Sexual Risk Behavior for HIV-InfectionNCT00378885
Effect Study of a Theory-Based Internet Intervention on Safe-Sex Practices
A study testing Cognitive-behavioral tailored intervention in people with Sexual Risk Behavior for HIV-Infection, run by Public Health Service of Amsterdam at 1 site in Netherlands.
Trial summary
The purpose of this study is to examine the efficacy of a theory based, online tailored intervention on stimulating safe-sex practices among men who have sex with men (MSM). Our hypothesis was that a tailored internet intervention would be more effective in stimulating safe-sex practices of gay men than a non-tailored… Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Risk Behavior for HIV-Infection
- What is being tested?
- Cognitive-behavioral tailored intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 642 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2003to Aug 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Men who have sex with men of all ages, HIV-negative or of unknown serostatus, single, and open to a steady relationship with a man in the future
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
GGD Amsterdam- Amsterdam Health Services
Amsterdam, 1018WT
About this study
Official title: The Effect of a Theory Based Tailored Intervention Online on the Reduction of Risk Behavior for HIV Transmission Among Men Who Have Sex With Men - a Randomized, Single-Blind, Active (Waiting-List) Controlled Trial
The purpose of this study is to examine the efficacy of a theory based, online tailored intervention on stimulating safe-sex practices among men who have sex with men (MSM). Our hypothesis was that a tailored internet intervention would be more effective in stimulating safe-sex practices of gay men than a non-tailored internet intervention when compared to a waiting-list control group.
Read the detailed description
Relationships are a high-risk setting for HIV-infection. This trial aimed at testing the efficacy of an online theory-based tailored intervention for preparing single MSM to practice safe sex with future steady partners-labeling it the 'cognitive vaccine approach'.
The target was the promotion of negotiated safety (NS): steady partners testing for HIV and reaching agreements to either be monogamous or to only have safe sex outside the relationship in order to have safe unprotected anal intercourse with each other. The intervention content was based on the information, motivation, behavioral-skills model and the intervention was tailored according to knowledge, motivation, and skill-related deficiencies of each participant. Condom use was promoted as the default alternative for NS. Using an online randomized controlled trial we examined the effects of a tailored versus non-tailored version of the intervention. The cognitive effect (i.e. response efficacy, intentions, and perceived behavioral control (PBC) was measured directly after the intervention and, after 6-months, the behavioral effect (i.e. NS and condom use) via e-mail follow-up.
- Conditions
- Sexual Risk Behavior for HIV-Infection
- Being tested
- Cognitive-behavioral tailored intervention
- Keywords
- HIV-prevention, Internet Prevention intervention, Online randomized controlled trial, Effect evaluation, MSM, Steady relationships
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral tailored interventionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on the practice of safe sex with steady partners at a six-months follow-up
Secondary outcomes (1)
Scores on response efficacy, intentions and perceived behavioral control regarding the practice of safe sex with steady partners directly after the administration of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
- Study startJan 2003
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Risk Behavior for HIV-InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 642 participants
Sponsor and investigators
- Lead sponsor
- Public Health Service of Amsterdam
- Sponsor type
- Other government
- Investigators
- Udi Davidovich, Dr., Principal investigator, Public Health Service of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378885
- Sponsor's protocol ID
- GGD 4013
- Status last verified
- Sep 2006
- First submitted
- 20 Sep 2006
- Last updated
- 21 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Theory Based Tailored Intervention Online on the Reduction of Risk Behavior for HIV Transmission Among Men Who Have Sex With Men - a Randomized, Single-Blind, Active (Waiting-List) Controlled Trial
- ClinicalTrials.gov ID
- NCT00378885
- Acronym / sponsor ID
- GGD 4013
- Conditions
- Sexual Risk Behavior for HIV-Infection
- Keywords
- HIV-prevention, Internet Prevention intervention, Online randomized controlled trial, Effect evaluation, MSM, Steady relationships
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 642 participants
- Lead sponsor
- Public Health Service of AmsterdamOther government
- Study start
- Jan 2003
- Study completion
- Aug 2003
- First posted
- 21 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the efficacy of a theory based, online tailored intervention on stimulating safe-sex practices among men who have sex with men (MSM). Our hypothesis was that a tailored internet intervention would be more effective in stimulating safe-sex practices of gay men than a non-tailored internet intervention when compared to a waiting-list control group.
Detailed description
Relationships are a high-risk setting for HIV-infection. This trial aimed at testing the efficacy of an online theory-based tailored intervention for preparing single MSM to practice safe sex with future steady partners-labeling it the 'cognitive vaccine approach'.
The target was the promotion of negotiated safety (NS): steady partners testing for HIV and reaching agreements to either be monogamous or to only have safe sex outside the relationship in order to have safe unprotected anal intercourse with each other. The intervention content was based on the information, motivation, behavioral-skills model and the intervention was tailored according to knowledge, motivation, and skill-related deficiencies of each participant. Condom use was promoted as the default alternative for NS. Using an online randomized controlled trial we examined the effects of a tailored versus non-tailored version of the intervention. The cognitive effect (i.e. response efficacy, intentions, and perceived behavioral control (PBC) was measured directly after the intervention and, after 6-months, the behavioral effect (i.e. NS and condom use) via e-mail follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Men who have sex with men of all ages, HIV-negative or of unknown serostatus, single, and open to a steady relationship with a man in the future
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-behavioral tailored intervention | Behavioural | – |
Primary outcome
Scores on the practice of safe sex with steady partners at a six-months follow-up
1 secondary outcome
Scores on response efficacy, intentions and perceived behavioral control regarding the practice of safe sex with steady partners directly after the administration of the intervention
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Udi Davidovich, Dr. principal investigator
Public Health Service of Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral tailored intervention in people with Sexual Risk Behavior for HIV-Infection, run by Public Health Service of Amsterdam at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores on the practice of safe sex with steady partners at a six-months follow-up. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2006.