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Early Community Client-LED ART Delivery in Nakivale Refugee Settlement

Early Community Client-Led ART Delivery (CCLAD) to Optimize HIV Care Engagement in Nakivale Refugee Settlement

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04736316
Acronym
Early CCLAD
Enrollment
92
Registered
2021-02-03
Start date
2020-06-29
Completion date
2022-03-31
Last updated
2023-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Seropositivity

Brief summary

To pilot early community client-led ART (anti-retroviral therapy) delivery (CCLAD) in Nakivale Refugee Settlement in Uganda and assess the feasibility and acceptability of this intervention in this setting.

Detailed description

Adults accessing routine HIV testing in Nakivale Refugee Settlement will be invited to participate. The study population will include adult refugees and Ugandan nationals of all genders older than 18 years of age. Pregnant women will be invited but Maternal Health Clinic will determine if they participate. Those that test positive for HIV will be invited to participate in the Early Community Client-Led ART Delivery group intervention. 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. 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. After consent but prior to HIV testing, the investigators will conduct a baseline survey. This will include collection of contact information, demographic information, physical assessment, migration patterns, HIV testing history, perceived stigma, screening for mental disorders, and assessment of social support. 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. The first meeting of each Early CCLAD group will include an HIV clinic clinician. 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. The group will work together to plan future meeting dates and locations. The participants will decide if they would like to support the person responsible for picking up the ART each month (e.g. money, transportation, childcare, food). The participants 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 participant 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/participant 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 information from the clinic and pre-packed ART for each group member. 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. If a participant misses a CCLAD group, they can present to the HIV clinic to pick up their ART refill if a member of the group cannot arrange delivery or pickup. 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 the investigators can better understand what aspects of the intervention were acceptable or not acceptable to them. 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. Some of this may occur in an interview setting which is recorded and then later transcribed. Additionally, data will be collected to assess retention in group care, ART medication pick-up, and HIV clinic outcomes.

Interventions

BEHAVIORALEarly CCLAD

Community-based client led antiretroviral therapy delivery groups.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Adults ≥ 18 years of age who present to the Nakivale Health Center and agree/consent to test for HIV.

Exclusion criteria

* Unable to understand one of the study languages (English, Kinyarwanda, Kiswahili, Runyankore). * Subjects who do not test positive for HIV at health center will not be eligible to participate in the early community-based client-led antiretroviral therapy delivery intervention

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants in HIV Care (Linkage) Among the Early CCLAD ParticipantsWithin 90 days of study initiation excluding the day of diagnosisAttendance in one Early CCLAD group meeting (yes/no)
Number of Early CCLAD Group Visits Attended (Retention) Among Early CCLAD Participants6 monthsAttendance in monthly Early CCLAD group meetings (yes/no). With an intention to treat, description of how many monthly group meetings were attended in the first 6 months of the intervention including Early CCLAD community visits, but not including HIV clinic visits
ART Initiation6 monthsNumber of participants who picked up anti-retroviral therapy (ART) at least once over the 6 month period as documented in the written HIV clinic record
Clinical Outcomes: Number of Participants With Viral Suppression6 month periodViral suppression defined by \<1000 copies/mL or CD4 count \>250 cells/mm3 as documented in the HIV clinic records
Total Number of Clinic Visits Per Participant (Incl. CCLAD Visits)6 monthsAll clinic and CCLAD visits per participant
Survey Score Related to Psychosocial Factors: Perceived Healthbaseline survey and 6 month follow-up surveyQuestion: In general, would you say your health is excellent, very good, good, fair or poor? Answer options: Excellent, very good, good, fair, poor, do not know, no answer This is among participants who completed both baseline and follow-up surveys only.
Survey Score Related Factors: Screened Positive for Depressionbaseline and 6 month surveysDepression measured via Patient health questionnaire depression assessment (PHQ-9); 9 questions with 0-3 score for each answer. Interpretation of score: 0-4= minimal or no depression; 5-9= mild depression; 10-14=moderate depression. For this study, we considered a positive screen for depression as a PHQ-9 score of \>=10. This analysis includes only those who participated in baseline and 6 month surveys.
Survey Score Related Factors: Screened Positive for AnxietyBaseline and 6 monthsAnxiety measured via Generalized anxiety disorder (GAD-7) tool; 7 questions with 0-3 score for each answer; Interpretation of total score: 0-4=minimal anxiety; 5-9= mild anxiety; 10-14=moderate anxiety; 15-21=severe anxiety. For this study, those with a score of \>= 10 were considered to have screened in for anxiety. This analysis includes only those who participated in baseline and 6 month surveys.
Survey Score Related Factors: Screening Positive for PTSDbaseline and 6 month surveysPTSD measured via Post-traumatic stress disorder (PCL-6) scale; 6 questions with 1-5 score for each question; Interpretation of Total score: greater than or equal to 14 is a positive screen. This analysis includes only those who participated in baseline and 6 month surveys.
Survey Score Related Factors: Screening Positive for Low of Social Supportbaseline and 6 month surveysSocial Support measured via Social support (BS6) scale; 6 questions with scores 1-4 for each answer; Interpretation of total score: 6-11= low (a positive screen for lack of social support), 12-17=moderate (at least occasional support); 18-23= high; 24=very high (maximum, always supported). For this study we considered \<= 11 as a positive screen for low of social support. This analysis includes only those who participated in baseline and 6 month surveys.

