Recruitment methods

Participants are recruited through in-person outreach at clinical and community sites serving YLWH, emails to clinics and providers, flyers posted at health clinics and community-based organisations, targeted online advertisements on Instagram, Craigslist, Facebook and Grindr and recontacting participants from prior studies who had expressed interest in being contacted about future studies. Finally, a participant referral method is used, and a $25 incentive is provided to both the referring participant and new participant.

Eligibility screening

Study staff provide a brief overview of the study to prospective participants, answer any questions and complete an eligibility screening on the telephone. Those who meet the inclusion criteria and are willing to participate in the study are asked for a photo ID to verify their date of birth and proof of HIV status (a letter of diagnosis, laboratory results or HIV medication prescription) via a photo text-messaged to the study telephone or by bringing these documents to the initial in-person visit.

Consent and enrolment procedure

The enrolment visit will be completed in person with a study staff member. Participants review the electronic consent form (see online supplementary appendix A) with a study staff member in a private setting. Individuals who are eligible and agree to participate electronically sign the consent and a medical release form using Qualtrics (Provo, UT, USA; version March 2017) an online survey platform and are provided a copy of the Experimental Subject’s Bill of Rights.

Baseline survey

Participants then complete the online baseline survey, which takes approximately 30–45 min. Study staff then help participants download a secure video chat mobile application (ie, Zoom, a (Health Insurance Portability and Accountability Act [HIPAA]–compliant video chat platform) on their telephones. Study staff demonstrate how to set up privacy settings on mobile telephones, such as keeping text message previews from showing up on locked screens and adding a security code to lock the telephone.

Randomisation

Following the baseline survey, research staff randomly assign participants to one of two condition groups (ie, intervention or waitlist control) with a prenumbered sealed envelope. Randomisation is done using SAS (version 9.4) based on randomly permuted block sizes to ensure equal-sized groups, and all study staff are blinded to the randomisation order. Approximately 40 participants will be randomised to the immediate intervention condition and receive their first session in person; about 40 participants will be randomised to the waitlist control condition for 4 months after study enrolment and then cross-over to the treatment arm and receive the study intervention entirely remotely with no in-person session with the counsellor. The counsellor and clinical research coordinator will not be blinded to the randomisation condition, as treatment will be prescribed as a result of the condition.

Participant retention

A number of steps are taken to retain participants throughout the study period. Participants are asked for multiple forms of contact information (including emergency contacts, clinical contacts and social media contacts) at the initial visit to prevent loss of contact. They receive three monthly follow-up text messages during the waiting period to confirm their contact information, appointment reminder text messages 24 hours and 15 min before scheduled counselling sessions, birthday text messages and a weekly text message with free fun local activities to facilitate rapport-building (see table 2).

Participants' Incentives

Participants receive up to $310 for completing all study activities, including payments for each counselling session that gradually increase throughout the study (in $10–$25 increments). Participants are given a ClinCard, a reloadable debit card and instructions for use at the initial visit. Participants are also entered into two raffles for chances to win $25 Amazon gift cards when they confirm their contact information or answer two session rating questions after each telehealth session. Additionally, participants who refer others to the study are paid $25 per successful recruitment.

Risks to participants

All risks to participants are monitored by study staff and documented at each session and study assessment. Study staff are trained to thoroughly explain these risks to participants as well as the steps taken to ensure privacy and confidentiality of all information. Safety-related risks to participants could include discomfort due to the sensitive nature of questions in study surveys including substance use, HIV health-related issues and mental health. Non-clinical study staff conducting interviews and participant communication refer to clinical study staff if participant distress is identified. Clinical staff delivering the intervention are trained to assess distress level of participants and refer to established protocols for any participant crisis. If a participant requires treatment due to distress, this will be determined by clinical staff; they will be referred to appropriate services following the crisis protocol, and the principal investigator (PI) will be informed.

Adverse events and auditing

The study staff monitor postsession participant ratings (via text message) as one method for identifying those who may have experienced an adverse event. If a participant reports low satisfaction with the intervention, study staff contact them in a timely manner to determine what occurred in the session. Study staff also provide participants with the study mobile telephone number to spontaneously report any adverse events or unintended effects of the intervention. Any adverse events will be documented on an adverse event form, and follow-up will be tracked. The form along with any session notes with details will be reported to the IRB by the PI within 10 working days. The team of investigators will also meet weekly to audit and discuss general trial conduct–related issues.

