referred to auxiliary services based on the needs of the client, which may include other sexual health services, mental health services, substance related harm reduction, and gender affirming services.
(1) For clients who disclosed sexual abuse, they shall be referred for clinical and psychosocial management and redress services. If reported within 5 days of occurrence, minimum clinical management include first – line support, HIV post–exposure prophylaxis (PEP) (if within 72 hours of sexual contact), STI presumptive treatment or prophylaxis, and other reproductive health–related services.
E. Retesting
1. The HTS provider shall advise the clients for retesting and contact them to notify retesting if they previously consented to provide their contact information.
2. Individuals who tested non–reactive and reported recent high–risk behaviour shall be retested at 4 weeks after the last HIV test.
3. Individuals presenting with STI or viral hepatitis, or those with recent HIV risk exposure shall be retested after 3 months from the last HIV test and then every 3 months for those with ongoing high–risk behaviour, especially as part of broader HIV prevention services.
4. Casual or intimate partners of PLHIV and key populations shall be retested for HIV annually.
5. Pregnant women who belong to key populations or partners of a PLHIV with unsuppressed VL shall be retested once in the first trimester (along with testing for HBsAg and Syphillis), once in a third trimester, and once postpartum (14 weeks, 6 months, or 9 months postpartum).
6. For all other pregnant women, consider retesting during 3rd trimester and postpartum (14 weeks, 6 months, or 9 months postpartum) if with an ongoing high risk of transmission.
7. Clients
with indeterminate or inconclusive rHIVda results shall be retested in
accordance with rHIVda guidelines (refer to A.O. 2019 – 0001)
VII. MONITORING AND EVALUATION
A. To ensure that HTS programs reach their intended population and identify previously undiagnosed HIV infections, the National HIV, AIDS and STI Prevention and Control Program (NASPCP) shall perform regular monitoring and evaluation and quality assurance and continuous quality improvement.
B. HTS Training on different modalities shall be delivered to providers of varied cadre.
C. Conducting an in–depth HTS situational analysis shall be done prior to optimizing HTS approaches. It shall also include a review of complementary packages of services to facilitate linkage to appropriate services, demand generation approaches for HTS, and its effectiveness.
D. Shared Ownership of Data
1. Securing clients’ personal data shall adhere to the protection provisions of R.A. No. 10173 Data Privacy Act of 2012 and its IRR of 2016.
2. All HTS providers involved in the implementation of any of the HTS delivery approaches shall observe proper documentation and report for monitoring and evaluation purposes.
3. Implementers may opt to keep copies of the reports and forms if all the following conditions are met:
a. The implementer fully understands the provisions of R.A. 11166 on confidentiality and R.A. 10173 on data privacy.
b. The implementer can provide a secured storage for the files.
c. Access to these files is limited to the HTS staff and the EB.
d. Test logs and other forms containing the client’s real name and personal information may only be kept by HTS providers.
E. The approach–specific indicators (see corresponding annexes) shall always be disaggregated in terms of geography, demographics, and particular population group (key population and their partners, pediatric and adolescent, pregnant). These shall be used to inform national – level indicators:
1. Number of PLHIV who know their status.
2. Number of key population clients tested for HIV and positivity rate.
3. Number of clients reached virtually.
F. While
internal assessments shall be done through internal auditing by site
supervisors and mentorship and supervision visits, there shall, likewise, be
external assessments through mechanisms which may include licensing for
laboratories, External Quality Assessment Schemes (EQAS), and other HTS
accreditation processes.
VIII. ROLES AND RESPONSIBILITIES
A. Disease Prevention and Control Bureau (DPCB) shall:
1. Augment resources of LGU to provide HTS.
2. Continually review and monitor the HTS Policies and Guidelines.
3. Formulate plans and policies to improve HTS implementation.
4. Forecast and plant availability of HTS supplies.
5. Inventory of HTS supplies.
6. Ensure availability of HIV testing, prevention, and treatment commodities.
B. Epidemiology Bureau (EB) shall:
1. Collect required data from regional and provincial epidemiology and surveillance units, HIV testing sites, and CHDs, and provide the status of outcome of HTS.
2. Maintain and update the HIV – AIDS & ART Registry of the Philippines (HARP) and the One HIV – AIDS and STI Information System (OHASIS).
