Early Community Client-Led ART Delivery (CCLAD) to Optimize HIV Care Engagement in Nakivale Refugee Settlement
Phase: NA
Conditions: HIV Seropositivity
Sponsor: University of Washington

 
 
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STUDY PROTOCOL 
 
Study Title: Early Community Client-Led ART Delivery (CCLAD) to Optimize HIV Care Engagement 
in Nakivale Refugee Settlement 
 
Document Date: 16 December 2019 
 
 
NCT04736316 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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School of Health Sciences Research and Ethics Committee  
College of Health Sciences, Makerere University 
 
RESEARCH PLAN FORM 107 
 
 
 
Name of the Principal Investigator: Kelli N. O’Laughlin, MD, MPH 
 
Research Study Title: Early Community Client-Led ART Delivery (CCLAD) to Optimize HIV Care 
Engagement in Nakivale Refugee Settlement 
 
Study Version Number/Date: Study Version #1/16 December 2019 
 
1. 
Background and rationale:  
Sub-Saharan Africa, home to 71% of all people living with HIV/AIDS worldwide, is the site of 3.4 
million refugees and asylum seekers and many long-standing refugee settlements (1, 2). While 
often thought to be a short-term phenomenon, refugees remain displaced for an average of 17 years 
(3). Though HIV prevalence among refugees is largely unknown, refugees are an extremely  
vulnerable population due to violence and persecution, and are at risk of exposure to HIV infection 
(4). Refugees also face unique challenges accessing HIV care. Efforts to meet daily survival needs 
while living in a refugee settlement can be all-consuming (5). As such, barriers to HIV services that 
are commonly encountered in resource-limited settings have magnified impacts for refugees (5). 
 
We have a research site at Nakivale Refugee Settlement in southwestern Uganda with a dedicated 
and skilled refugee-centered research team focused on investigating HIV-related interventions. 
Nakivale is 71 square miles and hosts over 100,000 refugees from 11 countries of origin. From 
prior research our team conducted in Nakivale, we found that only 54% of refugees and Ugandan 
nationals newly diagnosed with HIV subsequently linked to HIV clinical care in one of the four 
health centers in Nakivale Refugee Settlement (6). This finding motivates our current research to 
evaluate an intervention which may improve linkage to HIV care in this setting. 
 
2. Statement of the problem 
Refugees face unique barriers to accessing HIV care given the need to focus energy on meeting daily 
survival needs (5, 7). Refugees and Ugandan nationals newly diagnosed with HIV in Nakivale 
Refugee Settlement demonstrated difficulty overcoming barriers to linkage to HIV care, with only 
54% of newly diagnosed individuals linking to one of the four clinics in Nakivale that provide free 
HIV services (6).  
 
3. Study justification 
In recent research conducted by Dr. Kelli O’Laughlin (PI) and her research team in Nakivale 
Refugee Settlement to assess barriers to linkage to care in this setting, refugees and Ugandan 
nationals were hesitant to disclose their HIV status given fear of perceived stigma, and many 
endorsed lacking social support (unpublished research). Further, physical barriers to care (e.g. 
distance to clinic and time required to attend HIV clinic and pick-up antiretroviral therapy [ART]) 
make it difficult to engage in HIV clinical care in this setting. 
 
We aim to design and implement an HIV linkage intervention that is feasible, acceptable, and 
effective in Nakivale Refugee Settlement. We believe implementing community client-led ART 

 
 
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delivery (CCLAD) at the time of diagnosis will help people to link to HIV clinical care and remain 
engaged in care by providing psychosocial support, motivating engagement in HIV care, increasing 
ART accessibility, and decreasing the workload for HIV clinic staff. It is plausible that refugees will 
be more willing to engage in HIV care if they are immediately connected to peers in their 
community whom they can partner with to navigate living with HIV in the refugee settlement. This 
will help to provide needed social support and may decrease perceived stigma. Further, receiving 
ART as a group will help decrease the burden of frequent travel to clinic in terms of cost of travel, 
time required to attend clinic, and distraction from other daily activities needed to survive in this 
setting (e.g. getting water, collecting firewood, cooking, maintaining shelter, harvesting food/picking 
up food rations, ensuring security of self/family). It is likely that Early Community Client-Led ART 
Delivery, combined with support from a peer-navigator, will help to enhance linkage to care in this 
unique setting.  
 
