Hybrid Type I Effectiveness-Implementation Trial of Project nGage

HIV Seropositivity Clinical Trial

— nGage  

Official title:

Harnessing Social Network Support to Improve Retention in Care and Viral Suppression Among Young Black Men in Chicago and Alabama: A Hybrid Type I Effectiveness-implementation Trial of Project nGage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05723653
• Other study ID #: IRB22-0110
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2024
• Source: University of Chicago
• Contact: Alida Bouris, PhD
• Phone: 773-834-4304
• Email: abouris[@]uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 sexual minority men (YBSMM) aged 18-35.

Description:

This study is a Hybrid Type I effectiveness-implementation trial of Project nGage ("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 sexual minority men (YBSMM) aged 18-35. The study will be conducted in Chicago, Illinois (IL) and Alabama (AL), two high burden priority areas in the National Ending the HIV Epidemic (EHE) Plan. Nationwide, YBSMM bear the highest incidence of HIV and experience the poorest outcomes in the HIV Continuum of Care. Both retention in care and viral suppression are critical targets in the EHE Plan, as persons adherent to antiretrovirals are unlikely to transmit HIV, and retention in care allows for ongoing monitoring of viral load and the delivery of other important services, e.g., case management, mental health, and substance use treatment.

Most clinic-based strategies to improve Continuum of Care outcomes for YBSMM focus on newly created network members, e.g., support groups, peer navigators, or case managers. In contrast, we identify and activate organic Support Confidants (SC)-those people in men's networks who can offer the types of social support that can help to navigate life's complexities, including the stressors of living with HIV. The nGage intervention uses sociograms, highly engaging social network diagrams, to identify an ideally positioned SC. Once a SC is identified, the Index and their SC attend a single session, in-person intervention with a trained interventionist. The intervention uses the Information Motivation Behavioral Skills Model, Motivational Interviewing, and Cognitive Behavioral Theory to promote Continuum of Care-specific support in the Index-SC relationship.

This study will conduct a Hybrid Type I randomized controlled trial with N=600 YBSMM living with HIV, who will be randomized to receive nGage (n=300) or treatment as usual (TAU) (n=300). In addition, 300 SCs also will be enrolled. At 12-months post-intervention, we will re-randomize nGage dyads to continue receiving mini-boosters (Sustained nGage: n=150) or return to TAU (n=150). Data collection at baseline, 12, and 24 months will include surveys and electronic medical record (EMR) data. The study will be implemented in community-based clinics and academic-affiliated health centers in Chicago and in Birmingham and Huntsville, AL. To study implementation in each setting and geographic context, we will use the Consolidated Framework for Implementation Research (CFIR) as the determinant framework and Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) as the evaluation framework. The specific aims of the study are to:

Aim 1: Evaluate the (a) effectiveness of nGage vs. TAU over 12 months in N=600 YBSMM aged 18-35 and (b) value of continuing nGage over another 12 months (Sustained nGage). The primary outcomes are retention in care and viral suppression, as measured by EMR data on missed visit proportion (MVP) and viral load.

Aim 2: Examine if intervention effects (a) vary between Chicago and Alabama (AL), (b) are mediated by changes in the Index's level of motivational readiness, self-efficacy, and stigma expectancies, and (c) are moderated by mental health and substance abuse at the Index level.

Aim 3: Evaluate the implementation of nGage using the CFIR and the RE-AIM framework. Guided by CFIR, we will conduct surveys and focus groups with key stakeholders to assess the inner and outer settings, implementer and intervention characteristics, and multi-level process factors that influence implementation. We will use RE-AIM to assess Reach, Adoption, Implementation, and Maintenance, including implementation costs in each clinical setting and geographic context.

If effective, nGage has the potential to reduce HIV incidence by harnessing existing social support in the lives of YBSMM, strengthening the public health impact of Treatment as Prevention. Thus, the research holds significant promise for addressing racial and geographic health disparities among YBSMM and will result in a sustainable, scalable program and implementation strategy that can be disseminated in HIV clinics nationwide.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria for Index Men:

• Identify as Black

• Assigned male sex at birth and currently identify as a cis-gender man

• Age 18-35-years-old, inclusive

• Same gender anal/oral sex in the past six months

• Have at least one SC in their network

• 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.

Exclusion Criteria for Index Men:

• If a participant fails to meet all inclusion criteria

Inclusion Criteria for Support Confidants:

• Index agrees to engage the Support Confidant

• Age 18 years or older

• Speaks English

• Owns a cell phone not shared with others

• Is not a romantic/sexual partner of the Index young man.

