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OpenTrials
Completed

NCT Number: NCT03157258

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Social Network Training

Behavioral

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.

Single Care-Related Counseling Session and Referral to Care

Behavioral

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 outcomes

  1. HIV viral load values

    Time frame: 0 months; 6 months; 12 months

    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.

  2. HIV medical care visits

    Time frame: 0 months; 6 months; 12 months

    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.

  3. Antiretroviral medication adherence

    Time frame: 0 months; 6 months; 12 months

    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.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • St. Petersburg State Pavlov Medical University

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
May 17, 2017
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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