A Group-level Intervention to Reduce HIV/STI Risk for Women Who Have Sex With Women in Calgary and Toronto

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The CIHR Social Research Centre in HIV Prevention
Information provided by (Responsible Party):
Carmen Logie, MSW, PhD, University of Toronto
ClinicalTrials.gov Identifier:
NCT02067845
First received: February 18, 2014
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

The limited research that exists suggests that lesbian, bisexual and queer (LBQ) women are at similar risk for sexually transmitted infections (STI) as heterosexual women. This is a particularly important area to address, as literature highlights the convergence of sexual stigma and gender-based sexual violence as elevating LBQ women's risk for HIV and STI infection. However, recent Statistics Canada data indicated that: lesbians reported significantly lower rates of Pap testing than heterosexual or bisexual women; lesbians and bisexual women had higher odds of not having a regular doctor than heterosexual women; and bisexual women had higher reported unmet health care needs than lesbian and heterosexual women. These differences highlight the importance of implementing and evaluating interventions to address STI risk among LBQ women; however, no published study exists of this nature. A STI prevention intervention will be implemented with groups of LBQ women and WSW in Toronto and Calgary. The study has 5 distinct components: 1) key informant interviews to inform the development of the intervention training manual and survey questionnaire, 2) pre-test; 3) intervention (6 group sessions during a weekend retreat); 4) post-test directly following intervention, and 5) follow-up post-tests at 6 and 12 weeks. The study hypothesis is that, compared to pre-intervention, participants who receive the group-based intervention will report an increase in sexually transmitted infections (STI) knowledge post-intervention. The secondary hypotheses are that, compared with pre-intervention, participants will demonstrate higher mean scores of (a) safer sex self-efficacy; (b) STI testing; (c) safer sex practices; (d) resilient coping, (e) self-esteem, (f) social provisions, (g) community connectedness and (h) access to health care. We anticipated that compared to pre-intervention, participants post-intervention would report lower mean scores of (a) depression and (b) internalized stigma.


Condition Intervention
STI Knowledge
Behavioral: Adapted Many Men, Many Voices (3MV) group level intervention
Behavioral: A group-based HIV/STI prevention intervention for women who have sex with women

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pilot-testing a Group-level Intervention to Reduce Risk for Sexual Transmission of HIV/STIs Among Lesbian, Bisexual and Queer Women and Other Women Who Have Sex With Women in Calgary and Toronto

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • STI knowledge [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Sexually Transmitted Disease Knowledge Questionnaire (STD-KQ)


Secondary Outcome Measures:
  • Safer sex self-efficacy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    A modified Condom Use Self Efficacy Scale, for enhanced appropriateness for LBQ women

  • STI and HIV incidence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Self-reported HIV/STI testing history and incidence (lifetime and in past 3 months)

  • Safer sex practices [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Safer Sexual Practices among Lesbian Women' Scale

  • Resilient coping [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Brief Resilient Coping Scale

  • Social Provisions [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Social Provisions Scale

  • Internalized sexual stigma [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Revised Internalized Homophobia Scale (IHP-R)

  • Sexual stigma [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Homophobia Scale

  • Depression [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Patient Health Questionnaire 2

  • Access to care [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Participants will responded to questions asking if they had ever received (i) an HIV test and (ii) an STI test (not including HIV). Participants also responded to questions asking if they had ever experienced the following barriers to accessing health care: (i) cost travel, (ii) cost medications and (iii) belief that their HCP was not comfortable with their sexual orientation. Follow up surveys will ask if participants had received an HIV or STI test in the past 4 weeks.

  • Self-Esteem [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Rosenberg Self Esteem Scale


Estimated Enrollment: 44
Study Start Date: February 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Pre-post test design Behavioral: Adapted Many Men, Many Voices (3MV) group level intervention

The intervention will adapt the Many Men, Many Voices (3MV) group level intervention for MSM to address individual and social determinants of HIV/STI risk and vulnerability. This intervention involves 6 consecutive 2-3 hours sessions conducted at a weekend retreat. We will have 1 retreat in Calgary and 1 retreat in Toronto; each retreat will include 20 persons.

Based on the 3MV format, a draft template includes: Session 1: Intersectionality; Session 2: STI/HIV Prevention Among WSW and LBQ Women; Session 3: STI/HIV Risk Assessment and Prevention Options; Session 4: Relationship Issues; Session 5: Self-efficacy, Resilient Coping and Capacity for Change; Session 6: Social Support and Problem Solving to Maintain Change.

Delivery methods include discussion, role-plays and risk-reduction planning.

Behavioral: A group-based HIV/STI prevention intervention for women who have sex with women

Detailed Description:

This is a single-centre pragmatic N-of-1 pilot study. The target population is LBQ women in Calgary and Toronto, Canada. The authors aim to recruit 40 participants using purposive peer-driven recruitment methods. LBQ women from agencies that serve LBQ women will deliver the intervention. A survey will be conducted at pre and post-intervention to evaluate the impact of the intervention. Paired-sample t-tests will be used to assess pre- and post- intervention differences in sexual risk behaviour outcomes (safer sex practices, safer sex self-efficacy), protective factors (resilient coping, HIV/STI knowledge and testing) and social-structural determinants (social support, access to health care, internalized sexual stigma) directly following the intervention and 3 months post-intervention. Logistic and linear generalized estimating equation (GEE) regression models will be used to assess intervention effects for the follow-up period of 3 months to control for repeated within-subject measurements.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Self-identified lesbian, bisexual, queer, or women who have sex with women
  • Over 18 years old who
  • Are capable of providing informed consent
  • Are interested in attending a weekend retreat with 6 group sessions and 3 month follow up
  • Live in the greater Calgary and Toronto area.

Exclusion Criteria:

  • Below 18 years old
  • Does not identify as lesbian, bisexual or queer or a WSW
  • Insufficient interest/attention to attend the group sessions.
  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: NCT02067845

Locations
Canada, Alberta
Faculty of Social Work, University of Calgary
Calgary, Alberta, Canada
Canada, Ontario
University of Toronto, Factor-Inwentash Faculty of Social Work
Toronto, Ontario, Canada, M5S 1V4
Sponsors and Collaborators
University of Toronto
The CIHR Social Research Centre in HIV Prevention
Investigators
Principal Investigator: Carmen Logie, PhD University of Toronto, Factor-Inwentash Faculty of Social Work
  More Information

No publications provided

Responsible Party: Carmen Logie, MSW, PhD, Assistant Professor at the Factor-Inwentash Faculty of Social Work, University of Toronto, University of Toronto
ClinicalTrials.gov Identifier: NCT02067845     History of Changes
Other Study ID Numbers: CIHR SRC - 4487453
Study First Received: February 18, 2014
Last Updated: February 21, 2014
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by University of Toronto:
Lesbian, queer, bisexual women
HIV and STI prevention
Resilient coping
Sexual stigma
Depression
Safer-sex practices
Safer sex self-efficacy
HIV/STI knowledge and testing
Pilot-testing

ClinicalTrials.gov processed this record on October 20, 2014