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

This study has been completed.
Sponsor:
Collaborators:
University of Pittsburgh
University of California, San Francisco
Oregon Health and Science University
Medical University of South Carolina
Research Foundation for Mental Hygiene, Inc.
Duke University
The EMMES Corporation
San Francisco Department of Public Health
University of California
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Lisa Metsch, Columbia University
ClinicalTrials.gov Identifier:
NCT01154296
First received: June 29, 2010
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
HIV/AIDS
Sexually Transmitted Infections
Behavioral: RESPECT-2 Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Screening
Official Title: Project Aware: HIV Rapid Testing & Counseling in STD Clinics in the U.S. -- an Adaptation of CTN 0032

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • STI Incidence [ Time Frame: 6 months post randomization ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Sexual Risk Behavior -- # of Sex Acts [ Time Frame: 6 months post randomization ] [ Designated as safety issue: No ]
    Self-reported continuous variables to determine number of (vaginal and/or anal) sex acts.

  • Sexual Risk Behavior -- # of Unprotected Sex Acts [ Time Frame: 6 months post randomization ] [ Designated as safety issue: No ]
    Self-reported continuous variables to determine number of unprotected (vaginal and/or anal) sex acts

  • Sexual Risk Behavior -- # of Partners [ Time Frame: 6 months post randomization ] [ Designated as safety issue: No ]
    Self-reported continuous variables to determine number of partners with whom the participant had (vaginal and/or anal) sex.

  • Sexual Risk Behavior -- # of Unprotected Partners [ Time Frame: 6 months post randomization ] [ Designated as safety issue: No ]
    Self-reported continuous variables to determine number of partners with whom the participant had unprotected (vaginal and/or anal) sex.

  • Sexual Risk Behavior -- # of Sex Acts With Substance Use [ Time Frame: 6 months post randomization ] [ Designated as safety issue: No ]
    Self-reported continuous variables to determine number of (vaginal and/or anal) sex acts in which the participant reported using substances before the sex act.


Enrollment: 5012
Study Start Date: April 2010
Study Completion Date: February 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rapid HIV Testing w/ Counseling (Group 1)
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
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.
Other Name: RESPECT-2 Protocol
No Intervention: Rapid HIV Testing & Information Only (Group 2)
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.

Detailed Description:

An estimated 56,300 Americans are newly infected with HIV every year. In addition, of the more than one million Americans living with HIV, approximately one-fifth do not know they are infected. Identifying these individuals is among the biggest challenges for HIV prevention in the United States. Early diagnosis of such individuals, combined with prevention counseling and provision of health care, could decrease the spread of HIV and improve the survival of HIV-infected persons.

The recent introduction of rapid HIV testing offers a critical public health screening approach for facilitating earlier diagnoses of HIV infection. Rapid tests permit a sensitive and specific, fast, simple, minimally invasive, and cost-effective method to screen for HIV.

Project Aware expands on the CDC's Project RESPECT-2 study that was an expansion of the RESPECT study (a randomized controlled trial conducted in STD clinics in the mid-1990s before the advent of highly active antiretroviral therapy and before the advent of rapid testing). Project RESPECT demonstrated that a 2-session, client centered counseling session based on behavioral theory with HIV testing was superior to a program with HIV testing and information only. This project showed that the counseling arm had significant reduction of STIs compared to those in the information arm. However, RESPECT did not include men who have sex with men (who account for 53% of all new HIV infections in the U.S.) and did not examine the cost effectiveness of the intervention. RESPECT-2 did include MSM, but it only compared a 1-session counseling session with rapid testing to 2-session counseling with traditional testing and did not address the question of whether counseling and testing is more effective than testing alone.

