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Completed

NCT Number: NCT01242501

Brief HIV Prevention Counseling for STI Patients in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Connecticut

Storrs, Connecticut, 06269, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

60 Minute HIV/STI risk reduction counseling.Single 60 min Social Cognitive Theory-based counseling.

Behavioral

Single session risk reduction counseling delivered in STI clinic settings in South Africa.

20-Min education session

Behavioral

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 outcomes

  1. Chart abstracted sexually transmitted infections

    Time frame: 12 month aggregate

    STI clinic chart abstracted diagnoses over 12 month observation period.

Secondary outcomes

  1. Sexual behavior change

    Time frame: 3-month intervals

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

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Nov 17, 2010
Registry last updated
Mar 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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