Countries

Uganda

Participant flow

Participants by arm

ArmCount
Early CCLAD Participants
Subjects receiving CCLAD intervention
31
Non Early CCLAD Participants
As this was the pilot study/feasibility trial, the study design was not intended to compare the intervention group to a control group. This pilot study did not have a control group. This group represents subjects not receiving the Early CCLAD intervention. Although they were initially eligible, they were unable to be enrolled for a variety of reasons, such as distance to clinic or not living close to other Early CCLAD group members. We provide this demographic data to compare pilot study participants to non-participants, not as a control group.
61
Total92

Baseline characteristics

CharacteristicTotalEarly CCLAD ParticipantsNon Early CCLAD Participants
Age, Continuous33.1 years
STANDARD_DEVIATION 10.4
35.4 years
STANDARD_DEVIATION 10.4
31.9 years
STANDARD_DEVIATION 10.3
Education
Beyond Primary School
16 Participants5 Participants11 Participants
Education
Completed Primary School
11 Participants2 Participants9 Participants
Education
No School
18 Participants7 Participants11 Participants
Education
Some Primary School
47 Participants17 Participants30 Participants
Mental Health Conditions
Anxiety
34 Participants15 Participants19 Participants
Mental Health Conditions
Depression
37 Participants15 Participants22 Participants
Mental Health Conditions
Low Social Support
9 Participants5 Participants4 Participants
Mental Health Conditions
PTSD
58 Participants20 Participants38 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
92 Participants31 Participants61 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Refugees40 Participants21 Participants19 Participants
Self-Reported Health Status
Fair/Poor
49 Participants16 Participants33 Participants
Self-Reported Health Status
Good/Very Good
43 Participants15 Participants28 Participants
Sex: Female, Male
Female
53 Participants15 Participants38 Participants
Sex: Female, Male
Male
39 Participants16 Participants23 Participants
Willingness to particpate in an Early CCLAD group, n(%)74 Participants31 Participants43 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 310 / 61
other
Total, other adverse events
0 / 310 / 61
serious
Total, serious adverse events
0 / 310 / 61

Outcome results

Primary

ART Initiation

Number of participants who picked up anti-retroviral therapy (ART) at least once over the 6 month period as documented in the written HIV clinic record

Time frame: 6 months

Population: As this was the pilot study/feasibility trial, the study design was not intended to compare the intervention group to a control group. This pilot study did not have a control group. Data was not collected from the Non Early CCLAD Participants

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Early CCLAD ParticipantsART Initiation31 Participants
Primary

Clinical Outcomes: Number of Participants With Viral Suppression

Viral suppression defined by \<1000 copies/mL or CD4 count \>250 cells/mm3 as documented in the HIV clinic records

Time frame: 6 month period

Population: As this was the pilot study/feasibility trial, the study design was not intended to compare the intervention group to a control group. This pilot study did not have a control group. Data was not collected from the Non Early CCLAD Participants

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Early CCLAD ParticipantsClinical Outcomes: Number of Participants With Viral SuppressionVirally Suppressed (VL <1000 or CD4>250)20 Participants
Early CCLAD ParticipantsClinical Outcomes: Number of Participants With Viral SuppressionNot Virally Suppressed (VL≥1000 or CD4≤250)3 Participants
Early CCLAD ParticipantsClinical Outcomes: Number of Participants With Viral SuppressionMissing Clinical Data8 Participants
Primary

Number of Early CCLAD Group Visits Attended (Retention) Among Early CCLAD Participants

Attendance in monthly Early CCLAD group meetings (yes/no). With an intention to treat, description of how many monthly group meetings were attended in the first 6 months of the intervention including Early CCLAD community visits, but not including HIV clinic visits

Time frame: 6 months

Population: Data was not collected from the Non Early CCLAD Participants

ArmMeasureValue (MEAN)
Early CCLAD ParticipantsNumber of Early CCLAD Group Visits Attended (Retention) Among Early CCLAD Participants3.3 Early CCLAD group visits
Primary

Number of Participants in HIV Care (Linkage) Among the Early CCLAD Participants

Attendance in one Early CCLAD group meeting (yes/no)

Time frame: Within 90 days of study initiation excluding the day of diagnosis

Population: Data was not collected from the Non Early CCLAD Participants

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Early CCLAD ParticipantsNumber of Participants in HIV Care (Linkage) Among the Early CCLAD Participants31 Participants
Primary

Survey Score Related Factors: Screened Positive for Anxiety

Anxiety measured via Generalized anxiety disorder (GAD-7) tool; 7 questions with 0-3 score for each answer; Interpretation of total score: 0-4=minimal anxiety; 5-9= mild anxiety; 10-14=moderate anxiety; 15-21=severe anxiety. For this study, those with a score of \>= 10 were considered to have screened in for anxiety. This analysis includes only those who participated in baseline and 6 month surveys.

