NCT01931345

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

2.7 years

First QC Date

August 6, 2013

Last Update Submit

October 24, 2016

Conditions

Keywords

Rapid HIV testingMSMMotivational InterviewingHIV preventionHIV/AIDSAt-risk anal intercourseRandomized trial

Outcome Measures

Primary Outcomes (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).

    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)

  • Change from baseline importance that participants accord to taking the necessary steps to protect themselves from HIV at 6 months

    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)

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

    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)

  • Change from baseline intention to protect themselves from HIV at 6 months

    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)

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

    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)

Study Arms (2)

Motivational Interviewing Counseling

EXPERIMENTAL

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

Behavioral: Motivational Interviewing Counseling

Standard counseling

ACTIVE COMPARATOR

Counseling based on Quebec guidelines for rapid HIV testing

Behavioral: Standard counseling

Interventions

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

Motivational Interviewing Counseling

Counseling based on Quebec guidelines for rapid HIV testing

Standard counseling

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SPOT, 1223-A rue Amherst

Montreal, Quebec, H2L 3K9, Canada

Location

Related Links

MeSH Terms

Conditions

Unsafe SexAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Joanne Otis, Ph.D.

    Université du Québec a Montréal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Agent

Study Record Dates

First Submitted

August 6, 2013

First Posted

August 29, 2013

Study Start

July 1, 2013

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

October 25, 2016

Record last verified: 2016-10

Locations