Transgender Men's Perspectives on HIV Risk and HIV Prevention Interventions
Primary Purpose
Transgenderism, HIV Infections
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transgender men's perspectives on HIV risk and HIV prevention interventions
Sponsored by
About this trial
This is an interventional prevention trial for Transgenderism focused on measuring Transgender, LGBTQ, HIV, Qualitative
Eligibility Criteria
Inclusion Criteria: 18+; living in the United States; Assigned female at birth; Current gender identity of trans man or transmasculine; Sexual orientation of NOT heterosexual; Has access to the Internet. Exclusion Criteria: Under 18; Living outside of the US; Assigned male at birth; Current gender identity OUTSIDE of transgender man or transmasculine person; Heterosexual/straight; Does not have access to the Internet.
Sites / Locations
- Institute for Sexual and Gender Minority Health and Wellbeing
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Focus Groups
Arm Description
Focus groups will occur during the course of the study period.
Outcomes
Primary Outcome Measures
Post-hoc thematic analysis across five domains
Post-focus group thematic analysis of attitudes and preferences of HIV prevention messaging and strategies for transgender men and transmasculine people in five separate domains:
Partner selection and sorting among trans men who have sex with cis men (TMSM);
TMSM's perceptions of HIV risk in their lived experiences;
Exploring the various types of sexual behavior TMSM are engaging in;
Understanding HIV prevention strategies currently used by TMSM; and
Examine the preferences TMSM have for receiving information related to sexual health and HIV prevention.
Secondary Outcome Measures
Full Information
NCT ID
NCT05666102
First Posted
November 21, 2022
Last Updated
May 17, 2023
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT05666102
Brief Title
Transgender Men's Perspectives on HIV Risk and HIV Prevention Interventions
Official Title
Transgender Men's Perspectives on HIV Risk and HIV Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
January 30, 2023 (Actual)
Study Completion Date
August 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this pilot study is to gather and analyze qualitative data from focus groups with Transgender men who have sex with men (TMSM) to learn more about the life experiences unique to TMSM that influence their attitudes and beliefs about HIV risk, as well as to better understand the intersections of these specific sexual and gender identities.
Detailed Description
Men who have sex with men (MSM) are disproportionately impacted by HIV in the United States. While most new HIV infections are assumed to occur between cisgender men who have sex with other cisgender men, an increasing body of literature proposes that transgender men and transmasculine people who have sex with cisgender men (TMSM) might be at elevated risk for HIV infection. Despite data suggesting that transgender men and cisgender men are regularly engaging in sexual relationships, the majority of research on HIV among MSM focuses almost exclusively on sexual partnerships between cisgender gay and bisexual men. Additionally, when HIV prevention research does include transgender people, it almost exclusively focuses on HIV risk within transgender women and transfeminine people. TMSM are rarely mentioned as potential sexual partners for cisgender men and have historically been left out of most research on HIV prevention and in preventive intervention development. The goal of this pilot study is to gather and analyze qualitative data from focus groups with TMSM to learn more about the life experiences unique to TMSM influence their attitudes and beliefs about HIV risk, as well as to better understand the intersections of these specific sexual and gender identities. The investigators will enroll 30 TMSM in 5 focus groups where they will examine the unique contexts in which risk for HIV acquisition occurs for TMSM, and explore participant preferences for HIV prevention services. Focus group questions will focus on five areas: 1) Gathering information related to partner selection and sorting among TMSM; 2) assessing TMSM's perceptions of HIV risk in their lived experiences; 3) exploring the various types of sexual behavior TMSM are engaging in; 4) understanding the various HIV prevention strategies currently being deployed by TMSM; and 5) examine the preferences TMSM have for receiving information related to sexual health and HIV prevention information. Focus group guide content areas may be updated in subsequent groups to reflect additional topics that may emerge from conversations in prior focus groups. Data from the groups will be analyzed by the investigator and study team using an iterative, thematic process. These themes will be synthesized in the development of culturally relevant HIV prevention interventions for TMSM.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transgenderism, HIV Infections
Keywords
Transgender, LGBTQ, HIV, Qualitative
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Focus Groups
Arm Type
Other
Arm Description
Focus groups will occur during the course of the study period.
Intervention Type
Behavioral
Intervention Name(s)
Transgender men's perspectives on HIV risk and HIV prevention interventions
Intervention Description
Investigators will enroll 30 TMSM in 5 focus groups where they will examine the unique contexts in which risk for HIV acquisition occurs for TMSM, and explore participant preferences for HIV prevention services. Focus group questions will focus on five areas: 1) Gathering information related to partner selection and sorting among TMSM; 2) assessing TMSM's perceptions of HIV risk in their lived experiences; 3) exploring the various types of sexual behavior TMSM are engaging in; 4) understanding the various HIV prevention strategies currently being deployed by TMSM; and 5) examine the preferences TMSM have for receiving information related to sexual health and HIV prevention information.
Primary Outcome Measure Information:
Title
Post-hoc thematic analysis across five domains
Description
Post-focus group thematic analysis of attitudes and preferences of HIV prevention messaging and strategies for transgender men and transmasculine people in five separate domains:
Partner selection and sorting among trans men who have sex with cis men (TMSM);
TMSM's perceptions of HIV risk in their lived experiences;
Exploring the various types of sexual behavior TMSM are engaging in;
Understanding HIV prevention strategies currently used by TMSM; and
Examine the preferences TMSM have for receiving information related to sexual health and HIV prevention.
Time Frame
up to 9 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Study is open to individuals assigned/designated female at birth (AFAB/DFAB) but who currently identify as a transgender man or transmasculine person.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18+; living in the United States;
Assigned female at birth;
Current gender identity of trans man or transmasculine;
Sexual orientation of NOT heterosexual;
Has access to the Internet.
Exclusion Criteria:
Under 18;
Living outside of the US;
Assigned male at birth;
Current gender identity OUTSIDE of transgender man or transmasculine person;
Heterosexual/straight;
Does not have access to the Internet.
Facility Information:
Facility Name
Institute for Sexual and Gender Minority Health and Wellbeing
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Transgender Men's Perspectives on HIV Risk and HIV Prevention Interventions
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