Urban community randomised trial for prevention of sexually transmitted diseases
| ISRCTN | ISRCTN43722548 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43722548 |
| Protocol serial number | 059131 |
| Sponsor | University of Washington (USA) |
| Funder | Wellcome Trust |
- 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
Contact information
Prof King Holmes
Scientific
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 |
|---|---|
| worthy@u.washington.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | PREVEN |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
1. Gonorrhoea, chlamydia, trichomonas, bacterial vaginosis, syphilis and human immunodeficiency virus (HIV) infection |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 20 |
| Key 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 |
| Key exclusion criteria | 1. General population survey: over 29 years old 2. All surveys: under 18 years old |
| Date of first enrolment | 24/08/2002 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Peru
- United States of America
Study participating centre
University of Washington
Seattle, WA
98104
United States of America
98104
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
