Project nGage for HIV

(nGage Trial)

Recruiting at 6 trial locations

Overseen By David S Batey, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Non-black, Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

900 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new approach to help people living with HIV stay in care and maintain low virus levels. The treatment, called Project nGage, involves support from a person in the participant's social network, such as a friend or family member, along with regular interactions with a case manager. The trial will compare this method to the usual HIV care. Ideal candidates are English-speaking adults aged 18-49 who have missed HIV care visits or have not recently controlled their virus, and who live in Chicagoland or Alabama. As an unphased trial, this study offers a unique opportunity to contribute to innovative HIV care strategies.

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 prior data suggests that the Project nGage intervention is safe?

Research has shown that Project nGage was tested in earlier studies. These studies examined how social networks can help people with HIV adhere to their treatment plans. The program includes selecting a support person, conducting face-to-face meetings, and providing regular follow-ups through text or phone calls.

Results from these studies have been mostly positive, indicating that Project nGage can help people attend appointments and take medication as prescribed. However, challenges have arisen, such as ensuring full participation in the program.

Regarding safety, Project nGage is a behavioral program, meaning it doesn't involve new drugs or medical procedures. This generally suggests it is well-tolerated. No solid evidence of harmful effects exists, and since it relies on support and communication, it is considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Project nGage because it introduces a new approach to supporting people with HIV through social networks. Unlike standard treatments that mainly focus on medical care, Project nGage emphasizes the role of a Support Confidant to help patients stick to their treatment plans. This method involves interactive sessions that are personalized and can be delivered via text or phone, making it more flexible and accessible. By enhancing social support, the intervention aims to improve adherence to treatment and overall health outcomes, which could be a game-changer in managing HIV.

What evidence suggests that the Project nGage intervention is effective for promoting retention in care and viral suppression among people living with HIV?

Research has shown that Project nGage, which participants in this trial may receive, might help people with HIV remain engaged in their healthcare. A previous study found that using social networks can reduce risky behaviors related to HIV and increase HIV counseling and testing. Project nGage involves a trusted person in the participant's life to provide support. This method has shown promise in keeping young Black men who have sex with men involved in HIV care. By leveraging existing social support, Project nGage aims to improve health outcomes, such as maintaining viral control. ^{1 6 7 8 9}

Who Is on the Research Team?

Alida Bouris, PhD

Principal Investigator

University of Chicago

David S Batey, PhD

Principal Investigator

Tulane University

Are You a Good Fit for This Trial?

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

Own a cell phone not shared with anyone else

Have missed at least one HIV care scheduled visit in the past 12 months

I was born male and identify as a man.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Project nGage

Trial Overview 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.

How Is the Trial Designed?

Group I: Social Network Support Intervention Condition Experimental Treatment 1 Intervention

The intervention condition will be delivered by trained Intervention Case Managers to n=300 Index participants and their Support Confidant. The intervention consists of (1) selection and invitation of a Support Confidant, (2) a face-to-face intervention between the Intervention Case Manager and the Index and Support Confidant, and (3) quarterly interactive mini-booster sessions delivered to the Index and Support Confidant 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 Condition Active Control 1 Intervention

Treatment as Usual is comprehensive and follows Department of Health and Human Services 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

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Thrive Alabama

Collaborator

Trials

1

Recruited

900+

Howard Brown Health

Collaborator

Trials

1

Recruited

900+

1917 Clinic at the University of Alabama at Birmingham

Collaborator

Trials

1

Recruited

900+

Tulane University

Collaborator

Trials

129

Recruited

259,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Birmingham AIDS Outreach

Collaborator

Trials

3

Recruited

1,800+

Chicago Center for HIV Elimination

Collaborator

Trials

1

Recruited

900+

Published Research Related to This Trial

Project nGage, a randomized controlled trial involving 98 HIV-positive young black MSM, showed that engaging a support confidant significantly improved retention in HIV care, with participants being 3 times more likely to attend at least 3 provider visits over 12 months compared to the control group.

The intervention focused on enhancing HIV-care knowledge and social support, indicating that involving supportive network members can be an effective strategy to improve health outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Bouris, A., Jaffe, K., Eavou, R., et al.[2023]

The Positive Links smartphone app facilitated social support among 55 participants living with HIV over 8 months, with 52% of analyzed posts providing support, primarily emotional in nature.

