Project nGage for HIV
(nGage Trial)
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Chicago
Disqualifiers: Non-black, Non-English speakers, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The goal of this Hybrid Type I effectiveness-implementation trial is to test Project nGage, an evidence-based, flexible, and tailored intervention that leverages existing social network members to promote retention in care and viral suppression among young Black men and women ages 18-49.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Project nGage for HIV?
Project nGage showed that participants were three times more likely to attend at least three medical visits over 12 months compared to those who did not receive the intervention, suggesting it helps keep young Black men who have sex with men engaged in HIV care.
12345Is Project nGage safe for humans?
The available research on Project nGage does not specifically mention any safety concerns or adverse effects, suggesting it is generally safe for participants.
12345How is the Project nGage treatment for HIV different from other treatments?
Project nGage is unique because it focuses on engaging a supportive person from the patient's social network to help improve retention in HIV care, rather than relying solely on medication or traditional medical interventions. This approach aims to enhance social support and create a personalized care plan, which is particularly beneficial for young Black men who have sex with men.
13456Eligibility Criteria
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.Inclusion Criteria
Speak English
Own a cell phone not shared with anyone else
Have missed at least one HIV care scheduled visit in the past 12 months
+5 more
Exclusion Criteria
If a participant fails to meet all inclusion criteria
Romantic/Sexual partners of Index Men
Relationship strain or abuse present in Index-SC relationship
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Project nGage intervention with selection and invitation of a Support Confidant (SC), a face-to-face session, and quarterly mini-booster sessions
12 months
1 in-person session, quarterly virtual sessions
Re-randomization and Continued Intervention
Participants re-randomized to continue receiving mini-boosters or return to treatment as usual
12 months
Quarterly virtual sessions for continued intervention group
Follow-up
Participants are monitored for retention in care and viral suppression
24 months
Participant Groups
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.
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 Index participants 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 participants 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.
Project nGage is already approved in United States for the following indications:
🇺🇸 Approved in United States as Project nGage for:
- Improving retention in care and viral suppression among young Black sexual minority men (YBSMM) aged 18-35
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Howard Brown HealthChicago, IL
University of Alabama at Birmingham 1917 ClinicBirmingham, AL
Crown Family School of Social Work, Policy, and Practice at the University of ChicagoChicago, IL
Tulane UniversityNew Orleans, LA
More Trial Locations
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Who Is Running the Clinical Trial?
University of ChicagoLead Sponsor
Thrive AlabamaCollaborator
Howard Brown HealthCollaborator
1917 Clinic at the University of Alabama at BirminghamCollaborator
Tulane UniversityCollaborator
University of Alabama at BirminghamCollaborator
Birmingham AIDS OutreachCollaborator
Chicago Center for HIV EliminationCollaborator
References
Project nGage: Results of a Randomized Controlled Trial of a Dyadic Network Support Intervention to Retain Young Black Men Who Have Sex With Men in HIV Care. [2023]HIV-positive young black MSM (YBMSM) experience poor outcomes along the HIV care continuum, yet few interventions have been developed expressly for YBMSM retention in care. Project nGage was a randomized controlled trial conducted across five Chicago clinics with 98 HIV-positive YBMSM aged 16-29 between 2012 and 2015. The intervention used a social network elicitation approach with index YBMSM (n = 45) to identify and recruit a support confidant (SC) to the study. Each index-SC dyad met with a social worker to improve HIV-care knowledge, activate dyadic social support, and develop a retention in care plan. Each index and SC also received four mini-booster sessions. Control participants (n = 53) received treatment as usual. Surveys and medical records at baseline, 3-, and 12-months post-intervention assessed visit history (3 or more visits over 12 months; primary outcome), and sociodemographic, network, social-psychological, and behavioral factors. At baseline, there were no differences in age (M = 23.8 years), time since diagnosis (M ≤ 2 years), clinic visits in the previous 12 months (M = 4.1), and medication adherence (68.6 ≥ 90% adherence). In multivariate logistic regression analysis, intervention participants were 3.01 times more likely to have had at least 3 provider visits (95% CI 1.0-7.3) than were control participants over 12 months. Project nGage demonstrates preliminary efficacy in improving retention in care among YBMSM. Results suggest that engaging supportive network members may improve key HIV care continuum outcomes.
Long term impact of PositiveLinks: Clinic-deployed mobile technology to improve engagement with HIV care. [2020]PositiveLinks (PL) is a smartphone-based platform designed in partnership with people living with HIV (PLWH) to improve engagement in care. PL provides daily medication reminders, check-ins about mood and stress, educational resources, a community message board, and an ability to message providers. The objective of this study was to evaluate the impact of up to 24 months of PL use on HIV viral suppression and engagement in care and to examine whether greater PL use was associated with improved outcomes.
Social Support in a Virtual Community: Analysis of a Clinic-Affiliated Online Support Group for Persons Living with HIV/AIDS. [2018]Social support can improve outcomes for people living with HIV (PLWH) and could be provided through online support groups. The Positive Links smartphone app is a multicomponent intervention that allows users to interact in a clinic-affiliated anonymous online support group. We investigated how social support was exchanged in a group of 55 participants over 8 months, using an adaptation of the Social Support Behavior Code. Participant interviews assessed their experiences and perceptions of the app. Of 840 posts analyzed, 115 (14 %) were coded as eliciting social support and 433 (52 %) as providing social support. Messages providing support were predominantly emotional (41 %), followed by network (27 %), esteem (24 %), informational (18 %), and instrumental (2 %) support. Participants perceived connection and support as key benefits of the app. Technical issues and interpersonal barriers limited some participants in fully using the app. Mobile technology offers a useful tool to reach populations with barriers to in-person support and may improve care for PLWH.
Use of a Mobile Health Intervention by Older Versus Younger People with HIV: Analysis of Usage, Social Support, and Network Interactions. [2023]Label="Background" NlmCategory="UNASSIGNED">People with HIV in the United States are aging, with risk for negative health outcomes from social isolation. PositiveLinks is a mobile health (mHealth) intervention that includes an anonymous Community Message Board (CMB) for peer-to-peer conversations. We investigated differences in CMB usage and social support between younger (<50 years) and older (≥50) members.
A longitudinal examination of factors associated with social support satisfaction among HIV-positive young Black men who have sex with men. [2022]This study examined the long-term predictors of social support satisfaction among HIV-positive young Black men who have sex with men (YBMSM). Data were collected across three waves between October 2012 and November 2014 as part of the baseline assessment from Project nGage, a preliminary efficacy randomized control study examining the role of social support in improving HIV care among YBMSM. The sample included 92 YBMSM aged 18-29. Major results controlling for age, education and intervention effects indicated that psychological health, social network size, and education at baseline predicted differences in social support satisfaction at Wave 3, with no significant effects based on length of HIV diagnosis. Therefore, interventions that are intended to promote the quality of life for YBMSM and their engagement and retention in HIV care must focus on their psychological health concerns and network size.
Support groups for people living with HIV/AIDS: a review of literature. [2007]For more than a decade, support groups have been proposed as a key intervention for people living with HIV and AIDS (PLWAs). Despite this fact, there are still only a few articles that evaluate and compare outcomes of support groups so as to provide a scientific base for their usefulness and effectiveness. The purpose of this article is to critically review selected published literature on support groups and to assess gaps in research. In general, the reviewed literature evaluated support groups as an effective intervention, which is evident for this widespread support. However, because diverse populations of PLWAs have specific needs, the group and intervention should be designed to meet those needs. Specific recommendations for further research about support groups for PLWAs are offered.