NCT01726712

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2012

Completed
17 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 15, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

January 20, 2017

Status Verified

January 1, 2017

Enrollment Period

2.7 years

First QC Date

October 15, 2012

Last Update Submit

January 19, 2017

Conditions

Keywords

Patient Care ManagementPrimary Health CareHIVPatient Acceptance of Health Care

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months

Study Arms (2)

Routine Care

NO INTERVENTION

Supportive Contact

ACTIVE COMPARATOR
Other: Supportive Care

Interventions

Provide emotional support. Provide practical support. Support friend/family by helping him find information or help for those with HIV in the community

Supportive Contact

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • years of age or older;
  • English speaking; and
  • owns a cell phone that is not shared with other persons.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Patient Acceptance of Health Care

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • John A Schneider, MD, PhD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2012

First Posted

November 15, 2012

Study Start

November 1, 2012

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

January 20, 2017

Record last verified: 2017-01

Locations