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Project RESPECT: The Efficacy of HIV/STD Prevention Counseling

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ClinicalTrials.gov Identifier: NCT00362791
Recruitment Status : Completed
First Posted : August 10, 2006
Last Update Posted : August 10, 2006
Sponsor:
Collaborators:
San Francisco Department of Public Health
City of Long Beach Department of Health and Human Services
Colorado Department of Public Health and Environment
Baltimore City Health Department
City of Newark Health Department
Information provided by:
Centers for Disease Control and Prevention

Study Description
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Brief Summary:

The efficacy of counseling to prevent infection with the human immunodeficiency virus (HIV) and other sexually transmitted diseases (STDs) has not been definitively shown. This multi-center randomized controlled trial (Project RESPECT) sought to compare the effects of 2 interactive HIV/STD counseling interventions with didactic prevention messages typical of current practice.

A total of 5758 STD clinic patients were enrolled from 5 public STD clinics (Baltimore, Md; Denver, Colo; Long Beach, Calif; Newark, NJ; and San Francisco, Calif) between July 1993 and September 1996. Eligible participants were heterosexual, HIV-negative patients aged 14 years or older who came for full STD examinations. Using a block design, participating men and women were randomzied separately to 1 of 3 individual face-to-face interventions. Arm 1 received "enhanced counseling" consisting of 4 interactive counseling sessions based on the Theory of Reasoned Action and Health Belief Model. Arm 2 received "brief counseling", consisting of 2 interactive risk-reduction sessions based on CDC's client-centered counseling model. Arms 3 and 4 each received 2 brief didactic messages about HIV/STD prevention messages typical of current care at that time. Participants assigned to Arms 1, 2, and 3 were actively followed up after enrollment with questionnaires at 3, 6, 9, and 12 months and STD laboratory examinations and tests at 6 and 12 months. An intent-to-treat analysis was used to compare interventions. Arm 4 participants were followed passively to determine potential effects of active study follow-up.

The main outcome measures were self-reported condom use and new diagnoses of STDs (gonorrhea, chlamydia, syphilis, HIV) defined by laboratory tests.

Results: At the 3- and 6-month follow-up visits, self-reported 100% condom use was higher (P<.05) in both the enhanced counseling and brief counseling arms compared with participants in the didactic messages arm. Through the 6-month interval, 30% fewer participants had new STDs in both the enhanced counseling (7.2%; P = .002) and brief counseling (7.3%;P=.005) arms compared with those in the didactic messages arm (10.4%). Through the 12-month study, 20% fewer participants in each counseling intervention had new STDs compared with those in the didactic messages arm (P = .008). Consistently at each of the 5 study sites, STD incidence was lower in the counseling intervention arms than in the didactic messages intervention arm. Reduction of STD was similar for men and women and greater for adolescents and persons with an STD diagnosed at enrollment.

Subset analyses found that

Based on these results, we conclude that short counseling interventions using personalized risk reduction plans can increase condom use and prevent new STDs. Effective counseling can be conducted even in busy public clinics.


Condition or disease Intervention/treatment Phase
HIV Sexually Transmitted Diseases Behavioral: "Enhanced HIV/STD Counseling:" 4 face-to-face, interctive counseling sessions based on the Theory of Reasoned Action & Health Belief Model Behavioral: "Brief Counseling" (aka "client-centered counseling"): 2 brief, face-to-face interactive sessions targeted a patient-identified risk behavior Behavioral: "HIV Prevention Education": 2 brief, didactic sessions informing the patient about HIV/STD prevention strategies Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 6000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Multicenter Randomized Controlled Trial Evaluating the Efficacy of HIV/STD Prevention Counseling and Testing in Preventing High Risk Behaviors and New Sexually Transmitted Diseases (Project RESPECT)
Study Start Date : April 2003
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- patients who came to the STD clinic and who were eligible in routine clinic practice to undergo confidential HIV testing

Exclusion Criteria:

  • residence outside the clinics' catchment areas
  • had made firm plans (e.g., can give a new address) to move outside the clinic catchment area during the next 12 months
  • unable to provide informed consent to be tested for HIV and take part in the follow up aspect of the study (e.g., incarcerated, mental status changes from drugs, alcohol, medication)
  • reported that he or she had tested positive for HIV in the past
  • did not speak and comprehend English well enough to participate in the interventions
  • came to the clinic for something other than a full routine STD clinic examinations
  • was a man who reported sex with a man in the past 12 months
  • had been approached for study participation on a previous clinic visit, and hd already enrolled or refused participation
  • age < 14 years.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00362791


Sponsors and Collaborators
Centers for Disease Control and Prevention
San Francisco Department of Public Health
City of Long Beach Department of Health and Human Services
Colorado Department of Public Health and Environment
Baltimore City Health Department
City of Newark Health Department
Investigators
Principal Investigator: Mary L Kamb, MD, MPH US Centers for Disease Control and Prevention (CDC)
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00362791     History of Changes
Other Study ID Numbers: CDC-NCHSTP-1112.1
R30/CCR207113-03
R30/CCR307116-01
R30/CCR807114-04
R33/CCR907111-03
R30/CCR907117-03
First Posted: August 10, 2006    Key Record Dates
Last Update Posted: August 10, 2006
Last Verified: July 2005

Keywords provided by Centers for Disease Control and Prevention:
voluntary counseling and testing
HIV/STD prevention counseling
HIV/STD prevention intervention
counseling efficacy

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female