Project RESPECT: The Efficacy of HIV/STD Prevention Counseling

NCT00362791 | Completed

• 6 other identifiers: CDC-NCHSTP-1112.1R30/CCR207113-03R30/CCR307116-01R30/CCR807114-04R33/CCR907111-03R30/CCR907117-03
• Study Type: interventional
• Target: 6,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV; Sexually Transmitted Diseases

Keywords

voluntary counseling and testing; HIV/STD prevention counseling; HIV/STD prevention intervention; counseling efficacy

Interventions

"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 BEHAVIORAL

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• San Francisco Department of Public Health: collaborator
• City of Long Beach Department of Health and Human Services: collaborator
• Colorado Department of Public Health and Environment: collaborator
• Baltimore City Health Department: collaborator
• City of Newark Health Department: collaborator

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Health Belief Model

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Models, Theoretical; Investigative Techniques; Models, Psychological

Study Officials

• Mary L Kamb, MD, MPH

  US Centers for Disease Control and Prevention (CDC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED

Study Record Dates

• First Submitted: August 8, 2006
• First Posted: August 10, 2006
• Study Start: April 1, 2003
• Study Completion: July 1, 2005
• Last Updated: August 10, 2006

Record last verified: 2005-07