Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05666102
Other study ID # STU00217158
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date August 30, 2023

Study information

Verified date November 2023
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 specific sexual and gender identities.


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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date August 30, 2023
Est. primary completion date January 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Institute for Sexual and Gender Minority Health and Wellbeing Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
up to 9 months
See also
  Status Clinical Trial Phase
Completed NCT05454514 - Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS N/A
Completed NCT03760458 - The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age Phase 1/Phase 2
Completed NCT03067285 - A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study Phase 4
Completed NCT03141918 - Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS N/A
Recruiting NCT04579146 - Coronary Artery Disease (CAD) in Patients HIV-infected
Completed NCT06212531 - Papuan Indigenous Model of Male Circumcision N/A
Active, not recruiting NCT03256422 - Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients Phase 3
Completed NCT03256435 - Retention in PrEP Care for African American MSM in Mississippi N/A
Completed NCT00517803 - Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies N/A
Active, not recruiting NCT03572335 - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Completed NCT04165200 - Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV N/A
Recruiting NCT03854630 - Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection Phase 4
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT02234882 - Study on Pharmacokinetics Phase 1
Completed NCT01618305 - Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission Phase 4
Recruiting NCT05043129 - Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
Not yet recruiting NCT05536466 - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine N/A
Recruiting NCT04985760 - Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy Phase 1
Completed NCT05916989 - Stimulant Use and Methylation in HIV
Terminated NCT02116660 - Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) Phase 2