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Brief HIV Prevention Counseling for STI Patients in South Africa

Primary Purpose

Sexually Transmitted Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
60 Minute HIV/STI risk reduction counseling.Single 60 min Social Cognitive Theory-based counseling.
20-Min education session
Sponsored by
University of Connecticut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexually Transmitted Infections focused on measuring Prevention, Counseling, Behavioral interventions, HIV risk reduction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

  • University of Connecticut

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

60 Min. Risk Reduction Counseling

20-min single session education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Chart abstracted sexually transmitted infections
STI clinic chart abstracted diagnoses over 12 month observation period.

Secondary Outcome Measures

Sexual behavior change
Computer assisted interview behavioral assessments of sexual risk and risk reduction.

Full Information

First Posted
November 15, 2010
Last Updated
March 8, 2021
Sponsor
University of Connecticut
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1. Study Identification

Unique Protocol Identification Number
NCT01242501
Brief Title
Brief HIV Prevention Counseling for STI Patients in South Africa
Official Title
Randomized Trial of a Brief HIV Risk Reduction Counseling Intervention for Sexually Transmitted Infections Clinic Patients in Cape Town, South Africa
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
January 15, 2018 (Actual)
Study Completion Date
January 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Connecticut

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Infections
Keywords
Prevention, Counseling, Behavioral interventions, HIV risk reduction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 Group RCT
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1050 (Actual)

8. Arms, Groups, and Interventions

Arm Title
60 Min. Risk Reduction Counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
20-min single session education
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
60 Minute HIV/STI risk reduction counseling.Single 60 min Social Cognitive Theory-based counseling.
Intervention Description
Single session risk reduction counseling delivered in STI clinic settings in South Africa.
Intervention Type
Behavioral
Intervention Name(s)
20-Min education session
Intervention Description
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.
Primary Outcome Measure Information:
Title
Chart abstracted sexually transmitted infections
Description
STI clinic chart abstracted diagnoses over 12 month observation period.
Time Frame
12 month aggregate
Secondary Outcome Measure Information:
Title
Sexual behavior change
Description
Computer assisted interview behavioral assessments of sexual risk and risk reduction.
Time Frame
3-month intervals

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years and older STI clinic patient diagnosed with an STI at current visit Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seth Kalichman, Ph.D.
Organizational Affiliation
University of Connecticut
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut
City
Storrs
State/Province
Connecticut
ZIP/Postal Code
06269
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21778486
Citation
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.
Results Reference
result

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Brief HIV Prevention Counseling for STI Patients in South Africa

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