3. Validate LGU data as needed through the Regional Epidemiology Surveillance Unit (RESU).
4. Provide quarterly updates on HIV/AIDS surveillance to the National HIV, AIDS and STI Prevention and Control Program (NASPCP).
C. Health Promotion Bureau (HPB) shall:
1. Implement demand generation activities and other promotional strategies regarding HTS.
D. Supply Chain Management Service (SCMS) shall:
1. Forecast, monitor, and perform inventory of HTS supplies.
E. Philippine National AIDS Council (PNAC) shall:
1. Monitor programs and activities related to the implementation of R.A. 11166 and HTS.
F. DOH Centers for Health Development (CHDs) and Ministry of Health – Bangsamoro Autonomous Region in Muslim Mindanao (MOH – BARMM) shall:
1. Collaborate with CBOs and LGUs to ensure implementation of these guidelines.
2. Facilitate capacity–building activities to implement the guidelines.
3. Provide mentorship and supervision in the implementation of HTS.
4. Forecast and Plan availability of HTS supplies.
5. Manage, resource, commodities, and supplies.
6. Inventory of HTS supplies.
7. Strengthen service delivery network for HTS and regularly update its directory.
8. Ensure testing sites’ compliance to certification and licensing requirements.
9. Ensure facilities’ compliance to accreditation requirements.
10. Submit HTS related reports to the Central Office.
G. National Reference Laboratory – STD AIDS Cooperative Central Laboratory (NRL – SACCL) shall:
1. Improve national confirmatory laboratory referral network.
2. Conduct regular review of the national testing algorithm.
3. Mentor HTS facilities on the development of site SOPs and job aids.
H. CrCl or facilities with rHIVda services shall:
1. Ensure compliance as CrCL and license to operate (LTO).
2. Maintain close collaboration with NASCPCP, EB, Treatment facilities, LGU, and SACCL to provide quality rHIVda service.
I. HIV TH, PHCC, and HIV Testing Facilities shall:
1. Integrate HTS in all relevant departments through the coordination of HACT.
2. Ensure compliance to recording and reporting on HTS.
3. Conduct internal monitoring and supervision to ensure provision of quality HTS.
J. Local Government Units shall:
1. Implement HTS in various departments in hospitals, targeted communities, health centers, RHU, RWHC, PHCC, TH and other HTS facilities.
2. Ensure that infrastructure of the facilities implementing HTS are fully functional.
3. Support and allocate funds for the implementation of quality control and participation in EQAS.
4. Inventory of HTS Supplies.
5. Provide appropriate resources to implement the guideline.
6. Employ monitoring and supervision mechanisms to ensure adherence to guidelines.
K. Non–government / Community–based / Civil Society Organization shall:
1. Actively engage in the development and implementation of HTS guidelines.
2. Assist in the dissemination of this policy.
3. Collaborate and coordinate with LGUs in implementation of HTS guidelines.
4. Ensure immediate linkage of HTS clients to appropriate services.
5. Provide feedback to LGU and CBOs on the quality of HTS they provide.
6. Coordinate with local authorities for appropriate delivery of HTS services.
L. Development Partners shall be encouraged to:
1. Provide technical support for development of HTS – related resources and materials to aid service providers in the implementation of the guidelines.
2. Assist in monitoring and evaluation of and mentorship and supervision to ensure delivery of quality HTS service.
IX. SEPARABILITY CLAUSE
If any clause, sentence, or provision of this Order shall be declared invalid or unconstitutional, the other provisions not affected thereby shall remain valid and effective.
X. REPEALING CLAUSE
The Administrative Order 2017 – 0019 or “Policies and Guidelines in the Conduct of Human Immunodeficiency Virus (HIV) Testing Services (HTS) in Health Facilities” and all other issuances inconsistent or contrary to the provisions of this Administrative Order are hereby repealed, amended, or modified accordingly.
XI. EFFECTIVITY
This Order shall take effect after
fifteen (15) days following its publication in a newspaper of general
circulation and upon filing of three (3) certified copies to the University of
the Philippines Law Center.
MARIA
ROSARIO SINGH – VERGEIRE, MD, MPH, CESO III
Officer–In–Charge
Department of Health
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