Condition category
Urological and Genital Diseases
Date applied
22/07/2005
Date assigned
22/07/2005
Last edited
06/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.proyectopreven.org/index.php?lang=en

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

http://www.washington.edu/

Funders

Funder type

Charity

Funder name

Wellcome Trust

Alternative name(s)

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

  1. 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.

  2. 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.

Additional files

Editorial Notes