Protocol amendments

Protocol amendments will be shared with all stakeholders as they occur. Study staff communicate protocol modifications to investigators during monthly meetings, submit changes to www.clinicaltrials.gov as needed, submit IRB modifications and communicate changes to regulators during meetings every 6 months or via email as needed.

Series overview

Participants in the intervention arm meet with the counsellor in person immediately after enrolment, and the waitlist control arm participants meet with the counsellor via video chat after 4 months. Before the first meeting, the counsellor reviews the participant’s most recent assessment survey responses to determine the participant’s level of acuity and tailor appropriate session dosage. Mental health acuity is determined through the Patient Health Questionnaire (PHQ) 9 and PTSD Checklist (PCL); substance use acuity is determined through the Alcohol Use Disorders Identification Test (AUDIT) and Alcohol, Smoking and Substance Involvement Screening Test (ASSIST); HIV care acuity is calculated by a measure of HIV knowledge as well as current participant utilisation of HIV care services and antiretroviral medications. During the first session, the counsellor assesses the participant’s needs and identifies current gaps in knowledge and motivation regarding mental health, substance use and HIV care. The first three to six of the remaining 11 sessions cover core psychoeducational and health literacy–promoting content around engagement in HIV care, mental health and substance use challenges and treatments. Those with higher acuity receive two foundational psychoeducational modules rather than one in each of the three areas, amounting to a maximum of six core educational sessions.

The remaining sessions use an integrated behavioural health and HIV care– focused approach to further the conversations initiated in the core sessions. At the beginning of these sessions, the participant and counsellor choose from a list of topics identified in the first session, including HIV care, mental health, substance use, lifestyle health, social support, family of origin, romantic and sexual relationships, self-identity and disclosure, subsistence needs (housing, money and resources) and education and vocation. These sessions can be done in any order and repeated as needed. If a participant is in crisis and unable to be redirected to these options, a ‘wildcard’ session focused on crisis response and safety planning may be held. The final session includes reviewing the content covered and goals achieved in the previous sessions, identifying unmet needs, accessing community-based resources and learning strategies for maintaining changes.

Scheduling sessions

Four months are allocated to complete the 12 weekly counselling sessions to allow for missed and rescheduled sessions. Participants are encouraged to contact the counsellor or study staff to reschedule their appointments as needed. Participants receive session reminders via text message 24 hours and 15 min before each session.

Session documentation and fidelity

The counsellor completes session summary notes through a Qualtrics survey form, which includes closed-ended and multiple-choice questions such as session length, participant location, technical issues encountered, session topics selected, educational topics covered, goals set, a session content fidelity checklist and a narrative progress note.

Evaluation and curriculum modifications

The initial version of the Y2TEC intervention will be delivered to participants randomised to the intervention arm. The research team plans to adjust the intervention based on lessons learnt and feedback from participants to develop a modified version of the intervention (ie, intervention manual version 2.0). This version will be provided to all waitlist control participants, and outcome differences between the two arms will be explored during analysis. As a result, the intervention will have gone through an iterative refinement process and will be ready for implementation in a larger randomised controlled trial by the end of the pilot study.

Clinical data collection

At consent, participants sign a medical release form, and research staff obtain medical records from participants’ respective medical clinics at baseline, 4 months and 8 months. Information collected includes appointment attendance, medications and laboratory data including plasma HIV RNA and CD4+ cell count. The data point closest to baseline, 4 months and 8 months ± 1 month are used for data analysis.

Assessment data collection

Participants complete assessment surveys at baseline, 4 months and 8 months after enrolment. The surveys collect demographic, technology use, substance use, mental health and HIV care information (see table 3). The baseline surveys are completed online in-person at the initial visit, and the other two are completed remotely on the participants’ mobile devices.

Qualitative data collection

A subset of approximately 20 participants who have finished the intervention will be invited to complete an audio-recorded telephone semistructured individual qualitative exit interview with study staff for a $30 payment. Participants will be chosen to reflect a range of levels of engagement and attendance using a question adapted from the Session Rating Scale27 to determine the level of satisfaction with each telehealth session. Using mean scores of participant satisfaction over 12 telehealth sessions and attendance, participants will be divided into four groups: (1) high attendance, high satisfaction; (2) high attendance, low satisfaction; (3) low attendance, high satisfaction; and (4) low attendance, low satisfaction. Five participants will be randomly selected from each category and interviewed. Participants will receive information and consent for the qualitative interviews during the initial visit, along with the consent for the rest of the study. The interviews will focus on the acceptability of the intervention and participant feedback on the intervention, and the interviews will be audio- recorded and transcribed verbatim.

