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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Project Aware: HIV Rapid Testing & Counseling in STD Clinics in the U.S. -- an Adaptation of CTN 0032

Conditions
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HIV/AIDS, Sexually Transmitted Infections

Intervention / Treatment
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* Behavioral: RESPECT-2 Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rapid HIV Testing w/ Counseling (Group 1)<br>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<br>* 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.<br>* Other names: RESPECT-2 Protocol;|
| No Intervention: Rapid HIV Testing & Information Only (Group 2)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Risk Behavior -- # of Sex Acts | Self-reported continuous variables to determine number of (vaginal and/or anal) sex acts. | 6 months post randomization | 
| Sexual Risk Behavior -- # of Unprotected Sex Acts | Self-reported continuous variables to determine number of unprotected (vaginal and/or anal) sex acts | 6 months post randomization | 
| Sexual Risk Behavior -- # of Partners | Self-reported continuous variables to determine number of partners with whom the participant had (vaginal and/or anal) sex. | 6 months post randomization | 
| Sexual Risk Behavior -- # of Unprotected Partners | Self-reported continuous variables to determine number of partners with whom the participant had unprotected (vaginal and/or anal) sex. | 6 months post randomization | 
| Sexual Risk Behavior -- # of Sex Acts With Substance Use | 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. | 6 months post randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Rapid Testing, Counseling, STD, U.S.