Buddhist Understanding and Reduction of Myanmar Experiences of HIV Stigma and Exclusion
Phase: NA
Conditions: Hiv, Stigma, Social, Mindfulness
Sponsor: University of California, Los Angeles

 
 
 
Buddhist Understanding and Reduction of Myanmar Experiences of HIV Stigma and Exclusion 
(BURMESE) 
NCT05126225 
 
Study Protocol including Statistical Analysis Plan 
Document date: 7/15/2022 
 
 
 
 

 
3.5 APPROACH 
3.5.1 Setting: The local hospital of the Community Hospital Sanpatong District (CHSD), situated in Sanpatong 
district, ChiangMai province, Thailand, will be the study recruitment site. The CHSD is one of the most 
accessed public hospitals in northern Thailand and is considered the premier hospital for HIV/AIDS treatment 
at the community level. The CHSD hosts clinical trial research staff for HIV medication trials and for other HIV-
related social and behavioral research. It has initiated task-shifting HIV service from primary healthcare 
physicians to trained nurses. There are more than 5,000 individuals living with HIV currently under care at 
CHSD and 80% of them are currently receiving antiretroviral therapy (ART). The Community Advisory Board 
(CAB) and Scientific Advisory Board (SAB) will regularly review the progress of the clinical trial. Both the CAB 
and SAB members will receive a small honorarium for their participation.    
 
3.5.2 Recruitment: Potential PLWH participants will be identified with assistance from the healthcare providers 
(HCP) at Sanpatong Hospital. The HCP will identify potential participants from among clients visiting their HIV 
clinics. An information sheet explaining the study will be disseminated to all PLWH clients who meet the 
eligibility criteria. PLWH clients will be approached by a healthcare provider to determine their interest in the 
study. If a client is interested, the HCP will refer them to the project staff, who will describe the purpose and 
procedures of the study to them. Consenting participants will be asked to complete their interviews at 
Sanpatong Hospital after their appointment with their providers or at another convenient time. The focus group 
participants with stakeholders will be identified and invited by the site study team with assistance from the 
administrators of Sanpatong Hospital and the local public health office. When at least 5 members are found for 
each group, our research staff will then schedule the time and place for when each group will meet. All 
potential participants for both phases of the study will be reassured that their participation is completely 
voluntary. Upon completion of study activities, all participants will be compensated for their time. All potential 
participants will be reassured that their participation is completely voluntary. Upon completion of study 
activities, all participants will be compensated for their time. 
 
3.5.3 Inclusion and Exclusion Criteria: We will recruit Thai PLWH who are interested in participating in this 
study with the following inclusion and exclusion criteria. Inclusion criteria: Participants must (a) be at least 18 
years of age, (b) be self-identifying as PLWH, (c) be able to give informed consent to the study, and (e) be 
physically well enough to attend counseling sessions and follow-up visits. For focus group participants, they 
will need to (a) serving to PLWH population, and (b) willing to share their experiences with study team 
personnel. Exclusion criteria: Participants who (a) have a significant condition, such as neurological or 
cardiovascular diseases, that prevents them from fully participating the study, or (b) are unable to 
communicate.  
 
3.5.4 Procedures to Address Research Aims  
3.5.4.1 Aim 1: We aim to conduct in-depth interviews with 30 Thai PLWH and two focus group (n=12) 
with stakeholders to inform our adaptation of an evidence-based intervention for family-informed self-
management. In order to collect sufficiently diverse experiences of HIV stigma, we aim to recruit 10 women, 
15 men, and 5 transgender individuals. Among the men, at least 8 will be MSM. Among the 30 PLWH, at least 
8 will be sex workers, and 8 of them will be substance users. Gender, sexuality, and substance use may 
overlap and intersect with each other. For two focus groups of stakeholders, we aim to recruit healthcare 
providers (n=6), peer support/community leaders (n=4), family members and friends (n=2), if necessary. Two 
Thai-speaking researchers will conduct individual qualitative interviews in secure environments at the site 
offices or another participant-chosen location. Interviews will be audio-recorded with consent; however, no 
identifying information will be collected. The researchers will follow a semi-structured interview guide to 
understand participants’ complex lived experiences with HIV stigma, including: (a) how they experience and 
feel about their lives with HIV, (b) how they experience, understand, and interpret HIV stigma, and (c) how they 
reduce their HIV stigma, all in the context of Buddhist-Thai culture. Questions will include: How have you 
experienced changes in your life following your HIV diagnosis? How have you experienced negative events in 
your social relationships in relation to your HIV status, if so, what was that like? Have the events changed you 
regarding how you see yourself, your relationships, and the nature of human experience? What did you do to 
manage the negative events, as well as your responses? How might Buddhist teaching have influenced your 
thinking and feelings about your HIV status and negative events you have experienced? How do you think that 

