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Completed

NCT Number: NCT02067845

A Group-level Intervention to Reduce HIV/STI Risk for 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Social Work, University of Calgary, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adapted Many Men, Many Voices (3MV) group level intervention

Behavioral

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.

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

Behavioral

Primary outcomes

  1. STI knowledge

    Time frame: 3 months

    Sexually Transmitted Disease Knowledge Questionnaire (STD-KQ)

Secondary outcomes

  1. Safer sex self-efficacy

    Time frame: 3 months

    A modified Condom Use Self Efficacy Scale, for enhanced appropriateness for LBQ women

  2. STI and HIV incidence

    Time frame: 3 months

    Self-reported HIV/STI testing history and incidence (lifetime and in past 3 months)

  3. Safer sex practices

    Time frame: 3 months

    Safer Sexual Practices among Lesbian Women' Scale

  4. Resilient coping

    Time frame: 3 months

    Brief Resilient Coping Scale

  5. Social Provisions

    Time frame: 3 months

    Social Provisions Scale

  6. Internalized sexual stigma

    Time frame: 3 months

    Revised Internalized Homophobia Scale (IHP-R)

  7. Sexual stigma

    Time frame: 3 months

    Homophobia Scale

  8. Depression

    Time frame: 3 months

    Patient Health Questionnaire 2

  9. 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.

  10. Self-Esteem

    Time frame: 3 months

    Rosenberg Self Esteem Scale

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • The CIHR Social Research Centre in HIV Prevention

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 20, 2014
Registry last updated
Jan 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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