Motivational Interviewing as an Intervention to Improve Antiretroviral Treatment Initiation Among People who Inject Drugs (PWID): A Pilot Study in Jakarta and Bandung, Indonesia

Introduction: Progress towards the 95-95-95 target among People Who Inject Drugs (PWID) with Human Immunodeficiency Virus (HIV) infection was considerably low. A behavioral approach, such as motivational interviewing (MI), has been recognized as an effective strategy for improving HIV treatment outcomes among PWID. Objective: This study aimed at assessing the impact of MI counselling to improve ARV initiation among HIV-positive PWID. Methods: A cohort design pilot study was performed, and participants were recruited using a convenience sampling technique. Participants were PWID with HIV who accessed healthcare facilities in two Indonesian cities. Selected participants were assigned to an intervention group and a control group. The intervention group followed MI counselling, while the control group received ART following the standard of care. The participants were assigned to each group based on their preferences. The data was collected between January 2018 and January 2019. Results: In total, 115 PWID with HIV participated in this study in the intervention (n = 30) and control (n = 85) groups. All but one intervention group's participants started ART, while 68/85 in the control group did so. Receiving MI counselling significantly contributed to ART initiation. In addition, the participants were followed-up until 12 months after ARV initiation. During this period, we found that similar proportions of participants in both groups discontinued the treatment, and only a small number achieved HIV viral suppression. Conclusion: The positive effect of MI counselling on ART initiation provides insight into the possibility of its wider implementation. Further studies are needed to gain a deeper understanding of MI counselling and its effect on other outcomes of the HIV treatment cascade.


Introduction
Background/rationale 2 Explain the scientific background and rationale for the investigation being reported 1-2 In Indonesia, the proportion of PWID who initiated and retained in ART was even lower than that of other key populations (men who have sex with men, female sex workers, transgenders).
Studies showed positive effects of MI counselling, which was better than various types of health education program and the standard of care, on HIV treatment adherence among PLWH from various background.
Objectives 3 State specific objectives, including any prespecified hypotheses We undertook a prospective cohort study in Bandung and Jakarta Indonesia, to assess the impact of counselling using the MI approach to improve ART initiation among HIV-positive PWID.
We hypothesized that MI counselling, compared to standard of care, would improve the likelihood of PWID with HIV to initiate ART.

Study design 4
Present key elements of study design early in the paper This was a pilot study using a cohort design and a convenience sampling technique to recruit the participants.
Setting 5 Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection The participants were recruited from 14 study sites in Bandung and Jakarta.Among them, four were chosen as the intervention sites because they had the highest number of PWID with HIV patients during the observational phase of the study.Eligible patients in the intervention sites were given information about the HATI study and offered to participate by receiving MI counselling.They were to attend a minimum of four and a maximum of 10 counselling sessions over 12 months, and all sessions were recorded.The data was collected between January 2018 and January 2019.
Participants 6 (a) Cohort study-Give the eligibility criteria, and the sources and methods of selection of participants.Describe methods of follow-up.The eligibility criteria for inclusion were PWID with HIV aged 16 years or older who accessed the HIV clinic of the above-mentioned facilities and had never started ART (naïve) or had initiated it but then stopped (previously treated).The participants were recruited from 14 study sites in Bandung and Jakarta.Eligible patients in the intervention sites were given information about the HATI study and offered to participate by receiving MI counselling.
Those who agreed to participate had MI procedure explained.Participants were required to provide written consent to enrol in the study and follow the counselling.The control group consisted of the HATI study participants recruited from the nonintervention sites in Jakarta and Bandung during the observational cohort phase.
(b) Cohort study-For matched studies, give matching criteria and number of exposed and unexposed

2-3
The eligibility criteria for inclusion were PWID with HIV aged 16 years or older who accessed the HIV clinic of the above-mentioned facilities and had never started ART (naïve) or had initiated it but then stopped (previously treated).Those who agreed to participate had MI procedure explained.The control group consisted of the HATI study participants recruited from the nonintervention sites in Jakarta and Bandung during the observational cohort phase.
In total 30 and 85 participants recruited from the intervention and the control sites, respectively.

