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

NCT ID: NCT02167828

Last Updated: 2019-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2019-07-08

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.

Conditions

HIV; AIDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Social Support

Intervention Type: BEHAVIORAL

No Intervention

Participants in this arm will not receive an intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Social Support

Intervention Type: BEHAVIORAL

Other Intervention Names

Social Network Training

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey A. Kelly, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Yuri A. Amirkhanian, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Center for AIDS Intervention Research, Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Botkin Hospital for Infectious Diseases #30

Saint Petersburg, , Russia

Countries

United States; Russia

Other Identifiers

R21MH102193

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO00021451

Identifier Type: -

Identifier Source: org_study_id