POPS Chapter 1 - Focused HIV/STI/HCV Testing, Counseling and Linkage to HIV Medical Care
Purpose: This chapter provides guidelines for HIV Prevention contractors and subcontractors on the delivery of consistent quality services regarding HIV testing to include syphilis and HCV rapid testing, counseling, and linkage to medical care. These guidelines are in accordance with the National HIV/AIDS Strategy to reduce HIV transmission, identify persons living with undiagnosed HIV, enhance timely linkage to medical care, and reduce health disparities. These guidelines are written to assist prevention specialists, HIV testers, outreach workers, Disease Intervention Specialists (DIS), and others who provide testing for HIV, herein after referred to as “HIV tester” in offering HIV/STI/HCV testing, counseling, and linkage services to clients at greatest vulnerability for acquiring HIV.
HIV testing services should follow a status neutral approach. Services should be focused on the client’s concerns and situation. Services should also be culturally competent with respect to race, ethnicity, gender, sexual orientation, age, language, literacy, relationship status, and other relevant factors.
These guidelines are written in accordance with the following: Texas Health and Safety Code, Title 2, Subtitle D Chapters 81, 85, and 93 (relating to Education and Prevention Programs for Hepatitis C); Title 25 of the Texas Administrative Code (TAC) Chapters 97 Subchapter B; and Chapter 98; and Texas House Bill Number 4.
Contractors should also review guidance from the CDC on HIV testing in non-clinical settings.
Each DSHS contractor must select priority populations from those identified by DSHS for the geographic area where services are provided. These priority populations have been selected based on state and local morbidity. To narrow the overall focus population(s) and to reach persons most vulnerable to HIV, agencies will need to know what behaviors and other risk factors are related to HIV vulnerability, who is engaging in these behaviors or is affected by these factors, and where to identify the priority population(s). This process will help to tailor messages and services in a way that resonates with the priority population(s) and develop a plan for how to engage these communities. Priority Populations.
DSHS contractors are expected to develop a recruitment and outreach plan that outlines when, where, and how recruitment of the priority population(s) will be conducted. The plan must include specifics about where to reach the priority population(s), as well as the specific recruitment strategies and messages that will be used for community engagement to provide HIV testing and other health and supportive services. This plan is to be updated annually and submitted to DSHS.
In order to have an effective and innovative program, resources should be dedicated to implementing an outreach and recruitment plan. Successful recruitment and outreach programs typically include the following:
- Hire and train specific recruitment staff who are separate from HIV testing or other prevention staff, and who are from within the communities served
- Build partnerships in the community to ensure multidirectional referrals and expand recruitment networks
- Use innovative approaches for reaching the focus population through the Internet and social media
- Offer tangible reinforcements to reach previously underserved priority populations, generate interest in new services, or obtain buy-in for testing venues where clients with increased vulnerability to HIV could need extra motivation to access HIV testing (e.g., bar or club)
- Provide supportive services that meet the needs of clients beyond HIV-related care
A comprehensive recruitment plan aims to deliver strategic, culturally competent, community-based recruitment strategies that engage the priority populations and motivate them to access HIV testing services and other prevention interventions.
DSHS contractors are expected to collaborate with other organizations that have a history of working with and recruiting the priority population(s). Agencies must seek input from community stakeholders, such as their Community Advisory Board, to select the most appropriate program promotion and recruitment strategies. Community stakeholders can also be useful for crafting recruitment messages, which may focus on increasing public awareness of services, destigmatizing HIV and HIV testing, and providing key information about HIV and HIV testing.
The six primary categories of recruitment/outreach strategies are the following:
Street-based and venue-based outreach - Conducted by engaging the focused testing priority population(s) in their own environment, such as a particular street, neighborhood, hot spot, or venue (e.g., a bar, hotel, or community center). Outreach workers, who may include HIV testing providers, aim to reach the focus population with key messages about HIV and HIV testing. HIV testing services may also be offered in conjunction with street- and venue-based outreach, if appropriate.
Internet outreach - Involves reaching the focus population through online venues, such as chat rooms, social networking sites, hook-up sites, and other mobile geosocial applications. Internet-based outreach may be especially useful for reaching young people and men who have sex with men (MSM) who do not identify as gay or who cannot be found in traditional outreach settings.
Internal Referrals - Accessing the focus population through other services offered by the DSHS contractor such as, substance misuse programs, mental health services, evidence-based HIV prevention interventions, STI testing and treatment programs, and HIV medical care (for partners of people already in care).
External referrals - Persons from the focus population are referred to HIV testing services by agencies outside of the DSHS contractor. External agencies may include substance misuse programs, mental health services, evidence-based HIV prevention interventions, STI testing and treatment programs, HIV medical care, and homeless shelters. These offsite programs identify people who are accessing their services that may benefit from HIV testing or other related services e.g., HIV/STI testing, ARTAS, or other risk-reduction interventions). Building strong partnerships with external agencies that tend to serve clients at risk of acquiring HIV is important, as is sharing information with them about how to make appropriate referrals to your program.
Social networking - A peer-driven approach to recruitment involves identifying persons living with HIV or individuals vulnerable to HIV from the community to serve as “recruiters” for your agency. Recruiters deliver key messages and encourage HIV testing among persons at risk of acquiring HIV in their social, sexual, or drug-using networks. Partner referral is a type of social networking that involves recruiters referring their sexual partners to an HIV testing program or other risk reduction interventions.
Social marketing - The use of media (e.g., flyers and brochures, posters, or advertisements using print, radio, television, or social media) to recruit clients into HIV testing programs and other risk reduction interventions. Agencies can develop their own social marketing campaigns but are encouraged to use existing resources, such as those available from CDC, and tailor them to their community’s specific requirements.. CDC’s Let’s Stop HIV Together is a collection of resources and campaign materials. Additional materials are also available on the CDC's Effective Interventions page.
1.1.1 Community Advisory Board
Contractors must maintain a Community Advisory Board (CAB) to assist with programmatic decision-making.
At a minimum your CAB must have the following:
Bylaws or policies regarding its role in your organization
- CAB members should have a position description that outlines the role and time commitment required for participation
- At a minimum the CAB must meet bi-annually
- You must keep meeting minutes and have those available for review by DSHS
- CAB membership must be reflective of your priority populations.
1.1.2 Condom Distribution
Contractors must develop policies and procedures for conducting condom promotion and distribution activities. The goal of condom promotion and distribution is to increase condom availability and use amongst persons with HIV and those at high risk of acquiring HIV and/or other sexually transmitted infections. Contractors must complete a community assessment to determine condom availability, accessibility, and acceptability in the community. This assessment should be used to determine condom distribution sites and identify new distribution partners.
Contractors are responsible for setting up mechanisms to report how many condoms were distributed during the grant year. Condoms purchased by DSHS or with DSHS funds may not be used for resale purposes and must be offered to the community at no cost.
In accordance with Texas Health and Safety code Chapter 81.046 all testing information and results are confidential, whether the client is tested confidentially, anonymously, or declines testing. HIV testers are expected to maintain and demonstrate a high level of confidentiality regarding client information and strictly adhere to the policies and procedures of their agencies. To maintain confidentiality, no information will be divulged to unauthorized persons that could lead to the identity of the client. Trained staff conducting testing services are bound by rules regarding confidentiality specified by the employing agency, the laws of the State of Texas and the local jurisdiction in which work is performed.
Violation: In accordance with Health and Safety Code HSC §81.103 Confidentiality; Criminal Penalty, breach of confidentiality is a Class A misdemeanor and is punishable by up to one year in jail and fines of up to $5,000. Violation of confidentiality is also a civil offense that may result in liability for damages plus fines.
The HIV/STD Breach of Confidentiality Response (TB/HIV/STD 2011.04) policy applies to all DSHS employees, IT staff, temporary employees, volunteers, students, DSHS program contractors, and any other person who could potentially view and/or have access to HIV/STI confidential information. All persons affected by this policy, as specified above, are responsible for the reporting of suspected breaches.
