Condition category
Infections and Infestations
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
08/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Judith Stephenson

ORCID ID

Contact details

Department of Genitourinary Medicine
Public Health
University College London
The Mortimer Market Centre
Off Capper Street
Tottenham Court Road
London
WC1 6AU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RDC00058

Study information

Scientific title

Acronym

Study hypothesis

Despite clear evidence that gay men are at increased risk of HIV infection, there has been little rigorous evaluation of the effectiveness of behavioural intervention in reducing sexual risk behaviour in the group. We propose a randomised control trial (RCT) to examine the effectiveness of group work in promoting safer sex in gay men who have high risk sexual lifestyles, since they are at a high risk of transmitting and acquiring the HIV infection. Building on experience in this department, the feasibility of various forms of group intervention will be investigated during a pilot survey of gay men attending an STD clinic. In the subsequent RCT, high risk gay men will be randomly assigned to either the intervention under evaluation, or to standard management as currently provided in the clinic.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Infection and infestations: Sexually transmitted diseases

Intervention

One day 'safe' sex workshop vs standard management

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Outcome measures will focus on the nature, as well as the number of sexual partnerships and the type of sexual practices within those relationships. STD rates will be a further outcome measure. Differences in outcome will be compared between intervention and control groups at 6 and 12 months after intervention.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/1995

Overall trial end date

01/07/2000

Reason abandoned

Eligibility

Participant inclusion criteria

All participants will be gay men attending an STD clinic. In order to recruit gay men at high risk of human immunodeficiency virus (HIV) infection, those who present with an acute STD or who indicate that they are having unprotected anal sex will be invited to enter the trial (except those in stable monogamous relationships where both partners repeatedly test negative). Estimated sample size will be around 145 men in each group of the study.

Participant type

Patient

Age group

Not Specified

Gender

Male

Target number of participants

290

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/05/1995

Recruitment end date

01/07/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Genitourinary Medicine
London
WC1 6AU
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive London (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11408300

Publication citations

  1. Results

    Imrie J, Stephenson JM, Cowan FM, Wanigaratne S, Billington AJ, Copas AJ, French L, French PD, Johnson AM, , A cognitive behavioural intervention to reduce sexually transmitted infections among gay men: randomised trial., BMJ, 2001, 322, 7300, 1451-1456.

Additional files

Editorial Notes