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HIV Rapid Testing:
Resources and References for Reproductive
Health Care Providers

 

Hard copies of this resource are still available. Please contact Jennifer Kawatu, Program Manager at jkawatu@jsi.com to request copies.

Please contact Amy Behrens, Training Coordinator at abehrens@jsi.com
if any of the links are not up to date.

Welcome to the online version of HIV Rapid Testing: Resources and References for Reproductive Health Care Providers, a self-study module recently published in print and distributed throughout Region I.

HIV rapid testing is a quickly evolving field. Testing technologies continue to change and best practices continue to emerge. To keep current it is important to check websites regularly for new developments, relevant research and updated versions of key documents such as those included in this module. To make it easy to check for updates, we have created this online version of the module, which includes links to all of the documents included in the printed version. To access the most recent version of a document, go to the Table of Contents following this Introduction, and find the link for the document you wish to see. Please be aware that links change; it is prudent to periodically check the home page of the website a document is posted on for additional updates.

Table of Contents:

Project Background

Section I: Rapid Testing Basics
Section I documents provide an overview of HIV rapid testing. They include fact sheets, frequently asked questions (FAQs), and a matrix of available tests. The final document in the section, Implementing Rapid HIV Testing: A Primer for State Health Departments, provides a clear summary of reasons to adopt rapid testing as well as the potential barriers to doing so, along with a comprehensive discussion of the many factors to consider in developing an implementation plan for offering HIV rapid testing. Although the document is targeted to state health departments many of the considerations discussed are relevant to clinical sites.

Section II: Implementation Guidance
The documents in this section provide a comprehensive overview of program requirements for the implementation of HIV rapid testing, and very specific examples of policies, procedures and protocols for conducting HIV rapid testing and for counseling. The section begins with a self-assessment for agencies considering implementation of a rapid testing program, produced by the New York State Department of Health AIDS Institute. This is followed by CDC’s Quality Assurance Guidelines for Testing Using the OraQuick ® Rapid HIV-1 Antibody Test, and the Washington State Department of Health’s very complete rapid HIV testing and counseling guide. While the New York and Washington documents necessarily contain some information specific to those states and not directly applicable to Region I states, most of the information and guidelines provided are highly relevant to and useful for Title X settings in New England.

Section III: CLIA Certificate of Waiver
To be able to offer HIV rapid testing to clients, a family planning clinic must obtain a CLIA Certificate of Waiver, indicating that it has met certain basic conditions that ensure safe and effective administration of the test. This section’s documents provide information on the CLIA program, an explanation of the Certificate of Waiver and how to apply, sample forms, and CLIA contacts for all Region I states.

Section IV: HIV Counseling with Rapid Tests
This section’s documents include sample protocols for counseling with rapid tests, including the single-session protocols developed by Project RESPECT, a counseling with rapid testing flow sheet, guidelines for communicating the meaning of test results, and a sample documentation form. For a broader discussion of HIV risk assessment and HIV risk reduction counseling, please see Integrating HIV Prevention and Family Planning Services: Organizational Self-Assessment Manual (pdf).

Section V: HIV Rapid Testing Training Resources
Training is essential for all staff involved in HIV rapid testing, whether administering and interpreting the test, providing counseling around the test, delivering test results, or all of the above. This section’s documents provide leads as to where to look for such training, and include a training checklist, contact information for agencies that may offer rapid testing training, an online course description, and a summary of specific training resources available in Region I.

Section VI: Materials from the Manufacturer
This section’s documents include package inserts and subject information pamphlets for OraQuick Rapid HIV-1 Antibody Test, and OraQuick Advance Rapid HIV-1/2 Antibody Test, as well as the manufacturer’s step-by-step instructions for performing the tests. Package inserts for the test kit controls are also included. Please note that these materials are periodically revised as test technologies improve. It is especially important for health care providers to be sure that they have in hand the most up-to-date version of the package insert and test instructions, so please use these links often. The first document in Section VIII contains a link to the website for Orasure Technologies, the maker of the OraQuick tests.

Section VII: Lessons Learned: HIV Rapid Testing in Region I Title X Settings
This Word document includes the results of telephone interviews with several family planning clinics in Region I that are currently offering HIV rapid testing in their sites. In the summaries provided, respondents explain their “service model”—how HIV rapid testing is provided in their setting--and describe how HIV rapid testing has affected “clinic flow” in their sites. They discuss what they see as the benefits and drawbacks of rapid testing for both clients and staff, and whether rapid testing has brought new clients to the clinic. Finally they offer their thoughts on what family planning clinics should consider and do as they prepare to offer HIV rapid testing to clients. The “wisdom of experience” offered in this section provides a valuable complement to the factual information and technical guidance included in the other sections.

