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

Study Overview

• Status: Completed
• Conditions: Sexually Transmitted Infections
• Intervention / Treatment: Behavioral: 60 Minute HIV/STI risk reduction counseling.Single 60 min Social Cognitive Theory-based counseling.; Behavioral: 20-Min education session

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 Type: Interventional
• Enrollment (Actual): 1050
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Storrs, Connecticut, United States, 06269
      • University of Connecticut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 60 Min. Risk Reduction Counseling; Single 60 min Social Cognitive Theory-based counseling session delivered in STI clinic setting in Cape Town South Africa. Includes educational, motivational, and sexual risk reduction skills components delivered in a single face-to-face counseling session.	Behavioral: 60 Minute HIV/STI risk reduction counseling.Single 60 min Social Cognitive Theory-based 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. Includes only brief educational information on sexual risks for HIV infection in a single face-to-face counseling session.	Behavioral: 20-Min education session; Patients receive a single 20 min education session for STI/HIV informationSingle brief HIV/STI education only session for men and women receiving sexually transmitted infection clinic services in South Africa. Includes only brief educational information on sexual risks for HIV infection in a single face-to-face counseling session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chart abstracted sexually transmitted infections	STI clinic chart abstracted diagnoses over 12 month observation period.	12 month aggregate

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual behavior change	Computer assisted interview behavioral assessments of sexual risk and risk reduction.	3-month intervals

Collaborators and Investigators

• Sponsor: University of Connecticut
• Investigators: Principal Investigator: Seth Kalichman, Ph.D., University of Connecticut

Publications and helpful links

General Publications

• Kalichman SC, Cain D, Eaton L, Jooste S, Simbayi LC. Randomized clinical trial of brief risk reduction counseling for sexually transmitted infection clinic patients in Cape Town, South Africa. Am J Public Health. 2011 Sep;101(9):e9-e17. doi: 10.2105/AJPH.2011.300236. Epub 2011 Jul 21.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): January 15, 2018
• Study Completion (Actual): January 30, 2019

Study Registration Dates

• First Submitted: November 15, 2010
• First Submitted That Met QC Criteria: November 16, 2010
• First Posted (Estimate): November 17, 2010

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: HIV risk reduction; Counseling; Prevention; Behavioral interventions
• Additional Relevant MeSH Terms: Pathologic Processes; Communicable Diseases; Disease Attributes; Infections; Sexually Transmitted Diseases
• Other Study ID Numbers: H05-113

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No