The ADAPT-ITT model [25] comprises 8 sequential phases. Phase 1, the assessment, was conducted in a previous study [17]. Phase 2, the decision, was conducted by the parent study [31]. This paper describes in detail from the third to the sixth phases of the model: phase 3 (adaptation), phase 4 (production), phase 5 (topical experts), and phase 6 (integration). Phase 7 (training) and phase 8 (testing) will be presented in future papers.

This phase involved needs assessment of people living with HIV on MMT for reduction in CMDs. The study conducted 28 in-depth interviews (IDIs) with people living with HIV who inject drugs (n=16, 57%), HIV and MMT providers (n=8, 29%), and health care providers (n=4, 14%) in private clinic rooms in Hanoi, Vietnam in May 2018.

Results of the study showed that both health care providers and people living with HIV who inject drugs believed that people living with HIV who inject drugs were particularly susceptible to CMDs, especially depression, and had a high need for mental health treatment. The study also recommended integrating mental health care into MMT clinics to increase mental health access to people living with HIV on MMT [17].

This phase involved reviewing evidence-informed CMD programs and deciding which EIP to select for the new target population. Few programs addressing CMDs for people living with HIV exist in low- and middle-income countries, which have limited mental health resources. One of the few evidence-informed CMD counseling programs is the “FB” model, which has extensive validation in low- and middle-income countries [19]. FB helped to reduce CMDs, which was the aim of this study. In addition, FB has also been adapted for people living with HIV in Zimbabwe and Malawi [15,20,21] and may be suitable for people living with HIV on MMT in Vietnam.

In phase 3, stakeholders including people living with HIV on MMT, their family members, and health care providers reviewed the original FB content and implementation methods to answer questions related to who, when, where, and how to deliver FB in Vietnam for appropriate implementation in MMT clinics. The study conducted IDIs with 12 people living with HIV on MMT, 5 family members and caretakers of the patients, and 4 clinic directors. In all, 2 focus group discussions (FGDs) were conducted with MMT health care providers (each group had 5 people).

Inclusion criteria for patients were being aged ≥18 years, willing to participate in the study, and having at least one of the symptoms: depression, anxiety, stress disorders as indicated by the Depression, Anxiety, and Stress Scale-21 items (DASS-21), consisting of 21 questions and 3 items measuring levels of the emotional states of depression, anxiety, and stress. The DASS-21 is based on a dimensional conception of depression, anxiety, and stress as part of the full human experience rather than the categorical approach of either having a disorder or not (as used in the Diagnostic and Statistical Manual of Mental Disorders or International Classification of Diseases) [32]. Although FB was initially tested using the SSQ-14 to screen for CMDs, this tool has not been validated in Vietnam. The DASS-21, however, has been validated in this setting. Originally developed by Lovibond [32] in Australia in 1983 and tested to screen for CMDs in the community, the DASS-21 has been translated and successfully validated for a variety of study participants in Vietnam, including adolescents [33], rural women [34], health care workers [35], and people living with HIV on MMT [17]. The DASS-21 is aligned with the SSQ-14 in terms of screening CMDs, including depression and anxiety disorders in the general population, but is distinguished by having a stress disorder scale. Thus, the study team chose the DASS-21 as a research tool, as it has the advantages of validity in this population, brevity, ease of implementation, and measurement of depression, anxiety disorder, and stress disorder relevant to the purpose of the study. The study will also use suicide risk assessment that was effectively used in the HPTN074 study for people living with HIV who inject drugs in Vietnam [36].

Inclusion CMDs scores were at least a moderate level in which depression subscale score was ≥14, anxiety subscale score was ≥10, and stress subscale score was ≥19. People who were aged <18 years, did not meet the DASS-21 moderate score, had cognitive impairments, or had suicidal thoughts (exclusion, therefore, included referral for standard clinical follow-up care) were excluded from the study. Patients who met the inclusion criteria were invited to participate in an IDI. Family members and caretakers were the patients’ parents, spouses, or main caretakers who already knew the patients’ HIV and MMT status and who were introduced by the patients. Only family members and caretakers who had patients’ consent to approach and who already knew the patients’ HIV and MMT status were invited for IDIs. The inclusion criteria for health care providers were having at least two years of counseling and clinical experience with people living with HIV and people who inject drugs.

