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High-risk SexNCT01931345

The SPOT Project : Motivational Interviewing in Conjunction With Rapid HIV Testing

A study testing Motivational Interviewing Counseling and Standard counseling in people with High-risk Sex, run by Université du Québec a Montréal at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In 2009, a team of researchers from Montreal, Canada, implemented SPOT, an intervention aimed at reducing HIV transmission among men who have sex with men by offering rapid HIV testing in a community setting. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
High-risk Sex
What is being tested?
Motivational Interviewing Counseling and Standard counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
1 siteCanada
Study dates
Jul 2013to Apr 2016
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male
  • 18 years of age or older
  • Resident of Quebec
  • Able to understand French or English
  • Unprotected anal sex with a man on at least one occasion in the last 3 years
  • HIV-negative or HIV status unknown

Who cannot join

  • Symptoms of fever (over 38°C), headache, muscular pain, fatigue, and/or swollen lymp
  • Previously tested at SPOT
  • Enrolled as a participant in the IPERGAY study

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • SPOT, 1223-A rue Amherst

    Montreal, Quebec, H2L 3K9

Other trials in Canada

About this study

Official title: The SPOT Project: Effect of Counseling Based on Motivational Interviewing Offered in Conjunction With Rapid HIV Testing on the Occurrence of Unprotected Anal Sex and Its Determinants Among Men Who Have Sex With Men (MSM) in Montreal

In 2009, a team of researchers from Montreal, Canada, implemented SPOT, an intervention aimed at reducing HIV transmission among men who have sex with men by offering rapid HIV testing in a community setting. During the first phase, counseling based on Quebec guidelines for rapid HIV testing was offered (standard counseling - SC) and in the second phase, counseling based on motivational interviewing (MIC) was developed and validated. The current phase of the project aims to strengthen the work undertaken during previous phases. The objective of the study is to assess the short and medium term effect of MIC on the occurrence of at-risk anal intercourse and its cognitive determinants. Participants will be randomly assigned to either SC or MIC, and will respond to a baseline questionnaire documenting their sexual behavior and psychosexual profile prior to the intervention at the start of their initial visit (T0). The effect of counseling will be assessed following the intervention at the end of the initial visit (T1), at 3 months after the initial visit (T2) and at 6 months after the initial visit (T3).

Read the detailed description

In Canada, the prevalence and incidence of HIV remain high among men who have sex with men (MSM). Moreover, epidemiological data show that a significant proportion of transmission can be attributed people who are unaware of their HIV status. To address these challenges, HIV testing has the potential to be a major prevention strategy. Indeed, the combination of testing and treatment (test \& treat) is now seen to be one of the most promising strategies in terms of its potential contribution to the eradication of HIV.

To maximize testing among MSM, it has been recommended that services be diversified by offering HIV testing in close proximity to areas where people most at risk for HIV reside and socialize. Rapid HIV testing can also help reduce barriers in access to testing by reaching those most at risk more effectively in non-traditional venues. In addition, testing offers an excellent opportunity and psycho-affective context within which to provide individualized counseling in order to explore preventive practices and testing routines.

Since July 2009, the SPOT project has combined a number of strategies (testing services in close proximity to a residential area; free, anonymous, and rapid HIV testing; individualized preventive counseling) in an original way at an innovative community site located in the heart of Montreal's Gay Village. In the first phase of the study, standard counseling (SC) based on Quebec guidelines for rapid HIV testing was used. During the second, counseling based on a motivational interviewing approach (MIC) was developed and has been provided to participants since May 2011.

Taking advantage of the existing infrastructure, the objective of the current phase of the study is to assess the short and medium term impact of MIC and its cognitive determinants in comparison to SC. The occurrence of at-risk anal intercourse (unprotected anal sex with an HIV-positive partner or partner of unknown HIV status) will be measured at baseline and followed over six months. Four cognitive determinants of at-risk anal sex will also be measured: the importance that participants accord to taking the necessary steps to protect themselves from HIV, perceived personal efficacy in achieving this, intention to do so, and the extent to which participants have planned to do so.

To achieve this objective, a 24 months randomized trial will be implemented SPOT's community site. Participants who present for HIV testing will be randomized between the two conditions, MIC and SC, alternated at a ratio of 1/1 (experimental condition: MIC offered by a community worker; control condition: SC offered by a nurse). Outcome measures will be collected by means of questionnaires. Four measurement times are planned. A baseline questionnaire will be administered prior to pre-test counseling at the start of the initial visit. Outcome measures will be assessed at baseline (T0), and in follow-up questionnaires administered after post-test counseling at the end of the initial visit (T1), at 3 months after the initial visit (T2) and at 6 months after the initial visit (T3). Target enrolment at T0 is 900, for a final sample of 508 participants at T3, representing 254 participants per group (MIC, SC). Mechanisms will be put in place to ensure the integrity of both MIC and SC interventions as well as to retain participants and involve community members in the research process.

In the wake of the recommendations of the Federal Initiative to Address HIV/AIDS in Canada, this study will provide data on the effectiveness of different forms of preventive counseling tailored for use in conjunction with rapid HIV testing. If MIC proves to be effective, the training and clinical supervision offered to intervention staff as well as the tools and quality control procedures developed during the implementation of this approach to counseling will be made available in other settings where testing is offered. Important lessons may also be learned with regards to the organization of services and the benefits and challenges associated with the implementation of this type of HIV prevention infrastructure. Ultimately, this study will contribute to efforts to more effectively combat the HIV epidemic amongst MSM in Canada and reduce the direct and indirect costs associated with HIV in these communities.

Conditions
High-risk Sex
Being tested
Motivational Interviewing Counseling, Standard counseling
Keywords
Rapid HIV testing, MSM, Motivational Interviewing, HIV prevention, HIV/AIDS, At-risk anal intercourse, Randomized trial
Medical subject headings
Unsafe Sex, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motivational Interviewing CounselingBehavioural

    Counseling developed by the research team based on a motivational interviewing approach

  • Standard counselingBehavioural

    Counseling based on Quebec guidelines for rapid HIV testing

Study groups in NCT01931345
Study groupRoleWhat they receive
Motivational Interviewing CounselingExperimentalCounseling developed by the research team based on a motivational interviewing approach
Receives: Behavioral: Motivational Interviewing Counseling
Standard counselingActive comparatorCounseling based on Quebec guidelines for rapid HIV testing
Receives: Behavioral: Standard counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline occurrence of at-risk anal intercourse at 6 months

    Occurrence of at-risk anal intercourse will be assessed prior to pre-test counseling at the start of participants' initial visit (baseline, T0), after post-test counseling at the end of the initial visit (T1), at 3 months after the initial visit (T2), and at 6 months after the initial visit (T3).

    Measured: Prior to pre-test counseling at the start of participants' initial visit (baseline, T0), after post-test counseling at the end of the initial visit (T1), at 3 months after the initial visit (T2), and at 6 months after the initial visit (T3)

Secondary outcomes (4)
  1. Change from baseline importance that participants accord to taking the necessary steps to protect themselves from HIV at 6 months

    Importance that participants accord to taking the necessary steps to protect themselves from HIV will be assessed prior to pre-test counseling at the start of participants' initial visit (baseline, T0), after post-test counseling at the end of the initial visit (T1), at 3 months after the initial visit (T2), and at 6 months after the initial visit (T3).

    Measured: Prior to pre-test counseling at the start of participants' initial visit (baseline, T0), after post-test counseling at the end of the initial visit (T1), at 3 months after the initial visit (T2), and at 6 months after the initial visit (T3)

  2. Change from baseline perceived personal efficacy in protecting themselves from HIV at 6 months

    Perceived personal efficacy in protecting themselves from HIV will be assessed prior to pre-test counseling at the start of participants' initial visit (baseline, T0), after post-test counseling at the end of the initial visit (T1), at 3 months after the initial visit (T2), and at 6 months after the initial visit (T3)

    Measured: Prior to pre-test counseling at the start of participants' initial visit (baseline, T0), after post-test counseling at the end of the initial visit (T1), at 3 months after the initial visit (T2), and at 6 months after the initial visit (T3)

  3. Change from baseline intention to protect themselves from HIV at 6 months

    Intention to protect themselves from HIV will be assessed prior to pre-test counseling at the start of participants' initial visit (baseline, T0), after post-test counseling at the end of the initial visit (T1), at 3 months after the initial visit (T2), and at 6 months after the initial visit (T3)

    Measured: Prior to pre-test counseling at the start of participants' initial visit (baseline, T0), after post-test counseling at the end of the initial visit (T1), at 3 months after the initial visit (T2), and at 6 months after the initial visit (T3)

  4. Change from baseline extent to which participants have planned to protect themselves from HIV at 6 months

    Extent to which participants have planned to protect themselves from HIV will be assessed prior to pre-test counseling at the start of participants' initial visit (baseline, T0), after post-test counseling at the end of the initial visit (T1), at 3 months after the initial visit (T2), and at 6 months after the initial visit (T3)

    Measured: Prior to pre-test counseling at the start of participants' initial visit (baseline, T0), after post-test counseling at the end of the initial visit (T1), at 3 months after the initial visit (T2), and at 6 months after the initial visit (T3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionMar 2016
  4. Study completionApr 2016

Resources

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
900 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01931345
Sponsor's protocol ID
SPOT
Status last verified
Oct 2016
First submitted
6 Aug 2013
Last updated
25 Oct 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Motivational Interviewing Counseling and Standard counseling in people with High-risk Sex, run by Université du Québec a Montréal 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 3 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 25 Oct 2016. 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 occurrence of at-risk anal intercourse at 6 months (time frame: Prior to pre-test counseling at the start of participants' initial visit (baseline, T0), after post-test counseling at the end of the initial visit (T1), at 3 months after the initial visit (T2), and at 6 months after the initial visit (T3)). 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 25 Oct 2016.

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