1.2.1 Consent for HIV Testing
In accordance with Vernon's Texas Code Annotated HSC §§81.105 Informed Consent and Health and Safety Code and HSC §§81.106 General Consent, a test designed to identify HIV transmission may not be performed without first obtaining the informed consent of the person being tested.
Consent need not be written if there is documentation in the client’s chart that the test has been explained to the client and verbal consent has been obtained. A person who has signed a general consent form for the performance of medical tests or procedures is not required to sign a specific consent form relating to HIV testing during the time in which the general consent form is in effect.
The result of a test for HIV performed under the authorization of a general consent may be used only for diagnostic or other purposes directly related to medical treatment of the client. Some institutions may have stricter policies concerning consent for HIV testing than that stated in statutes.
Violation: An individual or entity that tests without consent has committed a Class A misdemeanor.
1.2.2 Minor Consent
In accordance with Texas Family Code §32.003 Consent to Treatment by Child, a minor may consent to the diagnosis and treatment of STI that are required by law to be reported, including HIV, gonorrhea, chlamydia, chancroid, and syphilis regardless of the minor’s age and without the consent of the minor’s parent or guardian.
1.2.3 Anonymous and Confidential Testing
The terms anonymous and confidential have specific meanings regarding HIV testing.
Anonymous HIV testing - Anonymous testing refers to the practice of selecting a pseudonym consisting of a first name with a series of numbers (e.g., John 123, Jane 234) to assign to the documentation. Anonymous test results do not go into a client’s medical record. The client should be made aware that unless the client returns for results, the testing center may not be able to locate the person to provide the test results.
Confidential HIV testing - Confidential testing links valid name and locating information to test documentation and the test results are placed in the client’s medical record. The client will be informed that the location information in their record will be used to contact a client who does not return for results.
Clients may choose to be tested either confidentially or anonymously. All test results are maintained in a confidential manner regardless of the method selected by the client.
An anonymous HIV test requires use of a pseudonym consisting of a first name with a series of numbers (e.g., John 123, Jane 234) on documentation and retains no identifying or locating information beyond the demographic information required for the collection of epidemiological information. Some clients may request a phone call or text when their test results are received by the agency. In this instance, locating information may be retained by the agency where the client sought the HIV test.
The pseudonym should not be placed in the client’s medical record. Clients who test anonymously will sign the consent form using the agreed-on pseudonym.
All positive HIV, STI, and preliminary positive results from a rapid HIV test will be reported according to standards and procedures outlined in Chapter 8, HIV/STI Surveillance.
For more information on disease reporting see the DSHS HIV/STD Disease Reporting page.
For more information on reporting rapid HIV test results refer to Technical Assistance Bulletin: Reporting Rapid HIV Test Results, March 2010.
DSHS contractors funded to provide HIV testing must complete the following tasks regardless of the testing technology used.
- Obtain informed consent from client.
- Gather sociodemographic information including:
- Year of birth
- Client State
- Client County
- Client zip code
- Client assigned sex at birth
- Client current gender identity
- Client race, and
- Client ethnicity
- Offer both anonymous and confidential HIV testing.
- Conduct a brief HIV vulnerability assessment including:
- Reason for HIV test
- Recent sexual and injection drug use behaviors since last HIV test
- In the past five years, has the client:
- Had sex with a male, female, or transgender person
- Injected drugs or substances
- Date and type of recent risk exposure
- History of STI diagnosis and treatment, and
- Date of last HIV test and test result
- Ensure delivery of HIV/STI test results to client in a timely and appropriate manner (All staff conducting HIV/STI testing must be permitted to deliver all HIV and/or STI results, including positive results, in both field and clinical settings.).
