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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.

Developing Online Interventions to Reduce Stigma-Related Stress, Sexual Health, and HIV Risk Among Young Chinese MSM

Study Type: Interventional
Start Date: April 19, 2021
Location: Hunan, China
Eligibility: Males, Ages 16–30, Accepts Healthy Volunteers

This study is a 2-arm RCT that will assess the efficacy of a culturally adapted, 10-session SGM-affirmative, internet-based cognitive behavioral therapy (iCBT) among young men who have sex with men (YMSM) in Hunan province China. The affirmative treatment called ESTEEM is based on a minority stress-focused, CBT framework. In collaboration with colleagues at Central South University (CSU), the investigators will assess whether a culturally adapted version of iCBT ESTEEM demonstrates significant reductions in HIV risk behavior and mental health symptoms (e.g., depression, anxiety) compared to self-monitoring of stress and mood.

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
Location: São Paulo, Brazil
Eligibility: Males, Ages 18 and Older, Accepts Healthy Volunteers

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.

The Shauriana Intervention for GBMSM in Kenya

Study Type: Interventional
Start Date: October 28, 2020
Location: Kisumu, Kenya
Eligibility: Males, Ages 18–35, Accepts Healthy Volunteers

The Shauriana intervention, developed from qualitative work using a community-based participatory approach, aims to integrate PrEP, sexual health, and mental health support for gay, bisexual, and other men who have sex with men in Kenya. This study consists of a brief pilot test phase with 10 participants, followed by a randomized, controlled trial with 60 participants.

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

Study Type: Interventional
Start Date: September 3, 2020
Locations: Miami, Florida; Boston, Massachusetts
Eligibility: Males, Ages 18 and Older, Accepts Healthy Volunteers

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

AllyQuest Adherence App Intervention for HIV-positive Men Who Have Sex With Men and Transgender Women: Pilot Trial

Study Type: Interventional
Start Date: July 8, 2020
Location: Chapel Hill, North Carolina
Eligibility: Males, Ages 15–24, Does Not Accept Healthy Volunteers

AllyQuest (AQ) is a theory-informed smart phone application that supports HIV medication adherence for young men who have sex with men and young transgender women who have sex with men (YMSM/YTW) via behavior change, social support, and game-based mechanics. This study aims to evaluate the feasibility and acceptability of AQ and AQ plus medication adherence counseling in a Sequential Multiple Assignment Randomization Trial.

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

Study Type: Interventional
Start Date: March 4, 2020
Location: Chicago, Illinois
Eligibility: Males, Ages 18–34, Does Not Accept Healthy Volunteers

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.

Improving Health Outcomes in Young Cisgender Men and Transgender Women (mLab App)

Study Type: Interventional
Start Date: January 21, 2020
Locations: Chicago, Illinois; New York, New York
Eligibility: Males, Ages 18–29, Accepts Healthy Volunteers

The mLab App combines HIV prevention information with push notifications/reminders to complete HIV testing and an automated image processing feature to provide real-time feedback on home-based HIV test results. Theoretically-guided by the Health Information Technology Usability Evaluation Model (Health-ITUEM), the proposed project will refine and test a next-generation diagnostic intervention delivered on a mobile platform to improve HIV testing and linkage-to-care outcomes among youth living with and at-risk for HIV. Given the pervasiveness, low cost, and convenience of mobile technology, the investigators hope that the App can help achieve the goals of the National HIV/AIDS Strategy in the US by increasing the number of persons living with HIV who know their serostatus, decreasing HIV-related disparities, and ultimately reducing the risk of HIV transmission and acquisition.

Comparison of Men's Prevention Apps to Research Efficacy

Study Type: Interventional
Start Date: October 14, 2019
Locations: Tampa, Florida; Atlanta, Georgia; Chicago, Illinois; Boston, Massachusetts; Bronx, New York; Philadelphia, Pennsylvania; Houston, Texas
Eligibility: Males, Ages 15–24, Accepts Healthy Volunteers

A randomized three arm control trial to examine the efficacy of two distinct apps (LYNX and MyChoices) developed for young men who have sex with men (YMSM) compared to standard of care (SOC) information about HIV testing and PrEP (Pre-Exposure Prophylaxis).

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
Location: Chicago, Illinois
Eligibility: Males, Ages 18–34, Accepts Healthy Volunteers

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.

