Intervention

The LINC-II intervention has three main components: (1) strengths-based HIV case management; (2) rapid ART initiation; and (3) pharmacotherapy for opioid use disorder.

As part of the strengths-based case management intervention, a peer (i.e., man or woman living with HIV and in stable recovery from addiction) case manager works one-on-one with patients to support and motivate their client in accessing HIV care, reducing barriers to HIV care, and maintaining their addiction treatment. Strengths-based case management rests on the premise that all patients have strengths, and, once recognized, these strengths can be the foundation for them to build their capacities to engage in HIV medical care and improve their HIV-related health outcomes [6]. The strengths-based approach is based on Social Cognitive Theory, emphasizing the client’s self-efficacy to create change, and includes psychoeducational support and counseling, which are aimed at helping patients gain additional knowledge about HIV care and ways to independently access available services. This approach also utilizes components from the Psychological Empowerment Theory, mainly in the way patients are supported by CMs in identifying their own strengths to improve healthcare-seeking behavior [7, 8].

The CM serves as a coordinator between the narcology and HIV systems of care, delivering HIV strengths-based case management via ten one-on-one sessions over a 12-month period. The first LINC-II case management session is preferably held at the City Addiction Hospital within days of study enrollment; and the second session is scheduled to take place at the City AIDS Center. Sessions are planned to occur at approximately 3 to 6-week intervals, with a goal of five sessions for every 6 months of intervention, for a total of ten sessions. Following session two, subsequent case management encounters can occur at any location of preference and via phone, if necessary.

The first two sessions consist of determining the patient’s psychological and resource-related strengths and developing goals related to HIV care and supporting recovery. CMs discuss with participant their most recent CD4 count and HVL results, if they are available, and the benefits of regular HIV care. Follow-up sessions reinforce prior sessions, reviewing previously set goals and patients’ strengths, creating new goals as needed.

LINC-II offers SMS messaging between sessions to reinforce the CM-patient relationship and contact. SMS are sent to participants, encouraging them to contact their CM if they so wish in times of need (e.g., a craving episode). CMs can also choose to replace the SMS with phone calls, if that mode of communication is preferred by the participant.

The World Health Organization’s guidelines for HIV treatment call for “rapid” initiation of ART, defined as starting treatment within 7 days of diagnosis [9]. With all HIV-positive individuals now eligible for ART in Russia, regardless of CD4 count, participants randomized to the intervention group are offered initiation of ART as quickly as possible, ideally while at the City Addiction Hospital. Rapid access to ART is facilitated by the City AIDS Center’s infectionist (HIV physician), who sees patients at the St. Petersburg City Addiction Hospital. All participants meet with the infectionist while hospitalized and have their blood drawn for CD4 count and HVL testing. As customary in Russia, all ART initiation requests in St. Petersburg must be approved by a special committee at the City AIDS Center. For participants randomized to the intervention group, the infectionist facilitates this approval with the ultimate goal of starting participants on ART while they are still hospitalized at the City Addiction Hospital. If a participant remains hospitalized at the time of ART approval, the infectionist delivers the first set of medications, a 1-month supply, to the patient while in the hospital. The CM helps schedule the subsequent visit to the City AIDS Center 1 month later to pick up the next refill of medication. If a participant is no longer at the City Addiction Hospital, then the CM will help the patient schedule his or her visit to the City AIDS Center as soon as possible, where the first set of medications will be provided. Once the initial visit to the City AIDS Center is made, participants continue HIV care at one of two possible sites: City AIDS Center or their local HIV outpatient clinic; all subsequent ART refills can be picked up at a local clinic.

Opioid agonist treatment (i.e., buprenorphine and methadone) is not available in Russia. Participants in the intervention arm receive one intramuscular gluteal injection of 380 mg of naltrexone for extended-release injectable suspension at the City Addiction Hospital. Since naltrexone can precipitate withdrawal in participants with a physiological dependence on opioids, participants are given a naloxone challenge prior to receiving naltrexone. Following hospital discharge, participants come to First St. Petersburg Pavlov State Medical University to receive a 1000 mg dissolvable naltrexone implant. Participants receive 4 naltrexone implants while in the study—every 10 to 12 weeks starting at week four post-study enrollment (weeks 4, 16, 28, 40), unless the participant relapses. Participants undergo a naloxone challenge at study visits during which the naltrexone implant is inserted and only if the participant’s urine is opioid-free. If participant does not pass the naloxone challenge due to relapse, they are referred to detox treatment and are invited to return upon completion of that treatment for a repeat naloxone challenge. Naltrexone implantation is an outpatient procedure conducted on site by a surgeon with the assistance of a study nurse. Participants are invited to return seven to 11 days following the implant for removal of sutures and every 4 weeks following the implant for a medication check-in visit. Assessors administer brief counseling (~ 5 min) to participants during all medication visits.