IDI and FGD guides were developed in English in accordance with previous FB interviews and the objectives of this study. The interview guides were reviewed for linguistic and cultural appropriateness. The guides were translated into Vietnamese, discussed, and revised by the research team, who had knowledge and experience on the study topic and participants. The guides were piloted among 5 patients who met the study inclusion criteria but received treatment from another MMT clinic and did not participate in the study. The IDIs and FGDs were facilitated in Vietnamese by 2 interviewers who were trained in qualitative research methods and had extensive experience working with people living with HIV who inject drugs. Each IDI had an average duration of 50 (SD 18) minutes. The average FGD duration was 1.5 (SD 25) hours. All IDIs and FGDs were conducted in Vietnamese, audio recorded, and transcribed verbatim. The interview and FGD transcriptions were deidentified and translated into English. The analysis was conducted according to the applied thematic analysis approach [37]. Thematic analysis was performed using NVivo (version 12.0; QSR International). All qualitative research was guided by the consolidated criteria for reporting qualitative studies), a 32-item checklist [38]. In all, 4 study members with experience in qualitative data analysis were involved in the data analysis process. The list of parent and child codes was developed and agreed upon by the coders. Parent and child codes and definitions were created a priori and were derived from the interview guide and literature review. Furthermore, 20% of the transcripts were double coded. Intercoder reliability was assessed after all coders coded the first 2 transcripts. A total of 2 meetings were held among the coders to discuss the coding results item by item. The official coding process began after all 4 coders agreed on the coding method and procedure. The codebook was refined throughout the analysis process and the findings were presented, discussed, and agreed upon by the study team.

In all, 3 external content experts reviewed the phase 3 results. The original FB manual study procedures and content were modified according to expert comments. On the basis of the content experts’ review, the manual was tailored for use by both health care providers and lay counselors. In addition, the experts’ feedback informed the study team to include relevant matters regarding injecting drugs and HIV transmission in Vietnam. Finally, all the case studies were revised to make them suitable for participants in Vietnam.

We solicited and integrated input and feedback on the first draft of the adapted FB program from 2 investigators, 2 creators of FB, and 1 topical expert on behavioral programs for people living with HIV and SUD from Hanoi Medical University (HMU). This feedback informed the development of the next draft of the FB manual. Culturally, Vietnamese illustrations were designed to replace Zimbabwean illustrations and were added to the second manual draft in English. A total of 2 translators of the study team had experience with people living with HIV who inject drugs and mental health and were responsible for translating the second draft. The Vietnamese topical expert revised the translated draft to ensure conceptual equivalency. The team then revised the translation again and agreed on the second FB manual version.

Using the second adapted version, the creators of FB led a Training of Trainers session for 6 study team members in Vietnam and 3 people from HMU via a 5-day virtual training course. Trainers in Vietnam then provided in-person 5-day training for lay counselors and health care counselors in MMT clinics. The second draft was then piloted with 5 eligible patients to further refine the session content. The process culminated in a final version of the adapted FB manual that would be ready for formal evaluation in an RCT study (Table 1).

The study protocol is available at ClinicalTrials.gov (NCT04790201). The study protocol, interview guides, and informed consent forms were approved by the institutional review boards at University of North Carolina at Chapel Hill on August 24, 2020 (study 20-1689), and HMU on June 19, 2020 (decision 119 ĐHYHN). All the study participants provided written informed consent in Vietnamese.

The results of the qualitative research in phase 3 were presented in a web-based meeting with 2 investigators, 2 creators of FB, and 1 expert from HMU to reach a consensus on the necessary adaptation of the FB manual. The original FB was adapted for use by both health care providers and lay counselors in Vietnam. Table 3 describes the details of FB adaptation. Overall, the manual illustrations of counselors were changed from Zimbabwean to Vietnamese and included both sexes. The illustrations of case studies have also been redrawn. The title “Lay Health Workers” was changed to “Counselors” to suit both groups of health care counselors and lay counselors for the study in Vietnam. The training curriculum was shortened from 8 to 5 days, and the new training program was written in a web-based format. The preface cited additional information about HIV infection and substance use patterns in Vietnam and provided a brief introduction to the adaptation of the FB manual to the study in Vietnam.

