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 |
| Secondary identifying numbers | RDC00058 |
- 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
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | 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 study start date | 01/05/1995 |
| Completion date | 01/07/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Male |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Department of Genitourinary Medicine
London
WC1 6AU
United Kingdom
WC1 6AU
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive London (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
