Ignite Creation Date:
2024-05-06 @ 2:32 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02067845
Status:
COMPLETED
Last Update Posted:
2015-01-06
First Post:
2014-02-18
Brief Title:
A Group-level Intervention to Reduce HIVSTI Risk for Women Who Have Sex With Women in Calgary and Toronto
Sponsor:
University of Toronto
Organization:
University of Toronto
Study Overview
Official Title:
Pilot-testing a Group-level Intervention to Reduce Risk for Sexual Transmission of HIVSTIs Among Lesbian Bisexual and Queer Women and Other Women Who Have Sex With Women in Calgary and Toronto
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 womens 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 HIVSTI 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None