HIV Testing in Nonclinical Settings

HIV testing can be done in a variety of nonclinical or community-based settings, including fixed venues, outreach sites, or in a person’s home. Nonclinical settings are easily accessible and comfortable for populations who might not access medical services regularly. They typically provide same-day rapid HIV testing, might offer other HIV prevention services, and conduct recruitment services to get high-risk populations in for targeted HIV testing. HIV testing in these settings offers an effective way to bring HIV testing to the community. This section offers key references and information for persons conducting HIV testing in nonclinical settings.

CDC Guidance on HIV Testing in Nonclinical Settings

NEW! CDC issued program guidance for HIV testing providers called Implementing HIV Testing in Nonclinical Settings: A Guide for HIV Testing Providers. This guide supports the implementation of HIV testing services in nonclinical settings in the United States. The purpose of the guide is to familiarize providers with key programmatic issues and updates that impact HIV testing service delivery in nonclinical settings. Although this guidance is intended for CDC-funded nonclinical HIV testing providers, non-grantees may also find the content useful.

• Implementing HIV Testing in Nonclinical Settings: A Guide for HIV Testing Providers
• Job Aids to Support Implementing HIV Testing in Nonclinical Settings
  • Protocol Cards for HIV Testing with Individuals in Nonclinical Settings
  • Provider Flip Card for HIV Testing with Individuals in Nonclinical Settings
  • Scripts for HIV Testing with Individuals in Nonclinical Settings
  • Protocol Cards for HIV Testing Together (Couples) in Nonclinical Settings
  • Provider Flip Card for HIV Testing Together (Couples) in Nonclinical Settings
  • Scripts for HIV Testing Together (Couples) in Nonclinical Settings
• Updated December 2016 Frequently Asked Questions about Implementing HIV Testing in Nonclinical Settings

Implementing HIV Testing in Nonclinical Settings: A Guide for HIV Testing Providers complements the document Planning and Implementing HIV Testing and Linkage Programs in Nonclinical Settings: A Guide for Program Managers, and the Evaluation Guide for HIV Testing and Linkage Programs in Nonclinical Settings, which are both intended for HIV program managers.

Laboratory Certificate Requirements for HIV Testing in Nonclinical Settings

Nonclinical HIV testing sites using waived rapid HIV tests must either obtain their own certificate of waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) or establish an agreement to work under the CLIA certificate of an existing laboratory. CLIA outlines quality standards for laboratory testing—including rapid HIV testing—to ensure the accuracy, reliability, and timeliness of patient test results. Agencies should contact their state or local health department for more information, including how to apply for a CLIA waiver. More information about CLIA certification and CLIA-waived tests, including how to establish a CLIA-waived HIV testing site, can be found on CDC’s website at the following links:

• CDC CLIA home page
• CDC CLIA of Certificate Waiver Fact Sheet
• State agency & regional office CLIA contacts
• How to establish an Individualized Quality Control Plan (IQCP) for HIV-CLIA waived testing
• Additional resources for setting up a nonclinical testing site

HIV Testing Technologies

• Updated November 2016 CLIA-waived rapid HIV tests
• Guidance for nonclinical HIV testing sites that use a laboratory-based algorithm
• Updated May 2016 Alere Determine™ HIV-1/2 Ag/Ab Combo Information Sheet for Testing Programs
• CDC’s Rapid HIV Testing Online Training Course

Related Recommendations and Guidelines

• HIV recommendations and guidelines
• STD & HIV Screening Recommendations
• Hepatitis C Virus testing information
• Recommendations for Partner Services Programs for HIV Infection, Syphilis, Gonorrhea, and Chlamydial Infection
• Partner Services Providers Quick Guide

Journal Articles

Acute HIV Infection

• Screening Yield of HIV Antigen/Antibody Combination and Pooled HIV RNA Testing for Acute HIV Infection in a High-Prevalence Population. Peters PJ, Westheimer E, Cohen S, et al. JAMA 2016;315(7):682-690.
• Estimating Per-act HIV Transmission Risk: A Systematic Review. Patel P, Borkowf CB, Brooks JT, et al. AIDS 2014;28(10):1509-19

Home-Based HIV Self-Testing

• HIV Self-Testing: A Review of Current Implementation and Fidelity. Estem KS, Catania J, Klausner JD. Curr HIV/AIDS Rep 2016 Feb 15; Epub.
• Acceptability and Feasibility of HIV Self-Testing Among Transgender Women in San Francisco: A Mixed Methods Pilot Study. Lippman SA, Moran L, Sevelius J, et al. AIDS Behav 2015 Oct 28; Epub.
• HIV-Negative Partnered Men’s Attitudes Toward Using an In-Home Rapid HIV Test and Associated Factors among a Sample of US HIV-Negative and HIV-Discordant Male Couples. Mitchell JW, Sullivan PS. Sex Transm Dis 2015;42(3):123–128.

