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

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Missed Visit Proportion

Viral Suppression

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Do I qualify?Apply below to find out