- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01726712
Network Supported Engagement In HIV Care (NSEC)
January 19, 2017 updated by: University of Chicago
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
105
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- University of Chicago Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
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;
- 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.
Exclusion Criteria:
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Routine Care
|
|
ACTIVE_COMPARATOR: Supportive Contact
|
Provide emotional support.
Provide practical support.
Support friend/family by helping him find information or help for those with HIV in the community
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John A Schneider, MD, PhD, University of Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (ACTUAL)
August 1, 2015
Study Completion (ACTUAL)
August 1, 2015
Study Registration Dates
First Submitted
October 15, 2012
First Submitted That Met QC Criteria
November 9, 2012
First Posted (ESTIMATE)
November 15, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
January 20, 2017
Last Update Submitted That Met QC Criteria
January 19, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 11-0654
- 1R34MH097622-01 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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