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Transforming the understanding
and treatment of mental illnesses.

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.


LetSync: Pilot Test of Mobile Health (mHealth) Intervention

Study Type: Interventional
Start Date: September 1, 2022
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.


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.


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): Rainbow Sky Association of Thailand, Bangkok, Thailand; Institute of HIV Research and Innovation, 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).


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.


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.


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.


Testing THRIVE 365 for Black Sexual Minority Men (On The Daily)

Study Type: Interventional
Start Date: September 14, 2021
Eligibility: Males, 16 Years and Older, Accepts Healthy Volunteers
Location(s): Devin English, Newark, New Jersey, United States

The primary goal of this study is to test a minority stress model of psychological health outcomes for Black sexual minority men (BSMM) while using and not using a novel intervention named THRIVE 365. THRIVE 365 combines mHealth and institutional support elements to provide four areas of support for BSMM: 1) Promote HIV and psychological health knowledge and motivation; 2) Foster a sense of community and positive social connections among BSMM; 3) Connect clients to BSMM-affirming healthcare, including HIV treatment and mental healthcare; 4) Provide resources for housing, transportation, and other economic empowerment. To examine the effects of the intervention, we will utilize a 14-day daily diary study to capture daily intervention engagement, HIV and psychological health outcomes, coping, and experiences of racial and sexual minority stressors. We will first examine main associations between intervention engagement and HIV (antiretroviral [ART] use) and psychological health (depressive symptoms, anxiety symptoms, emotion regulation difficulties outcomes) outcomes, then consider how intervention engagement affects coping and attenuates the impacts of racial and sexual minority stressors during the 14 day period.


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.


Enhancing Partner Services Among Men Who Have Sex With Men Living With HIV

Study Type: Interventional
Start Date: August 1, 2021
Eligibility: Males, 18 Years to 99 Years, Does Not Accept Healthy Volunteers
Location(s): Guangzhou Center for Diseases Control and Prevention, Guangzhou, Guangdong, China

Individuals will participate in a pilot randomized controlled trial (RCT) that implements and evaluates the feasibility, acceptability, and effectiveness of crowdsourced partner services (PS) or conventional PS among Chinese men who have sex with men (MSM) living with HIV.

The pilot RCT will include 120 newly identified MSM HIV cases who were born biologically male, aged 18 years old or older, newly identified as HIV positive, had oral or anal sex with a man, had at least one sexual partner in the previous 6 months and live in Guangzhou. Participants will undergo a series of computer-based interviews (baseline and 2 months after enrollment) and will be randomly assigned into two groups in 2:1 ratio (intervention: control) and receive crowdsourced PS and conventional PS, respectively.


Reducing Intersectional Stigma Among High-Risk Women in Brazil to Promote Uptake of HIV Testing and PrEP

Study Type: Interventional
Start Date: December 1, 2020
Eligibility: Males, 18 Years and Older, Accepts Healthy Volunteers
Location(s): CRT - Centro de Referência e Treinamento DST/AIDS, São Paulo, Brazil; SAE - Serviço de Assistência Especializada Campos Elíseos, São Paulo, Brazil

This is a randomized controlled trial of a multi-level intervention to prevent HIV acquisition among transgender women (N=400) in São Paulo, Brazil. The intervention will be evaluated using a randomized wait-list controlled trial to compare uptake of HIV testing (self-testing and clinic-based) (Aim 1), PrEP initiation and persistence (Aim 2), and other prevention services (e.g. harm reduction) among trans women in the intervention arm compared to those in the control arm with data collection scheduled every three-months. Investigators will assess changes in intersectional stigma (Aim 3), including reductions in internalized stigma and increased resilience to anticipated and enacted stigma, among those assigned to intervention compared to those assigned to the control arm, and assess how changes in stigma result in prevention uptake.


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.


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.


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.


A Pragmatic Trial of Two Strategies for Implementing an Effective eHealth HIV Prevention Program (Keep It Up! 3.0)

Study Type: Interventional
Start Date: October 9, 2019
Eligibility: Males, 18 Years to 34 Years, Accepts Healthy Volunteers
Location(s): Northwestern University, Chicago, Illinois, United States

This study evaluates and compares two implementation strategies of an online HIV prevention intervention: Strategy 1 in which community-based organizations apply, and are selected, for funding to deliver Keep It Up! through current HIV testing programs; and Strategy 2 which is a "direct-to-consumer" model where centralized staff at Northwestern University recruit participants nationally through online advertising campaigns and manage engagement.


Pre-exposure Prophylaxis (PrEP) at Home

Study Type: Interventional
Start Date: April 26, 2019
Eligibility: Males, 18 Years to 49 Years, Accepts Healthy Volunteers
Location(s): MetroHealth, Cleveland, Ohio, United States; Emory University, PRISM Health, Atlanta, Georgia, United States; Washington University AIDS Clinical Trial Unit, Saint Louis, Missouri, United States; Open Arms Health Care Center, Jackson, Mississippi, United States; The Fenway Institute, Boston, Massachusetts, United States

This study is a randomized clinical trial of PrEP@Home, a home care system for Human Immunodeficiency Virus (HIV) Pre-Exposure Prophylaxis (PrEP). Individuals entering into PrEP care at an initial in-person study visit will be randomized to the PrEP@Home system for home-based PrEP care follow-up visits or to the control standard of care for clinic-based follow-up visits. The primary aim of this study is to assess protective levels of PrEP medication for the intervention arm compared to the control arm.


eTest: Real-time, Remote Monitoring System for Home-based HIV Testing Among High-risk Men Who Have Sex With Men

Study Type: Interventional
Start Date: January 23, 2019
Eligibility: Males, 18 Years and Older, Accepts Healthy Volunteers
Location(s): Brown University School of Public Health, Providence, Rhode Island, United States

The proposed research will conduct a fully-powered efficacy trial of this approach in areas with large populations of AA and H/L MSM and high HIV incidence: Jackson, MS, Los Angeles, CA, and Boston, MA. High-risk MSM who have not tested for HIV in the last year will be recruited from MSM-oriented "hook-up" mobile apps, and assigned to receive either (1) HBST with post-test phone counseling/referral ("eTEST" condition), (2) "standard" HBST without active follow-up, or (3) reminders to get tested for HIV at a local clinic ("control" condition) at three month intervals over the course of 12 months. The investigators will explore the impact of the eTEST system on key outcomes, including rates of HIV testing, receipt of additional HIV prevention services, and PrEP initiation, compared with standard HBST or clinic-based testing reminders alone. The investigators will also explore the cost effectiveness of the eTEST system under various scenarios compared with relying on traditional, clinic-based testing alone.


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.