- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05666102
Transgender Men's Perspectives on HIV Risk and HIV Prevention Interventions
November 7, 2023 updated by: Ricky Hill, Northwestern University
Transgender Men's Perspectives on HIV Risk and HIV Prevention
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Institute for Sexual and Gender Minority Health and Wellbeing
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Focus Groups
Focus groups will occur during the course of the study period.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-hoc thematic analysis across five domains
Time Frame: up to 9 months
|
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:
|
up to 9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2022
Primary Completion (Actual)
January 30, 2023
Study Completion (Actual)
August 30, 2023
Study Registration Dates
First Submitted
November 21, 2022
First Submitted That Met QC Criteria
December 16, 2022
First Posted (Actual)
December 27, 2022
Study Record Updates
Last Update Posted (Actual)
November 9, 2023
Last Update Submitted That Met QC Criteria
November 7, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Urogenital Diseases
- Genital Diseases
- HIV Infections
Other Study ID Numbers
- STU00217158
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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