Variables 7
Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers.visually, and cox regression was used for formal comparisons.Cox regression was also performed to determine predictors of ART initiation (the participation in the MI counselling, HIV stage and ART status at recruitment, and demographic characteristics).The same methods were also used for failure to remain in treatment and to evaluate its predictors.In addition, logistic regression analysis was performed to determine variables that contribute to VL suppressions.The predictors were participation in the MI counselling, and HIV stage and art status at recruitment.Why (2) Motivational Interviewing (MI) is a client-centred approach that strengthens clients' motivation and commitment to change their behaviour.The counsellors will guide the clients toward change, but the clients are the centre of the intervention, the clients are encouraged and empowered to share their barriers of doing something and therefore to find solutions and make a decision for their situations.Since it is simple and brief, the MI counselling can be integrated in healthcare facilities.
In Jakarta & Bandung, the MI counselling was implemented as an intervention to support People Who Inject Drugs (PWID) in complying with HIV treatment.

What (Materials) (3)
The MI intervention was delivered following a module that has been developed for this research study.The module was divided into two parts.
Part 1: for clients in early stages of change (pre-contemplation, contemplation, and preparation).
This part described the five MI principles: Express empathy through reflective listening.
Develop discrepancy between clients' goals or values and their current behavior.
Avoid argument and direct confrontation.
Adjust to client resistance rather than opposing it directly.
Support self-efficacy and optimism.
Topics were delivered in several sections, as follows: Section 1: Understanding the stages of change: pre-contemplation, contemplation, preparation.
Section 2: Medication adherence and risk behaviours.
Section 3: Psychological impacts of non-adherence to antiretroviral treatment.
Section 4: Psychological impacts of substance use and methadone.
Section 5: Improving the treatment adherence and developing alternative behaviours to reach this goal.
Section 6: Expressing concern about the treatment adherence.
Section 7: Understanding personal values.
Section 8: Ambivalence about behaviour changes.
Section 9: Relationship with others and the environment.
For all participants, the first MI session started with the section 1 of the MI module Part 1.Other topics would depend on the results of the baseline measurement and the participants' ART status.At the beginning of every session following the first one, the client's psychological condition (depression, anxiety, stress), social support, and HIV knowledge were re-assessed to determine the section that needed to be provided.

Pre ARV treatment initiation
The MI counselling started with Part 1 of the module: Section 1 (Understanding the Stages of Change: pre-contemplation, contemplation, preparation), Section 2 (Medication Adherence and Risk Behaviours), Section 6 (Expression Concern about ART Adherence), and Section 10 (Social Responsibility).These sections were repeated as needed until the clients initiated the ART.There was no requirement concerning the number of the MI sessions to deliver such sections.However, if after repeating them for several times the client did not start the ART, the health worker discussed with the psychologist and the research team to consider the appropriateness of the MI counselling for the particular client.
The clients under this category included: The clients who were ARV treatment naïve: The newly diagnosed clients: during the post HIV test counselling they were offered to participate in the current study to receive the MI counselling.
The clients who were previously diagnosed but have never initiated ART.
The clients who previously lost to follow up after ART initiation and currently re-engaged with care.
For these clients, the MI counselling aimed at providing information about the importance of ART.Those who were newly diagnosed also were helped to accept the HIV test result.
Using the MI counselling, those who previously lost to follow up after ART initiation were encouraged to re-initiate the treatment.Their self-efficacy in complying with ART were assessed (using the HIV ASES questionnaire).Those who had a low score, meaning low self-efficacy, were given the topics from Part 1 of the MI module, namely Expression concern about ART adherence (section 6), Understanding personal values (section 7), Ambivalence about behaviour changes (section 8).

