Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof King Holmes
ORCID ID
Contact details
University of Washington
Professor of Medicine
Director
Cen
325 9th Ave.
Box 359931
Seattle
WA
98104
United States of America
+1 (0)206 731 3620
worthy@u.washington.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
059131
Study information
Scientific title
An urban community randomised trial of a multicomponent intervention for the prevention of sexually transmitted disease in female sex workers and the general population
Acronym
PREVEN
Study hypothesis
We aim to:
1. Determine the impact of a hybrid intervention on:
1.1. Prevalence of gonococcal, chlamydial, and trichomonal infection and syphilis seroreactivity in high-risk Female Sex Workers (FSW), bridging groups of clients of FSW, and the lower-risk young adult general population
1.2. The antimicrobial susceptibility and virulence-associated phenotypes of N. gonorrhoeae
2. Develop and employ mathematical models of gonorrhoea, chlamydial infection, syphilis and trichomoniasis to explain the observed impact of the interventions, and facilitate transfer of the intervention to other locations
Ethics approval
1. Universidad Peruana Cayetano Heredia, 07/12/1999, ref: #99084
2. University of Washington, 25/07/2000, ref: #99-2288
3. Naval Medical Research Center Detachment, 19/09/2002, ref: DOD#31556
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Sexually transmitted disease prevention
Intervention
Using data from a baseline survey in 24 Peruvian cities with populations more than 50,000, 20 cities were selected for the trial and placed into matched pairs based on region (coastal, jungle or Andean), size and STD prevalence. The pairs were then randomised into control or intervention groups, with the latter receiving a two-year hybrid intervention of:
1. Strengthened syndromic management through a network of physicians and pharmacists
2. STD screening and treatment of FSW
3. Social marketing of condoms
At the end of the two-year intervention, FSW and the young adult general population in all 20 cities will be surveyed again to evaluate its impact.
The anticipated end date of this trial has been extended to the 31st December 2006. The previous anticipated end date was 31/12/2005.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Gonorrhoea, chlamydia, trichomonas, bacterial vaginosis, syphilis and human immunodeficiency virus (HIV) infection
2. Demographic and behavioural information regarding sexual history and risk behaviours
Secondary outcome measures
No secondary outcome measures
Overall trial start date
24/08/2002
Overall trial end date
31/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. General population survey: one adult per household ages 18 to 29 years, either sex
2. FSW: willing to participate
3. Clients of FSW: sex with a commercial sex worker
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20 cities
Participant exclusion criteria
1. General population survey: over 29 years old
2. All surveys: under 18 years old
Recruitment start date
24/08/2002
Recruitment end date
31/12/2006
Locations
Countries of recruitment
Peru
Trial participating centre
University of Washington
Seattle, WA
98104
United States of America
Sponsor information
Organisation
University of Washington (USA)
Sponsor details
Center for AIDS and STD
325 9th Avenue
Box
Seattle
WA
98104
United States of America
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Wellcome Trust
Alternative name(s)
Wellcome
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22341824
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22878023
Publication citations
-
Results
García PJ, Holmes KK, Cárcamo CP, Garnett GP, Hughes JP, Campos PE, Whittington WL, , Prevention of sexually transmitted infections in urban communities (Peru PREVEN): a multicomponent community-randomised controlled trial., Lancet, 2012, 379, 9821, 1120-1128, doi: 10.1016/S0140-6736(11)61846-1.
-
Results
Cárcamo CP, Campos PE, García PJ, Hughes JP, Garnett GP, Holmes KK, , Prevalences of sexually transmitted infections in young adults and female sex workers in Peru: a national population-based survey., Lancet Infect Dis, 2012, 12, 10, 765-773, doi: 10.1016/S1473-3099(12)70144-5.