- Provide basic information about HIV transmission and HIV testing including:
- Benefits of testing
- Behaviors that transmit HIV
- How to prevent HIV transmission, including PrEP, nPEP, and Treatment as Prevention (TasP)
- Testing technology used (rapid test, blood draw, or self-test kit); DSHS no longer supports the use of HIV oral fluid testing according to Policy Number 2013.02, except for organizations that have received approval to conduct Self-Testing
- Estimated Detection Period (EDP); EDP is the time period estimated from possible exposure to detection specific to the testing technology used. Contractors should refer to manufacturer’s guidelines to determine EDP including relation to retesting and discuss this information with clients
- When and how HIV test results will be provided to client
- Procedure if client receives a positive diagnosis (e.g., confirmatory or subsequent testing, introduction of partner services, linkage to care)
- Procedure if client tests negative and is interested in accessing PrEP
- Provide clients with population-specific, age appropriate, culturally affirming health messages and materials that address the client’s vulnerability to HIV acquisition and prevention needs, which may include an in-depth session if appropriate for client needs and demands of the setting, including education on Combination Prevention.
- Screen for PrEP and nPEP eligibility, using a locally validated or CDC supported screening tool. Policies and procedures for provision of navigation services, including offering and following up on referrals to clinical providers must be in place.
- Screen for and make referrals, as appropriate, for essential support services including:
- Health benefits and navigation enrollment
- Evidence-based risk reduction interventions
- Behavioral health services
- Social services
- Ensure supplemental testing is collected by venipuncture immediately, on-site, after a point of care HIV and syphilis health check preliminary positive test result. All staff conducting HIV/STI testing must have the ability to obtain specimens via venipuncture. All staff must provide HIV and/or syphilis screening(s) by collecting blood-based specimens, in both field and clinical settings. Staff will perform these tests unless the client refuses.
- Maintain a policy on how to report all positive test results, including preliminary positive results, in accordance with disease reporting rules.
- Maintain documentation as required in POPS Chapter 2.
Contractors wishing to use DSHS resources for HIV, Syphilis, and/or HCV rapid testing must submit evidence to DSHS that their governing body has researched and established policies and procedures to reflect the effect HIV and HCV rapid testing will have on their facility including:
- Procedures and quality assurance plan for rapid testing.
- Assurances that current insurance and other liability coverage is appropriate.
- Legal implications for conducting medical and laboratory procedures.
- Standing delegation orders from contractor’s medical authority.
- Provisions for medical waste disposal.
- Guidelines and standards developed by the Occupational Safety and Health Administration (OSHA) for occupational exposure through blood borne pathogens.
Contractors should review the Field Use of the Rapid Syphilis Health Check (SHC) Test to help develop policies and procedures.
In order to use DSHS funds to purchase rapid testing technology the test must be approved by the Federal Drug Administration (FDA) and CLIA waived.
1.5.1 Clinical Laboratory Improvement Amendments (CLIA)
Prior to implementing HIV, Syphilis, and/or HCV rapid testing, all grantees and subcontractors must have a current CLIA certificate of Compliance or Waiver.
CLIA establishes quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of client test results, regardless of where the test was performed. Requirements are based on the complexity of the test and not the type of laboratory where the testing is performed.
CLIA requires all facilities that perform even one test, including waived tests on, “materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings,” to meet certain Federal requirements. If a facility performs tests for these purposes, it is considered a laboratory under CLIA and must apply and obtain a certificate from the CLIA program that corresponds to the complexity of tests performed.
Visit the HHS CLIA webpage to learn more.
The Health Facility and Licensing Compliance Division of DSHS can assist you in obtaining a CLIA certificate of waiver.
1.5.2 Rapid HIV Testing Quality Assurance
Testing personnel must be trained to perform the rapid test, quality control and other related procedures. Testing personnel must follow the agency's policy and procedures and have a quality assurance plan for rapid testing in addition to following the instructions provided by the manufacturer for how to conduct the test.
The rapid test kit package insert provides text that can be used as a procedure for steps in the testing process, including pretest information; materials and storage; test performance; and quality control.
Documentation must be maintained to confirm that external controls are being run according to the test manufacturer’s schedule and that test kits are properly stored.
Helpful information for developing rapid HIV testing quality assurance guidelines can be found on the CDC website.
