Clinical trial NCT01242501: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Infections
Keywords: Prevention
Counseling
Behavioral interventions
HIV risk reduction
Lead sponsor: University of Connecticut
Sponsor class: OTHER
First posted: 2010-11-17
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 Group RCT
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Chart abstracted sexually transmitted infections
timeFrame: 12 month aggregate
Secondary outcomes:
measure: Sexual behavior change
timeFrame: 3-month intervals
Other outcomes:
Locations:
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Seth Kalichman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.