HIVNSECNCT01726712
Network Supported Engagement In HIV Care
A study testing Supportive Care in people with HIV and Patient Acceptance of Health Care, run by University of Chicago at 1 site in United States.
Trial summary
The Network Supported Engagement in Care (NSEC) intervention is a brief, theory based and culturally sensitive intervention designed to capitalize on organic yet underutilized social support networks in the lives of young black men who have sex with men (YBMSM) who have been recently diagnosed with HIV. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV, Patient Acceptance of Health Care
- What is being tested?
- Supportive Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Index subjects
- Self-identify as African-American and male;
- same gender anal/oral sex in the past 2 years;
- English speaking;
- have at least one SC in their network;
- own a cell phone not shared with other persons;
Show all 14Show fewer
- agreeable to text-message mini-booster sessions; and
- between the ages of 16-29 years old.
- Supportive Contact:
- Index participant has agreed to including the supportive contact;
- Supportive contact is willing to attend face to face and telephone mini-booster sessions;
- 18 years of age or older;
- English speaking; and
- owns a cell phone that is not shared with other persons.
Who cannot join
- Index Subject:
- unable to provide assent/consent;
- plan to move out of the area within the next 12 months;
- are not willing to attend intervention sessions; or
- not willing to return for assessments
- Supportive Contact:
- unable to provide informed consent; or
- not willing to return for 3 and 12 month assessments.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
The Network Supported Engagement in Care (NSEC) intervention is a brief, theory based and culturally sensitive intervention designed to capitalize on organic yet underutilized social support networks in the lives of young black men who have sex with men (YBMSM) who have been recently diagnosed with HIV. The intervention has been developed with input from clients and their support network members, case managers, social workers, HIV primary care providers and pastoral care at a Federally Qualified Health Center. The goal of the intervention is to improve retention in care for newly diagnosed YBMSM who present for their first HIV primary care clinic appointment.
- Conditions
- HIV, Patient Acceptance of Health Care
- Being tested
- Supportive Care
- Keywords
- Patient Care Management, Primary Health Care, HIV, Patient Acceptance of Health Care
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive CareOther
Provide emotional support. Provide practical support. Support friend/family by helping him find information or help for those with HIV in the community
| Study group | Role | What they receive |
|---|---|---|
| Routine Care | No intervention | Not described |
| Supportive Contact | Active comparator | Not described Receives: Other: Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Missed Visit Proportion (MVP)
The primary aim is to test for differences in MVP by treatment group across the study time period of 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), ACCESS Community Health Network
- Responsible party
- Sponsor
- Investigators
- John A Schneider, MD, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726712
- Sponsor's protocol ID
- 11-0654
- Other IDs
- 1R34MH097622-01
- Acronym
- NSEC
- Status last verified
- Jan 2017
- First submitted
- 15 Oct 2012
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Network Supported Engagement In HIV Care
- ClinicalTrials.gov ID
- NCT01726712
- Acronym / sponsor ID
- NSEC / 11-0654
- Conditions
- HIV, Patient Acceptance of Health Care
- Keywords
- Patient Care Management, Primary Health Care, HIV, Patient Acceptance of Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), ACCESS Community Health Network
- Study start
- Nov 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 15 Nov 2012 (estimated)
- 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 Network Supported Engagement in Care (NSEC) intervention is a brief, theory based and culturally sensitive intervention designed to capitalize on organic yet underutilized social support networks in the lives of young black men who have sex with men (YBMSM) who have been recently diagnosed with HIV. The intervention has been developed with input from clients and their support network members, case managers, social workers, HIV primary care providers and pastoral care at a Federally Qualified Health Center. The goal of the intervention is to improve retention in care for newly diagnosed YBMSM who present for their first HIV primary care clinic appointment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Care | No intervention | – |
| Supportive Contact | Active comparator | Other: Supportive Care |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Index subjects
- Self-identify as African-American and male;
- same gender anal/oral sex in the past 2 years;
- English speaking;
- have at least one SC in their network;
Key exclusion criteria (8 listed)
- unable to provide assent/consent;
- plan to move out of the area within the next 12 months;
- are not willing to attend intervention sessions; or
- not willing to return for assessments
- unable to provide informed consent; or
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 |
|---|---|---|
| Supportive CareProvide emotional support. Provide practical support. Support friend/family by helping him find information or help for those with HIV in the community | Other | Supportive Contact |
Primary outcome
Missed Visit Proportion (MVP)
Time frame: 12 months
The primary aim is to test for differences in MVP by treatment group across the study time period of 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
Related trials for HIV
RecruitingPhase 2
Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption
HIV
Recruiting
Feasibility Study Comparing One vs Two Probes for TA Among Cervical Cancer Screen Positive WLWH in C1001P-CS5 Rwanda
HIV (Human Immunodeficiency Virus), HPV
Not yet recruiting
Combating HIV Stigma in Healthcare Settings: A Standardized Patient Approach
Hiv
Recruiting
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive WLWH in C1001P-CS9 South Africa
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive Women Living With HIV in C1001P-CS7 Zimbabwe
HIV (Human Immunodeficiency Virus), HPV
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. This study is not recruiting at the moment.
John A Schneider, MD, PhD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive Care in people with HIV and Patient Acceptance of Health Care, run by University of Chicago at 1 site 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 14 inclusion and 8 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: finished, as of the sponsor's last update on 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Missed Visit Proportion (MVP) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2017.