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Clinical Trials/NCT02067845
NCT02067845
Completed
Not Applicable

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

University of Toronto2 sites in 1 country44 target enrollmentFebruary 2014
ConditionsSafer Sex

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Safer Sex
Sponsor
University of Toronto
Enrollment
44
Locations
2
Primary Endpoint
STI knowledge
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
June 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carmen Logie, MSW, PhD

Assistant Professor at the Factor-Inwentash Faculty of Social Work, University of Toronto

University of Toronto

Eligibility 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.

Outcomes

Primary Outcomes

STI knowledge

Time Frame: 3 months

Sexually Transmitted Disease Knowledge Questionnaire (STD-KQ)

Secondary Outcomes

  • Access to care(3 months)
  • Safer sex self-efficacy(3 months)
  • STI and HIV incidence(3 months)
  • Resilient coping(3 months)
  • Self-Esteem(3 months)
  • Safer sex practices(3 months)
  • Social Provisions(3 months)
  • Sexual stigma(3 months)
  • Internalized sexual stigma(3 months)
  • Depression(3 months)

Study Sites (2)

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