Clinical trial NCT02067845: A Group-level Intervention to Reduce HIV/STI Risk for Women Who Have Sex With Women in Calgary and Toronto
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safer Sex
Keywords: 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
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: The CIHR Social Research Centre in HIV Prevention
First posted: 2014-02-20
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: STI knowledge
timeFrame: 3 months
Secondary outcomes:
measure: Safer sex self-efficacy
timeFrame: 3 months
measure: STI and HIV incidence
timeFrame: 3 months
measure: Safer sex practices
timeFrame: 3 months
measure: Resilient coping
timeFrame: 3 months
measure: Social Provisions
timeFrame: 3 months
measure: Internalized sexual stigma
timeFrame: 3 months
measure: Sexual stigma
timeFrame: 3 months
measure: Depression
timeFrame: 3 months
measure: Access to care
timeFrame: 3 months
measure: Self-Esteem
timeFrame: 3 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Faculty of Social Work, University of Calgary
state: Alberta
city: Toronto
country: Canada
facility: University of Toronto, Factor-Inwentash Faculty of Social Work
state: Ontario
Study officials:
affiliation: University of Toronto, Factor-Inwentash Faculty of Social Work
name: Carmen Logie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Logie CH, Lacombe-Duncan A, Weaver J, Navia D, Este D. A Pilot Study of a Group-Based HIV and STI Prevention Intervention for Lesbian, Bisexual, Queer, and Other Women Who Have Sex with Women in Canada. AIDS Patient Care STDS. 2015 Jun;29(6):321-8. doi: 10.1089/apc.2014.0355. Epub 2015 Apr 13.
citation: Logie CH, Navia D, Rwigema MJ, Tharao W, Este D, Loutfy MR. A group-based HIV and sexually transmitted infections prevention intervention for lesbian, bisexual, queer and other women who have sex with women in Calgary and Toronto, Canada: study protocol for a non-randomised cohort pilot study. BMJ Open. 2014 Apr 23;4(4):e005190. doi: 10.1136/bmjopen-2014-005190.