being a woman/gender and sexual minority/substance user may have influenced your experience of HIV and 
those negative events?    
To explore how community stakeholders perceive the stigma PLWH may have experienced, two 
researchers will facilitate the focus group discussions via face-to-face or Zoom meeting, considering the 
current pandemic, with participants recruited from Sanpatong Hospital. The focus groups will follow a flexible 
discussion guide that allows the researchers to understand participants’ personal experiences or observations 
of the PLWH’s stigma. The focus groups will further solicit their opinions about how healthcare services could 
help PLWH to better respond to the challenges they face.  
Questions will include: How long have you worked with the Sanpatong Hospital? Please describe your 
observations about the stigma that PLWH faced due to their serostatus? What are the needs of PLWH due to 
these unfair treatments? What challenges has you faced in trying to meet the needs of PLWH? How have the 
hospital staff assisted the PLWH currently? How have the services managed the stigma experienced by the 
PLWH? What else can be done to better meet the needs of PLWH? 
 
3.5.4.1.1 Analysis of Qualitative Data 
We will use the Interpretive Description qualitative analysis approach,127-129 guided by our working 
conceptual model, to analyze 30 in-depth interviews with Thai PLWH and 2 focus groups with 
stakeholders. We will apply procedures successfully employed in our previous mixed-method projects in 
which we collected and analyzed qualitative data to identify HIV stigma experiences among Myanmar PLWH. 
The notes and audio-recordings will be transcribed verbatim in Thai. We also follow the recommendations by 
Squires on cross-language qualitative studies.130 The first 10 transcriptions will be translated into English for 
analysis. These transcripts will be independently translated by two individuals to confirm accuracy. Two 
English-speaking researchers and two Thai-speaking researchers will independently review and carefully read 
the transcriptions to identify and code salient concepts and categorize them into more abstract themes, with 
the goal of developing a coding schema.131 Then the four researchers will meet to discuss their codes and 
corresponding meanings and compare their coding schemas. The researchers will resolve any discrepancies 
in their interpretation of the transcriptions and their organization of concepts through prolonged discussion. 
After reaching consensus on the coding schema, the two Thai-speaking researchers will finish coding the 
remaining transcriptions from in-depth interviews. To revise the model using qualitative data, we will map the 
results of this bottom-up coding approach onto our conceptual model and identify potential discrepancies 
between the data and the model. In places where the model significantly departs from the data, we will revise 
the model to accommodate additional constructs emerging from the lived experiences of Thai PLWH. Because 
our working conceptual model includes general HIV stigma and cultural factors that impact Thai PLWH, we will 
specifically identify both unique and common HIV stigma due to the intersecting minority identities in the local 
Buddhist-Thai culture, namely women, MSM, transgender, sex workers, and substance users, through 
constantly comparing the HIV stigma they have faced as well as their cultural meaning they assign to stigma 
across different groups. We will use the commercial software package Atlas.ti 8 to manage the analytic 
processing of qualitative data.132 Finally, to assess the credibility of the data and trustworthiness of the 
findings,133-135 we will present the summary and interpretations of the qualitative data analysis and revised 
conceptual model to the CAB and SAB for input.  
 
3.5.4.1.2 Cultural Adaptation of the Stigma Reduction Intervention Using the Revised Model 
To culturally adapt the intervention developed by the PI and colleagues, we will apply a modified 
ADAPT-ITT model. The original ADAPT-ITT has eight sequential steps,136-138 including assessment, decisions, 
adaptation, production, topic experts, integration, training, and testing. In our modified approach, the first two 
steps (assessing the needs of the target populations and making decisions about which interventions should 
be selected for adaptation) will be skipped as the tasks in these two steps will be completed before adaptation. 
Therefore, we will focus on the next five steps of adaptation as summarized in Table 2 below (the titles 
represent the steps), while leaving the last step of adaptation, testing, to Aim 2 of the study.  
 