4. Aims/specific objectives 
 
To pilot early community client-led ART delivery (CCLAD) in Nakivale Refugee Settlement and 
assess the feasibility and acceptability of this intervention in this setting. 
 
5. Research question:   
 
Is an early community client-led ART delivery (CCLAD) intervention feasible and acceptable in 
Nakivale Refugee Settlement and does it demonstrate a trend toward efficacy? 
 
6. Literature review 
There is global movement in HIV care to provide client-centered care that improves access to HIV 
services and meets the needs of individuals living with HIV to help them better engage in HIV care. 
A means to enhance client-centered HIV care is by providing “differentiated service delivery”. 
According to the International AIDS Society (IAS), differentiated ART delivery can be divided into 
four categories: health care worker-managed group models, client-managed group models, facility-
based individual models, and out-of-facility individual models (8). In all these models, clients 
continue to have clinical consultations in a variety of forms and intervals. To date, differentiated 
ART delivery has been evaluated in clients deemed to be stable in care (defined by >6months on 
ART, >3 months on same regimen, viral load < 1,000 copies/mL or no current evidence of 
immunological failure, and no clinical condition requiring more frequent follow-up). (8) For these 
models, ART refills have been stretched up to every 3 months and clinical consults occur as 
infrequent as every 6-12 months (8).  
 
There have been numerous studies evaluating models of differentiated service delivery for HIV in 
sub-Saharan Africa. An intervention that was assessed recently in Eswatini that assisted with linkage 
to HIV care was peer-delivered linkage case management along with same-day ART initiation (9). 
Following community-based HIV testing, peers offered linkage case management which included 
counselling and psychosocial support, treatment navigation, phone calls, reminders and follow-up 
counselling sessions on HIV disclosure and testing of partners/family (9). Peer navigation has been 
demonstrated to enhance linkage to HIV care in other resource limited settings as well as extended 
counselling and peer support (10, 11).  
 
An intervention that has been shown to improve retention in HIV care and viral suppression for 
adults stable in care in sub-Saharan Africa are health care worker-managed ART group models, 
sometimes called adherence clubs. Initially piloted by Medecins Sans Frontieres (MSF) in South 
Africa, adherence clubs were offered to adults with self-reported ART adherence, more than 12 
months on ART and with viral suppression (<400 copies/mL) (12). These groups met in the 

 
 
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community and were facilitated by community health workers. The groups met every 8 weeks for 
group counselling, a brief symptom screen and distribution of pre-packed ART. The group also had 
an annual visit in the community that included blood collection and a clinical consultation. Findings 
revealed retention in care at 12 months was 95% and at 24 months was 89%, and that of the 88% of 
clients with a viral load, 97% were ≤ 400 copies/mL (12-14). These adherence clubs were also cost-
effective and enhanced healthcare efficiency and patient accessibility to services (15).  
 