Linkage and Referral

• Brief Strengths-Based Case Management Promotes Entry Into HIV Medical Care: Results of the Antiretroviral Treatment Access Study-II. Craw J, Gardner LI, Marks G et al. J Acquir Immune Defic Syndr 2008;47(5):597-606.
• Demographic, Psychological, and Behavioral Modifiers of the Antiretroviral Treatment Access Study (ARTAS) Intervention. Gardner LI, Marks G, Craw J, et al. AIDS Patient Care STDs. 2009;23(9): 735-742.
• Optimizing Human Immunodeficiency Virus Testing Interventions for Men Who Have Sex With Men in the United States: A Modeling Study. Delaney KP, Rosenberg ES, Kramer MR, et al. Open Forum Infect Dis 2015;2(4):ofv153.

Prevention Counseling and HIV Testing

• Effect of Risk-Reduction Counseling with Rapid HIV Testing on Risk of Acquiring Sexually Transmitted Infections: The AWARE Randomized Clinical Trial. Metsch LR, Feaster DJ, Gooden L, et al. JAMA 2013;310(16):1701-10.

Targeting and Recruitment

• Comparison of Strategies to Increase HIV Testing among African-American Gay, Bisexual, and Other Men Who Have Sex With Men in Washington, DC. Baytop C, Royal S, Hubbard McCree D, et al. AIDS Care 2014;26(5):608-12.
• Cost-Effectiveness of Finding New HIV Diagnosis Using Rapid HIV Testing in Community-Based Organizations. Shrestha RK, Clark HA, Sansom SL, et al. Public Health Rep 2008;123 Suppl 3:94-100. 

Testing Couples Together for HIV

• Are Couple-Based Interventions More Effective than Interventions Delivered to Individuals in Promoting HIV Protective Behaviors? A Meta Analysis. Crepaz N, Tungol-Ashmon MV, Vosburgh HW, et al. AIDS Care 2015;27(11):1361-1366.
• Risk of Intimate Partner Violence and Relationship Conflict Following Couple-Based HIV Prevention Counseling: Results From the Harlem River Couples Project. McMahon JM, Chimenti R, Trabold N, et al. J Interpers Violence. 2015 Aug 27; Epub.
• Technical Assistance Needs for Successful Implementation of Couples HIV Testing and Counseling Intervention for Male Couples at US HIV Testing Sites. Stephenson R, Grabbe KL, Sidibe T, et al. AIDS Behav 2015 Aug 8. Epub.
• The Prevalence of Undiagnosed HIV Serodiscordance among Male Couples Presenting for HIV Testing. Sullivan PS, Wall KM, O’Hara B, et al. Arch Sex Behav 2014;43(1):173-80.
• Estimating the Proportion of HIV Transmissions from Main Sex Partners among Men Who Have Sex with Men in Five U.S. Cities. Sullivan PS, Salazaar L, Buchbinder S, and Sanchez TH. AIDS 2009;23(9):1153–1162.

Testing Technologies and Approaches

• Performance of Determine Combo and other point-of-care HIV tests among Seattle MSM. Stekler JD, Ure G, O’Neal JD, et al. J Clin Virol 2016;76:8-13.
• Using a Multitest Algorithm to Improve the Positive Predictive Value of Rapid HIV Testing and Linkage to HIV Care in Nonclinical HIV Test Sites. Delaney KP, Rurangirwa J, Facente S, et al. J Acqir Immune Defic Syndr 2016;71(1):78-86.
• Assessment of Oral Fluid HIV Test Performance in an HIV Pre-Exposure Prophylaxis Trial in Bangkok, Thailand. Suntharasamai P, Martin M, Choopanya K, et al. PLoS ONE 2015;10(12):e0145859.
• Comparison of HIV Oral Fluid and Plasma Antibody Results during Early Infection in a Longitudinal Nigerian Cohort. Luo W, Masciotra S, Delaney KP, et al. J Clin Virol 2013;58(Suppl 1):e113–e118.
• Performance of the Alere Determine HIV-1/2 Ag/Ab Combo Rapid Test with Specimens from HIV-1 Seroconverters from the US and HIV-2 Infected Individuals from Ivory Coast. Masciotra S, Luo W, Youngpairoj AS, et al. J Clin Virol 2013;58(Suppl 1):e54–e58.
• Relative Accuracy of Serum, Whole Blood, and Oral Fluid HIV Tests among Seattle Men Who Have Sex with Men. Stekler JD, O’Neal JD, Lane A, et al. J Clin Virol 2013;58(Suppl 1):e119-22.
• Evaluation of the Performance Characteristics of 6 Rapid HIV Antibody Tests. Delaney KP, Branson BM, Uniyal A, et al. Clin Infect Dis 2011;52(2):257-63.

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