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Clinical Trials/NCT01242501
NCT01242501
Completed
Not Applicable

Randomized Trial of a Brief HIV Risk Reduction Counseling Intervention for Sexually Transmitted Infections Clinic Patients in Cape Town, South Africa

University of Connecticut1 site in 1 country1,050 target enrollmentAugust 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sexually Transmitted Infections
Sponsor
University of Connecticut
Enrollment
1050
Locations
1
Primary Endpoint
Chart abstracted sexually transmitted infections
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2016
End Date
January 30, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Chart abstracted sexually transmitted infections

Time Frame: 12 month aggregate

STI clinic chart abstracted diagnoses over 12 month observation period.

Secondary Outcomes

  • Sexual behavior change(3-month intervals)

Study Sites (1)

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