Safer Sex Clinical Trial
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
| Verified date | January 2015 |
| Source | University of Toronto |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Canadian Institutes of Health Research |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 44 |
| Est. completion date | June 2014 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Canada | Faculty of Social Work, University of Calgary | Calgary | Alberta |
| Canada | University of Toronto, Factor-Inwentash Faculty of Social Work | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| University of Toronto | The CIHR Social Research Centre in HIV Prevention |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | STI knowledge | Sexually Transmitted Disease Knowledge Questionnaire (STD-KQ) | 3 months | No |
| Secondary | Safer sex self-efficacy | A modified Condom Use Self Efficacy Scale, for enhanced appropriateness for LBQ women | 3 months | No |
| Secondary | STI and HIV incidence | Self-reported HIV/STI testing history and incidence (lifetime and in past 3 months) | 3 months | No |
| Secondary | Safer sex practices | Safer Sexual Practices among Lesbian Women' Scale | 3 months | No |
| Secondary | Resilient coping | Brief Resilient Coping Scale | 3 months | No |
| Secondary | Social Provisions | Social Provisions Scale | 3 months | No |
| Secondary | Internalized sexual stigma | Revised Internalized Homophobia Scale (IHP-R) | 3 months | No |
| Secondary | Sexual stigma | Homophobia Scale | 3 months | No |
| Secondary | Depression | Patient Health Questionnaire 2 | 3 months | No |
| Secondary | Access to care | 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 | No |
| Secondary | Self-Esteem | Rosenberg Self Esteem Scale | 3 months | No |