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

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 4 5}

How 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. ^{1 3 4 5 6}

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.

Research Team

Alida Bouris, PhD

Principal Investigator

University of Chicago

David S Batey, PhD

Principal Investigator

Tulane University

Eligibility 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

Own a cell phone not shared with anyone else

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

Identify as Black

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

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

Treatment Details

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.

Participant Groups

Group I: Project nGage Condition Experimental Treatment 1 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 Condition Active Control 1 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

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+

Findings from Research

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 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]

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]

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]

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]

References

1. United States 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Long term impact of PositiveLinks: Clinic-deployed mobile technology to improve engagement with HIV care. [2020]

3. United States 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. [2018]

4. United States 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. [2023]

5. England 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

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