Confidentiality and data protection

All screening and consenting will take place in a private room. Study staff will use a secure, encrypted texting platform for all study text communication. Participants will receive support from study staff who will demonstrate how to set up additional privacy measures using the settings on their personal mobile telephones. Electronic data will be gathered through HIPAA-compliant platforms, stored on a secure network and password protected. Subjects will be coded by numbers and with no names; linking information will be kept in locked files. The data will not be shared unless via a data use agreement including deidentified data. The study has obtained a Certificate of Confidentiality from the National Institutes of Health to protect the privacy of potential and enrolled study participants.

Data monitoring

A Data Monitoring Committee (DMC), interim analyses and stopping guidelines are not needed because the study is a pilot feasibility study that has been classified as minimal risk by the UCSF IRB.

Feasibility, acceptability and clinical outcomes

Preliminary data on feasibility, acceptability and HIV clinical outcomes will be gathered throughout the study (see tables 4 and 5). Acceptability of the telehealth intervention will be determined throughout the study using several methods. Study staff will administer two-session rating questions via text after each weekly telehealth session, asking if the participant ‘felt heard, understood and respected by the counsellor’ and if the ‘session was right’ for them. Additionally, a 30-item exit survey is administered through Qualtrics after the intervention is completed, including questions pertaining to (1) the overall rating of the study; (2) satisfaction with each study procedure; (3) ease or difficulty with each study procedures; (4) helpfulness of communication with study staff; (5) self-perception of improved ART adherence, mental health and substance use with study participation; (6) recommending a study similar to this to a friend; and (7) participating again in a similar study. Study staff will also conduct qualitative exit interviews with 20 participants to gather in-depth descriptions of participant experiences, perceptions and acceptability of the intervention. Clinical outcomes within the two study arms include HIV RNA, CD4+ cell count, self-reported adherence, appointment attendance, substance use (Drug Abuse Screening Test [DAST] and ASSIST) and mental health (PHQ-9 and PCL-5; see table 5).

Quantitative analysis plan

One-way frequency tables will be generated for all baseline and follow-up survey questions, and measures of central tendency and variability will be computed for continuous measures. Results from these analyses will quantify important sample characteristics and participant use of various telehealth modalities as well as proportions and means of the feasibility and acceptability measures. Primary preliminary outcome analyses will use linear mixed models to compare mean log10 HIV RNA across the intervention and control groups at 4 months relative to baseline. Secondary exploratory preliminary outcome analyses will use the same analytic methods to compare the 8-month time point within the intervention arm to baseline to examine whether the intervention had longer-term effects. A parallel exploratory analysis will compare waitlist controls at 4 months versus 8 months.

Additional secondary exploratory analyses will repeat this set of analyses on other secondary outcomes such as CD4+ cell count, HIV knowledge, self-reported adherence and appointment attendance, PHQ-9 and PCL-5 mental health measures, AUDIT alcohol use measure and the DAST substance use measure. Finally, all analyses described above will be repeatedly stratified by participant gender to explore whether there is any evidence of gender differences in effects. Due to the modest sample size and pilot focus of the study, significance testing will be de-emphasised in favour of performing inferential analyses as a feasibility check to ensure all measures and analysis protocols are in place for a larger formal efficacy trial.28 29

Qualitative analysis plan

Study staff will complete, audio- record and transcribe individual in-depth interviews with 20 YLWH following completion of the clinical intervention. The analytic team will identify broad themes from the interview transcripts, discuss and refine them and then enter them into a Microsoft Excel–based matrix with a column for each theme and a row for each case. One coder will initially identify patterns in the themes and code each interview to identify subthemes, and a second coder will double code a random subsample (n=5) of the interview codes within the matrix. Discrepancies in coding will be discussed by the team until a consensus is reached and interrater reliability will be calculated. A sequential mixed-method design will be used to integrate our quantitative and qualitative data analysis.

Dissemination plan

Study staff will work with the UCSF Centre for AIDS Prevention Studies’ Community Engagement Core and the Youth Advisory Board to disseminate results to the community and participants via presentations, community forums, email updates and/or social media. Study staff will conduct town hall presentations and publish findings in peer-reviewed journals to communicate results with healthcare professionals.