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

NCT01816828 | Completed DMC

• 1 other identifier: DCO150GP
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV

Keywords

HIV, MSM, unprotected anal intercourse, sexual health

Outcome Measures

Primary Outcomes (1)

• 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.

  2 months

Study Arms (2)

Immediate

EXPERIMENTAL

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

Wait List/Standard of Care

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.

Other: Wait List/Standard of Care

Interventions

Gay Poz Sex BEHAVIORAL

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.

Immediate

Wait List/Standard of Care OTHER

Participants are given referrals to existing resources in the community. Referrals and uptake will be tracked.

Wait List/Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Currently participating in counseling using motivational interviewing

Sponsors & Collaborators

• Toronto Metropolitan University: lead
• University of Windsor: collaborator
• Simon Fraser University: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

Positive Living Society of British Columbia

Vancouver, British Columbia, V6A 1R8, Canada

Location

Ryerson University

Toronto, Ontario, M5B 2K3, Canada

Location

Study Officials

• Trevor A Hart, PhD

  Toronto Metropolitan University

  PRINCIPAL INVESTIGATOR

• Barry D Adam, PhD

  Windsor University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: March 22, 2013
• Study Start: March 1, 2013
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

CA (2)