Social Network Intervention to Engage Out-of-Care PLH Into Treatment
|ClinicalTrials.gov Identifier: NCT01825018|
Recruitment Status : Active, not recruiting
First Posted : April 5, 2013
Last Update Posted : October 26, 2017
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 or disease||Intervention/treatment|
|HIV AIDS||Behavioral: Social Network Leader Endorsement Behavioral: HIV Counseling|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||750 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Social Network Intervention to Engage Out-of-Care PLH Into Treatment|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||October 2018|
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.
- Change in Medical Appointment Keeping [ Time Frame: 6 months; 12 months ]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 ]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 ]Changes in treatment adherence relative to baseline will be measured by standardized scales and clinical care records at 6 and 12 months post-intervention.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01825018
|Botkin Hospital for Infectious Diseases|
|St. Petersburg, Russian Federation|
|Principal Investigator:||Jeffrey A Kelly, PhD||Medical College of Wisconsin|
|Principal Investigator:||Yuri A. Amirkhanian, PhD||Medical College of Wisconsin|