Table 2: Activities in the Cultural Adaptation of the Intervention for Stigma Reduction 
Adaptation: In the original ADAPT-ITT model, the evidence-based intervention is presented to groups of PLWH in theatrical formats 
to gather information about which components should be changed to fit the local culture. In our modified approach, however, we will 
use our revised conceptual model from AIM 1 to guide our initial adaptation. During the adaptation, we will identify the 
theoretical constructs that are in the revised conceptual model but are inconsistent with the original intervention. We will create 
additional intervention components to be included in the treatment, in particular those inspired by the HIV stigma process among 
Thai PLWH in the context of Buddhist-Thai cultural beliefs and practices. For example, how sexuality and substances associated 

with HIV are perceived and discussed in the local community, as well as how they impact familial relationships. After the initial 
adaptation, the first draft of the adapted intervention will be presented to stakeholders, Thai PLWH and if needed, their family 
members and friends. All the discussion sessions will be audiotaped. The participating stakeholders will also fill out a brief survey 
containing closed- and open-ended questions regarding the cultural appropriateness of intervention components. 
Production: The data collected from the adaptation procedure will be further used to guide the production of the second draft of the 
intervention. In this step, an adaptation plan will be created in which all the information will be considered simultaneously and 
evaluated on the basis of its theoretical and therapeutic importance. In this step, we will seek to achieve a balance among fidelity 
to the core elements and internal logic of the original intervention, the revised conceptual model of family-informed self-
management among Thai PLWH, and the results of the focus groups. The core elements refer to the features of the original 
intervention that are thought to be responsible for its effectiveness. The product is the second draft of the adapted intervention.  
Topic Experts: The second draft of the intervention will be sent to selected topic experts for review. These topic experts include the 
local healthcare and psychosocial service providers identified by the Sanpatong Hospital staff members and the research team. 
These experts may include, but are not limited to, physicians, nurses, social workers, and other scholars with the required expertise 
in HIV care, who are also familiar with the local Buddhist-Thai cultural practices. Written and oral feedback will be solicited from 
these experts. The experts will, in particular, focus on validating the cultural appropriateness of the intervention and resolving 
potential conflicts among the core components of the original intervention, the revised affective processing model, and results of 
focus groups.  
Integration: Feedback from the topic experts will be further integrated to generate the third draft of the intervention.  
Training: After the completion of the third draft of the intervention, the PI (Dr. Chen), a Co-I (Dr. Shiu), and a clinical psychologist 
(Dr. Yang) will host a week-long training workshop on site. The purpose of this workshop is to train staff at Sanpatong Hospital to be 
interventionists for the project. The workshop will review fundamental behavioral intervention skills as well as the content of the 
adapted intervention. Role-play and other instructional methods will be used to develop the skills and mastery necessary to 
successfully deliver the intervention. The study team will also train research administrative staff to support the operation of the study.   
Testing: We will test the feasibility, acceptability, and preliminary efficacy of the adapted intervention in Aim 2. 
 
3.5.4.2 Aim 2: To test the feasibility, acceptability, and preliminary efficacy of the adapted intervention 
for stigma reduction, we will employ a randomized-controlled design in which we will randomize 80 
Thai PLWH to two groups and follow them for 10 weeks.  
 
3.5.4.2.1 Treatment group assignment: We propose to recruit 80 Thai PLWH who will be randomly assigned to 
either the Enhanced Treatment group (ET; N=40) or the Treatment-as-Usual group (TAU; N=40). While the ET 
group participants will receive the 
proposed stigma reduction 
intervention, the TAU group 
participants will receive typical 
services available in the 
Sanpatong Hospital that are also 
available to the participants in the 
ET group, including care co-ordination and linkage to public health nurses in local communities. Using a 
computer program, we will generate a list of random numbers to assign participants to either group. Numbered 
envelopes indicating condition assignment will be prepared and sealed. However, to ensure equivalence of 
gender/sexuality/substance use composition between study arms, we will stratify the sample and randomize 
each gender/sexuality/substance use category separately, so that each arm will consist of 40 participants with 
balanced gender/sexuality/substance use compositions. This balanced composition between groups will 
guarantee sufficient sample sizes for key subpopulations and, hence, enable subsequent analyses for possible 
heterogeneity of treatment effects. See Table 3 for the sample allocation for both the ET and TAU groups. 
Study staff will not be aware of the assignment until the envelope is opened and the baseline survey has been 
performed.  
 