Exclusion Criteria:

• Romantic/Sexual partners of Index Men

• Relationship strain or abuse present in Index-SC relationship

Related Conditions & MeSH terms

• HIV Seropositivity

Intervention

Behavioral:
• Project nGage
Project nGage ("nGage") is an evidence-based, flexible, and tailored intervention that leverages existing social network members to promote retention in care and viral suppression among young Black sexual minority men. The nGage intervention consists of (1) selection and invitation of a Support Confidant (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.

Locations

Country	Name	City	State
United States	Birmingham AIDS Outreach	Birmingham	Alabama
United States	University of Alabama at Birmingham 1917 Clinic	Birmingham	Alabama
United States	Chicago Center for HIV Elimination	Chicago	Illinois
United States	Crown Family School of Social Work, Policy, and Practice at the University of Chicago	Chicago	Illinois
United States	Howard Brown Health	Chicago	Illinois
United States	Thrive Alabama	Huntsville	Alabama
United States	Tulane University	New Orleans	Louisiana

Sponsors (8)

Lead Sponsor	Collaborator
University of Chicago	1917 Clinic at the University of Alabama at Birmingham, Birmingham AIDS Outreach, Chicago Center for HIV Elimination, Howard Brown Health, Thrive Alabama, Tulane University, University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (29)

Bouris A, Jaffe K, Eavou R, Liao C, Kuhns L, Voisin D, Schneider JA. 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. AIDS Behav. 2017 Dec;21(12):3618-3629. doi: 10.1007/s10461-017-1954-8. — View Citation

Bouris A, Voisin D, Pilloton M, Flatt N, Eavou R, Hampton K, Kuhns LM, Eder M, Schneider JA. Project nGage: Network Supported HIV Care Engagement for Younger Black Men Who Have Sex with Men and Transgender Persons. J AIDS Clin Res. 2013 Aug 31;4:10.4172/2155-6113.1000236. doi: 10.4172/2155-6113.1000236. — View Citation

Cabral HJ, Tobias C, Rajabiun S, Sohler N, Cunningham C, Wong M, Cunningham W. Outreach program contacts: do they increase the likelihood of engagement and retention in HIV primary care for hard-to-reach patients? AIDS Patient Care STDS. 2007;21 Suppl 1:S59-67. doi: 10.1089/apc.2007.9986. — View Citation

Centers for Disease Control and Prevention. Estimated HIV incidence and prevalence in the United States, 2010-2015. HIV Surveillance Supplemental Report 2018;23(No. 1). http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html. Published March 2018. Accessed [1 Dec 2022].

Craw JA, Gardner LI, Marks G, Rapp RC, Bosshart J, Duffus WA, Rossman A, Coughlin SL, Gruber D, Safford LA, Overton J, Schmitt K. Brief strengths-based case management promotes entry into HIV medical care: results of the antiretroviral treatment access study-II. J Acquir Immune Defic Syndr. 2008 Apr 15;47(5):597-606. doi: 10.1097/QAI.0b013e3181684c51. — View Citation

Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812. — View Citation

Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50. — View Citation

Department of Health and Human Services. Ending the HIV Epidemic: A Plan for America. 2019; https://www.hhs.gov/sites/default/files/ending-the-hiv-epidemic-fact-sheet.pdf.

Diggle P, Liang K, Zeger S. Analysis of Longitudinal Data: Oxford Statistical Science Series. 1994.

Eisinger RW, Dieffenbach CW, Fauci AS. HIV Viral Load and Transmissibility of HIV Infection: Undetectable Equals Untransmittable. JAMA. 2019 Feb 5;321(5):451-452. doi: 10.1001/jama.2018.21167. No abstract available. — View Citation

Fauci AS, Redfield RR, Sigounas G, Weahkee MD, Giroir BP. Ending the HIV Epidemic: A Plan for the United States. JAMA. 2019 Mar 5;321(9):844-845. doi: 10.1001/jama.2019.1343. No abstract available. — View Citation

Fisher JD, Fisher WA, Amico KR, Harman JJ. An information-motivation-behavioral skills model of adherence to antiretroviral therapy. Health Psychol. 2006 Jul;25(4):462-73. doi: 10.1037/0278-6133.25.4.462. — View Citation

Fitzmaurice GM, Laird NM, Ware JH. Applied longitudinal analysis. Vol 998: John Wiley & Sons; 2012.

