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Brief HIV Prevention Counseling for STI Patients in South Africa

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ClinicalTrials.gov Identifier: NCT01242501
Recruitment Status : Completed
First Posted : November 17, 2010
Last Update Posted : November 17, 2010
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Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Sexually Transmitted Infections Behavioral: 60 Minute HIV/STI risk reduction counseling Behavioral: 20-Min education session Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 617 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : August 2005
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Chart abstracted sexually transmitted infections [ Time Frame: 12 month aggregate ]
    STI clinic chart abstracted diagnoses over 12 month observation period.


Secondary Outcome Measures :
  1. Sexual behavior change [ Time Frame: 3-month intervals ]
    Computer assisted interview behavioral assessments of sexual risk and risk reduction.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

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): NCT01242501


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

Responsible Party: Seth Kalichman, University of Connecticut
ClinicalTrials.gov Identifier: NCT01242501     History of Changes
Other Study ID Numbers: H05-113
First Posted: November 17, 2010    Key Record Dates
Last Update Posted: November 17, 2010
Last Verified: November 2010

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

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