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Behavioral Intervention
Project nGage for HIV (nGage Trial)
N/A
Recruiting
Led By Alida Bouris, PhD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
nGage Trial Summary
This trial tests an intervention to help young Black sexual minority men aged 18-35 stay in care and lower viral levels.
Who is the study for?
This trial is for young Black sexual minority men aged 18-35 with HIV who speak English, own a personal cell phone, and have missed an HIV care visit in the past year. They must identify as cisgender men and agree to involve a non-romantic social support person in the intervention.Check my eligibility
What is being tested?
Project nGage is being tested for its effectiveness in helping participants stay engaged in their HIV care and maintain viral suppression. It's a tailored approach that uses patients' social networks to support their treatment journey.See study design
What are the potential side effects?
Since Project nGage is a behavioral intervention leveraging social support rather than medication, it may not have typical medical side effects but could impact interpersonal dynamics within the participant's social network.
nGage Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Missed Visit Proportion
Viral Suppression
nGage Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Project nGage ConditionExperimental Treatment1 Intervention
The Project nGage condition will be delivered by trained Intervention Case Managers to n=300 men (referred to as Index men) and their Support Confidant (SC).
The Project nGage intervention consists of (1) selection and invitation of a SC, (2) a face-to-face intervention between the Intervention Case Manager and the Index and SC, and (3) quarterly interactive mini-booster sessions delivered to the Index and SC via text or telephone, based on participant preference.
At 12 months, Index men in the experimental condition will be re-randomized to either continue receiving quarterly interactive mini-booster sessions or to stop receiving mini-boosters and return to treatment as usual.
Group II: Treatment as Usual ConditionActive Control1 Intervention
Treatment as Usual (TAU) is comprehensive and follows Department of Health and Human Services (DHHS) guidelines and local protocols on the provision of HIV primary care, which include scheduling one HIV primary care visit and lab tests (including viral load) once every six months, i.e., two HIV primary care visits per year. In addition, all sites provide standard case management and mental health and psychosocial support services to all patients.
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Who is running the clinical trial?
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
818,877 Total Patients Enrolled
Thrive AlabamaUNKNOWN
Howard Brown HealthUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I was born male and identify as a man.I am between 18 and 35 years old.I have had same-gender anal or oral sex in the last six months.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment as Usual Condition
- Group 2: Project nGage Condition
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research open to persons of advanced age?
"The age range of this trial is 18-35 years, inclusive."
Answered by AI
Am I eligible to enroll in this clinical trial?
"To be eligible, the patient must have a positive HIV status and fall within an age range of 18-35. Approximately 900 participants are needed to complete this trial."
Answered by AI
Can participants still sign up to join this research endeavor?
"Contrary to what is indicated on clinicaltrials.gov, this trial has paused patient recruitment for the time being - it was initially posted in February 1st 2023 and last modified 10 days later. Nevertheless, there are 18 alternative medical studies that require participants currently."
Answered by AI
What is the geographic scope of this research initiative?
"Currently, this medical study is being conducted across 10 sites. Patients are invited to select the closest one in order to reduce their burden of travel; these locations include Huntsville, Chicago, and New Orleans as well as seven others."
Answered by AI
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