Completed

A Small Group Intervention to Reduce HIV Sexual Transmission Risk Behaviour Among HIV Positive Men Who Have Sex With Men: Gay Poz Sex (GPS)

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What is being tested

Gay Poz Sex

+ Wait List/Standard of Care

BehavioralOther
Who is being recruted

Over 18 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorToronto Metropolitan University
Last updated: March 10, 2020
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Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

The randomized control trial (RCT) component will test the efficacy of GPS, an HIV prevention intervention for HIV+ men who have sex with men (MSM). The present study is intended to be a rigorous evaluation, with the ultimate aim of testing the scale-up of the GPS program using a Phase IV effectiveness trial, per standard procedures for evaluating health interventions. The study hypothesis is that the study intervention will result in reduced prevalence of unprotected anal intercourse (UAI) acts among HIV+ MSM at 6-month follow-up with partners who are negative or of unknown HIV status. The secondary hypotheses are that the intervention will result in (1) reduced prevalence of UAI at 6-months follow-up with partners who are HIV+, and (2) a reduction in the number of sexual partners. This is a 2-site, 2-arm, randomized controlled trial that will randomize 180 participants to either a 8 session group motivational interviewing intervention (GPS) starting within 2 weeks after randomization, or to a wait-list control group. For ethical reasons, participants randomized to the control group will have the option to attend a GPS session after a 6-month wait period. Participants will complete 8 sessions of a small-group sexual health intervention to reduce sexual risk behaviour. Assessments will be conducted prior to the 8-session group, at the completion of the sessions and at 3-month and 6-month follow up post-intervention. The wait-list control group will complete 3- and 6-month follow-up assessments during their waiting period as well as after completing their GPS session. The 6 month follow-up assessment during their waiting period will be considered to be the baseline measure for their GPS session. Participants in both groups will complete interviews at the end of the 8 sessions and at the 6-month follow up. GPS takes the form of a small counseling group, since this is one of the most common intervention forms for similar populations. Participants will be organized into 15 groups per arm of approximately 6 participants, each of which will be led by 2 facilitators who are HIV+ MSM. This study builds upon a one-armed open-label Canadian Institutes for Health Research (CIHR)-funded grant that demonstrated that GPS is feasible to administer and appears to result in significant risk reduction. The study also showed that GPS results in promising reductions in UAI, thus forming a solid foundation for moving toward an RCT. In preliminary GPS data (n=25), we found a reduction in UAI from 88% at baseline to 60% at 3-month follow-up. More importantly for HIV prevention, we found a reduction in UAI with partners of HIV-negative or unknown HIV status from 56% at baseline to 36% at 6 month follow-up. Participants reported high satisfaction with the GPS program and our initial study site has found GPS to be highly feasible in their community organization. The proposed study will provide data on the efficacy of a motivational interviewing behavioural intervention for HIV+ MSM. Although research among primarily American samples documents moderate effect sizes for HIV prevention interventions among MSM, none have found a significant effect of an HIV prevention intervention for HIV+ MSM in Canada, nor have any studies examined the effect of a small-group based intervention using HIV+ MSM peers who are trained to administer motivational interviewing for HIV+ MSM. Armed with the data from the present study demonstrating the efficacy of the intervention, we will design and implement the next stage of the research program, which will be a Phase IV study to examine the effectiveness of the intervention in Toronto, Vancouver, and at least 2 other sites serving HIV+ MSM in Canada. The intervention should result in a decreased likelihood of having risky sex versus being on a waitlist. Previous data from formative research with this same intervention indicates promising findings that indicate a decreased prevalence of risky sex amongst GPS participants.

Principal SponsorToronto Metropolitan University
Last updated: March 10, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

173 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
Anticipate that you will be able to attend all workshops

Are an HIV-positive man who reports unprotected anal intercourse in the past two months

Are willing to participate in program monitoring and evaluation

Speak and understand English

1 exclusion criteria prevent from participating
Currently participating in counseling using motivational interviewing

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
In the immediate arm, participants will begin the 8 session group motivational interviewing intervention, Gay Poz Sex, within 2 weeks of randomization.

Group II

Active Comparator
Participants in the wait list/standard of care group will be given active referrals to existing community resources available to HIV+ MSM. For ethical reasons, participants randomized to the control group will have the option to attend the Gay Poz Sex program after a 6-month wait period.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Positive Living Society of British Columbia

Vancouver, CanadaOpen Positive Living Society of British Columbia in Google Maps

Ryerson University

Toronto, Canada
Completed2 Study Centers