Different than “adherence clubs” which are health care worker-managed, client-managed community 
ART groups have also been demonstrated to be an effective differentiated care model. In client-
managed ART groups, group members take turns attending HIV clinic on behalf of the group, 
reporting on each members’ health status and picking up ART for each group member. They then 
returned to the group and delivered the medications as well as any important information from the 
clinic. A study of community ART groups in Mozambique showed favorable long-term retention in 
care with retention 97% at 12 months, 96% at 24 months, 93% at 36 months, and 92% at 48 months 
(16). While this study was also conducted among those “stable” on ART, the authors wrote that there 
was a need to investigate the impact of enrolling clients earlier on ART into community ART groups 
(16). Community ART groups in Mozambique, were shown to be successful at providing peer 
support and decreasing barriers to ART helping to address low retention rates and health facilities 
absorptive capacity (17). In Lesotho, participants in community ART groups had 99% retention in 
care at one year compared to 90% for those in standard care (18). Further, community ART groups 
improved access to ART for participants and improved their life within the community (18). 
Medecins Sans Frontieres reported their experiences with community ART in four countries in sub-
Saharan Africa (Malawi, South Africa, Democratic Republic of the Congo, and Mozambique), 
noting the intervention benefited patients by enhancing retention in care and benefited the health 
system by lightened the burden for clinical providers (19). 
 
“Community Client-Led ART Delivery (CCLAD)” groups, are recognized by the Ugandan Ministry 
of Health as a differentiated service delivery model option for those stable in care (20). The Ugandan 
Ministry of Health outlines the “Community Client-Led ART Delivery (CCLAD) Model” in the 
2017 “Implementation Guide for Differentiated Service Delivery Models of HIV Services in 
Uganda,” (20). CCLAD groups are described as psychosocial community ART groups to improve 
access and to empower clients to rotate collection and delivery of ART to group members. Group 
members are asked to visit a health facility twice a year for a comprehensive clinical assessment. 
Team leaders work with health workers to coordinate communication between groups and the health 
facility. Clients go to the clinic at any point if any issues arise. The Ministry of Health recommends 
groups of 3-12 members. They outline steps for CCLAD implementation (13). 
 
7. Methodology 
Study area  
Nakivale Refugee Settlement, established in 1960, is in southwestern Uganda and spans 71 mi2. 
There are over 100,000 refugees from 11 countries living in Nakivale; the predominant countries of 
origin presently are the Democratic Republic of the Congo, Rwanda, Somalia, and Burundi. Free 
HIV services, including HIV testing and anti-retroviral therapy (ART), can be utilized by refugees 
and Ugandan nationals and are offered at Nakivale Health Center III and three smaller clinics in the 
settlement (Rubondo Health Center II, Kibengo Health Center II, and Juru Health Center II). HIV 
testing at these sites follows the Ugandan Ministry of Health approved serial testing algorithm 
(Ministry of Health, National HIV testing Services Policy and Implementation Guidelines Uganda, 
2016). 
 

 
 
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Study population 
Adults accessing routine HIV testing at Nakivale Health Center III, Kibengo Health Center II and 
Juru Health Center II will be invited to participate. These are established study enrollment sites from 
prior research conducted in Nakivale by our research team. The study population will include adult 
refugees and Ugandan nationals. Those that test positive for HIV will be invited to participate in the 
Early Community Client-Led ART Delivery group intervention.  
 
Study design 
Enrollment: Individuals will be offered research participation which will include an intake survey, an 
HIV test, and the option to participate in early community client-led ART delivery (early CCLAD) 
groups if diagnosed with HIV. The consent process will occur before HIV testing, so some of those 
consenting for the research will not have the option to participate in early CCLAD intervention. This 
method of consenting prior to HIV testing is a method we have used for years in our research in 
Nakivale as it permits us to ask questions that may be otherwise answered differently if someone 
was just diagnosed with HIV (i.e. sensitive screening surveys on depression, anxiety, PTSD, social 
support and perceived stigma). Those interested in participating will have a consent form read aloud 
to them by a Research Assistant before being tested for HIV. Consent forms will be available in 4 
languages: Runyankore, Kinyarwanda, Kiswahili and English, and will be read by multi-lingual 
Research Assistants. These individuals will be told at the outset that they can alternatively access 
free HIV testing at the outpatient department clinic if they prefer to not participate in any aspect of 
the research. Those accessing testing through the outpatient department clinic can do so after 
consultation with a clinical officer (then obtaining referral to the lab) or by going to the HIV clinic to 
request at an HIV test from the HIV clinic staff. 
 
