Urban community randomised trial for prevention of sexually transmitted diseases

ISRCTN ISRCTN43722548
DOI https://doi.org/10.1186/ISRCTN43722548
Secondary identifying numbers 059131
Submission date
22/07/2005
Registration date
22/07/2005
Last edited
06/02/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof King Holmes
Scientific

University of Washington
Professor of Medicine, Director, Cen
325 9th Ave., Box 359931
Seattle, WA
98104
United States of America

Phone +1 (0)206 731 3620
Email worthy@u.washington.edu

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleAn urban community randomised trial of a multicomponent intervention for the prevention of sexually transmitted disease in female sex workers and the general population
Study acronymPREVEN
Study objectivesWe 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(s)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
Health condition(s) or problem(s) studiedSexually transmitted disease prevention
InterventionUsing 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 typeOther
Primary outcome measure1. 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 measuresNo secondary outcome measures
Overall study start date24/08/2002
Completion date31/12/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants20 cities
Key inclusion criteria1. 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
Key exclusion criteria1. General population survey: over 29 years old
2. All surveys: under 18 years old
Date of first enrolment24/08/2002
Date of final enrolment31/12/2006

Locations

Countries of recruitment

  • Peru
  • United States of America

Study participating centre

University of Washington
Seattle, WA
98104
United States of America

Sponsor information

University of Washington (USA)
University/education

Center for AIDS and STD
325 9th Avenue, Box
Seattle, WA
98104
United States of America

Website http://www.washington.edu/
ROR logo "ROR" https://ror.org/00cvxb145

Funders

Funder type

Charity

Wellcome Trust
Private sector organisation / International organizations
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 24/03/2012 Yes No
Results article results 01/10/2012 Yes No