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Completed

NCT Number: NCT02167828

Increasing Social Support to Improve HIV Care Engagement and Adherence in St. Petersburg, Russia

Prior research has documented serious health, mental health, and social-behavioral issues among people living with HIV (PLH) in St. Petersburg. The investigators have established that PLH are clustered in friendship groups with other HIV+ persons and that an intervention delivered to groups composed of HIV+ men who have sex with men (MSM) who were friends in real life reduced mental health distress more than individual counseling. Specific aims of the collaborative mixed-methods, qualitative/ quantitative research are to: (1) identify facilitators and barriers of medical care attendance and ART adherence among PLH in St. Petersburg; (2) integrate these data into an intervention designed to increase HIV care attendance, retention, and adherence; (3) carry out a test-of-concept pilot study that recruits groups of PLH friends and delivers an intervention to intact PLH friendship groups to encourage mutual social support for attending medical appointments and adhering to HIV care; and (4) evaluate the effects of the intervention on both behavioral and biological measures, including viral load. These specific aims will be achieved by research carried out in two phases:

In Phase I, we will conduct in-depth interviews with 60 PLH and key informants in St. Petersburg purposively selected to include HIV+ persons in and not in medical care, adherent or not adherent to ART, and including men and women representing diverse exposure risks. In-depth interviews will be analyzed to identify factors associated with attending or not attending care and adhering or not adhering to ART, as well as identifying how HIV+ friends can support one another in HIV care entry, retention, and adherence.

In Phase II, the investigators will undertake a randomized intervention pilot study in which 20 groups of PLH friends are recruited by enrolling a PLH seed who is not reliably in care or is ART nonadherent and then recruiting all friends known by the seed to also be HIV+. A 7-session group intervention will be undertaken with all members of the friendship groups in the experimental condition to increase care and adherence-related social support, problem-solving, and mutual assistance for care. Baseline to 6-month followup data will determine whether the intervention produces greater improvement than found in the comparison group in care attendance and treatment adherence, improved mental health, lower substance use, and lower HIV viral load.

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Key information

Conditions

HIV AIDS Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Treatment Adherence and Compliance Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Botkin Hospital for Infectious Diseases #30, Saint Petersburg, Russia

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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
  • Except for initial seeds, must be named by an already-enrolled participant as an HIV-positive friend
  • Do not plan to move from the St. Petersburg area for the next 12 months
  • Able to provide written informed consent and do not exhibit severe alcohol intoxication, drug use impairment, or acute psychiatric impairment.

Exclusion criteria

  • Age 17 or younger
  • Self-report as HIV-negative
  • Not named as an HIV-positive friend by an already-enrolled participant
  • Plans to move from the St. Petersburg area in the next 12 months
  • Exhibit severe alcohol intoxication, drug use impairment, or acute psychiatric impairment

Treatment and study plan

Social Support

Behavioral

Other names: Social Network Training

Primary outcomes

  1. Number of Medical Appointments Attended

    Time frame: 6 months

    measure--through self-report--the number of medical appointments each participant attends in a six-month period.

Secondary outcomes

  1. Number of Prescribed Antiretroviral Medication Doses Taken

    Time frame: 6 months

    measure--through self-report--the number of medication doses each participant takes in a six-month sample.

  2. CD4 Level

    Time frame: 6 months

    Viral load (i.e., CD4 level) in each participant will be measured via blood test.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Increasing Social Support to Improve HIV Care Engagement and Adherence

Important dates

Study start
2014
Primary completion
2016
Study completion
2019
First posted
Jun 19, 2014
Registry last updated
Oct 7, 2019

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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