Intervention Research to Reduce HIV Sexual Transmission Among HIV Positive Men Who Have Sex With Men

March 9, 2020 updated by: Trevor Hart, Ryerson University

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

Gay Poz Sex (GPS) is a peer-facilitated holistic sexual health program for gay and bisexual HIV-positive men. Groups of five to eight men attend eight weekly sessions which cover basic sexual health information, review the current legal context surrounding HIV non-disclosure and use motivational interviewing (MI) to support participants in setting and achieving personal goals.

In this randomized control trial phase of the research, the investigators are assessing the efficacy of the group counseling intervention, GPS. Participants are randomized to receive GPS immediately or to a wait list/standard of care condition. Participants are followed for a 6 month period and are asked to complete baseline quantitative assessments, as well as two qualitative interviews.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

173

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6A 1R8
        • Positive Living Society of British Columbia
    • Ontario
      • Toronto, Ontario, Canada, M5B 2K3
        • Ryerson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Are an HIV-positive man who reports unprotected anal intercourse in the past two months
  • Speak and understand English
  • Anticipate that you will be able to attend all workshops
  • Are willing to participate in program monitoring and evaluation

Exclusion Criteria:

  • Currently participating in counseling using motivational interviewing

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate
In the immediate arm, participants will begin the 8 session group motivational interviewing intervention, Gay Poz Sex, within 2 weeks of randomization.
Behavioral: Gay Poz Sex
Gay Poz Sex is a community-driven, peer-facilitated program for HIV+ gay and bisexual men. This eight week program is offered to small groups of 5-8 men and provides information about sexual health, the legal context of HIV non-disclosure and uses motivational interviewing to support each individual in setting and achieving a personal goal.
Active Comparator: Wait List/Standard of Care
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.
Other: Wait List/Standard of Care
Participants are given referrals to existing resources in the community. Referrals and uptake will be tracked.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of UAI acts with HIV-negative or status unknown partners
Time Frame: 2 months
The main outcome measure for the GPS study is number of UAI acts with HIV-negative or status unknown partners reported by HIV+ MSM participants within the past 2 months.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ryerson University

Collaborators

Canadian Institutes of Health Research (CIHR)
Simon Fraser University
University of Windsor

Investigators

  • Principal Investigator: Trevor A Hart, PhD, Ryerson University
  • Principal Investigator: Barry D Adam, PhD, Windsor University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

March 19, 2013

First Submitted That Met QC Criteria

March 21, 2013

First Posted (Estimate)

March 22, 2013

Study Record Updates

Last Update Posted (Actual)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCO150GP (Other Grant/Funding Number: Canadian Institutes of Health Research)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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