HIV Rapid Testing & Counseling in Sexually Transmitted Disease (STD) Clinics in the U.S.

NCT01154296 | Completed Results DMC

• 2 other identifiers: AAAK31531RC2DA028973-01
• Study Type: interventional
• Target: 5,012
• Locations: 1 country
• Sites: 9

Brief Summary

Project Aware is a randomized controlled clinical trial in which individuals seeking medical or health services at sexually transmitted disease (STD) clinics are recruited to participate in a multi-center HIV testing and counseling study. The investigators will assess the relative effectiveness and cost-effectiveness of (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling vs. (2) on-site HIV rapid testing with information only. The investigators will evaluate the effect of counseling on one primary outcome: STI incidence. Secondary outcomes will be reduction of sexual risk behaviors, substance use during sex (i.e., being under the influence during sex) and cost and cost effectiveness of counseling and testing. Participants will be assessed for sexually transmitted infections, HIV testing history and sexual and drug use risk behaviors at baseline and at 6-months follow-up. Approximately 5,000 individuals seeking medical or health services from approximately 9 STD clinics throughout the United States will be randomized. These individuals will be 18 years of age or older and efforts will be made to recruit a sample of study participants that reflects the proportion of minorities and gender in the STD clinic performance sites from which the investigators are recruiting.

Conditions

HIV/AIDS; Sexually Transmitted Infections

Keywords

HIV; Rapid Testing; Counseling; STD; U.S.

Outcome Measures

Primary Outcomes (1)

• STI Incidence

  Composite STI incidence (Yes/No) at 6-month follow-up in which a person is considered positive for STIs if they are positive on any tested STI.

  6 months post randomization

Secondary Outcomes (5)

• Sexual Risk Behavior -- # of Sex Acts

  6 months post randomization

• Sexual Risk Behavior -- # of Unprotected Sex Acts

  6 months post randomization

• Sexual Risk Behavior -- # of Partners

  6 months post randomization

• Sexual Risk Behavior -- # of Unprotected Partners

  6 months post randomization

• Sexual Risk Behavior -- # of Sex Acts With Substance Use

  6 months post randomization

Study Arms (2)

Rapid HIV Testing w/ Counseling (Group 1)

EXPERIMENTAL

Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.

Behavioral: RESPECT-2 Counseling

Rapid HIV Testing & Information Only (Group 2)

NO INTERVENTION

Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.

Interventions

RESPECT-2 Counseling BEHAVIORAL

Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.

Also known as: RESPECT-2 Protocol

Rapid HIV Testing w/ Counseling (Group 1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Site Eligibility:
• high rates of STIs and HIV in their geographic target area,
• sufficient number of patients so that they would be able to recruit the required 556 participants over the study time period,
• prior participation in research and clinical studies, and
• previous collaboration with investigators.
• Participant eligibility:
• be seeking medical or health services at the participating STD clinic,
• be at least 18 years old,
• report being HIV-negative or status unknown,
• provide informed consent,
• provide locator information,
• be able to communicate in English,
• agree to be tested for STIs/STDs and HIV;
• sign a HIPAA form and/or medical record release form to permit medical record abstraction of HIV and STI/STD tests, results and treatment; and
• report living in the vicinity of the clinic and being able to return to the clinic for the 6-month follow-up visit.

You may not qualify if:

• Sites:
• low rates of STIs and HIV in their geographic target area,
• insufficient number of patients to meet study needs of 556 per site
• no prior participation in research and clinical studies, and
• no previous collaboration with investigators.
• Participants:
• Not seeking medical or health services at the participating STD clinic,
• under 18 years old,
• HIV positive,
• unwilling to provide Informed Consent,
• refuse to provide locator information,
• not able to communicate in English,
• Disagree to be tested for STIs/STDs and/or HIV, and
• unwilling to sign a HIPAA form and/or medical record release form to permit medical record abstraction of HIV and STI/STD tests, results and treatment,
• report living out of the vicinity and unable to return to the clinic for the 6-month follow-up visit.

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• University of Pittsburgh: collaborator
• University of California, San Francisco: collaborator
• Oregon Health and Science University: collaborator
• Medical University of South Carolina: collaborator
• Research Foundation for Mental Hygiene, Inc.: collaborator
• Duke University: collaborator
• The Emmes Company, LLC: collaborator
• San Francisco Department of Public Health: collaborator
• University of California: collaborator
• Weill Medical College of Cornell University: collaborator

Study Sites (9)

Los Angeles Gay & Lesbian Center

Los Angeles, California, 90028, United States

Location

San Francisco Department of Public Health

San Francisco, California, 94102, United States

Location

Whitman-Walker Clinic

Washington D.C., District of Columbia, 20009, United States

Location

Duval County Health Department

Jacksonville, Florida, 32206, United States

Location

Miami-Dade County Health Department

Miami, Florida, 33125, United States

Location

Multnomah County Health Department

Portland, Oregon, 97204, United States

Location

Allegheny County Health Department

Pittsburgh, Pennsylvania, 15213, United States

Location

Richland County Health Department

Colombia, South Carolina, 29204, United States

Location

Public Health Seattle & King County

Seattle, Washington, 98107, United States

Location

Related Publications (2)

• Metsch LR, Feaster DJ, Gooden L, Schackman BR, Matheson T, Das M, Golden MR, Huffaker S, Haynes LF, Tross S, Malotte CK, Douaihy A, Korthuis PT, Duffus WA, Henn S, Bolan R, Philip SS, Castro JG, Castellon PC, McLaughlin G, Mandler RN, Branson B, Colfax GN. Effect of risk-reduction counseling with rapid HIV testing on risk of acquiring sexually transmitted infections: the AWARE randomized clinical trial. JAMA. 2013 Oct 23;310(16):1701-10. doi: 10.1001/jama.2013.280034.

  PMID: 24150466 RESULT

• Alcaide ML, Feaster DJ, Duan R, Cohen S, Diaz C, Castro JG, Golden MR, Henn S, Colfax GN, Metsch LR. The incidence of Trichomonas vaginalis infection in women attending nine sexually transmitted diseases clinics in the USA. Sex Transm Infect. 2016 Feb;92(1):58-62. doi: 10.1136/sextrans-2015-052010. Epub 2015 Jun 12.

  PMID: 26071390 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Lisa Metsch, PhD, Stephen Smith Professor and Chair of Sociomedical Sciences
• Organization: Department of Sociomedical Sciences/Mailman School of Public Health/Columbia University

lm2892@columbia.edu

212-305-3577

Study Officials

• Lisa R. Metsch, Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

• Grant N Colfax, M.D.

  San Francisco Department of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stephen Smith Professor of Sociomedical Sciences and Chair, Department of Sociomedical Sciences

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: June 30, 2010
• Study Start: April 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: February 1, 2012
• Last Updated: September 29, 2014
• Results First Posted: September 29, 2014

Record last verified: 2014-09

Locations

US (9)