Condition category
Infections and Infestations
Date applied
22/09/2010
Date assigned
20/12/2010
Last edited
20/12/2010
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 Jochen Mikolajczak

ORCID ID

Contact details

Antomnie van leeuwenhoeklaan 9
3721 MA Bilthoven
Bilthoven
3721 MA
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Evaluation of an online human immunodeficiency virus (HIV)-prevention intervention to promote HIV-testing among men who have sex with men: a randomised controlled trial

Acronym

Study hypothesis

Aim:
An online randomised controlled trial (RCT) to investigate the effects of a systematically developed online human immunodeficiency virus (HIV)-prevention intervention aimed at promoting HIV-testing among men who have sex with men (MSM) in the Netherlands.

Hypotheses:
1. Exposure to the newly developed intervention would lead to a significant increase in participants intention to take an HIV/STI-test (i.e. a Sexual Health Checkup), compared to exposure to the control, a pre-existing online intervention
2. Theory predicts that high intentions towards taking a test increase the chances of actually taking a test. Therefore, compared to the control condition, significantly more participants in the experimental condition would have taken a Sexual Health Checkup at the moment of follow-up (3 months after exposure to one of the interventions).

Rationale:
The theme we chose for our health promotion program was: "Queermasters, the online gay health show". In consultation with our linkage group, it was considered a theme that fitted well with our target population. The concept of an online gay health show allowed us to include different rounds for different program components, virtual relational agents in terms of a show master and his assistant, and a virtual MSM audience in the background representing a reference group, and expressing an injunctive social norm.

In our program, we deliberately avoided the use of risk information and risk communication as means of motivating participants to take an HIV-test. This decision was taken on the basis of our qualitative and quantitative findings. Additional empirical evidence in support of our decision comes from the results of a study that indicated that increasing the perceived risk for HIV-infection might not be a successful method to motivate (at risk) individuals to take an HIV-test.

Ethics approval

The Psychology Ethics Committee (Ethische commissie Psychologie [ECP]) of the Faculty of Psychology & Neuroscience, Maastricht University approved on the 12th December 2006 (ref: ECP 48 / 3-4-2006-4)

Study design

Randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

Human immunodeficiency virus (HIV) testing

Intervention

Recruitment:

1. Online recruitment:
Banners were placed on several large and popular Dutch MSM websites, a click-through button was placed on the home page of the most popular Dutch MSM chat website (www.chatboy.nl), and a chatter's profile was placed in the Chatboy chatbox inviting visitors to participate.

2. Offline recruitment:
Advertisements were placed in the popular Dutch MSM press.

An online randomised controlled trial was set up in which for one month, visitors of the website queermasters.nl (n = 5030) were randomly assigned to one of two groups.

1. Experimental group: A newly developed intervention -
The scope of our program focused primarily on the advantages of regular sexual health checkups and the fact that most other MSM favor regular checkups, to motivate participants to take up regular sexual health checkups and consequently get tested for HIV.

2. Control group: An existing online HIV-test promotion intervention -
The scope of the existing program focused on both risk information and risk communication to motivate participants to take an HIV- and an STI-test.

3 months later participants were invited for follow-up.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Intention to take an HIV-test within the next three months, which was measured with two items. For example: 'I intend to take an HIV-test within the next three months', measured on a seven-point scale (very surely not - very surely so). Measurement of intention took place before participation in one of the interventions (either experimental of control), and immediately thereafter.

2. Actual testing behaviour, which was measured three months after participation in one of the interventions (during the follow-up session)

All measures were self-reported.

Secondary outcome measures

1. Attitude towards taking an HIV-test within the next three months was measured with four items. For example: "I consider taking an HIV-test within the next three months to be...", measured on a seven-point scale (very unwise - very wise)
2. Subjective social norm towards taking an HIV-test within the next three months was measured with two items. For example: "My best friends think that I should take an HIV-test within the next three months", measured on a seven-point scale (very surely not - very surely so)
3. Self-efficacy towards taking an HIV-test in the next three months was measured with eight items. For example: "I consider making an appointment to take an HIV-test at a testing location to be … ", measured on a seven-point scale (very difficult - very easy)

All outcomes were self-reported measurements which took place before participation in one of the interventions (either experimental of control), and three months after participation in one of the interventions (during the follow-up session).

Overall trial start date

01/11/2006

Overall trial end date

14/02/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Having had casual sex partners in the past six months
2. Not HIV-positive
3. Living in the Netherlands

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

Target not specified at onset. Final recruitment was 5030

Participant exclusion criteria

1. Participants who did not complete all the questions on demographics
2. Living in the city of Nijmegen. For the purpose of another evaluation study, participants living in the city of Nijmegen were not randomly assigned to one of two intervention conditions, but always assigned to the experimental intervention.

Recruitment start date

01/11/2006

Recruitment end date

14/02/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Antomnie van leeuwenhoeklaan 9
Bilthoven
3721 MA
Netherlands

Sponsor information

Organisation

Maastricht University (UK)

Sponsor details

Faculty of Psychology and Neuroscience
PO Box 616
Maastricht
6200 MD
Netherlands

Sponsor type

University/education

Website

http://www.maastrichtuniversity.nl

Funders

Funder type

University/education

Funder name

Maastricht University (Netherlands)

Alternative name(s)

Maastricht University, UM

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Netherlands

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

Mikolajczak, J., Kok, G., & Hospers, H.J. (2008). Queermasters: developing a theory- and evidence-based Internet HIV-prevention intervention to promote HIV-testing among men who have sex with men (MSM). Applied Psychology: an international review, 57: 681-697.

Publication citations

Additional files

Editorial Notes