3.5.4.2.2 Implementation: The stigma reduction intervention will consist of four group counseling 
sessions delivered by trained interventionists. In each session, a designated interventionist will meet with 
participants for 120 minutes in a designated room at the Sanpatong Hospital. To help build rapport among the 
group members, we will host, in total, 5 groups, including 1 group for cisgender straight men who are non-
substance users (n = 8), 1 group for cisgender straight women who are non-substance users (n = 8), 1 group 
for MSM who are non-substance users (n = 10), 1 group for transgender individuals who are non-substance 
Table 3: Sample Allocation for ET and TAU Groups (# in ET/ # in TAU) 
Cisgender 
Straight Men 
Cisgender 
Straight Women 
MSM 
Transgender 
Substance User 
8/8 
8/8 
10/10 
5/5 
9/9 

users (n = 5), and 1 group for substance users (n = 9). The interventionist will follow the intervention manual to 
deliver the intervention and assign homework for group members to practice on their own. In the following 
sessions, the interventionist will review progress with participants, guide participants through exercises, and 
identify additional problems to be addressed in subsequent sessions.  
 
3.5.4.2.3 Fidelity check: To ensure intervention fidelity, all the intervention sessions will be audio-recorded and 
interventionists’ progress notes will be reviewed for supervision purposes; in addition, subsequent analysis of 
interventionists’ reliability will be conducted. At the end of each month, the Thai-speaking researchers and the 
team will randomly select and review 20% of the recordings and progress notes throughout the study period. 
The research staff will host biweekly supervision sessions for the interventionists to discuss difficult cases, 
including their intervention decisions. Finally, the PIs (Dr. Chen and Shiu) will travel to the study site at least 
twice a year to provide oversight to the research personnel. The PIs will also be available daily through online 
communication with the research personnel for immediate troubleshooting to ensure smooth research 
operations. Drs. Chen, Detels, and Shiu will meet regularly and frequently online to review progress, solve 
emerging issues during project operations, and revise the plans for action.  
 
3.5.4.2.4 To minimize attrition, we will implement specific procedures beginning at baseline. The procedures, 
which we successfully employed in prior projects, include verifying contact information at each assessment, 
obtaining any potential upcoming changes in addresses every month, using potential friend and family locators, 
collecting email addresses, and sending cards when approaching follow-up dates. Based on our prior 
experiences, we expect that attrition will be lower than 15% with application of these procedures. Therefore, 
we aim to recruit 80/(1-0.15) = 94 participants at our baseline, which after attrition may result in a sample of 80 
for analysis. 
 
3.5.4.2.5 Measurement plans: As in our ongoing studies, structured instruments (see Table 4) will be used to 
assess Thai PLWH regarding their demographics, key clinical characteristics, and psychosocial factors 
addressed in the intervention, including stigma, attribution styles, physical and emotional arousals, karma 
beliefs, insights on sufferings, mindfulness, compassion, social support, and care engagement. The 
psychometric properties have been established for most of the instruments among Asian populations, in 
particular, in our ongoing R21 project. The survey will be available in the Thai language. The survey will have 
250 items in total; however, there are multiple skip patterns. Depending on the responses of Thai PLWH, the 
survey may have as few as 160 items. These self-report measures will be conducted via Audio Computer-
Assisted Self-Interview (ACASI) and will typically be completed within 30-40 minutes. Use of ACASI lessens 
the likelihood of socially desirable answers and minimizes data entry errors. Similar ACASI survey programs 
have proven successful in studies of participants with little or no prior computer experience in Asian 
populations.139 Regarding care engagement measures, many studies have used single items to measure ART 
adherence, for example, gathering categorical data (yes or no) to measure whether patients achieved 95% 
adherence. However, in this project, we will create a latent variable for all these items to further control 
potential measurement errors.106,140-142 Viral load (VL) also be collected as an objective measure for 
adherence. The research staff in charge of data collection will be completely blind to treatment assignments of 
participants. Please note, our primary outcome is internal stigma, while our secondary outcomes are the 
indicators for care engagement, including self-reported adherence, viral load, self-reported patient 
engagement, and clinic visits.  
Table 4: Measuring Instruments 
Instrument 
Items 
Instrument description 
Cronbach 
α 
Demographic
s and clinical 
outcomes 
15 
Participants are asked about their age, gender, race, ethnicity, education, income, health 
insurance, possible HIV transmission route, when they first learned of their HIV diagnosis, 
opportunistic infections and ART-taking status, morbidity, VL, and current CD4.  
 