Intake survey: After consent but prior to HIV testing, we will conduct a baseline survey. This 
method of obtaining consent prior to HIV testing has been effective in prior research in Nakivale as 
it allows for baseline data collection before individuals learn of a new HIV diagnosis which could 
alter their survey answers. This will include collection of contact information, demographic 
information, physical assessment (height, weight, blood pressure), migration patterns (e.g. country of 
origin, years in Nakivale, recent time away from Nakivale), HIV testing history, perceived stigma, 
screening for mental disorders (PTSD, depression, anxiety), and assessment of social support (see 
Appendix I: “Survey”- Runyankore, Kinywarwanda, Kiswahili, English). The purpose of the intake 
survey is to understand if any of these factors are associated with uptake of or engagement in the 
Early CCLAD groups as a means to enhance engagement in care in the future. Like the consent 
process, the survey will be available in 4 languages: Runyankore, Kinyarwanda, Kiswahili or 
English, and will be read aloud to participants with responses entered directly into a passcode-
protected electronic tablet.  
 
Early Community Client-Led ART Delivery (Early CCLAD) intervention: Willing participants 
newly diagnosed with HIV will be placed into a Community Client-Led ART Delivery group. The 
goal will be to place participants into groups within the first month of diagnosis. We will attempt to 
ask participants what their ideal group would look like (i.e. sex of other group members, proximity 
of house to other group members, country of origin of other group members, size of group), and we 
will work to place participants in groups that they anticipate will work best for them. We anticipate 
groups will range in size from 3-12 participants. As enrollment permits, we will invite participates to 
indicate their preferred group size and group characteristics (sex, age, country of origin of 
participants). We will not initiate a participant into group after 90 days of diagnosis. To facilitate 
linkage to the Early CCLAD group, clients will be linked to an expert client peer navigator. The 

 
 
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expert client peer navigators will be tasked with supporting the Early CCLAD intervention groups 
and helping provide psychosocial support to newly diagnosed individuals and helping them 
seamlessly integrate with their group.  
 
HIV clinical care for “Early CCLAD” participants: The first meeting of each Early CCLAD group 
will include an HIV clinic clinician (most likely an HIV RN as is standard in HIV clinics in the 
refugee settlement). Most commonly this first meeting will be for all participants in a single group. 
In unique circumstances, we may have an individual meet with the HIV clinician on their own for 
their first meeting and then join an existing group (e.g. if it is difficult to find a group that fits in 
terms of location and group characteristics). The first meeting is the one time in the intervention 
where participants will be compensated for their transportation to the clinic or to the meeting site 
(20,000 USH will be provided for each participant who attends this meeting). The HIV clinician, 
who will have been trained in the Early CCLAD group intervention, will help individuals in the 
group to understand their roles and responsibilities (as guided by the Ugandan Ministry of Health 
“Implementation Guide for Differentiated HIV Services in Uganda” (20), pages 58-59). The group 
will work together to plan future meeting dates and locations. They will decide if they would like to 
support the person responsible for picking up the ART each month (e.g. money, transportation, 
childcare, food). They will specify which dates they will be responsible to attend HIV clinic and pick 
up ART for the group. They will discern if they would like to identify a connecting activity to be 
integrated into their group (e.g. exercise, faith, livelihood, craft). The group will select a Team 
Leader to coordinate communication between the group and the healthcare facility. Finally, an 
important part of this first meeting is that the HIV clinician will conduct a standard comprehensive 
clinical exam and will refer each person for any necessary laboratory testing.  
 
