HIV SeropositivityNCT05723653
Hybrid Type I Effectiveness-Implementation Trial of a Social Network Support Intervention
A study testing Social Network Support Intervention in people with HIV Seropositivity, run by University of Chicago at 7 sites in United States.
Trial summary
The goal of this Hybrid Type I effectiveness-implementation trial is to test an evidence-based, flexible, and tailored intervention that leverages existing social network members to promote retention in care and viral suppression among people living with HIV aged 18-49. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Seropositivity
- What is being tested?
- Social Network Support Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 7 sitesUnited States
- Study dates
- 13 Feb 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-49 years old, inclusive
- Speak English
- Own a cell phone not shared with anyone else
- Have missed at least one HIV care scheduled visit or have not been virally suppressed in the past 24 months.
- Resides in Chicagoland, Illinois or Alabama
- Index agrees to engage the Support Confidant
Show all 10Show fewer
- Age 18 years or older
- Speaks English
- Owns a cell phone not shared with others
- Is not a romantic/sexual partner of the Index participant
Who cannot join
- If a participant fails to meet all inclusion criteria
- Romantic/Sexual partners of Index participant
- Relationship strain or abuse present in Index-Support Confidant relationship
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Not yet recruiting
University of Alabama at Birmingham 1917 Clinic
Birmingham, Alabama, 35205
Kathy Gaddis, kgaddis@uabmc.edu
Kathy Gaddis, MSW
- Recruiting
Birmingham AIDS Outreach
Birmingham, Alabama, 35233
Emma S Kay, PhD, emma@mcwc-bao.org
Emma S Kay, PhD
- Recruiting
Howard Brown Health
Chicago, Illinois, 60613
Juan Rivera, juanr@howardbrown.org
Kelly Ducheny, PsyD
- Recruiting
Chicago Center for HIV Elimination
Chicago, Illinois, 60637
Rebecca Eavou, reavour@medicine.bsd.uchicago.edu
John Schneider, MD
- Not yet recruiting
Crown Family School of Social Work, Policy, and Practice at the University of Chicago
Chicago, Illinois, 60637
Alida Bouris, PhD, 773-834-4304, abouris@uchicago.edu
- Recruiting
Thrive Alabama
Huntsville, Alabama, 65801
Erin Bortel, ebortel@thrivealabama.org
Jitesh Parmar
- Not yet recruiting
Tulane University
New Orleans, Louisiana, 70118
David S Batey, PhD, dsbatey@tulane.edu
David S Batey, PhD
About this study
Official title: Harnessing Social Network Support to Improve Retention in Care and Viral Suppression Among People Living With HIV in Chicago and Alabama: A Hybrid Type I Effectiveness-implementation Trial
The goal of this Hybrid Type I effectiveness-implementation trial is to test an evidence-based, flexible, and tailored intervention that leverages existing social network members to promote retention in care and viral suppression among people living with HIV aged 18-49.
Read the detailed description
This study is a Hybrid Type I effectiveness-implementation trial of an evidence-based, flexible, and tailored intervention that leverages existing social network members to promote retention in care and viral suppression. The study will be conducted in Chicago, Illinois and Alabama, two high burden priority areas in the National Ending the HIV Epidemic Plan. Both retention in care and viral suppression are critical targets in ongoing efforts to eliminate HIV, 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 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 who can offer the types of social support that can help to navigate life's complexities, including the stressors of living with HIV. The intervention uses sociograms, highly engaging social network diagrams, to identify an ideally positioned Support Confidant. Once a Support Confidant is identified, the Index and their Support Confidant 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-Support Confidant relationship.
This study will conduct a Hybrid Type I randomized controlled trial with N=600 participants living with HIV, who will be randomized to receive the intervention (n=300) or treatment as usual (n=300). In addition, 300 Support Confidants also will be enrolled. At 12-months post-intervention, we will re-randomize dyads to continue receiving mini-boosters (n=150) or return to treatment as usual (n=150). Data collection at baseline, 12, and 18 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, Alabama. To study implementation in each setting and geographic context, we will use the Consolidated Framework for Implementation Research as the determinant framework and Reach, Effectiveness, Adoption, Implementation, and Maintenance as the evaluation framework. The specific aims of the study are to:
Aim 1: Evaluate the (a) effectiveness of a social support intervention versus treatment as usual over 12 months with 600 people living with HIV ages 18-49 and (b) value of continuing to offer social support over another 6 months. The primary outcomes are retention in care and Viral Suppression, as measured by electronic medical record data on missed visit proportion and viral load.
Aim 2: Examine if intervention effects (a) vary between Chicago and Alabama, (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 use at the Index level.
Aim 3: Evaluate the implementation of the intervention using the Consolidated Framework for Implementation Research and the Reach, Evaluation, Adoption, Implementation and Maintenance frameworks. 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 within the Consolidated Framework for Implementation Research. We will assess the following implementation outcomes for the study in each clinical setting and geographic context: Reach, Adoption, Implementation, and Maintenance.
If effective, the intervention has the potential to reduce HIV incidence by harnessing existing social support in the lives of people living with HIV, strengthening the public health impact of Treatment as Prevention. Thus, the research holds significant promise for addressing racial and geographic health disparities and will result in a sustainable, scalable program and implementation strategy that can be disseminated in HIV clinics nationwide.
- Conditions
- HIV Seropositivity
- Being tested
- Social Network Support Intervention
- Keywords
- HIV care engagement, HIV viral suppression, Social support, Social networks
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Network Support InterventionBehavioural
The Social Network Support Intervention is an evidence-based, flexible, and tailored intervention that leverages existing social network members to promote retention in care and viral suppression among people living with HIV. 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.
| Study group | Role | What they receive |
|---|---|---|
| Social Network Support Intervention Condition | Experimental | 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. Receives: Behavioral: Social Network Support Intervention |
| Treatment as Usual Condition | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Viral Suppression
Viral load (suppressed or not) will be measured in RNA copies/mL, with ≤200 copies/mL defined as viral suppression.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start13 Feb 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for HIV SeropositivityStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Following study registration (at which a unique Study Identification (ID) will be assigned), Index participants will be randomized to either the intervention group (n=300) or Treatment as Usual (n=300). Intervention arm Indexes will identify a Support Confidant (SC) (creating Index-SC dyads). Study staff will discuss pros and cons of treatment as usual (equipoise induction) to balance the desirability of the two intervention conditions. After the 12-month follow-up survey, we will re-randomize the 300 Index-Support Confidant dyads in the intervention condition with equal probability to continue receiving standard mini-boosters (n=150 Index-Support Confidant dyads) or a return to treatment as usual (n=150 Index-Support Confidant dyads). The randomization schedule will be prepared in advance, and treatment assignment will be obtained using the randomization module in REDCap.
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Tulane University, University of Alabama at Birmingham, Birmingham AIDS Outreach, Chicago Center for HIV Elimination, Howard Brown Health, Thrive Alabama
- Responsible party
- Sponsor
- Investigators
- Alida Bouris, PhD, Principal investigator, University of ChicagoDavid S Batey, PhD, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723653
- Sponsor's protocol ID
- IRB22-0110
- Status last verified
- Apr 2026
- First submitted
- 30 Jan 2023
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be available to researchers outside of the study team.
Publications
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.
PubMed 29079949Bouris 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.
PubMed 24404408Cabral 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.
PubMed 17563291Centers 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.
PubMed 18285714Curran 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.
PubMed 22310560Damschroder 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.
PubMed 19664226Department 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.
PubMed 30629090Fauci 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.
PubMed 30730529Fisher 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.
PubMed 16846321Fitzmaurice 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.
PubMed 10474547
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing Social Network Support to Improve Retention in Care and Viral Suppression Among People Living With HIV in Chicago and Alabama: A Hybrid Type I Effectiveness-implementation Trial
- ClinicalTrials.gov ID
- NCT05723653
- Acronym / sponsor ID
- IRB22-0110
- Conditions
- HIV Seropositivity
- Keywords
- HIV care engagement, HIV viral suppression, Social support, Social networks
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Tulane University, University of Alabama at Birmingham, Birmingham AIDS Outreach, Chicago Center for HIV Elimination, Howard Brown Health, Thrive Alabama
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this Hybrid Type I effectiveness-implementation trial is to test an evidence-based, flexible, and tailored intervention that leverages existing social network members to promote retention in care and viral suppression among people living with HIV aged 18-49.
Detailed description
This study is a Hybrid Type I effectiveness-implementation trial of an evidence-based, flexible, and tailored intervention that leverages existing social network members to promote retention in care and viral suppression. The study will be conducted in Chicago, Illinois and Alabama, two high burden priority areas in the National Ending the HIV Epidemic Plan. Both retention in care and viral suppression are critical targets in ongoing efforts to eliminate HIV, 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 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 who can offer the types of social support that can help to navigate life's complexities, including the stressors of living with HIV. The intervention uses sociograms, highly engaging social network diagrams, to identify an ideally positioned Support Confidant. Once a Support Confidant is identified, the Index and their Support Confidant 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-Support Confidant relationship.