Universal Cognitive-Behavioral components of HIV Stigma 
HIV stigma 
(external and 
internal) 
10 
 
 
 
 
16 
The HIV-serostatus subscale of the Multiple Discrimination Scale30 will be used to measure 
external HIV stigma. Participants will report whether they experienced 10 different 
discrimination events in the past year for each of the three discrimination types, including 
violence, institutional discrimination, and interpersonal discrimination (Yes: 1, and No:0). A 
summary score will sum across the 10 items. The personalized stigma and negative image 
subscales of the HIV Stigma Scale31,32,100 will be used to measure internal stigma, The scales 
ask participants to rank to what extent they agree with 16 statements about HIV stigma in 
0.85 
 
 
 
 
> 0.90 

 
3.5.4.2.6 Timeline: The timeline for intervention sessions and data collection is summarized in Table 5. 
There are four data collection points: Week 1 (before intervention for enhanced treatment (ET) group), Week 4 
(right after intervention for the ET group), Week 7, and Week 10. Therefore, in this data collection schedule, 
the ET group will have one-baseline (Week 1), one post-intervention evaluation (Week 4), and two follow-ups 
with 3-week intervals (Week 7 and Week 10). Assessment consists of a survey and a dried blood spot test at 
Weeks 1 and 4.   
Table 5: Data Collecting Time Points 
Note: ET = Enhanced Treatment; TAU = Treatment-as-Usual; SV = Survey; and VL = Viral Load. 
 
3.5.4.2.7 A summary flowchart of the randomized waitlist-controlled trial 
relation to their personhood and self-image (strongly disagree:0 to strong agree: 3 ). A 
summary score will be computed to sum across the 16 items.  
Attributions 
48 
Attribution Style Questionnaire 143-145 is a classic measurement to assess individuals’ 
attribution style. This assessment lists 12 good or bad outcomes and probes participants with 
4 questions regarding the internality, stability, and globality of these events.   
> 0.70 
Emotional & 
physical 
Reactions 
47 
 
The Trait Physiological Hyperarousal Scale146 & Dissociation and Arousal subscales of Acute 
Stress Disorder Scale147,148 will be used to measure participants’ perceptions of bodily 
activation and acute stress reactions (very slightly or not at all: 1 to extremely: 5) during 
stressful events.  
> 0.85 
Buddhist Philosophy and Practice 
Karma belief 
4 
The Fatalistic Karma subscale of the Buddhist COPE Scale33 will measure participants’ karma 
belief regarding to what extent they agree that they believe their actions have consequences 
for themselves and others and that the consequences will occur no matter what they do 
(strongly disagree:0 to strongly agree: 3)..  
0.70 
 
Insights on 
suffering 
52 
The Self-Other Four Immeasurable Scale34 & Nonattachment Scale149 will be used to 
measure participants’ insights on suffering through capturing their sense of self, others and 
their insights into the constructed and impermanent nature of mental representations.  
> 0.80 
Mindfulness 
9 
The Cognitive and Affective Mindfulness Scale-Revised35,36 will be used to measure 
participants’ mindfulness practice, including attention, awareness, and acceptance, in their 
daily lives. (Rarely/Not at all: 1 to Almost always: 4) 101 
> 0.75 
Compassion 
26 
The Self-Compassion Scale37,38 will be used to measure participants’ kindness toward 
themselves during failure, perceiving one’s experiences as part of the larger human 
experience, and holding painful thoughts and feelings in mindful awareness.  
> .85 
 
Care Engagement 
HIV 
medication 
Adherence 
6 
Participants will be presented with a list of current ART medications and questions to record 
their history of taking or stopping antiretroviral medication. The instrument will record their 
current ART regimen and reasons they stopped taking ART medications, where appropriate. 
Note that viral load will also be used as an objective measure of adherence.  
0.96 
3-day recall of 
ART 
adherence 
1 
This one-item visual analog scale is based on 150 a 3-day adherence assessment. It accesses 
3-day adherence along a continuum of “none of my doses” to “every one of my doses.” 
 
30-day recall 
of ART 
adherence 
1 
This one-item visual analog scale150 assesses 30-day adherence, reported separately for 
each drug, along a continuum of “none of the doses” to “every dose.” This scale has been 
shown to correlate with other adherence measures such as MEMS caps. 
 
Care 
Engagement 
13 
The Patient Activation Measure – Short Form will be used to measure participants’ 
engagement in their care, as assessed by their agreement with statements about their beliefs 
in their active roles in care, confidence and knowledge to take action, capacity in taking 
action, and staying the course under stress. (Strong disagree: 1 to Strongly agree: 5) 
0.88 
Clinic Visits 
2 
How many missed visits over the past month? How many delayed visits over the past month?  
 
Time 
Points 
Week 1 
Week 2 
Week 3 
Week 4 
Week 7 
Week 8 
Week 9 
Week 10 
ET 
Group 
Intervention  Intervention Intervention Intervention 
 
 
 
 
SV, VL 
 
 
SV, VL 
SV, VL 
 
 
SV, VL 
TAU 
Group 
 
 
 
 
 
 
 
 
SV, VL 
 
 
SV, VL 
 SV, VL 
 
 
SV, VL 

A flowchart is presented in Figure 4 to summarize recruitment, enrollment, randomization, intervention 
delivery, and assessments. Please note that, for the ET group, the Week 1 assessment occurs right before the 
first intervention session, and the Week 4 
assessment occurs right after the fourth 
intervention. In contrast, for the TAU group, 
there is no additional stigma reduction 
intervention, but the group will be assessed 
at Weeks 1, 4, 7, and 10. The same 3-week 
intervals will enable direct comparisons 
across conditions and assessments.   
 
3.5.4.2.8 STATISTICAL ANALYSIS PLAN  
 
3.5.4.2.8.1 To evaluate feasibility and acceptability: To evaluate feasibility, defined as the participation rate 
among eligible Thai PLWH, we will carefully document in study logs the numbers of Thai PLWH who are 
eligible to participate, approached by staff, willing to participate, and eventually enrolled in the study. We will 
assess acceptability, defined as the study completion rate, with detailed documentation of their attendance in 
intervention sessions, and program completion or termination. We will record their reasons for non-participation 
and early termination. The numbers of prompts and reminders needed to ensure participation will also be 
recorded. To further shed light on factors contributing to intervention acceptability, we will triangulate the study 
logs with an extensive structured post-intervention exit interview, which will probe participants about their 
opinions on different aspects of the adapted intervention, including relevance, delivery, and satisfaction with 
the activities and materials. At the end of the exit interview, any improvements that participants suggest to 
enhance the efficacy of the intervention in helping Thai PLWH more effectively manage their family relations 
and illness will be documented and implemented. All the exit interviews (N=40) will also be audio-recorded and 
transcribed. Standard qualitative coding and theme-extracting approaches as described in Section 3.5.4.1.1 
will be applied to identify areas for further improvement. Finally, the interventionists will keep detailed progress 
notes for each session, documenting which topics and activities were covered in the sessions as well as Thai 
PLWH’s patterns of participation. These progress notes will be triangulated with transcriptions of intervention 
session audio-recordings and with the exit interviews to identify active intervention components and assess 
their acceptability. Participants’ health outcomes as a result of the stigma reduction intervention, along with 
their responses regarding its feasibility and acceptability, will allow us to better understand ways to assist Thai 
PLWH in managing their relationships and their HIV, improving their well-being, and contributing to overall 
health and containment of the HIV epidemic. 
 
3.5.4.2.8.2 To evaluate preliminary efficacy: Our study design involves a two-group randomized-controlled 
clinical trial with four assessments for each participant and a total of 320 observations. The study is not fully 
powered for efficacy, limiting the sophistication of the analyses we can conduct to test efficacy. 
However, to obtain robust estimations, we will take the following steps: (a) we will examine the scope and 
mechanisms for missing data and attrition to investigate the extent to which the missing-at-random (MAR) 
assumption is violated, and, if it is violated, we will adapt procedures recommended by Barnes et al.;151 (b) we 
will examine all measures at each observation time using univariate statistics to identify potential irregular 
response patterns and determine overall quality of data; (c) we will assess scale reliability and compare it to 
published psychometrics in comparable populations; (d) we will triangulate objective and self-report 
measurement of adherence; (e) we will give special attention to our key primary outcome variables (quality of 
life and objective health measures) as well as secondary outcome variables (stigma, disclosure preparedness, 
family relations, family support, self-management efficacy, adherence, depressive and anxiety symptoms, and 
physical symptoms; note that all the outcomes are continuous); and (f) we will investigate the quality of random 
assignment by conducting a series of bivariate statistics comparing selected demographic, clinical, and 
psychosocial factors between treatment groups at baseline. Important findings may result in the modification of 
subsequent analyses. 
We will use Generalized Estimating Equations (GEE) to test the proposed hypotheses while controlling 
for stratification and basic demographic backgrounds. This GEE framework allows us to carry out statistical 
tests for all the major hypotheses by comparing “population averages” between groups while appropriately 
adjusting for autocorrelations in observations due to repeated measures for the same groups of participants. 
We will further apply the small-sample estimator of variance to accommodate our sample size.152 To compute 

standard errors and confidence intervals for statistical inferences, we will use a clustered sandwich estimator to 
obtain robust estimations. Note that, for simplicity of the exposition, controlling variables are not shown in the 
equations. All the statistical testing will be analyzed with the statistical software packages Stata and R. Please 
note, our interpretations will focus on the size of the between-group effect and its replication in the DT 
group because this study is not designed to have power to detect small effects. 
We will fit the following GEE 
intent-to-treat model with the Thai 
PLWH: 𝑔𝑔൫𝐸𝐸(𝑌𝑌𝑖𝑖𝑖𝑖)൯= 𝛽𝛽01 +  𝛽𝛽02 ∗
𝑊𝑊𝑊𝑊𝑊𝑊𝑊𝑊𝑖𝑖4 + 𝛽𝛽03 ∗𝑊𝑊𝑊𝑊𝑊𝑊𝑊𝑊𝑖𝑖7 + 𝛽𝛽04 ∗
𝑊𝑊𝑊𝑊𝑊𝑊𝑊𝑊𝑖𝑖10 + 𝛽𝛽05 ∗𝐼𝐼(𝐸𝐸𝐸𝐸𝑖𝑖) + 𝛽𝛽06 ∗𝐼𝐼(𝐸𝐸𝐸𝐸𝑖𝑖) ∗
𝑊𝑊𝑊𝑊𝑊𝑊𝑊𝑊𝑖𝑖4 + 𝛽𝛽07 ∗𝐼𝐼(𝐸𝐸𝐸𝐸𝑖𝑖) ∗𝑊𝑊𝑊𝑊𝑊𝑊𝑊𝑊𝑖𝑖7 + 𝛽𝛽08 ∗
𝐼𝐼(𝐸𝐸𝐸𝐸𝑖𝑖) ∗𝑊𝑊𝑊𝑊𝑊𝑊𝑊𝑊𝑖𝑖10 where g(.) denotes a 
proper link function; 𝑌𝑌𝑖𝑖𝑖𝑖 denotes 
primary or secondary outcomes in 
separate models for participant i at 
Week t; t = 1, 4, 7, and 10; and 
𝐼𝐼(𝐸𝐸𝐸𝐸𝑖𝑖) denotes a binary variable 
indicating whether participant i belongs 
to the immediate treatment group. In 
this model, 𝛽𝛽01 represents the mean 
outcome levels for DT at Week 1; 𝛽𝛽02represents the slope for TAU between Week 1 and Week 4; 𝛽𝛽03 
represents the slope for DT between Week 1 and Week 7;  𝛽𝛽04 represents the slope for TAU between Week 1 
and Week 10; 𝛽𝛽05 represents the average group difference in outcomes between TAU and ET groups at Week 
1; 𝛽𝛽06 represents the average group difference in the slope between TAU and ET groups between Week 1 and 
Week 4; 𝛽𝛽07 represents the average group difference in the slope between TAU and ET groups between Week 
1 and Week 7; and 𝛽𝛽08 represents the average group difference in the slope between TAU and ET groups 
between Week 1 and Week 10. We define that the main between-group treatment effect is equal to 𝛽𝛽06; 
therefore, we expect that 𝛽𝛽06will be significantly different from 0.  
 
3.5.4.2.8.3 Sample Size Considerations: As the goal of qualitative components is to explore a range of 
experiences among Thai PLWH’s experiences in family relations and self-management, as well as their 
opinions regarding acceptability of the adapted intervention, it is critical to include participants with a wide 
enough range of experiences to reach conceptual saturation. Although “saturation” and “a priori determined 
sample size” have stimulated debates in the literature,153-155 it is generally agreed that a sample size of 30 
participants should be sufficient to capture a range of experiences.154 Therefore, the 30 in-depth interviews we 
utilize in our AIM 1 to revise the conceptual model, as well as the 40 exit interviews we will conduct in our AIM 
2 to evaluate acceptability of the intervention, should provide sufficient saturation and guide future intervention 
revisions. Please note, we do not intend to fully power the quantitative data to formally test the model in this 
project. Rather, we will focus on the magnitude and valence of the treatment effect as well as its overall pattern 
during replication. However, in order to understand the size of the difference in slopes (𝛽𝛽06) between treatment 
groups our data can detect given our sample size, observation time points and the GEE model, we used the 
liu.liang.linear,power function in the longpower package156 in the R statistical software and supplied with the 
preliminary data from our ongoing R21 project. The results are illustrated in Figure 5. Given our study designs 
with N = 80 and model choice (GEE), we can detect as small as 2.4 in 𝛽𝛽06 with 80% power.  
 