We retained the content of 8 out of the 23 chapters in the original manual. The 8 chapters included PST, counseling skills, FB cards, emotions, stabilization, strong emotional reactions, men’s health-seeking behaviors, and self-care. We completely removed 6 of the 23 chapters, namely epilepsy, belief in supernatural powers, psychosis, home visits, group circle, and proverbs. We edited the contents in 8 of the 23 chapters. Key edits included using the words Common Mental Disorders to refer to a collective term of depression, anxiety, and stress-related disorders instead of “kufungisisa” (Zimbabwean for depression and anxiety), replacement of SSQ-14 to DASS-21, and suicide risk assessment and management procedures, which were used in the study in Vietnam. In addition, we excluded sessions on abuse of bronchodilators, alcohol and pregnancy, and information about antipsychotics, as they were not related to the study population. Information about the use of FB on tablets was removed, as the Vietnam FB program used paper forms to record counseling session information. Information on HIV transmission through injection, substance abuse disorders caused by injecting drugs, and amphetamine-type stimulants, which were common issues of people who inject drugs—the study population in the RCT—was added.

All cases were revised, and the PST case was rewritten. In the original FB, the PST case featured a common problem in the Zimbabwe community, and the main character was a person with an unknown HIV status, a person with SUD, or a woman experiencing domestic violence. The new character in the adaptation was people living with HIV who inject drugs with short-term, solvable problems about employment, family matters, finances, and relationships with neighbors.

The first English version was sent to 2 investigators, 2 creators of FB, and 1 expert from HMU for viewing and editing. All of them are associate professors with intensive expertise in the areas of mental health, HIV or AIDS, and substance use. They have led clinical studies and trials on a global scale. Experts advised correcting cases of PST to adjust them to Vietnamese culture. They recommended not changing the in-person counseling procedures and having up to 6 individual counseling sessions for each patient. An FB creator wrote scripts for the counselors to be included in the draft. The creator also advised maintaining the PST structure, with 4 main parts in each counseling session. The 4 main parts were the following: open your mind, make a list of problems, plan to solve the problem according to the Specific, Measurable, Achievable, Realistic, and Timely method, and encourage the clients to implement the plan. The 4 main parts of the PST were implemented into 7 small steps: (1) How does the client deal with problems? (2) How to recognize a problem? (3) How to select a problem, find the goal, and define the problem? (4) How to brainstorm for solutions? (5) How to select a solution? (6) How to make a Specific, Measurable, Achievable, Realistic, and Timely action plan? and (7) Did it work?

On October 20, 2021, a meeting was held on the web with 3 content experts, the study team in Vietnam, and 2 investigators. The investigators agreed on continuing to revise the case example of a typical people who inject drugs who encounters common mental problems in their life. These problems should be specific, simple, and solvable within 1 week. For example, “I want to quit using drugs for the next 1 year because next week is my son’s birthday.” The study team agreed to remove the group discussion portion, as it would be ineffective where MMT clinics are far from each other, without finding additional study resources. The study team then synthesized the expert revision to create the second draft in English. Illustrations of Vietnamese people were added to the second English version to make the third version which was sent to 3 content experts and 2 investigators to review and finalize. The third English version was translated into Vietnamese with the same content and images. A Vietnamese topical expert reviewed the translated third version to ensure conceptual equivalency.

This study successfully illustrates the process of operationalizing the ADAPT-ITT framework to adapt to a mental health program in Vietnam. The outcome of this study was an adapted FB manual to be used for training and piloting to create the final program manual.

We note that our study departs from the standard ADAPT-ITT framework by selecting an EIP that does not come from the CDC database of EIPs [26] and by adapting a program addressing CMDs rather than HIV prevention per the usual ADAPT-ITT goals [25]. Nevertheless, our study was methodologically aligned with the ADAPT-ITT goals, as we chose a proven, effective program for adaptation. FB improved CMDs among people living with HIV in Zimbabwe and Malawi, and we hope to use FB to address CMDs among people living with HIV on MMT in Vietnam.