ART Initiation
The clients under this category were those who were currently on ART, including those who were already established on ART when they were recruited and recent initiators (who initiated ART during the MI intervention).For such clients, the MI counselling focused on emphasizing the information related to the ART adherence and assisting them to create a plan concerning the adherence.
Those who were already established on ART when they were recruited filled in the DASS-21, the SSNQ, and the HIV knowledge questionnaire.The MI counselling were given following the same rules as mentioned above.However, the sections were repeated until the participants reach better results of each measurement.
The treatment adherence of all clients who were on ART was assessed using a self-report questionnaire.If they did not take ART for two days or more, then the counselling was delivered following the section 3 (Psychological impacts of nonadherence to antiretroviral treatment), section 4 (Psychological impacts of substance use and methadone), section 5 (Improving the treatment adherence and developing alternative behaviours to reach this goal), and section 12 (Problem Solving) of the MI module Part 1 and the section 1 (Understanding the stages of change: Action, Maintenance) of the MI module Part 2. In addition, their self-efficacy in complying with ART was also assessed using the HIV ASES questionnaire.Those who had a low score received the MI counselling based on the MI module Part one: section 6 (Expression concern about ART adherence), section 7 (Understanding personal values), section 8A (Ambivalence about behaviour changes), section 11 (Selfconfidence in & high-risk situations for the treatment adherence), and section 13 (Goal Setting and Planning).

ART Maintenance
This category was for the clients who were already established on ART and in the level of change of maintenance.It means that they scored high on the HIV ASES and the self-report adherence (0 to 1 missed dose day).Therefore, in the MI counselling both parts of the module were given, in particular section 14 of Part 1 (Review & Termination), section 2 (Identifying issues related to medication adherence) and section 11 (Future Planning) of Part 2.
Who Provided (5) The health workers provided the MI counselling.They were medical doctors, nurses, and counsellors, who worked at the HIV/AIDS or harm reduction clinic of the intervention sites.They were appointed by the head of each site to participate in the current study.Most of them received other counselling skill trainings (e.g.basic and HIV counselling skills) before participating in the current study and have been doing counselling as part of their clinical work.
All health workers were required to follow the Two-day intensive group training and in-house trainings prior to the initiation of the MI intervention.In delivering the MI counselling, the health workers were supervised and assessed by the appointed psychologists.Monthly monitoring & evaluation and case conference were performed in each intervention city throughout the -The HIV Adherence Self-Efficacy Scale measures the client's level of efficacy in complying with ART, a higher score infers that the client has the ability to comply with ART -The Social Support Network Questionnaire assess the social support network available for the client -The HIV knowledge questionnaire evaluates the client's knowledge about HIV and ART, a higher score means that the client has more knowledge about HIV and ART -The Self-report Adherence form measures the client's level of adherence to ART, a higher score reflects a higher adherence level -The pill count form is used to document the number of left-over pills during each visit, this data is also used to determine the client's level of adherence (the more the left-over pills, the less adhere is the client to ART) -The counselling notes were used to document the counselling process, including the client's current stage of changes Supplementary Table 3

Education Group
Lower education (junior high school and above) 11 37.9 1 1 Higher education (high school and above) 32 37.2 1.0 0.5 1.9 0.9 1.1 0.5 2.3 0.9 (b) Describe any methods used to examine subgroups and interactions NCohort study-If applicable, explain how loss to follow-up was addressed 3 Report numbers of individuals at each stage of study-eg numbers potentially eligible, examined for eligibility, confirmed eligible, included in the study, completing follow-up, and analysed 3 In total 30 and 85 participants recruited from the intervention and the control sites, respectively.(b) Give reasons for non-participation at each stage characteristics of study participants (eg demographic, clinical, social) and information on exposures and potential confounders

Table 2 . Template for Intervention Description and Replication (TIDIeR) MI Intervention.
An Explanation and Elaboration article discusses each checklist item and gives methodological background and published examples of transparent reporting.The STROBE checklist is best used in conjunction with this article (freely available on the Web sites of PLoS Medicine at http://www.plosmedicine.org/,Annals of Internal Medicine at http://www.annals.org/,and Epidemiology at http://www.epidem.com/).Information on the STROBE Initiative is available at www.strobestatement.org. Note: