Project RESPECT: The Efficacy of HIV/STD Prevention Counseling
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Purpose
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 | Intervention |
|---|---|
|
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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind 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) |
| Estimated Enrollment: | 6000 |
| Study Start Date: | April 2003 |
| Estimated Study Completion Date: | July 2005 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 14 Years and older (Child, Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00362791
| Principal Investigator: | Mary L Kamb, MD, MPH | US Centers for Disease Control and Prevention (CDC) |
More Information
Additional 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 |
| Study First Received: | August 8, 2006 |
| Last Updated: | August 9, 2006 |
| Health Authority: | United States: Federal Government |
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 |
ClinicalTrials.gov processed this record on September 28, 2016