Monthly “Early CCLAD” meetings: The “Early CCLAD” intervention will require monthly group 
meetings. This is intentionally more frequent than is suggested in the Ugandan Ministry of Health 
guidelines (which recommends visits every 3 months) as this intervention will occur at the time of 
diagnosis rather than when a person is deemed “stable” in care. Before the designated individual 
goes to clinic in any given month, they will be responsible for connecting with each group member 
to ask about how they are feeling and to see if they have any questions to ask of the HIV clinic staff. 
That individual will then attend HIV clinic and communicate about the status of each group member. 
They will collect useful information from the clinic and pre-packed ART for each group member. 
ART may be distributed in MEMS Cap bottles if these are available and if the participant is willing. 
These allow for transmission of the date and time of bottle opening to research staff only to better 
monitor medication adherence. The “Early CCLAD” group will then meet at their predetermined 
location so that the individual who attended clinic can share information from the clinic and can 
distribute the ART to each person in the group.  
 
Anticipated annual health care visit schedule*:  
 
Month 1: ART start for group + comprehensive clinical exam + laboratory testing as needed 
Month 2: ART refill (in community) 
 
Month 3: ART refill (in community) 
 
Month 4: ART refill (in community) 
 
Month 5: ART refill (in community) 
 
Month 6: ART refill for group + clinical review + laboratory testing as indicated/needed 
 
Month 7: ART refill (in community) 
 
Month 8: ART refill (in community) 
 
Month 9: ART refill (in community) 
 
Month 10: ART refill (in community) 

 
 
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Month  11: ART refill (in community) 
 
Month 12: ART refill for group + clinical review + laboratory testing as indicated/needed 
 
 
*Alternatively, some groups may decide to rotate and have group members attend clinic in 6-
month intervals but not necessarily with other group or with all the group members. 
 
Additional clinic attendance: All participants assigned to an “Early CCLAD” group will be expected 
to attend HIV clinic in person twice yearly for a clinical evaluation and a viral load check. The HIV 
clinician will work with the team to decide if they prefer their twice annual HIV clinic visits on the 
same day but individually, on the same day as a group, or individually on different schedules from 
others in the group. Additionally, individuals will attend clinic in person when they do not feel well, 
when they have any questions they prefer to ask the clinicians directly, when additional laboratory 
testing is required, and when requested by HIV clinic staff to optimize their medical care. In cases 
where the participants are deemed clinically unstable and are in need of regular clinical follow up 
(e.g. develops an opportunistic infection, develops other co-morbidity, has a viral load > 1,000 
copies/mL), clients will be asked to attend the clinic monthly with the rotating group member 
collecting group ART refill or to step in as the group member responsible for attending clinic that 
month. Individuals “Up referred” by HIV clinic staff to monthly HIV clinic visits should still 
participate in the “Early CCLAD” groups to receive psychosocial support and other benefits of 
community group care. 
 
Option to stop the “Early CCLAD” group at any time: Participants can opt to stop Early CCLAD 
participation at any time. If willing, they will be asked to participate in a brief exit interview so we 
can better understand what aspects of the intervention were acceptable or not acceptable to them. If 
necessary, we will restructure Early CCLAD groups to maintain a minimum of 3 per group. 
 
“Early CCLAD” groups and HIV clinic connectedness: To ensure the Early CCLAD intervention 
participants remain well integrated into HIV clinic, the research staff will meet regularly with the 
HIV clinic staff to update them on the intervention and to discuss specific problems and specific 
individuals needing specialized care. Additionally, efforts will be made so that participant HIV clinic 
files and pre-packed medications are ready for the visit of the individual Early CCLAD group 
member each month. Finally, participants will be reminded frequently that they are expected and 
welcome to attend clinic when they do not feel well or when they have any questions or needs that 
are not being met through group care.  
 
Follow-up data collection: Early CCLAD group participants will be given components of the intake 
survey (i.e. to assess mental health screening, perceived stigma, and social support) again 6-months 
after they began participation in the intervention. Additionally, data will be collected to assess 
retention in group care, ART medication pick-up, and HIV clinic outcomes.  
 