3.5.4.3 Aim 3: To revise and finalize the study protocols using results from AIM 1 and AIM2.  
The study protocols have two parts, including intervention protocol and operational protocol. The intervention 
protocol is the intervention manual providing a detailed, step-by-step guide for each of the intervention 
sessions. The goals, topics, intervention approaches, and timeframe for each module will be clearly delineated. 
We will use the study results from AIM 2— the feasibility, acceptability, and effect sizes—to finalize the 
intervention protocol. Since our intervention will be adapted using the qualitative data from our prior studies 
with additional input from stakeholders, we expect most intervention components will be feasible and 
acceptable to our participants; yet, by using the qualitative data from exit interviews and study logs, we will 
identify specific intervention components in need of revision, and particularly those clearly not acceptable to 
Thai PLWH. To further increase feasibility and acceptability of the intervention, we will recommend additional 

adjustments to the intervention and submit them to the CAB and SAB for final review. We will calculate power 
and required sample size of the future R01 study using the preliminary effect sizes from the current project.        
The operation protocol, in contrast, will address a series of necessary activities for the success of the 
subsequent R01 study. We will adapt an existing operation protocol from a similar project conducted by the PI 
in her K award as described in Section 3.3.2. In that project, the PI and the research team developed an 
operation protocol and successfully set up a preliminary randomized controlled trial to test efficacy of a family-
centered self-management intervention for Chinese women living with HIV in China. The operation protocol will 
include topics such as project set-up, required facilities, inclusion and exclusion criteria, participation 
recruitment and retention, random assignment procedures, training materials and supervision, intervention 
fidelity, data collection and storage, data quality assurance, arrangement of clinical referrals for participants 
with mental illness, reporting of potential harm to others or themselves, timeline and important dates, and tasks 
and duties for personnel, among others. To refine our operation protocol so that it can cover as many diverse 
conditions as possible, we will further collect data from all stages of the research implementation and 
keep detailed logs of all the study activities. In this documentation, study staff will be instructed to detail not 
only what has happened according to the study plans but also unexpected situations that may facilitate or 
impede the designed activities. During regular supervision with Drs. Moolphate, Chen, Detels, and Shiu, this 
documentation will be reviewed and discussed thoroughly within the team members. Special attention will be 
given to participant recruitment and retention, and we will enlist several strategies to handle different situations 
and to engage participants. The feasibility data from the recruitment and retention study logs will be analyzed 
to identify barriers for Thai PLWH to partake and be retained in the study. Solutions to these potentially 
emerging problems will be brainstormed and implemented to test their effectiveness. The study team will also 
review related literature to identify best practices. Indeed, we previously published a study on building cross-
cultural HIV research collaborations using these administrative research documents93 and made 
recommendations for selecting approaches that may help forge healthy international HIV research 
collaborations. Finally, the CAB members will review different drafts of the protocol and provide feedback for 
further improvement. 
Although this current R34 study will be implemented at the Sanpatong Hospital, we will actively 
involve stakeholders in the local area. We have successfully collaborated with the researchers affiliated with 
the Sanpatong hospital and other service organizations in the local network of HIV care and have developed 
local CABs and SABs consisting of local Thai PLWH community members, service providers and experts from 
the areas. From the beginning of the R01 project, we will host CAB and SAB meetings on a regular basis. 
During the meetings, Drs. Moolphate, Chen, Detels, and Shiu will report study progress, submit documents for 
review, and discuss topics that need input from the CAB and SAB. The CAB and SAB will share 
responsibilities in overseeing the project, helping interpret qualitative data arising from the study activities, 
reviewing intervention adaptation, and finalizing study protocols. We will compare the perspectives from the 
CAB and SAB and integrate them into the final protocols. The final intervention and operation protocols will be 
approved by the CAB and SAB, which represent all partner agencies.