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

Sponsor
Medical College of Wisconsin (Other)
Overall Status
Completed
CT.gov ID
NCT02167828
Collaborator
National Institute of Mental Health (NIMH) (NIH)
174
2
2
61.2
87
1.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Social Support
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
174 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Increasing Social Support to Improve HIV Care Engagement and Adherence
Study Start Date :
Jun 1, 2014
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
Jul 8, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Social Support

Participants will be trained to give one another ongoing, theory-based but personally-tailored advice, recommendations, and support to encourage entry to HIV medical care, remaining in care, and adhering to medication regimens when they are prescribed. The intervention's intent is to increase mutual support, positive attitudes, intentions, plans, and collective self-efficacy for care engagement.

Behavioral: Social Support
Other Names:
  • Social Network Training
  • No Intervention: No Intervention

    Participants in this arm will not receive an intervention.

    Outcome Measures

    Primary Outcome Measures

    1. Number of Medical Appointments Attended [6 months]

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

    Secondary Outcome Measures

    1. Number of Prescribed Antiretroviral Medication Doses Taken [6 months]

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

    2. CD4 Level [6 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Center for AIDS Intervention Research, Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    2 Botkin Hospital for Infectious Diseases #30 St. Petersburg Russian Federation

    Sponsors and Collaborators

    • Medical College of Wisconsin
    • National Institute of Mental Health (NIMH)

    Investigators

    • Principal Investigator: Jeffrey A. Kelly, PhD, Medical College of Wisconsin
    • Principal Investigator: Yuri A. Amirkhanian, PhD, Medical College of Wisconsin

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medical College of Wisconsin
    ClinicalTrials.gov Identifier:
    NCT02167828
    Other Study ID Numbers:
    • PRO00021451
    • R21MH102193
    First Posted:
    Jun 19, 2014
    Last Update Posted:
    Oct 7, 2019
    Last Verified:
    Oct 1, 2019
    Keywords provided by Medical College of Wisconsin

    Study Results

    No Results Posted as of Oct 7, 2019