Electronic SBI(RT) for MSM in Argentina

After completing Stage 1 of the study, during which we will develop the e-SBI and pilot it to assess acceptability and obtain feedback from intended end users, we will launch the Stage 2 pilot Randomized Controlled Trial (RCT) with 200 participants. As a pilot RCT (not powered to assess efficacy of e-SBI) conducted as part of an R34 study, the main goal of this RCT is to develop the materials, processes, and procedures for a future efficacy trial of the intervention. The primary goals of the pilot RCT are to assess the feasibility and acceptability of implementing the e-SBI within the Nexo HIV Testing program. As a secondary aim, we will assess uptake, acceptability, and feasibility of delivering MHP at Nexo and subsequent linkage to SATx among those with high-risk substance use or dependence. And, lastly, we will conduct a preliminary exploration of substance use and sexual risk reduction outcomes.

1. Recruitment. MSM coming to Nexo for HIV testing and who are 18 years of age or older will be offered participation in the study. These clients will be given a flyer that, consistent with goal choice interventions, will create a low threshold for study participation by stressing personal choice, goal selection, and an intervention tailored specifically for MSM to figure out how to best reduce behavior that puts them at risk of HIV infection. Clients who wish to participate will complete informed consent, be randomized immediately, and given a tablet logged on to their respective study arm (and disposable headphones) to complete their study procedures. Research staff will record the number of clients who refuse participation.
2. Baseline Assessment. Participants in both conditions will complete a demographics questionnaire then a self-administered tablet-based 30-day Timeline Followback (TLFB) to track days of drug use, number heavy drinking days, and HIV risk behavior, defined as anal sex with: 1) an HIV positive partner who they were not sure had an undetectable viral load, or 2) a partner who had not tested HIV negative within the past three months). After completing their respective condition (described below) all participants will complete quantitative acceptability assessments based on the TFA
3. RCT Study Conditions. Participants will be randomized at a ratio of 3 (e-SBI) to 1 (Assessment Only) and followed for 6-months.
4. Intervention group participants. After completing the baseline assessment, the tablet will immediately lead these participants to the e-SBI. The e-SBI branching logic will allow the intervention to be tailored based on factors such as participants' substance use risk level (based on ASSIST and AUDIT score), risk perception, and readiness to change. The e-SBI will also target the participant's sexual risk behavior and help them to develop a risk reduction plan, regardless of their substance use. Then, they will proceed to the usual HIV testing process at Nexo.
5. Control group participants. After completing the baseline assessment, the tablet will lead these participants to the same screening instruments as in the e-SBI but with no MI-based BI. Due to ethical considerations, control group participants with moderate or high-risk substance use based on the ASSIST or AUDIT scores will receive brief feedback on the tablet stating their level of risk, availability of MHP at Nexo, and instructions to see the receptionist for an appointment, if desired. Then, they will proceed to the usual HIV testing process at Nexo.
6. Referral for MHP. All individuals with moderate or high-risk substance use will be recommended for MHP (either actively motivated through e-SBI or informed about it in the control condition). MHP sessions will be conducted in-person at Nexo (later sessions can occur remotely, based on the participant's preference using a HIPAA compliant platform such as Zoom Healthcare). For participants with moderate risk substance use, MHP will focus on reducing substance use and sexual risk behavior. For participants with high-risk use or dependence, MHP sessions will focus on building motivation to enter specialized substance abuse treatment.
7. Follow-Up Assessments. All participants, including those who enter MHP or SATx, will repeat the self-administered 30-day TLFB at 3- and 6-months after enrollment to assess drug use, alcohol use, and sexual risk behavior. At 6-months they will also complete the screener instruments in the e-SBI, and retrospective acceptability assessments based on the Theoretical Framework of Acceptability of e-SBI and MHP (if they entered MHP), all of which will be programmed in RedCap and self-administered. We will also conduct IDIs with up to 45 participants (or less if saturation is reached), 15 with participants from either study condition who entered or completed MHP and/or SATx and 15 from each arm who met criteria for MHP but did not request it.