Sample size determination 
From our routine HIV testing study conducted at Nakivale Health Center III in 2013 (O’Lauglin et 
al, JAIDS 2014), we found an HIV prevalence of 4.5%. With a current population of about 110,000 
(https://reliefweb.int/sites/reliefweb.int/files/resources/69449.pdf), this means approximately 4,950 
in Nakivale are living with HIV. As this is a pilot study, sample size determination is not applicable. 
However, to assess the feasibility and acceptability of this intervention, we aim to enroll 
approximately 70 individuals into the early community client-led ART delivery (early CCLAD) 
intervention. To reach this number, we plan to enroll 3,000-4,000 individuals to participate in the 
initial survey and HIV test. 

 
 
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Sampling method and procedures 
We will invite all individuals newly diagnosed with HIV to participate in the intervention. There will 
be no randomization. 
 
Outcomes and Variables to be measured in the study 
Primary outcome: 
- 
Linkage to HIV clinical care: attendance of one Early CCLAD group meeting within 90 days 
of study initiation 
 
Secondary outcomes: 
- 
Retention in care: Early CCLAD group meeting attendance each month  
- 
ART medication pick-up 
- 
Date and time ART medication bottle is opened (if the client is willing to use a MEMS Cap 
bottle which will record this information) 
- 
HIV clinical outcomes (CD4, viral load, clinic visits outside required visits) 
- 
Variables collected in the intake survey (and 6-month survey for those in Early CCLAD 
groups): 
1. Demographic information (i.e. refugee status, marital status) 
2. Non-communicable disease screening 
3. Migration patterns 
4. Perceived health  
5. HIV testing history  
6. HIV-related stigma 
7. Patient health questionnaire depression assessment (PHQ-9)  
8. Generalized anxiety disorder (GAD-7) 
9. Post-traumatic stress disorder (PCL-6)  
10. Social support (BS6) 
 
Process outcomes: 
- 
Uptake/Acceptability: number offered Early CCLAD, number accepted Early CCLAD (and 
reason for not accepting for those unwilling to participate), number placed into an Early 
CCLAD group, number attending first Early CCLAD meeting, number retained in Early 
CCLAD meetings. 
- 
Early CCLAD group characteristics: size, sex of group, age of group, country of origin of 
group, location of group meetings, time of group meetings, group leader characteristics, 
choice of whether or not/how to support individual attending clinic monthly, group 
connecting activity, the frequency of “up referral” and retention in group care for those 
referred to resume monthly clinic visits in person 
- 
Assessing Early CCLAD group intervention feasibility and fidelity: 
1. Group size remains between 3-12  
2. First group meeting to include the following components: 
▪ Includes all team members 
▪ Occurs within 90 days of initial diagnosis for all team members 
▪ Is led by the clinic HIV RN 
▪ Plan made for future meetings dates/locations 
▪ Decision made about whether or not to support group member attending clinic 
each month and in what way to support them 

 
 
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▪ Specify the clinic attendance schedule for the next 6 months 
▪ Choose whether or not to have a “connecting activity” 
▪ Select a Team Leader 
▪ Each individual to have a comprehensive clinical exam and any necessary 
laboratory testing 
3. Monthly group responsibilities (to be checked each month): 
▪ A representative group member scheduled to attend clinic that month is to check 
in with each individual prior to going to clinic 
▪ A group representative attends HIV clinic and picks up ART for the group 
4. Monthly group meeting to include the following components: 
▪ Meet as a group in the selected location at the predesignated time and distribute 
ART 
 
i. 
Note: The Team Leader for each Early CCLAD group will be 
responsible for collecting and submitting the following information 
to the research team each month: Date of meeting (and was this the 
originally planned date, if not, why/how did it change) 
ii. 
Time of meeting (and was this the planned time, if not, why/how 
did it change) 
iii. 
Location of meeting (and was this the planned location, if not 
why/how did it change) 
iv. 
Number of participants in attendance (record de-identified code for 
each participant in attendance) 
v. 
Length of meeting (in minutes) 
vi. 
Estimate of time spent discussing information from clinic (in 
minutes) 
vii. 
Estimate of time spent discussing family/friends/life/suggestions 
about living with HIV (in minutes) 
viii. 
Was a Connecting Activity a part of this meeting (yes/no; if so, 
how much time was spent with this and what was it) 
ix. 
What else did the group spend time on (estimate of time in 
minutes, specify the other topic/activity) 
 
- 
With permission from the group, we will intermittently observe group meetings. Research 
staff will seek to learn from group members about  
facilitators and barriers to engagement in the intervention. We will collect feedback from 
participants, Team Leaders, HIV clinic staff, expert peer-client navigators and Research 
Assistants to help refine the intervention. We will  document changes to group sizes and to 
any program adaptations needed. 
 
Eligibility criteria (inclusion and exclusion criteria) 
- 
Adults ≥ 18 years of age 
- 
Newly diagnosed with HIV (within last 90 days) but not yet engaged in HIV care 
- 
Able to provide informed consent 
- 
Willing to share HIV test results and HIV clinic follow-up data for research purposes 
- 
Willing to participate in community client-led ART group 
- 
Willing to have information about group activities and group participation collected for 
research purposes 
 

 
 
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Data collection methods and procedures 
As we have done previously for research in Nakivale, we will collect data off-line onto passcode 
protected electronic tablets (e.g. mobile REDCap). In regular and frequent intervals, we will push the 
data to a secure web-based platform.  
 
Regarding HIV testing, for those diagnosed HIV negative, repeat testing shall be conducted based on 
client’s level of recent exposure and or ongoing risk of exposure to rule in or rule out sero-
conversion. Additionally, all individuals newly diagnosed with HIV shall be re-tested before ART 
initiation. This second HIV test will be conducted on the same day as the initial test and will be 
performed by the health center laboratory staff. The ART treatment guidelines used will be those 
approved by the Ugandan Ministry of Health (Consolidated Guidelines for the Prevention and 
Treatment of HIV and AIDS in Uganda, September 2018).  
 
 
Quality control measures 
The data will be reviewed at least twice monthly by the research team to ensure the validity and 
integrity of the data as well as adherence to the IRB-approved protocol. In addition, data will be 
reviewed no less frequently than monthly by the PI (Dr. O’Laughlin). If there are any deviations 
from the IRB-approved protocol, the PI will be notified immediately, and the study will be stopped. 
The research team will closely monitor the study to ensure the safety of subjects. The Head Research 
Assistant (i.e. Project Manager) will conduct safety reviews twice monthly at the study site. HIV 
counselors will attend periodic training sessions to assist them in their role and to ensure quality 
procedures are used when conducting rapid HIV tests. Study staff will use precautions when 
conducting HIV testing and all materials will be disposed of in a secure fashion using biohazard 
containers as is the protocol in Nakivale. Research assistants will receive specific training in data 
security and methods to ensure safety of subjects and they will be given information on proper 
expectations regarding reporting of adverse events. The study will be monitored closely for any 
breaches in confidentiality. In the event of any of the problems described above, the study staff will 
notify the PI (Dr. O’Laughlin) and she will intervene to correct the problem.   
 
Data management and analysis 
Data will be stored and reviewed in the web-based data storage platform (e.g. REDCap). Data 
analysis will be conducted in conjunction with a biostatistician at the University of Washington. All 
data shared with biostatisticians, or anyone outside of the immediate research team, will be 
deidentified prior to transfer. 
 
Dissemination plan 
During the study period, the Head Research Assistant and the PI will discuss the study with 
stakeholders at the clinic and will share regular feedback about the progress of the study. Upon study 
conclusion, the PI will meet with stakeholders to share the study findings. If the accepted, the results 
will also be presented at international conferences and published in a peer-reviewed journal. 
 
