Brief HIV Prevention Counseling for STI Patients in South Africa

Sexually Transmitted Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01242501
• Other study ID #: H05-113
• Status: Completed
• Phase: N/A
• Start date: August 1, 2016
• Est. completion date: January 30, 2019

Study information

• Verified date: March 2021
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1050
• Est. completion date: January 30, 2019
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years and older

• STI clinic patient diagnosed with an STI at current visit

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Infection
• Sexually Transmitted Diseases
• Sexually Transmitted Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Connecticut	Storrs	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
University of Connecticut

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chart abstracted sexually transmitted infections	STI clinic chart abstracted diagnoses over 12 month observation period.	12 month aggregate
Secondary	Sexual behavior change	Computer assisted interview behavioral assessments of sexual risk and risk reduction.	3-month intervals