Participants reported feeling a sense of connection and support through the app, although some faced technical issues that hindered their full engagement, highlighting the app's potential to improve care for those unable to access in-person support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social Support in a Virtual Community: Analysis of a Clinic-Affiliated Online Support Group for Persons Living with HIV/AIDS. Flickinger, TE., DeBolt, C., Waldman, AL., et al.[2018]

The PositiveLinks (PL) smartphone platform significantly improved engagement in care and HIV viral suppression among 127 participants over a 24-month period, with notable improvements seen as early as 6 months.

Patients who used PL more frequently were over twice as likely to achieve viral suppression and 1.5 times more likely to engage in care compared to those with lower usage, highlighting the effectiveness of mobile technology in managing HIV care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long term impact of PositiveLinks: Clinic-deployed mobile technology to improve engagement with HIV care. Canan, CE., Waselewski, ME., Waldman, ALD., et al.[2020]

In a study involving 92 HIV-positive young Black men who have sex with men, psychological health, social network size, and education were found to be significant predictors of social support satisfaction over time.

Interventions aimed at improving the quality of life and HIV care engagement for this population should prioritize enhancing psychological health and expanding social networks, rather than focusing on the duration of their HIV diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A longitudinal examination of factors associated with social support satisfaction among HIV-positive young Black men who have sex with men. McCullagh, C., Quinn, K., Voisin, DR., et al.[2022]

Support groups are generally considered an effective intervention for people living with HIV and AIDS, but there is a lack of comprehensive research evaluating their specific outcomes.

The effectiveness of support groups can vary based on the diverse needs of different populations of PLWAs, highlighting the importance of tailoring these interventions to meet specific community requirements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Support groups for people living with HIV/AIDS: a review of literature. Spirig, R.[2007]

In a study of 87 participants with HIV, older members (≥50 years) used the PositiveLinks app significantly more than younger members (<50 years), with higher app launches and Community Message Board (CMB) posts at both 6 and 12 months.

Older participants not only engaged more with the app but also provided more social support through their posts, suggesting that mobile health interventions can effectively foster social connections among older adults living with chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Mobile Health Intervention by Older Versus Younger People with HIV: Analysis of Usage, Social Support, and Network Interactions. Flickinger, TE., Campbell, BR., Timm, A., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3881415/

Project nGage: Network Supported HIV Care Engagement for ... Pending study results, a larger RCT would compare the relative effectiveness of the Project nGage intervention versus TAU over 18 to 24 months. Keywords: HIV ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05723653/hybrid-type-i-effectiveness-implementation-trial-of-project-ngage

Hybrid Type I Effectiveness-Implementation Trial of Project ... If effective, nGage has the potential to reduce HIV incidence by harnessing existing social support in the lives of people living with HIV ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05723653?cond=hiv&aggFilters=status%3A

Hybrid Type I Effectiveness-Implementation Trial of a Social ... 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.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5705428/

Project nGage: Results of a Randomized Controlled Trial ... Social network oriented interventions have been effective for preventing HIV-related risk behaviors (25, 26), and for increasing HIV counseling and testing ...

5. commons.case.edu commons.case.edu/facultyworks/255/

"Project nGage: Results of a Randomized Controlled Trial of a ... Project nGage was a randomized controlled trial conducted across five Chicago clinics with 98 HIV-positive YBMSM aged 16–29 between 2012 and ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24404408/

Project nGage: Network Supported HIV Care Engagement ... Project nGage is a randomized controlled (RCT) trial evaluating the feasibility and preliminary efficacy of a brief, dyadic intervention designed to promote ...

7. researchgate.net researchgate.net/publication/259632310_Project_nGage_Network_Supported_HIV_Care_Engagement_for_Younger_Black_Men_Who_Have_Sex_with_Men_and_Transgender_Persons

Project nGage: Network Supported HIV Care Engagement ... The primary outcome is appointment attendance; the secondary outcomes are medication adherence and viral load. Implementation challenges include ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2214109X24005394

The effect of a social network-based intervention to ... This study presents positive findings from a randomised controlled trial of a combined social network and HIV self-testing intervention to ...

9. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06186-z

Social network-based group intervention to promote HIV ... The primary outcomes are HIV testing and condom use among alter participants; secondary outcomes are engagement in HIV prevention advocacy and ...