1.5.3 Standing Delegation Orders
In accordance with Title 22, Texas Administrative Code §193.2, a licensed physician shall supervise any medical care or procedure provided under a testing program. Orders should be available detailing the authorized staff/positions to administer the protocol and what test and diseases are covered by the standing delegation order. The Standing Delegation order must be reviewed and updated annually.
In accordance with DSHS Policy Number 2013.02, confirmatory testing must be collected by venipuncture on-site immediately after a point of care (e.g., rapid) preliminary positive test result. All indeterminate and non-reactive confirmatory tests must be automatically referred to for Nucleic Acid Amplification Testing (NAAT) to determine if a client has an acute HIV transmission. Blood specimens allow access to the newest and most sensitive technology that can detect acute infections and provide an opportunity to test for syphilis. Confirmatory testing using another protocol must be pre-approved by DSHS in writing.
HIV, gonorrhea, chlamydia, chancroid, and syphilis are reportable diseases. Texas law requires a report of disease be submitted to the local and regional health department. Please review this requirement on the DSHS HIV/STD Disease Reporting page. Reportable conditions include preliminary positive HIV test results.
Specific arrangements should be made to ensure all clients receive their HIV test results in a timely and appropriate manner. A reliable process for verifying the client’s identity before providing test results and protecting client confidentiality must be established prior to providing any test result.
Negative HIV and syphilis test results may be given by telephone or other technology. Policies and procedures must be in place and describe under what circumstances negative results will be made available by telephone or other technology and outline the protocol for giving negative results. Programs that wish to provide negative test results via telephone or other technology must make their program’s policies and procedures available to DSHS.
All staff conducting HIV/STI testing must be permitted to disclose the reason s/he is contacting the client (ex. notification of results, follow up on a preliminary positive, linkage to HIV and/or STI testing, treatment and care activities, etc.).
Providers must ensure that all clients tested for HIV receive information on Combination Prevention, including PrEP, nPEP, and TasP, and are referred to clinical, social services, and other needed services as appropriate. Combination Prevention educational information must be supported with materials approved by DSHS.
In accordance with Health and Safety Code HSC §81.109 Counseling Required for Positive Test Results, a client must receive their HIV diagnosis with the immediate opportunity for individual, face-to-face counseling. For this reason, all HIV diagnosis and indeterminate test results in DSHS, or DSHS-affiliated sites, will be given in person with an immediate opportunity for counseling. If unable to deliver results to persons with an HIV diagnosis (unable to locate, client does not return for results, etc.), all available information on the person should be submitted to the local or regional health department for public health follow-up. Communication with the local or regional health department must be noted in the client file.
Not every client who requests an HIV test requires an enhanced assessment. Trained staff use professional discretion based on a brief assessment to determine the level of assessment required. Enhanced assessments are appropriate for those persons with increased vulnerability to acquiring or transmitting HIV, STI, and HCV, and should integrate combination prevention education. In general, a person is thought to be vulnerable to HIV, STI, and HCV, based on their sexual and drug use behavior and the community viral load.
Decisions about the duration or extent of a session will be based on several factors, including:
- Setting - In-depth, personalized assessment prevention counseling may not be feasible in some settings. The intent of some events may be to screen a high number of people in a short amount of time, in which case conducting enhanced assessment would not be appropriate because staff would be able to test and counsel only a small number of clients.
- Client risk profile - If the setting is conducive to individualized counseling, qualified staff should consider the client’s reported vulnerabilities /vulnerability to HIV acquisition. If the client reports little to no vulnerability for HIV, STI and HCV acquisition, there is no need to conduct an enhanced assessment. Instead, staff can provide brief tailored health messages about Combination Prevention reducing vulnerability to HIV acquisition and close the session. If the client does report increased vulnerability behaviors that may lead to HIV acquisition, an attempt to conduct an enhanced assessment should be made.
- Client willingness - If the client reports behaviors that may increase/ increased vulnerability to HIV acquisition and a readiness to engage in the process of individualized Combination Prevention, qualified staff can proceed with an enhanced assessment. If the client is reluctant, provide tailored health messages, test the client, and let the client know that they may return in the future to continue the discussion of reducing vulnerability to HIV acquisition.
