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

ISRCTN	ISRCTN52832382
DOI	https://doi.org/10.1186/ISRCTN52832382
Protocol serial number	N/A
Sponsor	Maastricht University (UK)
Funder	Maastricht University (Netherlands)

Submission date: 22/09/2010
Registration date: 20/12/2010
Last edited: 20/12/2010

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jochen Mikolajczak
Scientific

Antomnie van leeuwenhoeklaan 9
3721 MA Bilthoven
Bilthoven
3721 MA
Netherlands

Study information

Primary study design	Interventional
Study design	Randomised active controlled parallel group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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).
Completion date	14/02/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	5030
Key inclusion criteria	1. Having had casual sex partners in the past six months 2. Not HIV-positive 3. Living in the Netherlands
Key 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.
Date of first enrolment	01/11/2006
Date of final enrolment	14/02/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

Antomnie van leeuwenhoeklaan 9

Bilthoven
3721 MA
Netherlands

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?
Other publications		08/07/2008		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes