# Studies Recruiting Only Men

Mental disorders affect women and men differently — some disorders are more common in men or may be characterized by different symptoms in men and women. Learn more about men and mental health.

## Featured Studies

Featured studies include only those **currently recruiting participants**. Studies with the most recent start date appear first.

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### Supporting Trans Affirmation, Relationships, and Sex, Phase 3 **

**Study Type:** Interventional**Start Date:** June 20, 2023**Eligibility:** Males, 18 Years and Older, Accepts Healthy Volunteers**Location(s):** Brown University, Providence, Rhode Island, United States    

The purpose of this clinical trial is to evaluate and test a newly developed gender-affirming intervention that addresses the dual and interconnected risks of HIV and intimate partner victimization (IPV) among transgender women (TW). The main questions it aims to answer are: (1) will the study intervention reduce HIV risk within the context of IPV and related risk factors (e.g., substance use and PTSD); (2) will STARS improve primary prevention behaviors, such as condom use, pre-exposure prophylaxis (PrEP) use, and repeat HIV testing; and (3) what are the mechanisms of change relevant to the theoretical foundations of the intervention, including gender affirmation, empowerment, and self-efficacy. The findings from this study will provide the necessary groundwork to examine the efficacy of this combined HIV-IPV intervention in a future, large-scale clinical trial.

There are several components to this research study:

First, participants will be asked to complete a series of screening interviews/questionnaires to determine eligibility, including completing a HIV test. If eligible, participants will then take part in a 2-3 hour baseline assessment consisting of both interviewer administered questionnaires as well as self-administered surveys. Participants will then be randomly assigned to one of two treatment conditions: (1) a newly developed gender affirming intervention, known as Program STARS (Supporting Trans Affirmation, relationships, and Sex) or (2) a time-matched, attention-controlled program that offers free training in relaxation and stress reduction techniques (a.k.a., the comparison group). Both interventions offer unique components and the researchers do not yet know the impact the programs may have on participants' overall well-being. Participants randomized to Project STARS, will be invited to complete a semi-structured exit interview (lasting 60-90 min.) after the completion of the program. This clinical trial has three follow-up assessments: (1) post-intervention (i.e., after the peer-counseling programs are complete); (2) at 4-months follow-up; and (3) at 6-months follow-up. The follow-up assessments are structured the same way as the baseline assessment and are estimated to take around 1-2 hours.

The total study involvement for this clinical trial is estimated to take approximately 10 to 12 hours over the course of six months.

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### Telehealth Delivery (Tele-B6) **

**Study Type:** Interventional**Start Date:** April 18, 2023**Eligibility:** Males, 18 Years to 29 Years, Does Not Accept Healthy Volunteers**Location(s):** Grady Infectious Diseases Program Clinic, Atlanta, Georgia, United States    

The research team has developed an interventional group program for young men living with HIV and will be adapting it for telehealth delivery. The purpose of the study is to determine whether or not this program can help improve social connections and the health of young men in online delivery and evaluate its potential for implementation in a community setting. The study has three phases: (1) engaging a community advisory board to create and adapt the intervention for online delivery, (2) a randomized clinical trial of the online intervention, and (3) evaluation of the program for community implementation with our partner organization. Participants in the second phase of the study will meet with a study team member to discuss the research process and provide informed consent. The community organization employees will provide consent online prior to completion of a survey and indicate whether they consent to be contacted further for in-depth interviews.

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### Improving HIV Testing, Linkage, and Retention in Care for Men Through U=U Messaging **

**Study Type:** Interventional**Start Date:** March 31, 2023**Eligibility:** Males, 15 Years and Older, Accepts Healthy Volunteers**Location(s):** Cape Town Metro, Cape Town, Western Cape, South Africa; Buffalo City Metro, East London, Eastern Cape, South Africa    

This study will evaluate the impact of U=U messaging and counseling on gaps in the HIV care cascade for men, including testing uptake and ART initiation (Aim 1), achieving viral suppression and retention in care (Aim 2) in two provinces in South Africa. The U=U message communicates the compelling idea that PLHIV who take ART and have an undetectable viral load (<200 copies/mL) cannot sexually transmit HIV. Additionally, the investigators will conduct a multi-method evaluation to inform future implementation of U=U messaging interventions (Aim 3).

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### LetSync: Pilot Test of Mobile Health (mHealth) Intervention **

**Study Type:** Interventional**Start Date:** March 15, 2023**Eligibility:** Males, 18 Years and Older, Accepts Healthy Volunteers**Location(s):** University of California San Francisco, San Francisco, California, United States    

The Pilot Test (AKA Study B) will entail a pilot randomized, controlled trial (RCT) of an mHealth behavioral intervention, LetSync, with 80 couples (N=160) to assess its acceptability, feasibility, and preliminary impact on retention in care and ART adherence as measured by antiretroviral concentrations in hair. Participants in the intervention arm will use LetSync v1.0 for 6 months and provide acceptability and feasibility data. In the ensuing 2 months, the investigators will make refinements based on participants' data to produce LetSync v2.0. Then, participants in the waitlist-control arm will receive LetSync v2.0, use it for 6 months, and provide acceptability and feasibility data. The intervention arm will continue using LetSync v1.0, for a total of 14 months. Based on acceptability and feasibility data from waitlist control arm participants between T3 and T4, the investigators will develop LetSync v3.0, which will be used for efficacy testing in a full RCT trial in the future.

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### Pharmacy-based Pre-exposure Prophylaxis **

**Study Type:** Interventional**Start Date:** May 19, 2022**Eligibility:** Males, 18 Years and Older, Does Not Accept Healthy Volunteers**Location(s):** Emory University, Atlanta, Georgia, United States    

The proposed research will develop a culturally appropriate pharmacy PrEP delivery model for black men who have sex with men (BMSM) who live in high poverty, racial minority neighborhoods. Increasing access to PrEP through pharmacies has the potential to increase PrEP uptake among BMSM thereby reducing HIV incidence and racial inequities in HIV.

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### Development of a Telehealth-delivered Peer Navigation and Coping Skills Intervention to Increase PrEP Use in Young Black MSM **

**Study Type:** Interventional**Start Date:** April 1, 2022**Eligibility:** Males, 15 Years to 24 Years, Accepts Healthy Volunteers**Location(s):** Massachusetts General Hospital, Boston, Massachusetts, United States    

This proposal seeks to adapt an existing peer navigation protocol (by adding coping skills and using telehealth) to be feasible, acceptable, and capable of supporting both PrEP uptake and P-E adherence for YBMSM ages 15-24.

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### Developing mHealth to Promote PrEP Use Among Thai Young Men Who Have Sex With Men **

**Study Type:** Interventional**Start Date:** February 23, 2022**Eligibility:** Males, 16 Years to 25 Years, Accepts Healthy Volunteers**Location(s):** SWING Foundation, Bangkok, Thailand; Institute of HIV Research and Innovation, Bangkok, Thailand; Rainbow Sky Association of Thailand, Bangkok, Thailand    

The goal of this study is to develop and pilot test technology-based interventions to promote Pre-exposure Prophylaxis (PrEP) uptake and adherence among Thai young men who have sex with men (YMSM).

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### Peer-driven Intervention on PrEP **

**Study Type:** Interventional**Start Date:** January 6, 2022**Eligibility:** Males, 18 Years and Older, Accepts Healthy Volunteers**Location(s):** The Miriam Hospital, Providence, Rhode Island, United States    

The objective of this study is to develop an effective peer-driven intervention (PDI) approach and assess its feasibility and efficacy on pre-exposure prophylaxis (PrEP) uptake among men who have sex with men.

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### Addressing the Continuum of Care Among High-risk Thai Men **

**Study Type:** Interventional**Start Date:** November 27, 2021**Eligibility:** Males, 15 Years to 29 Years, Accepts Healthy Volunteers**Location(s):** M-Health Office Ubon, Ubon Ratchathani, Thailand; M-Health Office Maha Sarakham, Maha Sarakham, Thailand    

Young Thai men who have sex with men (YMSM) are at high risk for HIV. However, the Thailand National HIV Strategy does not adequately cover HIV prevention for YMSM using specific methods relevant to them, and instead uses a one-size-fits all approach. Partnering with the Thailand Ministry of Public Health (MOPH), the proposed study seeks to finalize, implement and evaluate a multicomponent, multi-level, community mobilization, combination intervention (HUG-M+) to address the entire Continuum of Prevention and Care. The investigators propose to test the efficacy of this approach by conducting research in two Northeastern Thai cities, one randomized to the intervention condition, which will receive HUG-M+ and the other to the control condition, where standard of care will be provided. If HUG-M+ is found to be efficacious, it might be scaled up, with the support of the MOPH, to other regions in Thailand, elsewhere in Asia and the US.

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### Parrying the Pitfalls of PrEP: Project PEACH **

**Study Type:** Interventional**Start Date:** November 20, 2021**Eligibility:** Males, 18 Years to 45 Years, Does Not Accept Healthy Volunteers**Location(s):** PRISM Research Center, Atlanta, Georgia, United States    

The study is a prospective cohort of young MSM who are followed for 2 years either in-person at the PRISM Health Research Clinic and/or virtually with telehealth study visits. Follow-up visits occur as frequently as every 3 months, or as appropriate to clinical needs of HIV PrEP or STI PEP. The investigators will enroll men who may decide to start or stop PrEP, change from daily oral PrEP to on-demand oral PrEP or from on-demand oral PrEP to daily PrEP, to start or stop STI PEP at any point in the study period, or injectable PrEP as an alternative to daily oral PrEP or on-demand oral PrEP. All men will be provided with the study's mobile smart phone app to support early identification of risks for PrEP discontinuation, to provide information about STI PEP and document usage patterns of on-demand oral PrEP and STI PEP, and to support easy linkage to support services for PrEP counseling and addressing concerns or questions about STI PEP and injectable PrEP.

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### 11C-YJH08 PET Imaging for the Detection of Glucocorticoid Receptor Expression in Patients With Metastatic Prostate Cancer **

**Study Type:** Interventional**Start Date:** August 10, 2021**Eligibility:** Males, 18 Years and Older, Does Not Accept Healthy Volunteers**Location(s):** University of California San Francisco, San Francisco, California, United States    

This phase I trial studies if positron emission tomography (PET) imaging using 11C-YJH08 can be useful for detecting certain cell receptor expression in tumor cells in patients with prostate cancer that has spread to other parts of the body (metastatic). 11C-YJH08 is a small-molecule radiotracer that binds to receptors on cells (glucocorticoid receptor) so that they show up better on the PET scan. Anti-hormone therapy (including enzalutamide) can cause more glucocorticoid receptors to be produced in tumor cells, which can make the tumor cells resist hormone therapies. If researchers can find a better way to detect whether glucocorticoid receptors are increasing during therapy, it may lead to more successful therapies using glucocorticoid receptor antagonists.

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### Life-Steps Counseling to Enhance Adherence and Engagement in PrEP Care **

**Study Type:** Interventional**Start Date:** September 3, 2020**Eligibility:** Males, 18 Years and Older, Accepts Healthy Volunteers**Location(s):** University of Miami, Miami, Florida, United States; Fenway Health, Boston, Massachusetts, United States    

The purpose of this study is to test how different types of interventions may affect how someone takes their pre-exposure prophylaxis (PrEP) medication.

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### Biomedical HIV/AIDS Prevention Program Yunnan **

**Study Type:** Interventional**Start Date:** August 1, 2020**Eligibility:** Males, 18 Years and Older, Accepts Healthy Volunteers**Location(s):** Yunnan Center for Disease Prevention and Control, Kunming, Yunnan, China    

B-HAPPY is an implementation project to study the process by which pre-exposure prophylaxis (PrEP) is introduced and integrated into a specific international health system facing high rates of HIV incidence among men who have sex with men. The study will use a stepped wedge design to compare implementation outcomes across eight municipalities in Yunnan, China.

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### An Avatar-based Mobile Phone Intervention to Promote Health in African American MSM **

**Study Type:** Interventional**Start Date:** March 4, 2020**Eligibility:** Males, 18 Years to 34 Years, Does Not Accept Healthy Volunteers**Location(s):** University of Illinois at Chicago, Chicago, Illinois, United States    

The investigators propose to determine the efficacy of "My Personal Health Guide," a theory-based innovative talking relational human Avatar mobile phone application to engage HIV-positive AAMSM in adherence and retention in care. Providing an empathetic talking Avatar source of HIV-related information, motivation, and behavioral skills that is as private and convenient as their own mobile phone might produce a high impact by overcoming barriers to HIV adherence and retention in care such as stigma and health literacy.

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### Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning **

**Study Type:** Observational**Start Date:** July 31, 2010**Eligibility:** Males, 18 Years to 55 Years, Accepts Healthy Volunteers**Location(s):** Connecticut Mental Health Center, Clinical Neuroscience Research Unit, New Haven, Connecticut, United States    

The aim of the present study is to assess the availability of cannabinoid receptors (CB1R) in the human brain. CB1R are present in everyone's brain, regardless of whether or not someone has used cannabis. The investigators will image brain cannabinoid receptors using Positron Emission Tomography (PET) imaging and the radioligand OMAR, in healthy individuals and several conditions including 1) cannabis use disorders, 2) psychotic disorders, 3) prodrome of psychotic illness and 4) individuals with a family history of alcoholism, 5) Post-Traumatic Stress Disorder 6) Opioid Use Disorder using the PET imaging agent or radiotracer, [11C]OMAR. This will allow us to characterize the number and distribution of CB1R in these conditions. It is likely that the list of conditions will be expanded after the collection of pilot data and as new data on cannabinoids receptor function and psychiatric disorders becomes available.

Those in the cannabis us disorder arm of the study will have a PET scan on at least three occasions: once while smoking as usual, once after 48-hours of abstinence from cannabis, and a final time after 4 weeks of abstinence. Additional scans may be conducted within the 4 weeks and the last scan may be conducted well beyond 4 weeks. Similarly, while most schizophrenia patients may get scanned just once, a subgroup of patients may get scanned more than once. For example to tease out the effects of medications, unmedicated patients may get scanned while unmedicated and again after treatment with antipsychotic medications. Similarly prodromes may get scanned while in the prodromal stage off medications, on medications and after conversion to schizophrenia.