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Social Network Intervention to Engage Community PLH to Engage in HIV Medical Care

Primary Purpose

Human Immunodeficiency Virus, HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Network Training
Single Care-Related Counseling Session and Referral to Care
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Immunodeficiency Virus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 or older;
  • Self-report as being HIV-positive, with positive HIV status confirmed in study-provided testing;
  • Except for initial seeds, must be named by an already-enrolled participant as a PLH friend; and
  • Do not plan to move from the St. Petersburg, Russia, area for the next 18 months.

Exclusion Criteria:

  • Age 17 or younger;
  • Self-report as HIV-negative or HIV-positive serostatus is not confirmed by testing;
  • Not be named as a PLH friend by an already-enrolled participant; and
  • Intend to move from the St. Petersburg, Russia, area during the next 18 months.

Sites / Locations

  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Social Network Endorsement

HIV Counseling and Referral to Care

Arm Description

All participants will receive a brief single care-related counseling session and referral to HIV medical care upon enrollment. After randomization to this arm, all members of HIV+ social networks will attend a multi-session group intervention during which they will be trained to deliver messages endorsing compliance with medical guidelines and adherence to medical treatment regimens to friends. Additionally, these leaders will be trained how to deliver effective messages.

All study participants will receive a brief single care-related counseling session and referral to HIV medical care at baseline.

Outcomes

Primary Outcome Measures

HIV viral load values
Change in HIV viral load values at baseline will be compared with HIV viral load values determined at 6 months post-intervention and 12 months post-intervention.
HIV medical care visits
Change in the number of self-reported HIV medical care visits, comparing the number of visits reported at baseline to the number reported at followup assessments.
Antiretroviral medication adherence
Change in medication adherence (as measured by the visual analogue scale; J.C. Walsh, et al, 2002), comparing the adherence percentage reported at baseline to the adherence percentage reported at followup assessments.

Secondary Outcome Measures

Full Information

First Posted
May 9, 2017
Last Updated
February 27, 2023
Sponsor
Medical College of Wisconsin
Collaborators
St. Petersburg State Pavlov Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03157258
Brief Title
Social Network Intervention to Engage Community PLH to Engage in HIV Medical Care
Official Title
Social Network Intervention to Engage Community PLH to Engage in HIV Medical Care
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 8, 2017 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
St. Petersburg State Pavlov Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
People living with HIV infection (PLH) are clustered in friendship groups with other HIV+ persons, and an intervention delivered to all members of PLH social networks allows HIV+ people who are friends in day-to-day life to provide one another with support for entering, remaining, and adhering to HIV medical care. Moreover, an intervention delivered to groups attended by HIV+ persons who are friends increases HIV medical care engagement and decreases problem drinking more than individual counseling, probably because the network intervention harnessed mutual peer social support among friends who share the same HIV status, face similar coping issues, and interact together in day-to-day life. The planned research will be conducted in two phases in St. Petersburg, Russia.
Detailed Description
Phase I of the planned research will be the conduct of in-depth interviews with 30 HIV+ persons not in medical care or not adherent to anti-retroviral therapy (ART) regimens, including men and women representing diverse exposure risks (drug use, men who have sex with men, and heterosexual transmission). Interviews will elicit information on ways in which HIV-positive friends can support one another in HIV care entry, retention, and adherence; types of support from PLH friends that would best support treatment engagement; and how peer supports can lessen the negative effects of substance use on care engagement. Phase 2 will recruit 48 out-of-care or ART nonadherent HIV+ individuals from community settings in St. Petersburg, Russia. These individuals, who are referred to as "network seeds," will invite their HIV+ friends, who will in turn invite their own HIV+ friends into the study, creating a sample of 48 networks (expected n=288, 6 members/network x 48 networks). Following baseline assessment of care engagement, ART adherence, treatment attitudes, psychosocial distress, substance use, and CD4+ and viral load, 24 networks (n=144 participants) will be randomized to an intervention condition and 24 networks (n=144) to the comparison condition. All members of each intervention condition network will together attend a 4-session intervention to strengthen attitudes, intentions, and skills for entering, remaining, and adhering to HIV medical care. Because participants will attend sessions with other individuals who are their own friends in day-to-day life, the intervention will build and increase mutual social support within each network for HIV care and adherence. Peer champions identified in each intervention network will attend 3 additional sessions in which they are guided to reinforce and help to sustain friends' medical care engagement. Intervention outcomes will be determined by baseline to 6- and 12-month followup change on primary measures of participant attendance at HIV medical care visits, adherence to ART regimens, and viral load as well as secondary measures of alcohol use, drug use, sexual risk behavior, treatment attitudes, and psychosocial distress.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus, HIV/AIDS

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
341 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Social Network Endorsement
Arm Type
Experimental
Arm Description
All participants will receive a brief single care-related counseling session and referral to HIV medical care upon enrollment. After randomization to this arm, all members of HIV+ social networks will attend a multi-session group intervention during which they will be trained to deliver messages endorsing compliance with medical guidelines and adherence to medical treatment regimens to friends. Additionally, these leaders will be trained how to deliver effective messages.
Arm Title
HIV Counseling and Referral to Care
Arm Type
Active Comparator
Arm Description
All study participants will receive a brief single care-related counseling session and referral to HIV medical care at baseline.
Intervention Type
Behavioral
Intervention Name(s)
Social Network Training
Intervention Description
Members of HIV+ social networks randomized to this arm will be trained to endorse compliance with medical guidelines and adherence to medical treatment regimens to their friends.
Intervention Type
Behavioral
Intervention Name(s)
Single Care-Related Counseling Session and Referral to Care
Intervention Description
Members of HIV+ social networks randomized to this arm will attend a single, brief care-related counseling session and referral to care at baseline.
Primary Outcome Measure Information:
Title
HIV viral load values
Description
Change in HIV viral load values at baseline will be compared with HIV viral load values determined at 6 months post-intervention and 12 months post-intervention.
Time Frame
0 months; 6 months; 12 months
Title
HIV medical care visits
Description
Change in the number of self-reported HIV medical care visits, comparing the number of visits reported at baseline to the number reported at followup assessments.
Time Frame
0 months; 6 months; 12 months
Title
Antiretroviral medication adherence
Description
Change in medication adherence (as measured by the visual analogue scale; J.C. Walsh, et al, 2002), comparing the adherence percentage reported at baseline to the adherence percentage reported at followup assessments.
Time Frame
0 months; 6 months; 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 or older; Self-report as being HIV-positive, with positive HIV status confirmed in study-provided testing; Except for initial seeds, must be named by an already-enrolled participant as a PLH friend; and Do not plan to move from the St. Petersburg, Russia, area for the next 18 months. Exclusion Criteria: Age 17 or younger; Self-report as HIV-negative or HIV-positive serostatus is not confirmed by testing; Not be named as a PLH friend by an already-enrolled participant; and Intend to move from the St. Petersburg, Russia, area during the next 18 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuri A. Amirkhanian, PhD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey A. Kelly, PhD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Social Network Intervention to Engage Community PLH to Engage in HIV Medical Care

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