NCT01242501

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,050

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2010

Completed
5.7 years until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

November 15, 2010

Last Update Submit

March 8, 2021

Conditions

Keywords

PreventionCounselingBehavioral interventionsHIV risk reduction

Outcome Measures

Primary Outcomes (1)

  • Chart abstracted sexually transmitted infections

    STI clinic chart abstracted diagnoses over 12 month observation period.

    12 month aggregate

Secondary Outcomes (1)

  • Sexual behavior change

    3-month intervals

Study Arms (2)

60 Min. Risk Reduction Counseling

EXPERIMENTAL

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.

20-min single session education

ACTIVE COMPARATOR

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

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

60 Min. Risk Reduction Counseling

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.

20-min single session education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

Related 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.2011.300236. Epub 2011 Jul 21.

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Seth Kalichman, Ph.D.

    University of Connecticut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 3 Group RCT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2010

First Posted

November 17, 2010

Study Start

August 1, 2016

Primary Completion

January 15, 2018

Study Completion

January 30, 2019

Last Updated

March 11, 2021

Record last verified: 2021-03

Locations