Section VIII: Other Resources
The first document in this section is a Word document containing an annotated listing of helpful websites (CDC, AIDS Education and Training Centers (AETCs), Region I state departments of health, etc.) This is followed by two documents not directly relevant to family planning settings but that may be of interest to some users: CDC’s Rapid HIV Antibody Testing During Labor and Delivery for Women of Unknown HIV Status, and Rapid HIV Tests: Guidelines for Use in HIV Testing and Counseling Services in Resource-Constrained Settings by the World Health Organization.

Authors and Contributors

Project Background

For the past several years, through a CDC cooperative agreement, JSI Research and Training Institute, Inc. has offered training and technical assistance on HIV integration and client-centered counseling to reproductive health providers in Region I. This cooperative agreement is a collaboration with the Region I Title X Family Planning Training Center (RTC), funded through the Office of Population Affairs/Office of Family Planning (OPA/OFP). Its overall purpose is to support integration of HIV prevention services into reproductive health clinical and community settings.

In keeping with CDC’s Advancing HIV Prevention Initiative, a key activity for project year 2005 was to develop a self-study resource module on HIV rapid testing. The module, entitled HIV Rapid Testing: Resources and References for Reproductive Health Care Providers, is a compilation of the best references and resources available to inform and guide family planning agencies and other reproductive health care providers as they consider, plan and implement rapid testing in their particular setting. While the module can stand alone, it is also intended as a supplement to Region I’s 2004 publication, Integrating HIV Prevention and Family Planning Services: Organizational Self-Assessment Manual (pdf).

To gather the references and resources included in the module, JSI conducted a comprehensive search of websites of organizations that are leaders in the field of HIV prevention and treatment, including federal agencies such as CDC, FDA and HRSA; state departments of public health; other public health professional organizations, such as NASTAD; websites directed at HIV clinical providers, and test manufacturer websites. All materials included are in the public domain, or are documents that have been made available as pdfs. Many of the documents selected for inclusion focus on the OraQuick rapid HIV test, as this is the test for which CDC has established quality assurance guidelines. Basic information on the other HIV rapid tests currently available may be found in Section I.

Back to Table of Contents

 

Section I: Rapid Testing Basics

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Section II: Implementation Guidance

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Section III: CLIA Certificate of Waiver

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Section IV: HIV Counseling with Rapid Tests

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Section V: HIV Rapid Testing Training Resources

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Section VI: Materials from the Manufacturer

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Section VII: Lessons Learned: HIV Rapid Testing in Region I Title X Settings

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Section VIII: Other Resources

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Authors and Contributors

Project Manager: Gail Merriam, MSW, MPH, JSI Research and Training Institute, Inc.
Binder Coordinator: Deborah Dean, MSPH, JSI Research and Training Institute, Inc.
Project Assistant: Nebulla Stephen, JSI Research and Training Institute, Inc.

Review Team:
Michele Clark, MPH, JSI Research and Training Institute, Inc.

Kathy Desilets, Family Planning Program Manager
New Hampshire Office of Community and Public Health

Deborah Dill, MSN, WHNP, Clinical Manager
ABCD/Boston Family Planning

Susan Grantham, MPP
JSI Research and Training Institute, Inc.

Susan Hellen, Manager of Training and Special Projects
Planned Parenthood of Connecticut (PPCT)

Myriam Hernandez Jennings, MA
JSI Research and Training Institute, Inc.

Marcia Szymanski, MSW, Assistant Director
Health Care of Southeastern Massachusetts, Inc. (HCSM)

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For further information about HIV rapid testing, contact the CDC, National Center for HIV, STD and TB Prevention, Division of HIV/AIDS Prevention, or your state health department’s HIV/AIDS office.

 

 

 
   
   
     
 
   
 
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  Please note that this site contains HIV prevention messages that may not be appropriate for all audiences.
   
  Creation and administration of this site is partially funded by the Office of Family Planning, Office of Population Affairs, Office of Public Health and Science, the Department of Health and Human Services, and the Centers for Disease Control and Prevention, Division of Reproductive Health. Contents of this site are solely the responsibility of JSI Research & Training Institute and do not necessarily represent the official views of the Department of Health and Human Services or the Centers for Disease Control and Prevention.
   
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