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Brief HIV Prevention Counseling for STI Patients in South Africa

This study has been completed.
Sponsor:
Collaborator:
Human Sciences Research Council, South Africa
Information provided by:
University of Connecticut
ClinicalTrials.gov Identifier:
NCT01242501
First received: November 15, 2010
Last updated: November 16, 2010
Last verified: November 2010
History of Changes
  Purpose

This is a Phase IIB randomized trial to test a brief single session risk reduction counseling intervention on HIV and STI behavioral outcomes in Cape Town South Africa.


Condition Intervention Phase
Sexually Transmitted Infections
 Behavioral: 60 Minute HIV/STI risk reduction counseling
Behavioral: 20-Min education session
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Trial of a Brief HIV Risk Reduction Counseling Intervention for Sexually Transmitted Infections Clinic Patients in Cape Town, South Africa

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Connecticut:

Primary Outcome Measures:
  • Chart abstracted sexually transmitted infections [ Time Frame: 12 month aggregate ] [ Designated as safety issue: No ]
    STI clinic chart abstracted diagnoses over 12 month observation period.


Secondary Outcome Measures:
  • Sexual behavior change [ Time Frame: 3-month intervals ] [ Designated as safety issue: No ]
    Computer assisted interview behavioral assessments of sexual risk and risk reduction.


Enrollment: 617
Study Start Date: August 2005
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 60 Min. Risk Reduction Counseling
Single 60 min theory-based counseling session delivered in STI clinic setting in Cape Town South Africa.
 Behavioral: 60 Minute HIV/STI risk reduction counseling
Single session risk reduction counseling delivered in STI clinic settings in South Africa.
Active Comparator: 20-min single session education
Single brief HIV/STI education only session for men and women receiving sexually transmitted infection clinic services in South Africa.
 Behavioral: 20-Min education session
Patients receive a single 20 min education session for STI/HIV information.

Detailed Description:

This 5 year study will conduct a randomized clinical trial of a gender and culturally tailored theory-based behavioral risk reduction intervention for men and women who are receiving sexually transmitted infection (STI) diagnostic and treatment services from STI treatment providers in South Africa. As many as one in five South Africans is HIV positive and there are an estimated 1,500 new HIV infections in South Africa each day. The experimental intervention in this study was developed by South African and US investigators and pilot tested in South Africa. The intervention is grounded in the experience of South African health service provider, empirical research on AIDS-related stigmas, and elements of a social cognitive theory of health behavior change. The intervention consists of a single 60-minute risk reduction counseling session delivered within the context of STI services. Participants will be STI clinic patients over age 18 that have been treated for a previous STI. Participants will be baseline assessed and randomized to receive either (a) the 60 min theory-based and culturally tailored risk reduction intervention or (b) a time and contact matched standard of care HIV and health education session. Participants will be followed for 12 months post intervention. Assessments will be conducted using computer assisted interviews (ACASI). The randomized trial will determine the efficacy of the risk reduction intervention for South African men and women receiving STI clinic services. Outcome analyses will include differences between conditions on new STI diagnoses over 12 months. We will also test the mediating effects of attitudes and beliefs on intervention outcomes. Results of this research will therefore test a clinic-based HIV prevention intervention model that is urgently needed in South Africa.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years and older
  • STI clinic patient diagnosed with an STI at current visit

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242501

Locations
United States, Connecticut
University of Connecticut
Storrs, Connecticut, United States, 06269
Sponsors and Collaborators
University of Connecticut
Human Sciences Research Council, South Africa
Investigators
Principal Investigator: Seth Kalichman, Ph.D. University of Connecticut
  More Information

No publications provided

Responsible Party: Seth Kalichman, University of Connecticut
ClinicalTrials.gov Identifier: NCT01242501     History of Changes
Other Study ID Numbers: H05-113
Study First Received: November 15, 2010
Last Updated: November 16, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut:
Prevention
Counseling
Behavioral interventions
HIV risk reduction

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

ClinicalTrials.gov processed this record on May 16, 2013