Garamszegi LZ. Comparing effect sizes across variables: generalization without the need for Bonferroni correction. Behavioral Ecology. 2006;17(4):682-687.

Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322. — View Citation

Higa DH, Marks G, Crepaz N, Liau A, Lyles CM. Interventions to improve retention in HIV primary care: a systematic review of U.S. studies. Curr HIV/AIDS Rep. 2012 Dec;9(4):313-25. doi: 10.1007/s11904-012-0136-6. — View Citation

Hogan B, Carrasco JA, Wellman B. Visualizing Personal Networks: Working with Participant-aided Sociograms. Field Methods. 2007;19(2):116-144.

Hoots BE, Finlayson TJ, Wejnert C, Paz-Bailey G; National HIV Behavioral Surveillance (NHBS) Study Group. Updated Data on Linkage to Human Immunodeficiency Virus Care and Antiretroviral Treatment Among Men Who Have Sex With Men-20 Cities, United States. J Infect Dis. 2017 Oct 17;216(7):808-812. doi: 10.1093/infdis/jix007. Erratum In: J Infect Dis. 2017 Oct 17;216(7):922. — View Citation

Jiang H, Kulkarni PM, Mallinckrodt CH, Shurzinske L, Molenberghs G, Lipkovich I. Covariate Adjustment for Logistic Regression Analysis of Binary Clinical Trial Data. Statistics in Biopharmaceutical Research. 2017;9(1):126-134.

Liang K-Y, Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika. 1986;73(1):13-22.

McCullagh P, Nelder J. Generalized linear models., 2nd edn.(Chapman and Hall: London). Standard book on generalized linear models. 1989.

Naar-King S, Templin T, Wright K, Frey M, Parsons JT, Lam P. Psychosocial factors and medication adherence in HIV-positive youth. AIDS Patient Care STDS. 2006 Jan;20(1):44-7. doi: 10.1089/apc.2006.20.44. — View Citation

Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. Department of Health and Human Services. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. Available at http://www.aidsinfo.nih.gov/ContentFiles/ AdultandAdolescentGL.pdf.

Starace F, Massa A, Amico KR, Fisher JD. Adherence to antiretroviral therapy: an empirical test of the information-motivation-behavioral skills model. Health Psychol. 2006 Mar;25(2):153-62. doi: 10.1037/0278-6133.25.2.153. — View Citation

Valeri L, Vanderweele TJ. Mediation analysis allowing for exposure-mediator interactions and causal interpretation: theoretical assumptions and implementation with SAS and SPSS macros. Psychol Methods. 2013 Jun;18(2):137-50. doi: 10.1037/a0031034. Epub 2013 Feb 4. Erratum In: Psychol Methods. 2013 Dec;18(4):474. — View Citation

VanderWeele TJ, Tchetgen Tchetgen EJ. Mediation analysis with time varying exposures and mediators. J R Stat Soc Series B Stat Methodol. 2017 Jun;79(3):917-938. doi: 10.1111/rssb.12194. Epub 2016 Jun 27. — View Citation

VanderWeele TJ, Vansteelandt S. Mediation Analysis with Multiple Mediators. Epidemiol Methods. 2014 Jan;2(1):95-115. doi: 10.1515/em-2012-0010. — View Citation

Vittinghoff E, Sen S, McCulloch CE. Sample size calculations for evaluating mediation. Stat Med. 2009 Feb 15;28(4):541-57. doi: 10.1002/sim.3491. — View Citation

White IR, Royston P, Wood AM. Multiple imputation using chained equations: Issues and guidance for practice. Stat Med. 2011 Feb 20;30(4):377-99. doi: 10.1002/sim.4067. Epub 2010 Nov 30. — View Citation

* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Missed Visit Proportion	We count visits as scheduled (non-acute) visits to an antiretroviral prescribing provider. Missed Visit Proportion (MVP) is calculated as the proportion of total scheduled visits that are missed during the follow-up period. To permit longitudinal analyses, we shall also split the two-year follow-up period into eight three-month quarters and record, for each participant, whether he completed or missed his scheduled appointment during that quarter. Appointment and visit history to calculate MVP will be collected from each clinic's electronic medical record data.	24 months
Primary	Viral Suppression	Viral load (suppressed or not) will be measured in RNA copies/mL, with =200 copies/mL defined as viral suppression.	24 months