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

November 15, 2010
November 16, 2010
August 2005
August 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01242501 on ClinicalTrials.gov Archive Site
Sexual behavior change [ Time Frame: 3-month intervals ] [ Designated as safety issue: No ]
Computer assisted interview behavioral assessments of sexual risk and risk reduction.
Same as current
Not Provided
Not Provided
 
Brief HIV Prevention Counseling for STI Patients in South Africa
Randomized Trial of a Brief HIV Risk Reduction Counseling Intervention for Sexually Transmitted Infections Clinic Patients in Cape Town, South Africa

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Sexually Transmitted Infections
  • Behavioral: 60 Minute HIV/STI risk reduction counseling
    Single session risk reduction counseling delivered in STI clinic settings in South Africa.
  • Behavioral: 20-Min education session
    Patients receive a single 20 min education session for STI/HIV information.
  • Experimental: 60 Min. Risk Reduction Counseling
    Single 60 min theory-based counseling session delivered in STI clinic setting in Cape Town South Africa.
    Intervention: Behavioral: 60 Minute HIV/STI risk reduction counseling
  • 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.
    Intervention: Behavioral: 20-Min education session
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
617
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01242501
H05-113
No
Seth Kalichman, University of Connecticut
University of Connecticut
Human Sciences Research Council, South Africa
Principal Investigator: Seth Kalichman, Ph.D. University of Connecticut
University of Connecticut
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP