Increasing Social Support to Improve HIV Care Engagement and Adherence in St. Petersburg, Russia
2 other identifiers
interventional
174
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv
Started Jun 2014
Longer than P75 for not_applicable hiv
2 active sites
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 1, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedFirst Posted
Study publicly available on registry
June 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2019
CompletedOctober 7, 2019
October 1, 2019
1.8 years
May 1, 2014
October 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Medical Appointments Attended
measure--through self-report--the number of medical appointments each participant attends in a six-month period.
6 months
Secondary Outcomes (2)
Number of Prescribed Antiretroviral Medication Doses Taken
6 months
CD4 Level
6 months
Study Arms (2)
Social Support
EXPERIMENTALParticipants 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.
No Intervention
NO INTERVENTIONParticipants in this arm will not receive an intervention.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Center for AIDS Intervention Research, Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Botkin Hospital for Infectious Diseases #30
Saint Petersburg, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey A. Kelly, PhD
Medical College of Wisconsin
- PRINCIPAL INVESTIGATOR
Yuri A. Amirkhanian, PhD
Medical College of Wisconsin
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2014
First Posted
June 19, 2014
Study Start
June 1, 2014
Primary Completion
April 1, 2016
Study Completion
July 8, 2019
Last Updated
October 7, 2019
Record last verified: 2019-10