This study will conduct a Hybrid Type I randomized controlled trial with N=600 participants living with HIV, who will be randomized to receive the intervention (n=300) or treatment as usual (n=300). In addition, 300 Support Confidants also will be enrolled. At 12-months post-intervention, we will re-randomize dyads to continue receiving mini-boosters (n=150) or return to treatment as usual (n=150). Data collection at baseline, 12, and 18 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, Alabama. To study implementation in each setting and geographic context, we will use the Consolidated Framework for Implementation Research as the determinant framework and Reach, Effectiveness, Adoption, Implementation, and Maintenance as the evaluation framework. The specific aims of the study are to:
Aim 1: Evaluate the (a) effectiveness of a social support intervention versus treatment as usual over 12 months with 600 people living with HIV ages 18-49 and (b) value of continuing to offer social support over another 6 months. The primary outcomes are retention in care and Viral Suppression, as measured by electronic medical record data on missed visit proportion and viral load.
Aim 2: Examine if intervention effects (a) vary between Chicago and Alabama, (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 use at the Index level.
Aim 3: Evaluate the implementation of the intervention using the Consolidated Framework for Implementation Research and the Reach, Evaluation, Adoption, Implementation and Maintenance frameworks. 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 within the Consolidated Framework for Implementation Research. We will assess the following implementation outcomes for the study in each clinical setting and geographic context: Reach, Adoption, Implementation, and Maintenance.
If effective, the intervention has the potential to reduce HIV incidence by harnessing existing social support in the lives of people living with HIV, strengthening the public health impact of Treatment as Prevention. Thus, the research holds significant promise for addressing racial and geographic health disparities and will result in a sustainable, scalable program and implementation strategy that can be disseminated in HIV clinics nationwide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Following study registration (at which a unique Study Identification (ID) will be assigned), Index participants will be randomized to either the intervention group (n=300) or Treatment as Usual (n=300). Intervention arm Indexes will identify a Support Confidant (SC) (creating Index-SC dyads). Study staff will discuss pros and cons of treatment as usual (equipoise induction) to balance the desirability of the two intervention conditions. After the 12-month follow-up survey, we will re-randomize the 300 Index-Support Confidant dyads in the intervention condition with equal probability to continue receiving standard mini-boosters (n=150 Index-Support Confidant dyads) or a return to treatment as usual (n=150 Index-Support Confidant dyads). The randomization schedule will be prepared in advance, and treatment assignment will be obtained using the randomization module in REDCap.
| Arm | Type | Receives |
|---|---|---|
| Social Network Support Intervention Condition | Experimental | Behavioral: Social Network Support InterventionThe 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. |
| Treatment as Usual Condition | No 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Aged 18-49 years old, inclusive
- Speak English
- Own a cell phone not shared with anyone else
- Have missed at least one HIV care scheduled visit or have not been virally suppressed in the past 24 months.
- Resides in Chicagoland, Illinois or Alabama
Key exclusion criteria (3 listed)
- If a participant fails to meet all inclusion criteria
- Romantic/Sexual partners of Index participant
- Relationship strain or abuse present in Index-Support Confidant relationship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Network Support InterventionThe Social Network Support Intervention is an evidence-based, flexible, and tailored intervention that leverages existing social network members to promote retention in care and viral suppression among people living with HIV. 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. | Behavioural | Social Network Support Intervention Condition |
Primary outcome
Missed Visit Proportion
Time frame: 18 months
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.
Viral Suppression
Time frame: 18 months
Viral load (suppressed or not) will be measured in RNA copies/mL, with ≤200 copies/mL defined as viral suppression.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Background: PubMed 29079949Bouris 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.
- Background: PubMed 24404408Bouris 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.
- Background: PubMed 17563291Cabral 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.
- BackgroundCenters 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].
- Background: PubMed 18285714Craw 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.
- Background: PubMed 22310560Curran 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.
- Background: PubMed 19664226Damschroder 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.
- BackgroundDepartment 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.
- BackgroundDiggle P, Liang K, Zeger S. Analysis of Longitudinal Data: Oxford Statistical Science Series. 1994.
- Background: PubMed 30629090Eisinger 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.
- Background: PubMed 30730529Fauci 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.
- Background: PubMed 16846321Fisher 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.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be available to researchers outside of the study team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alida Bouris, PhD principal investigator
University of Chicago
David S Batey, PhD principal investigator
Tulane University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Network Support Intervention in people with HIV Seropositivity, run by University of Chicago at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alida Bouris, PhD (773-834-4304, abouris@uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Missed Visit Proportion (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05723653, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.