HIVNCT01726153
A Pilot Trial of an Individualized Web-Based Condom Use Intervention
A study testing Condom-HIM in people with HIV, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the efficacy of an online intervention in increasing condom use among HIV+ gay males. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Condom-HIM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Nov 2014
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- are HIV-seropositive,
- Men who are having sex with men,
- engaging in unprotected anal intercourse with a partner who is serostatus negative or unknown
- age 18 years and older,
- ability to read English
- have access to a computer and internet.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomized Control Trial (RCT) of an Individualized Condom-HIM Web-based Intervention for Condom USe Among HIV+ Gay Males
The purpose of this study is to evaluate the efficacy of an online intervention in increasing condom use among HIV+ gay males.
- Conditions
- HIV
- Being tested
- Condom-HIM
- Keywords
- Condom Use, HIV+ gay males, Intervention, Tailored, On-line, Internet, Web-based
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Condom-HIMBehavioural
The tailored on-line Condom-HIM intervention is composed of a single session involving activities to increase individuals self-efficacy and intention to use condoms.
| Study group | Role | What they receive |
|---|---|---|
| Web sites | No intervention | Individuals assigned to this arm are given a list of websites where they can view additional information relating to condom use. |
| Condom-HIM | Experimental | Individuals assigned to this arm must follow an on-line one session tailored intervention. Receives: Behavioral: Condom-HIM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in participants self-efficacy in condom use at 2-weeks post-intervention
The Self-Efficacy for condom use measure contains a set of items to rate participant's belief that they will be able to use condoms every time they have anal sex in a variety of situations. A four-point response scale, ranging from 'strongly agree' (0) to 'strongly disagree' (4) is used. The psychometric properties of the measure have been examined and have been shown to have good internal consistency with Cronbach's alpha coefficient of 0.96.
Measured: baseline and 2-weeks post intervention
Secondary outcomes (1)
Change from Baseline in participants intention to use condoms at 2-weeks post-intervention
The intention to use condoms measure asks participants their intention to consistently use condoms. The psychometric properties of the measure have been examined and have shown to have good internal consistency with Cronbach's alpha coefficient of 0.89.
Measured: Baseline and 2-weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2013
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joyal Miranda, PhD, Principal investigator, Ryerson University and Centre hospitalier de l'Universite de Montreal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726153
- Sponsor's protocol ID
- R0018767
- Status last verified
- Nov 2012
- First submitted
- 6 Nov 2012
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Miranda J, Cote J, Godin G, Blais M, Otis J, Gueheneuc YG, Fadel G, Barton L, Fowler S. An Internet-Based Intervention (Condom-Him) to Increase Condom Use Among HIV-Positive Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2013 Oct 16;2(2):e39. doi: 10.2196/resprot.2723.
PubMed 24132072
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Control Trial (RCT) of an Individualized Condom-HIM Web-based Intervention for Condom USe Among HIV+ Gay Males
- ClinicalTrials.gov ID
- NCT01726153
- Acronym / sponsor ID
- R0018767
- Conditions
- HIV
- Keywords
- Condom Use, HIV+ gay males, Intervention, Tailored, On-line, Internet, Web-based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 14 Nov 2012 (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 evaluate the efficacy of an online intervention in increasing condom use among HIV+ gay males.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web sites | No intervention | –Individuals assigned to this arm are given a list of websites where they can view additional information relating to condom use. |
| Condom-HIM | Experimental | Behavioral: Condom-HIMIndividuals assigned to this arm must follow an on-line one session tailored intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- are HIV-seropositive,
- Men who are having sex with men,
- engaging in unprotected anal intercourse with a partner who is serostatus negative or unknown
- age 18 years and older,
- ability to read English
Key exclusion criteria (1 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 |
|---|---|---|
| Condom-HIMThe tailored on-line Condom-HIM intervention is composed of a single session involving activities to increase individuals self-efficacy and intention to use condoms. | Behavioural | Condom-HIM |
Primary outcome
Change from Baseline in participants self-efficacy in condom use at 2-weeks post-intervention
Time frame: baseline and 2-weeks post intervention
The Self-Efficacy for condom use measure contains a set of items to rate participant's belief that they will be able to use condoms every time they have anal sex in a variety of situations. A four-point response scale, ranging from 'strongly agree' (0) to 'strongly disagree' (4) is used. The psychometric properties of the measure have been examined and have been shown to have good internal consistency with Cronbach's alpha coefficient of 0.96.
1 secondary outcome
Change from Baseline in participants intention to use condoms at 2-weeks post-intervention
Time frame: Baseline and 2-weeks post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Derived from this study: PubMed 24132072Miranda J, Cote J, Godin G, Blais M, Otis J, Gueheneuc YG, Fadel G, Barton L, Fowler S. An Internet-Based Intervention (Condom-Him) to Increase Condom Use Among HIV-Positive Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2013 Oct 16;2(2):e39. doi: 10.2196/resprot.2723.
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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.
Joyal Miranda, PhD principal investigator
Ryerson University and Centre hospitalier de l'Universite de Montreal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Condom-HIM in people with HIV, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 6 inclusion and 1 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: finished, as of the sponsor's last update on 24 Jul 2020. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline in participants self-efficacy in condom use at 2-weeks post-intervention (time frame: baseline and 2-weeks post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01726153, which also lists 1 linked publication.
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 24 Jul 2020.