Social Network Intervention to Engage Out-of-Care PLH Into Treatment

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01825018
First received: March 22, 2013
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

Formative Research Phase (Months 1-6) The investigators will undertake qualitative formative studies to: (1) identify barriers to highly active antiretroviral therapy (HAART) and strategies currently used to engage PLH in care; (2) identify access points and ways to reach a diversity of PLH social networks; (3) gain an understanding of PLH views, motivations, barriers, and facilitators of care entry, maintenance, and adherence; (4) examine the structure and segments of the PLH community in St. Petersburg; and (5) elicit input from members of the PLH community and its stakeholders concerning the planned network recruitment, assessment, and intervention procedures and content. The investigators will refine protocols used in their intervention pilot study based on findings of the formative research phase.

Main Trial Phase (Months 7-60)

Overview of the main intervention outcome trial's experimental design. The main trial is a two-arm randomized outcome study. A total of 32 sociocentric social networks of PLH will be recruited by first identifying initial seeds—always PLH who are either out-of-care or treatment nonadherent—in multiple access points that were identified in the formative phase. The investigators will then enroll three rings of HIV+ friends outward beginning with each seed. Each sociocentric network is expected to consist of approximately 16 to 18 individuals (expected n=32x18=576 participants). This estimate is based on the size and density of participants' personal networks observed in our pilot studies. Each network member will be assessed at baseline using measures to be described shortly and will receive individual motivational counseling in care and adherence. This session will "prime" participants to an understanding about the availability, accessibility, and benefits of care. Members of the 16 PLH networks randomized to the experimental condition will then receive the network intervention. Cadres of empirically identified influence leaders within each network will be identified, trained, and engaged to reinforce network member engagement and adherence. At 6- and 12-month followup points, assessment data will again be collected to determine intervention impact on the primary and secondary outcomes.


Condition Intervention
HIV
AIDS
Behavioral: Social Network Leader Endorsement
Behavioral: HIV Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Social Network Intervention to Engage Out-of-Care PLH Into Treatment

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Change in Medical Appointment Keeping [ Time Frame: 6 months; 12 months ] [ Designated as safety issue: No ]
    Changes in the number of medical appointments scheduled and kept relative to baseline will be compared at 6 and 12 months post-intervention.

  • Change in HIV Viral Load [ Time Frame: 6 months; 12 months ] [ Designated as safety issue: No ]
    Change in HIV viral load relative to baseline will be compared at 6 and 12 months post-intervention.

  • Change in Antiretroviral Treatment Adherence [ Time Frame: 6 months; 12 months ] [ Designated as safety issue: No ]
    Changes in treatment adherence relative to baseline will be measured by standardized scales and clinical care records at 6 and 12 months post-intervention.


Estimated Enrollment: 750
Study Start Date: May 2013
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Social Network Leader Endorsement
Leaders of social networks randomized to this arm will be taught to endorse compliance with medical guidelines, safer behaviors, and effective ways to communicate these concepts to social network members.
Behavioral: Social Network Leader Endorsement
Leaders of the 16 intervention condition networks will attend a 7-session intervention, with the first 5 sessions held weekly and the last 2 at biweekly intervals. Networks will include persons with differing care histories including PLH never in care, those who dropped out of care, and those who attend medical appointments irregularly or are inconsistent in adherence. Network leaders will be trained to tailor communications to each friend's care circumstances. Issues of current injecting drug users (IDUs) may differ from non-IDUs. Therefore, intervention content will be tailored based on formative phase findings, and groups for IDU network leaders will be held separately.
Active Comparator: Comparison Group
Members of social networks assigned to this group will receive only HIV counseling at the baseline session.
Behavioral: HIV Counseling
At the baseline session, participants in the comparison condition will receive counseling about the benefits and availability of HIV care and the importance of treatment adherence.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria for Formative Phase subjects:

    1. Extensive knowledge of and/or personal experience within PLH community in St. Petersburg, Russia;
    2. 18 years of age or older;
    3. Ability to interact verbally in Russian.

Inclusion criteria for Seeds (aka "Indexes"):

  1. Self-reported positive HIV diagnosis at time of screening;
  2. Self-report of no medical care, not presently on antiretroviral regimen, or <80% HAART adherence in the past month;
  3. 18 years of age or older;
  4. Reports personally knowing other HIV-positive persons;
  5. Ability to interact verbally in Russian and to complete instruments written in Russian.
  6. No plans to move from the area in the next 18 months

Inclusion criteria for Network Members:

  1. Self-reported positive HIV diagnosis at time of screening;
  2. 18 years of age or older;
  3. No plans to relocate from area in next 18 months;
  4. Named by a seed as a social network member;
  5. Ability to interact verbally in Russian and to complete instruments written in Russian.

Exclusion Criteria:

  • Inclusion criteria for Formative Phase subjects:

    1. Extensive knowledge of and/or personal experience within PLH community in St. Petersburg, Russia;
    2. 18 years of age or older;
    3. Ability to interact verbally in Russian.

Inclusion criteria for Seeds (aka "Indexes"):

  1. Self-reported positive HIV diagnosis at time of screening;
  2. Self-report of no medical care, not presently on antiretroviral regimen, or <80% HAART adherence in the past month;
  3. 18 years of age or older;
  4. Reports personally knowing other HIV-positive persons;
  5. Ability to interact verbally in Russian and to complete instruments written in Russian.
  6. No plans to move from the area in the next 18 months

Inclusion criteria for Network Members:

  1. Self-reported positive HIV diagnosis at time of screening;
  2. 18 years of age or older;
  3. No plans to relocate from area in next 18 months;
  4. Named by a seed as a social network member;
  5. Ability to interact verbally in Russian and to complete instruments written in Russian.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01825018

Locations
Russian Federation
Botkin Hospital for Infectious Diseases
St. Petersburg, Russian Federation
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Jeffrey A Kelly, PhD Medical College of Wisconsin
Principal Investigator: Yuri A. Amirkhanian, PhD Medical College of Wisconsin
  More Information

No publications provided

Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01825018     History of Changes
Other Study ID Numbers: PRO00019160
Study First Received: March 22, 2013
Last Updated: October 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
HIV
AIDS
treatment adherence

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014