Safer SexNCT02067845
A Group-level Intervention to Reduce HIV/STI Risk for Women Who Have Sex With Women in Calgary and Toronto
A study testing Adapted Many Men, Many Voices (3MV) group level intervention and A group-based HIV/STI prevention intervention for women who have sex with women in people with Safer Sex, run by University of Toronto at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Safer Sex
- What is being tested?
- Adapted Many Men, Many Voices (3MV) group level intervention and A group-based HIV/STI prevention intervention for women who have sex with women
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesCanada
- Study dates
- Feb 2014to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Below 18 years old
- Does not identify as lesbian, bisexual or queer or a WSW
- Insufficient interest/attention to attend the group sessions.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Faculty of Social Work, University of Calgary
Calgary, Alberta
University of Toronto, Factor-Inwentash Faculty of Social Work
Toronto, Ontario, M5S 1V4
About this study
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
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.
Read the 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.
- Conditions
- Safer Sex
- Being tested
- Adapted Many Men, Many Voices (3MV) group level intervention, A group-based HIV/STI prevention intervention for women who have sex with women
- 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
- Medical subject headings
- Homosexuality, Female, Homosexuality, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Many Men, Many Voices (3MV) group level interventionBehavioural
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 womenBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Pre-post test design | Other | Not described Receives: Behavioral: Adapted Many Men, Many Voices (3MV) group level intervention; Behavioral: A group-based HIV/STI prevention intervention for women who have sex with women |
What is being measured
The primary outcome is the main question the study is designed to answer.
STI knowledge
Sexually Transmitted Disease Knowledge Questionnaire (STD-KQ)
Measured: 3 months
Secondary outcomes (10)
Safer sex self-efficacy
A modified Condom Use Self Efficacy Scale, for enhanced appropriateness for LBQ women
Measured: 3 months
STI and HIV incidence
Self-reported HIV/STI testing history and incidence (lifetime and in past 3 months)
Measured: 3 months
Safer sex practices
Safer Sexual Practices among Lesbian Women' Scale
Measured: 3 months
Resilient coping
Brief Resilient Coping Scale
Measured: 3 months
Social Provisions
Social Provisions Scale
Measured: 3 months
Internalized sexual stigma
Revised Internalized Homophobia Scale (IHP-R)
Measured: 3 months
Sexual stigma
Homophobia Scale
Measured: 3 months
Depression
Patient Health Questionnaire 2
Measured: 3 months
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.
Measured: 3 months
Self-Esteem
Rosenberg Self Esteem Scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Safer SexStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- The CIHR Social Research Centre in HIV Prevention
- Responsible party
- Principal investigator, Carmen Logie, MSW, PhD, University of Toronto
- Investigators
- Carmen Logie, PhD, Principal investigator, University of Toronto, Factor-Inwentash Faculty of Social Work
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067845
- Sponsor's protocol ID
- CIHR SRC - 4487453
- Status last verified
- Jan 2015
- First submitted
- 18 Feb 2014
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25867642Logie 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.
PubMed 24760356
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02067845
- Acronym / sponsor ID
- CIHR SRC - 4487453
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- The CIHR Social Research Centre in HIV Prevention
- Study start
- Feb 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 20 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-post test design | Other | Behavioral: Adapted Many Men, Many Voices (3MV) group level intervention, Behavioral: A group-based HIV/STI prevention intervention for women who have sex with women |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Below 18 years old
- Does not identify as lesbian, bisexual or queer or a WSW
- Insufficient interest/attention to attend the group sessions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Many Men, Many Voices (3MV) group level interventionThe 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. | Behavioural | Pre-post test design |
| A group-based HIV/STI prevention intervention for women who have sex with women | Behavioural | Pre-post test design |
Primary outcome
STI knowledge
Time frame: 3 months
Sexually Transmitted Disease Knowledge Questionnaire (STD-KQ)
10 secondary outcomes
Safer sex self-efficacy
Time frame: 3 months
STI and HIV incidence
Time frame: 3 months
Safer sex practices
Time frame: 3 months
Resilient coping
Time frame: 3 months
Social Provisions
Time frame: 3 months
Internalized sexual stigma
Time frame: 3 months
Sexual stigma
Time frame: 3 months
Depression
Time frame: 3 months
Access to care
Time frame: 3 months
Self-Esteem
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
- Derived from this study: PubMed 25867642Logie 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.
- Derived from this study: PubMed 24760356Logie 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Logie, PhD principal investigator
University of Toronto, Factor-Inwentash Faculty of Social Work
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Many Men, Many Voices (3MV) group level intervention and A group-based HIV/STI prevention intervention for women who have sex with women in people with Safer Sex, run by University of Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
STI knowledge (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02067845, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2015; AzTrials last refreshed its copy on 1 Nov 2026.