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

January 4, 2015 updated by: Carmen Logie, MSW, PhD, University of Toronto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Faculty of Social Work, University of Calgary
    • Ontario
      • Toronto, Ontario, Canada, M5S 1V4
        • University of Toronto, Factor-Inwentash Faculty of Social Work

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
STI knowledge
Time Frame: 3 months
Sexually Transmitted Disease Knowledge Questionnaire (STD-KQ)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safer sex self-efficacy
Time Frame: 3 months
A modified Condom Use Self Efficacy Scale, for enhanced appropriateness for LBQ women
3 months
STI and HIV incidence
Time Frame: 3 months
Self-reported HIV/STI testing history and incidence (lifetime and in past 3 months)
3 months
Safer sex practices
Time Frame: 3 months
Safer Sexual Practices among Lesbian Women' Scale
3 months
Resilient coping
Time Frame: 3 months
Brief Resilient Coping Scale
3 months
Social Provisions
Time Frame: 3 months
Social Provisions Scale
3 months
Internalized sexual stigma
Time Frame: 3 months
Revised Internalized Homophobia Scale (IHP-R)
3 months
Sexual stigma
Time Frame: 3 months
Homophobia Scale
3 months
Depression
Time Frame: 3 months
Patient Health Questionnaire 2
3 months
Access to care
Time Frame: 3 months
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.
3 months
Self-Esteem
Time Frame: 3 months
Rosenberg Self Esteem Scale
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Collaborators

The CIHR Social Research Centre in HIV Prevention

Investigators

  • Principal Investigator: Carmen Logie, PhD, University of Toronto, Factor-Inwentash Faculty of Social Work

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

February 18, 2014

First Submitted That Met QC Criteria

February 19, 2014

First Posted (Estimate)

February 20, 2014

Study Record Updates

Last Update Posted (Estimate)

January 6, 2015

Last Update Submitted That Met QC Criteria

January 4, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CIHR SRC - 4487453

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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