Project Aware combines the RESPECT-2 counseling approach by adapting the HIV Rapid Testing and Counseling in Drug Abuse Treatment Study (CTN 0032), a NIDA-sponsored randomized controlled clinical trial being conducted in the NIDA Clinical Trials Network (CTN) to sexually transmitted disease (STD) clinics to provide important and timely data on the effect of counseling in high-risk populations tested in health care settings. In this adaptation of CTN 0032, we will assess the relative effectiveness of (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling vs. (2) on-site HIV rapid testing with information only (as recommended in the CDC guidelines). Secondary outcomes are 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 (approximately 5,000 from 9 STD clinics) will be assessed for STIs, HIV testing history and sexual and drug use risk behaviors at baseline and at 6-months follow-up. The battery of STI tests will screen for Neisseria gonorrhea (GC), Chlamydia trachomatis (CT), Trichomonas vaginalis, Herpes Simplex 2 (HSV-2) and Treponema pallidum (syphilis). HIV test results that yield a reactive result will receive a confirmatory HIV blood test that day, with results delivered 5-10 days later. All participants will be randomized into one of two arms: Group 1- HIV testing and brief, client-centered counseling or Group 2- HIV testing and information only. Group 1 will receive a rapid HIV test with brief prevention counseling that addresses risk reduction based on an evidence-based counseling approach (RESPECT-2 counseling), while Group 2 will receive a rapid HIV test with information only.

The primary outcome will be analyzed using logistic regression for the binary outcome, new diagnoses of STIs (Yes/No). The logistic regression analysis will predict 6-month STI incidence as a function of randomization group controlling for the baseline incidence of STI. ANCOVA will be used for the secondary continuous outcomes, number of sexual risk behaviors and number of sexual episodes involving substance use. Costs will be compared based on study records supplemented by site-level data collection. Primary analyses will be performed under intent-to-treat (ITT) criteria.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Site Eligibility:

    1. high rates of STIs and HIV in their geographic target area,
    2. sufficient number of patients so that they would be able to recruit the required 556 participants over the study time period,
    3. prior participation in research and clinical studies, and
    4. previous collaboration with investigators.
  • Participant eligibility:

    1. be seeking medical or health services at the participating STD clinic,
    2. be at least 18 years old,
    3. report being HIV-negative or status unknown,
    4. provide informed consent,
    5. provide locator information,
    6. be able to communicate in English,
    7. agree to be tested for STIs/STDs and HIV;
    8. 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
    9. report living in the vicinity of the clinic and being able to return to the clinic for the 6-month follow-up visit.

Exclusion Criteria:

  • Sites:

    1. low rates of STIs and HIV in their geographic target area,
    2. insufficient number of patients to meet study needs of 556 per site
    3. no prior participation in research and clinical studies, and
    4. no previous collaboration with investigators.
  • Participants:

    1. Not seeking medical or health services at the participating STD clinic,
    2. under 18 years old,
    3. HIV positive,
    4. unwilling to provide Informed Consent,
    5. refuse to provide locator information,
    6. not able to communicate in English,
    7. Disagree to be tested for STIs/STDs and/or HIV, and
    8. 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,
    9. report living out of the vicinity and unable to return to the clinic for the 6-month follow-up visit.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01154296

Locations
United States, California
Los Angeles Gay & Lesbian Center
Los Angeles, California, United States, 90028
San Francisco Department of Public Health
San Francisco, California, United States, 94102
United States, District of Columbia
Whitman-Walker Clinic
Washington, District of Columbia, United States, 20009
United States, Florida
Duval County Health Department
Jacksonville, Florida, United States, 32206
Miami-Dade County Health Department
Miami, Florida, United States, 33125
United States, Oregon
Multnomah County Health Department
Portland, Oregon, United States, 97204
United States, Pennsylvania
Allegheny County Health Department
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Richland County Health Department
Colombia, South Carolina, United States, 29204
United States, Washington
Public Health Seattle & King County
Seattle, Washington, United States, 98107
Sponsors and Collaborators
Columbia University
University of Pittsburgh
University of California, San Francisco
Oregon Health and Science University
Medical University of South Carolina
Research Foundation for Mental Hygiene, Inc.
Duke University
The EMMES Corporation
San Francisco Department of Public Health
University of California
Weill Medical College of Cornell University
Investigators
Principal Investigator: Lisa R. Metsch, Ph.D. University of Miami
Principal Investigator: Grant N Colfax, M.D. San Francisco Department of Public Health
  More Information

Publications:
Responsible Party: Lisa Metsch, Stephen Smith Professor of Sociomedical Sciences and Chair, Department of Sociomedical Sciences, Columbia University
ClinicalTrials.gov Identifier: NCT01154296     History of Changes
Other Study ID Numbers: AAAK3153, 1RC2DA028973-01
Study First Received: June 29, 2010
Results First Received: July 29, 2014
Last Updated: September 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
HIV
Rapid Testing
Counseling
STD
U.S.

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
HIV Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014