This trial is active, not recruiting.

Conditions hiv, aids
Treatment social support
Sponsor Medical College of Wisconsin
Collaborator National Institute of Mental Health (NIMH)
Start date June 2014
End date April 2016
Trial size 174 participants
Trial identifier NCT02167828, PRO00021451, R21MH102193


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
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.
social support Social Network Training
(No Intervention)
Participants in this arm will not receive an intervention.

Primary Outcomes

Number of Medical Appointments Attended
time frame: 6 months

Secondary Outcomes

Number of Prescribed Antiretroviral Medication Doses Taken
time frame: 6 months
CD4 Level
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Increasing Social Support to Improve HIV Care Engagement and Adherence
Principal investigator Jeffrey A. Kelly, PhD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Medical College of Wisconsin.