Study laminations 
Not applicable. 
 
Ethical considerations 
Risks and Discomforts: There is minimal anticipated discomfort due to finger prick for the HIV test. 
The surveys used for data collection will may cause distress, however, research staff can refer 
participants to non-research clinic staff for counselling as the need arises. While patients choosing to 

 
 
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test for HIV may experience stress and anxiety related to the testing process and receipt of the result, 
the research assistants will be trained to provide support and all clients with a positive test will be 
encouraged to meet with an HIV counselor in the HIV clinic that same day and will be offered 
participation in the group-based intervention. The counselors will remind each person that they are 
free to decline to participate in the survey and they may leave any or all answers blank if they do not 
feel comfortable answering a question. Patients will also be reminded that they can change their 
mind regarding HIV testing and study participation at any time. Care will be taken to protect the 
confidentiality of the data collected and all data will be stored in a locked location or on password-
protected computers equipped with anti-virus software. Clients participating in the Community 
Client-Led ART Delivery groups are at greater risk for breaches in confidentiality as family or 
neighbors may hear or see them communicating with other group members. However, we will 
counsel all study participants at the outset regarding the importance of maintaining confidentiality 
among the group and respecting others’ wishes regarding if they are willing or not to have their HIV 
status disclosed in the community.  
 
Potential Benefits: The study provides additional measures to protect the rights and welfare of 
refugees by working to ensure that HIV services are more readily available for them.  The 
hypothesis of this intervention study is that this intervention will increase the number of individuals 
linked to HIV treatment. If this is found to be the case, then the intervention will help ensure their 
right to HIV care and will allow individuals to obtain treatment for HIV improving their own health 
and decreasing the chance that they will expose their sexual contacts to HIV. This study may have 
important individual benefits to participants who chose to participate in the ART treatment groups. 
Those testing positive will be able to access Community Client-Led ART Delivery, allowing them to 
attend HIV clinic less frequently while still accessing ART.  Those testing negative may benefit 
from psychological relief as well as from the opportunity to increase knowledge about risk factors 
and HIV prevention strategies. This study has important benefits to healthcare delivery in the 
refugee setting as it will provide scientific evidence regarding the feasibility, acceptability, and 
impact of an HIV linkage intervention in this population.   
 
Study budget 
This study is funded by a K23 award titled, “Linking Refugees to HIV Care in Uganda,” from the 
National Institute of Mental Health (PI: Dr. Kelli O’Laughlin; K23 MH108440-01A1). Funds from 
this grant that will be spend towards this project are approximately $41,543 and cover the costs of 
the research staff ($35,543), study supplies ($2,000), transport for study staff ($3,500), and 
compensation to research participants ($500).  
 
Study timeline 
This study will be implemented as soon as all necessary approvals are obtained, likely in January of 
2020. We will enroll participants into groups until near the end of 2020. We will continue to monitor 
the intervention and collect process data and HIV clinic data through 2021.  
 
 

 
 
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1. 
UNHCR. 2015 UNHCR country operations profile- Africa 2015 [Available from: 
http://www.unhcr.org/pages/4a02d7fd6.html. 
2. 
World Health Organization Regional Office for Africa. HIV in the WHO African region: 
progress towards achieving universal access to priority health sector interventions. 2011. 
3. 
Women's Refugee Commission. Building livelihoods: a field manual for practitioners in 
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APPENDICES  
 
 
Consent Forms 
 
Appendix 1a. Consent Runyankore 
 
Appendix 1b. Consent Kinyarwanda 
 
Appendix 1c. Consent Kiswahili 
 
Appendix 1d. Consent English 
 
 
Survey 
Appendix 2a. Survey Runyankore 
 
Appendix 2b. Survey Kinyarwanda 
 
Appendix 2c. Survey Kiswahili 
 
Appendix 2d. Survey English