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

Primary Purpose

HIV

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Gay Poz Sex
Wait List/Standard of Care
Sponsored by
Toronto Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring HIV, MSM, unprotected anal intercourse, sexual health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Positive Living Society of British Columbia
  • Ryerson University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate

Wait List/Standard of Care

Arm Description

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

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.

Outcomes

Primary Outcome Measures

number of UAI acts with HIV-negative or status unknown partners
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.

Secondary Outcome Measures

Full Information

First Posted
March 19, 2013
Last Updated
March 9, 2020
Sponsor
Toronto Metropolitan University
Collaborators
University of Windsor, Simon Fraser University, Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT01816828
Brief Title
Intervention Research to Reduce HIV Sexual Transmission Among HIV Positive Men Who Have Sex With Men
Official Title
A Small Group Intervention to Reduce HIV Sexual Transmission Risk Behaviour Among HIV Positive Men Who Have Sex With Men: Gay Poz Sex (GPS)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Toronto Metropolitan University
Collaborators
University of Windsor, Simon Fraser University, Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV
Keywords
HIV, MSM, unprotected anal intercourse, sexual health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate
Arm Type
Experimental
Arm Description
In the immediate arm, participants will begin the 8 session group motivational interviewing intervention, Gay Poz Sex, within 2 weeks of randomization.
Arm Title
Wait List/Standard of Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Gay Poz Sex
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Wait List/Standard of Care
Intervention Description
Participants are given referrals to existing resources in the community. Referrals and uptake will be tracked.
Primary Outcome Measure Information:
Title
number of UAI acts with HIV-negative or status unknown partners
Description
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.
Time Frame
2 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trevor A Hart, PhD
Organizational Affiliation
Toronto Metropolitan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barry D Adam, PhD
Organizational Affiliation
Windsor University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Positive Living Society of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6A 1R8
Country
Canada
Facility Name
Ryerson University
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 2K3
Country
Canada

12. IPD Sharing Statement

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

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