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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Ryerson University
Sponsor:
Collaborators:
University of Windsor
Simon Fraser University
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Trevor Hart, Ryerson University
ClinicalTrials.gov Identifier:
NCT01816828
First received: March 19, 2013
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
HIV
Behavioral: Gay Poz Sex
Other: Wait List/Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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)

Resource links provided by NLM:


Further study details as provided by Ryerson University:

Primary Outcome Measures:
  • number of UAI acts with HIV-negative or status unknown partners [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 180
Study Start Date: March 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01816828

Locations
Canada, British Columbia
Positive Living BC Not yet recruiting
Vancouver, British Columbia, Canada, V6B 5S8
Contact: Sarah Chown, MPH    604.349.4230    sarahc@positivelivingbc.org   
Principal Investigator: Malcolm Steinberg, MBBCH, DoH, MSc         
Canada, Ontario
Ryerson University Recruiting
Toronto, Ontario, Canada, M5B 2K3
Contact: AMY C WILLIS, MA    416.979.5000 ext 1-2179    amy.c.willis@arts.ryerson.ca   
Sponsors and Collaborators
Ryerson University
University of Windsor
Simon Fraser University
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Trevor A Hart, PhD Ryerson University
Principal Investigator: Barry D Adam, PhD Windsor University
  More Information

No publications provided

Responsible Party: Trevor Hart, Associate Professor, Ryerson University
ClinicalTrials.gov Identifier: NCT01816828     History of Changes
Other Study ID Numbers: DCO150GP
Study First Received: March 19, 2013
Last Updated: May 21, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Ryerson University:
HIV, MSM, unprotected anal intercourse, sexual health

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014