Randomised controlled evaluation of the effectiveness of behavioural intervention in high risk gay men attending an sexually transmitted disease (STD) clinic

ISRCTN	ISRCTN27508373
DOI	https://doi.org/10.1186/ISRCTN27508373
Protocol serial number	RDC00058
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive London (UK)

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 08/12/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Judith Stephenson
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Infection and infestations: Sexually transmitted diseases
Intervention	One day 'safe' sex workshop vs standard management
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/07/2000

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Male
Target sample size at registration	290
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/05/1995
Date of final enrolment	01/07/2000

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Genitourinary Medicine

London
WC1 6AU
United Kingdom

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	16/06/2001		Yes	No