Brief HIV Prevention Counseling for STI Patients in South Africa

Not Applicable

Completed

• Conditions: Sexually Transmitted Infections

• Registration Number: NCT01242501
• Lead Sponsor: University of Connecticut

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.

Study Timeline

• Study First Submitted: 2010-11-15
• Study First Submitted QC: 2010-11-16
• Study First Posted: 2010-11-17
• Study Start: 2016-08-01
• Primary Completion: 2018-01-15
• Study Completion: 2019-01-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1050

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Chart abstracted sexually transmitted infections	12 month aggregate	STI clinic chart abstracted diagnoses over 12 month observation period.

Secondary Outcome Measures

Name	Time	Method
Sexual behavior change	3-month intervals	Computer assisted interview behavioral assessments of sexual risk and risk reduction.

Trial Locations

Locations (1)

University of Connecticut; 🇺🇸 Storrs, Connecticut, United States