TransgenderismNCT05666102
Transgender Men's Perspectives on HIV Risk and HIV Prevention Interventions
A study testing Transgender men's perspectives on HIV risk and HIV prevention interventions in people with Transgenderism and HIV Infections, run by Northwestern University at 1 site in United States.
Trial 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… 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
- Transgenderism, HIV Infections
- What is being tested?
- Transgender men's perspectives on HIV risk and HIV prevention interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 30 Aug 2023
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Sexual and Gender Minority Health and Wellbeing
Chicago, Illinois, 60611
About this study
Official title: 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.
Read the 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.
- Conditions
- Transgenderism, HIV Infections
- Being tested
- Transgender men's perspectives on HIV risk and HIV prevention interventions
- Keywords
- Transgender, LGBTQ, HIV, Qualitative
- Medical subject headings
- Transsexualism, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transgender men's perspectives on HIV risk and HIV prevention interventionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Focus Groups | Other | Focus groups will occur during the course of the study period. Receives: Behavioral: Transgender men's perspectives on HIV risk and HIV prevention interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start1 Nov 2022
- Primary completion30 Jan 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransgenderismStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricky Hill, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666102
- Sponsor's protocol ID
- STU00217158
- Status last verified
- Nov 2023
- First submitted
- 21 Nov 2022
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transgender Men's Perspectives on HIV Risk and HIV Prevention
- ClinicalTrials.gov ID
- NCT05666102
- Acronym / sponsor ID
- STU00217158
- Conditions
- Transgenderism, HIV Infections
- Keywords
- Transgender, LGBTQ, HIV, Qualitative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 27 Dec 2022 (actual)
- 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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focus Groups | Other | Behavioral: Transgender men's perspectives on HIV risk and HIV prevention interventionsFocus groups will occur during the course of the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- Under 18;
- Living outside of the US;
- Assigned male at birth;
- Current gender identity OUTSIDE of transgender man or transmasculine person;
- Heterosexual/straight;
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 |
|---|---|---|
| Transgender men's perspectives on HIV risk and HIV prevention interventionsInvestigators 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. | Behavioural | Focus Groups |
Primary outcome
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.
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 9 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transgender men's perspectives on HIV risk and HIV prevention interventions in people with Transgenderism and HIV Infections, run by Northwestern University at 1 site in United States.
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 6 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 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Post-hoc thematic analysis across five domains (time frame: up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2023.