N/A
N=5,012
HIV Rapid Testing & Counseling in Sexually Transmitted Disease (STD) Clinics in the U.S.
HIV/AIDS · Sexually Transmitted Infections
Bottom Line
View on ClinicalTrials.gov: NCT01154296 ↗Enrolled (actual)
5,012
Serious AEs
0.1%
Results posted
Sep 2014
Primary outcome: Primary: STI Incidence — 250; 226 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RESPECT-2 Counseling (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY STI Incidence |
250; 226 | — |
| SECONDARY Sexual Risk Behavior -- # of Sex Acts |
28.6; 29.1 | — |
| SECONDARY Sexual Risk Behavior -- # of Unprotected Sex Acts |
17.4; 18.3 | — |
| SECONDARY Sexual Risk Behavior -- # of Partners |
2.7; 3.0 | — |
| SECONDARY Sexual Risk Behavior -- # of Unprotected Partners |
1.1; 1.1 | — |
| SECONDARY Sexual Risk Behavior -- # of Sex Acts With Substance Use |
115; 106 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01154296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.