The application of the ADAPT-ITT framework for the systematic adaptation of EIP can vary depending on the program, population, and resources [28,30,39]. A key strength of this study is that it used a linear approach to adapt the ADAPT-ITT framework on a small scale [28]. Results of the previous phases provided informative contributions for the next phase [40] in terms of the program procedures and content of the program manual. Other study and adaptation strengths were the translation into Vietnamese and the creation of local illustrations to increase the clarity of the concepts while maintaining the original meaning of the English version.

The results from phase 3 informed the program procedures built upon the existing resources and administrative strength of MMT clinics [40]. As a result of adaptation, the study will choose health care providers and people living with HIV or community members who are trusted by the study participants to work as study counselors. The counselors will be trained and managed closely to ensure the quality of counseling. The counseling locations must be private and safe in MMT clinics. Counseling appointments will be scheduled between counselors and patients in parallel. Standardized criteria of counselors to deliver the program are defined as being understanding and having the trust of the patients but not necessarily having a high level of counseling techniques before training. Instead of using tools and procedures in the original FB program, the study will use questionnaires and protocols relevant to the study participants.

Regarding the content of the manual, the ADAPT-ITT framework guided the appropriate adaptation of the program while maintaining the core components of the PST of the original program throughout the counseling techniques in all program sessions [25,26]. The strength of our adaptation process was that the PST of the original FB fits the goals of reducing CMDs for people living with HIV on MMT in Vietnam; therefore, we did not have to change PST counseling as well as other chapters mentioning CMDs, HIV, and SUD in the original program that address common problems that global and Vietnamese people living with HIV and people who inject drugs encounter [41,42]. Feedback from topical experts informed the study team to alter some contents of the original program to ensure that it was suitable for Vietnamese people living with HIV on MMT and in MMT settings [27,40]. Specifically, unlike the original program conducted in Zimbabwe, we cut content that is not common in Vietnamese culture such as a church, beliefs in supernatural power, and praying together. The study also changed the illustrations from Zimbabwean to Vietnamese. Information from a qualitative study in phase 3 about common health problems faced by people living with HIV on MMT (the results are not reported within the scope of this paper) helped the study team rewrite sample PST cases to reflect typical problems in the key population. In addition, because of the new study with people living with HIV on MMT in Vietnam, we added additional guidelines on HIV, injecting drugs, and SUD to the original program to make it more culturally relevant and relevant to the study population. As recommended by topical experts, we dropped group activities that were proven more adaptive to the Zimbabwean setting and chapters less relevant to the target population (fatherhood, alcohol and pregnancy, epilepsy, and psychosis).

This study has some limitations, the first being that the process of adaptation and production has not yet tested the feasibility and acceptability of the adapted manual. In addition, the semistructured interviews had not presented the original manual to the study participants. Therefore, we did not have comments from them on the content of the manual. Instead, the content of the manual was reviewed and revised in detail according to the study team’s revisions and experts’ comments. There might be challenges such as following the structure of FB counseling sessions, applying relevant counseling skills required in FB, following PST methods for health care, and lay counselors using the adapted manual as a resource material in conducting PST counseling sessions as they first work with this approach. As such, the adapted manual will be used to train counselors and piloted with the study participants of the future RCT to receive feedback to finalize the manual. Study participants and counselors can provide their feedback during the pilot phase. Future RCTs will test the acceptability and fidelity of the finalized adapted program.

This initial exploratory study demonstrates a successful process of following the ADAPT-ITT to adapt a proven mental health program for people living with HIV on MMT in Vietnam. This study selected and culturally adapted an evidence-informed PST program to improve CMDs among people living with HIV on MMT in Vietnam. The adaptation of the program through qualitative interviews and discussions with stakeholders and study participants and the use of feedback to tailor the program procedures allowed us to identify and preemptively address potential barriers to implementation. The production, integration, and expert input phases were used to tailor the manual to reflect typical manageable problems that people living with HIV on MMT encounter daily. If the adapted FB manual is acceptable and feasible, it may be used in MMT clinics in Vietnam to reduce CMDs for patients on MMT, which would contribute to the effectiveness of drug treatment and ART.