High-risk Sex Clinical Trial
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).
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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