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
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
-
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.