- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01423357
Targeting Interventions at Venues Where Risk of HIV Transmission is High (PLACE)
August 24, 2011 updated by: Ingvild Fossgard Sandoy, University of Zambia
The aim of this study is to investigate whether distribution of condoms and condom demonstrations by youth peer educators in venues where people meet new sexual partners in Livingstone, Zambia, leads to increased condom use among guests socializing in these venues.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In countries where the HIV prevalence is high, focusing on high risk places such as venues where people meet new sexual partners is probably more effective in reducing the transmission rate of HIV than targeting interventions just at perceived high risk groups.
A survey conducted in 2005 in places where people met new sexual partners in Livingstone found that guests socializing there were engaging in high risk sex, but condoms were not always available in the venues.
In this intervention study, youth peer educators will distribute condoms and demonstrate condom use in venues where people meet new sexual partners.
After the intervention has run for a year, condom use among guests socializing in such venues in the intervention township will be compared with condom use among people socializing in similar venues in a comparison township.
Study Type
Interventional
Enrollment (Actual)
537
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Livingstone, Zambia
- Dambwa
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Livingstone, Zambia
- Maramba
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Socializing in a venue where people are said to be meeting new sexual partners
- Age 18 years and above
Exclusion Criteria:
- Too drunk to give sensible answers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Condom distribution and peer education
Youth peer educators distribute condoms and conduct condom demonstration in venues where people meet new sexual partners, i.e. bars, night clubs, sherbeens, guest houses
|
Condom distribution and condom demonstrations by youth peer educators at least twice a week
|
NO_INTERVENTION: Business as usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Condom use with last sexual partner met in this venue
Time Frame: in post-intervention survey (1 year after start of intervention)
|
Guests socializing in venues where people meet new sexual partners are asked about condom use with the last sexual partner met in the venue where interview conducted
|
in post-intervention survey (1 year after start of intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Condom availability in the last 12 months in venues where people meet new sexual partners
Time Frame: in post-intervention survey (1 year after start of intervention)
|
One person representing each venue included in the survey is asked about the availability of condoms in the venue in the last 12 months
|
in post-intervention survey (1 year after start of intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Charles C Michelo, MD, MPH, PhD, University of Zambia
- Principal Investigator: Cosmas M Zyaambo, MD, MPhil, University of Zambia
- Study Chair: Knut M Fylkesnes, DMD. DrPhilos, University of Bergen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sandoy IF, Siziya S, Fylkesnes K. Lost opportunities in HIV prevention: programmes miss places where exposures are highest. BMC Public Health. 2008 Jan 24;8:31. doi: 10.1186/1471-2458-8-31.
- Sandoy IF, Zyaambo C, Michelo C, Fylkesnes K. Targeting condom distribution at high risk places increases condom utilization-evidence from an intervention study in Livingstone, Zambia. BMC Public Health. 2012 Jan 5;12:10. doi: 10.1186/1471-2458-12-10.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (ACTUAL)
March 1, 2010
Study Completion (ACTUAL)
March 1, 2010
Study Registration Dates
First Submitted
August 23, 2011
First Submitted That Met QC Criteria
August 24, 2011
First Posted (ESTIMATE)
August 25, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
August 25, 2011
Last Update Submitted That Met QC Criteria
August 24, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PLACE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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