When the need for an enhanced assessment is determined, trained staff should use active communication skills to:
- Determine client concerns, needs, and priorities;
- Provide basic information about HIV, STI and HCV transmission, and testing;
- Support the client to reach a better understanding of personal HIV/STI vulnerability;
- Discuss combination prevention approach; and
- Make referrals as appropriate.
Contractors will maintain appropriate referral networks to provide accessible and appropriate referrals to clients in need of additional services (mental health counseling, substance abuse treatment, intensive case management, etc.).
Any client who has a positive HIV result must be provided with the following:
- Face-to-face counseling
- Emotional support to understand the meaning of the test result and access social support
- Explanation of the benefit of initiating and remaining in HIV medical care as well as medication adherence
- Coordinated partner services and public health follow-up with the local or regional health department
- Confirmation of linkage to HIV-medical care (DSHS standard is to maintain communication with the client for a minimum of 90 days or until the first HIV medical appointment is confirmed.)
- Essential support services referrals, as appropriate;
- Ongoing support/navigation services for engagement and re-engagement in HIV-medical care
- A copy of test results to the client for proof of diagnosis (An anonymous test will not include the client’s name.)
Contractors shall work with a client to establish an HIV-related medical care appointment, follow up with the client, prepare client for medical care, and confirm the client attended the appointment. This applies to individuals newly diagnosed as well as those previously diagnosed and not currently in HIV-related medical care.
Contractors must immediately link persons to HIV medical care based on a preliminary positive result. A confirmatory HIV diagnosis is not required to begin this process.
Support needed by clients to enter care may differ based on their diagnosis and history of treatment. To determine which services are needed, providers must verify testing history and participation in HIV-related medical care with disease surveillance staff. This process includes:
- Obtaining written client authorization to allow the local health authority or regional public health department to release information related to the client’s HIV diagnosis and treatment history. An Authorization to Release Confidential Information Form should be completed and signed by the client. The form will specify to whom the information is being released, the purpose of the release and the specific information to be released.
- Sharing the signed Authorization to Release Confidential Information form with the local health authority or regional public health department and obtaining the client’s HIV diagnosis and treatment history.
If the client refuses permission for such verification, then client self-report of diagnosis history and participation in care should be used to guide linkage activities.
1.9.1 Confirmation of HIV Medical Care
Contractors must verify and document client’s attendance of a HIV-related medical appointment. The following are evidence options:
- Verbal or written confirmation from the care provider
- Medical appointment in a care reporting system
- CD4 or viral load test with confirmation of a medical appointment
- Confirmation from an intermediate provider, such as Disease Intervention Specialist (DIS), or case manager
- Self-report from the client (DSHS will accept client self-report in the rare circumstances that the DSHS contractor has attempted and was unable to verify client attendance using the above approaches.)
Varied attempts (phone call, letter, field visit, e-mail, text message) to contact persons should be made when trying to link to medical care. Date, time, activity, and result of attempts to link clients must be documented. Contractors should continue to attempt to link clients to medical care for a minimum of 90 days.
Contractors must ensure client confidentiality is maintained while attempting to link persons to care.
Contractors should visit the DSHS Laboratory website for information on specimen collection, submission, Laboratory Testing Forms, and shipping. Contractors are not required to use DSHS lab for specimen submission.
List of Helpful Websites and Websites Referenced in Chapter 1
The Use of Testing Technology to Detect HIV Infection Policy Number 2013.02 can be found at the following DSHS website: Policies 2013-02
Information regarding reportable diseases can be found at the following DSHS website: HIV/STD Reporting
Information on HIV/STI training requirements can be found at the following DSHS website: HIV/STD Training
DSHS Laboratory information can be found at the following DSHS website: Laboratory Information
Information regarding Facility Security Agreement and User Security Rights and Confidentiality can be found at the following DSHS website: Remote Data
CLIA certificate of wavier and certificate application can be found at the following HHS website: Clinical Laboratory Improvement Amendments
Information for developing rapid HIV testing quality assurance guidelines can be found on the CDC website: Testing QA Guidlines