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

NCT01825018 | Completed

• 1 other identifier: PRO00019160
• Study Type: interventional
• Target: 721
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV; AIDS

Keywords

HIV; AIDS; treatment adherence

Outcome Measures

Primary Outcomes (3)

• Change in Medical Appointment Keeping

  Changes in the number of medical appointments scheduled and kept relative to baseline will be compared at 6 and 12 months post-intervention.

  6 months; 12 months

• Change in HIV Viral Load

  Change in HIV viral load relative to baseline will be compared at 6 and 12 months post-intervention.

  6 months; 12 months

• Change in Antiretroviral Treatment Adherence

  Changes in treatment adherence relative to baseline will be measured by standardized scales and clinical care records at 6 and 12 months post-intervention.

  6 months; 12 months

Study Arms (2)

Social Network Leader Endorsement

EXPERIMENTAL

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

Comparison Group

ACTIVE COMPARATOR

Members of social networks assigned to this group will receive only HIV counseling at the baseline session.

Behavioral: HIV Counseling

Interventions

Social Network Leader Endorsement BEHAVIORAL

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.

Social Network Leader Endorsement

HIV Counseling BEHAVIORAL

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.

Comparison Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Extensive knowledge of and/or personal experience within PLH community in St. Petersburg, Russia;
• years of age or older;
• Ability to interact verbally in Russian.
• Self-reported positive HIV diagnosis at time of screening;
• Self-report of no medical care, not presently on antiretroviral regimen, or \<80% HAART adherence in the past month;
• years of age or older;
• Reports personally knowing other HIV-positive persons;
• Ability to interact verbally in Russian and to complete instruments written in Russian.
• No plans to move from the area in the next 18 months
• Self-reported positive HIV diagnosis at time of screening;
• years of age or older;
• No plans to relocate from area in next 18 months;
• Named by a seed as a social network member;
• Ability to interact verbally in Russian and to complete instruments written in Russian.

You may not qualify if:

• Extensive knowledge of and/or personal experience within PLH community in St. Petersburg, Russia;
• years of age or older;
• Ability to interact verbally in Russian.
• Self-reported positive HIV diagnosis at time of screening;
• Self-report of no medical care, not presently on antiretroviral regimen, or \<80% HAART adherence in the past month;
• years of age or older;
• Reports personally knowing other HIV-positive persons;
• Ability to interact verbally in Russian and to complete instruments written in Russian.
• No plans to move from the area in the next 18 months
• Self-reported positive HIV diagnosis at time of screening;
• years of age or older;
• No plans to relocate from area in next 18 months;
• Named by a seed as a social network member;
• Ability to interact verbally in Russian and to complete instruments written in Russian.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Botkin Hospital for Infectious Diseases

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Health Behavior; Behavior

Study Officials

• Jeffrey A Kelly, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

• Yuri A. Amirkhanian, PhD

  Medical College of Wisconsin

  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: March 22, 2013
• First Posted: April 5, 2013
• Study Start: May 1, 2013
• Primary Completion: October 1, 2018
• Study Completion: July 8, 2019
• Last Updated: July 10, 2019

Record last verified: 2019-07

Locations

RU (1)