NCT01423357

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
537

participants targeted

Target at P75+ for phase_1 hiv

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

February 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2011

Completed
Last Updated

August 25, 2011

Status Verified

August 1, 2011

Enrollment Period

1.1 years

First QC Date

August 23, 2011

Last Update Submit

August 24, 2011

Conditions

Keywords

HIV preventioncondom distributionyouth peer educationhigh risk placescondom useprevention through increased condom use

Outcome Measures

Primary Outcomes (1)

  • Condom use with last sexual partner met in this venue

    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 Outcomes (1)

  • Condom availability in the last 12 months in venues where people meet new sexual partners

    in post-intervention survey (1 year after start of intervention)

Study Arms (2)

Condom distribution and peer education

EXPERIMENTAL

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

Other: Condom distribution and peer education

Business as usual

NO INTERVENTION

Interventions

Condom distribution and condom demonstrations by youth peer educators at least twice a week

Condom distribution and peer education

Eligibility Criteria

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

You may qualify if:

  • Socializing in a venue where people are said to be meeting new sexual partners
  • Age 18 years and above

You may not qualify if:

  • Too drunk to give sensible answers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dambwa

Livingstone, Zambia

Location

Maramba

Livingstone, Zambia

Location

Related Publications (2)

  • 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.

    PMID: 18218124BACKGROUND
  • 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 Officials

  • Charles C Michelo, MD, MPH, PhD

    University of Zambia

    STUDY DIRECTOR
  • Cosmas M Zyaambo, MD, MPhil

    University of Zambia

    PRINCIPAL INVESTIGATOR
  • Knut M Fylkesnes, DMD. DrPhilos

    University of Bergen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

August 23, 2011

First Posted

August 25, 2011

Study Start

February 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

August 25, 2011

Record last verified: 2011-08

Locations