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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01154296
• Date of registration: 29/06/2010
• Primary sponsor: University of Miami
• Public title: HIV Rapid Testing & Counseling in Sexually Transmitted Disease (STD) Clinics in the U.S. Aware
• Scientific title: Project Aware: HIV Rapid Testing & Counseling in STD Clinics in the U.S. -- an Adaptation of CTN 0032
• Date of first enrolment: April 2010
• Target sample size: 5012
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01154296
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Screening

Countries of recruitment

United States

Contacts

• Name: Grant N Colfax, M.D.
• Affiliation: San Francisco Department of Public Health

• Name: Lisa R. Metsch, Ph.D.
• Affiliation: University of Miami

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV/AIDS

Sexually Transmitted Infections

Intervention(s)

Behavioral: RESPECT-2 Counseling

Primary Outcome(s)

STI incidence [Time Frame: 6 months post randomization]

Secondary Outcome(s)

cost/cost-effectiveness [Time Frame: 6 months post randomization]

sexual risk behavior [Time Frame: 6 months post randomization]

Secondary ID(s)

1RC2DA028973-01

20090675

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Duke University

Medical University of South Carolina

National Institute on Drug Abuse (NIDA)

Oregon Health and Science University

Research Foundation for Mental Hygiene

San Francisco Department of Public Health

The EMMES Corporation

University of California

University of California, San Francisco

University of Pittsburgh

Weill Medical College of Cornell University