CClinicalTrials.gg
CompletedNCT01242501Updated Mar 11, 2021

Brief HIV Prevention Counseling for STI Patients in South Africa

An interventional study of 60 Minute HIV/STI risk reduction counseling.Single 60 min Social Cognitive Theory-based counseling. and 20-Min education session in Sexually Transmitted Infections, sponsored by University of Connecticut. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-11.

Sponsored by University of Connecticut · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,050
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sexually Transmitted Infections

Keywords

  • Prevention
  • Counseling
  • Behavioral interventions
  • HIV risk reduction
03

In context

Infections

6,688 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 1,050 is above the median of 120 across 4,201 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

University of Connecticut is the lead sponsor of 133 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
1,050 participants (actual)

Study arms

  • 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.

  • 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

Interventions

  • Behavioral60 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.

  • Behavioral20-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.

06

What researchers measure

Primary outcomes

  1. Chart abstracted sexually transmitted infections

    STI clinic chart abstracted diagnoses over 12 month observation period.

    Time frame: 12 month aggregate

Secondary outcomes

  1. Sexual behavior change

    Computer assisted interview behavioral assessments of sexual risk and risk reduction.

    Time frame: 3-month intervals

07

Study locations

1 site
  • University of Connecticut
    Storrs, Connecticut 06269, United States
08

References and documents

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. PubMed 21778486 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01242501
Lead sponsor
University of Connecticut
Responsible party
Sponsor
First posted
Nov 17, 2010
Start date
Aug 1, 2016
Primary completion
Jan 15, 2018
Completion
Jan 30, 2019
Last update
Mar 11, 2021

Study contacts

Seth Kalichman, Ph.D.
principal investigator · University of Connecticut

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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