Personalized HIV and STI Testing Tool

Study Type: Interventional
Start Date: September 18, 2019
Location: San Francisco, California
Eligibility: Males, Ages 18–29, Accepts Healthy Volunteers

The PHASTT Study is focused on understanding of facilitators and barriers to mHealth use among young Black men who have sex with men (MSM), and testing a novel mobile app to increase HIV/STI testing and PrEP uptake.

PrEP Seguro: Antiretroviral-based HIV Prevention Among Men at High Risk in Mexico

Study Type: Interventional
Start Date: May 15, 2019
Location: Mexico City, DF, Mexico
Eligibility: Males, Ages 18 and Older, Accepts Healthy Volunteers

The objective of this R34 application is to prepare for testing innovative user-centered ways to promote PrEP adherence at scale. Our central hypothesis is that adherence to PrEP can be improved among MSW if PrEP is provided for free along with highly-tailored conditional economic incentives (CEI). The specific aims are: Aim 1: To refine the design of PrEP adherence intervention with user-centered conditional economic incentives to maximize sustained adherence behaviors through a user-responsive computerized survey (n=200). We incorporate quantitatively identified preferences for CEIs through a user- responsive computerized survey. We use conjoint analysis to understand preferences for CEI intervention components and how CEIs should be integrated into an optimal combination package to be tested in Aim 2. Aim 2: Measure the extent to which a user-centered CEI intervention can help MSW increase their adherence to free PrEP in a randomized controlled pilot (n=100). Among MSW who accept to take free PrEP, and return at month 1 for a second pill bottle, we will randomize n=100 MSW to either: standard of care (SoC: information, prescription, free PrEP) or CEI (SoC + incentives contingent on sufficiently-high adherence to PrEP). We will assess the primary outcome (biomarker of adherence using scalp hair analysis) at months 3 and 6, as well as secondary outcomes: clinic attendance/retention, medication possession ratio, self-reported PrEP use, and sexual behavioral disinhibition (number of partners, condom use, incident STI). Aim 3: Estimate the preliminary cost-effectiveness of incentives for PrEP adherence to maximize future policy and practice relevance of this promising intervention strategy. Our working hypothesis is that conditional economic incentives for PrEP adherence will be cost-effective in terms of cost per fully- adherent month on PrEP, cost per HIV infection averted, and cost per disability-adjusted life year saved when compared to controls not receiving the conditional incentives. The expected outcome of this R34 is a demonstration that is feasible to implement user-centered CEIs in this context, as well as preliminary efficacy and cost-effectiveness data. The project will have positive impact because it is a critical step toward scaled-up implementation of PrEP in this highly-at-risk population of MSWs in Mexico, with implications for other concentrated epidemics among MSW worldwide.

Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men (YMSM)

Study Type: Interventional
Start Date: May 7, 2019
Location: Chapel Hill, North Carolina
Eligibility: Males, Ages 16–29, Does Not Accept Healthy Volunteers

Tough Talks is a virtual reality based HIV disclosure intervention that allows HIV+ individuals to practice disclosing to romantic partners. Tough Talks allows participants to have the opportunity to practice disclosing using a variety of strategies and experience different outcomes including acceptance, confusion, lack of HIV knowledge, and rejection.

Pre-exposure Prophylaxis (PrEP) at Home

Study Type: Interventional
Start Date: April 26, 2019
Locations: Atlanta, Georgia; Boston, Massachusetts; Jackson, Mississippi; Saint Louis, Missouri; Cleveland, Ohio
Eligibility: Males, Ages 18–49, Accepts Healthy Volunteers

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
Location: Providence, Rhode Island
Eligibility: Males, Ages 18 and Older, Accepts Healthy Volunteers

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.

Black Men's Care, and Intervention to Re-Engage HIV+ Black Men in Care

Study Type: Interventional
Start Date: May 25, 2018
Location: San Francisco, California
Eligibility: Males, Ages 18 and Older, Does Not Accept Healthy Volunteers

The proposed study aims to develop an intervention that is strategic in that it will 1) be a focused on an approach that combines an in-person session with post-session, two-way text messaging to continue the intervention and reinforce the gains from the in-person session and 2) ultimately find HIV+ Black men who have sex with men who have left HIV care where they are likely to present (e.g., city and county health clinics, community-based organizations, emergency rooms).

Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning

Study Type: Observational
Start Date: July 31, 2010
Location: New Haven, Connecticut
Eligibility: Males, Ages 18–55, Accepts Healthy Volunteers

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.