NCT03157258

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
341

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
22 days until next milestone

Study Start

First participant enrolled

June 8, 2017

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

January 14, 2026

Status Verified

February 1, 2023

Enrollment Period

5.1 years

First QC Date

May 9, 2017

Last Update Submit

January 12, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    0 months; 6 months; 12 months

  • HIV medical care visits

    Change in the number of self-reported HIV medical care visits during the prior six months, comparing the number of visits reported at baseline to the number reported at six and twelve months at post-intervention followup assessments.

    0 months; 6 months; 12 months

  • Antiretroviral medication adherence

    Change in medication adherence during the past 30 days (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 the six and twelve month postintervention followup assessments.

    0 months; 6 months; 12 months

Study Arms (2)

Social Network Endorsement

EXPERIMENTAL

All participants in this arm will receive two intervention elements: (1) they will receive a brief single care-related counseling session and referral to HIV medical care upon enrollment; and (2) all members of the 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.

Behavioral: Social Network Training

HIV Counseling and Referral to Care

ACTIVE COMPARATOR

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

Behavioral: Single Care-Related Counseling Session and Referral to Care

Interventions

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.

Social Network Endorsement

Members of HIV+ social networks randomized to this arm will attend a single, brief care-related counseling session and referral to care at baseline.

HIV Counseling and Referral to Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53202, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Yuri A. Amirkhanian, PhD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR
  • Jeffrey A. Kelly, PhD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 9, 2017

First Posted

May 17, 2017

Study Start

June 8, 2017

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

January 14, 2026

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations