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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Focus Groups
Focus groups will occur during the course of the study period.
Behavioral: Transgender men's perspectives on HIV risk and HIV prevention interventions
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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:

  1. Partner selection and sorting among trans men who have sex with cis men (TMSM);
  2. TMSM's perceptions of HIV risk in their lived experiences;
  3. Exploring the various types of sexual behavior TMSM are engaging in;
  4. Understanding HIV prevention strategies currently used by TMSM; and
  5. Examine the preferences TMSM have for receiving information related to sexual health and HIV prevention.
up to 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 27, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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