Social Network Intervention to Engage Out-of-Care PLH Into Treatment
NCT01825018 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 721
Last updated 2019-07-10
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
Interventions
- 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.
- 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.
Sponsors & Collaborators
-
Medical College of Wisconsin
lead OTHER
Principal Investigators
-
Jeffrey A Kelly, PhD · Medical College of Wisconsin
-
Yuri A. Amirkhanian, PhD · Medical College of Wisconsin
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-05-31
- Primary Completion
- 2018-10-31
- Completion
- 2019-07-08
Countries
- Russia
Study Locations
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