Time frame: Baseline and 6 months

Population: As this was the pilot study/feasibility trial, the study design was not intended to compare the intervention group to a control group. This pilot study did not have a control group. Data was not collected from the Non Early CCLAD Participants

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Early CCLAD ParticipantsSurvey Score Related Factors: Screened Positive for AnxietyBaseline9 Participants
Early CCLAD ParticipantsSurvey Score Related Factors: Screened Positive for Anxiety6 Month Follow-Up6 Participants
Primary

Survey Score Related Factors: Screened Positive for Depression

Depression measured via Patient health questionnaire depression assessment (PHQ-9); 9 questions with 0-3 score for each answer. Interpretation of score: 0-4= minimal or no depression; 5-9= mild depression; 10-14=moderate depression. For this study, we considered a positive screen for depression as a PHQ-9 score of \>=10. This analysis includes only those who participated in baseline and 6 month surveys.

Time frame: baseline and 6 month surveys

Population: As this was the pilot study/feasibility trial, the study design was not intended to compare the intervention group to a control group. This pilot study did not have a control group. Data was not collected from the Non Early CCLAD Participants

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Early CCLAD ParticipantsSurvey Score Related Factors: Screened Positive for DepressionBaseline10 Participants
Early CCLAD ParticipantsSurvey Score Related Factors: Screened Positive for Depression6 Month Follow-Up4 Participants
Primary

Survey Score Related Factors: Screening Positive for Low of Social Support

Social Support measured via Social support (BS6) scale; 6 questions with scores 1-4 for each answer; Interpretation of total score: 6-11= low (a positive screen for lack of social support), 12-17=moderate (at least occasional support); 18-23= high; 24=very high (maximum, always supported). For this study we considered \<= 11 as a positive screen for low of social support. This analysis includes only those who participated in baseline and 6 month surveys.

Time frame: baseline and 6 month surveys

Population: As this was the pilot study/feasibility trial, the study design was not intended to compare the intervention group to a control group. This pilot study did not have a control group. Data was not collected from the Non Early CCLAD Participants

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Early CCLAD ParticipantsSurvey Score Related Factors: Screening Positive for Low of Social Supportbaseline4 Participants
Early CCLAD ParticipantsSurvey Score Related Factors: Screening Positive for Low of Social Support6 month survey2 Participants
Primary

Survey Score Related Factors: Screening Positive for PTSD

PTSD measured via Post-traumatic stress disorder (PCL-6) scale; 6 questions with 1-5 score for each question; Interpretation of Total score: greater than or equal to 14 is a positive screen. This analysis includes only those who participated in baseline and 6 month surveys.

Time frame: baseline and 6 month surveys

Population: As this was the pilot study/feasibility trial, the study design was not intended to compare the intervention group to a control group. This pilot study did not have a control group. Data was not collected from the Non Early CCLAD Participants

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Early CCLAD ParticipantsSurvey Score Related Factors: Screening Positive for PTSDBaseline12 Participants
Early CCLAD ParticipantsSurvey Score Related Factors: Screening Positive for PTSD6 Month Follow-Up9 Participants
Primary

Survey Score Related to Psychosocial Factors: Perceived Health

Question: In general, would you say your health is excellent, very good, good, fair or poor? Answer options: Excellent, very good, good, fair, poor, do not know, no answer This is among participants who completed both baseline and follow-up surveys only.

Time frame: baseline survey and 6 month follow-up survey

Population: As this was the pilot study/feasibility trial, the study design was not intended to compare the intervention group to a control group. This pilot study did not have a control group. Data was not collected from the Non Early CCLAD Participants

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Early CCLAD ParticipantsSurvey Score Related to Psychosocial Factors: Perceived HealthBaselineFair/Poor11 Participants
Early CCLAD ParticipantsSurvey Score Related to Psychosocial Factors: Perceived HealthBaselineGood/Very Good10 Participants
Early CCLAD ParticipantsSurvey Score Related to Psychosocial Factors: Perceived Health6 Month Follow-UpFair/Poor5 Participants
Early CCLAD ParticipantsSurvey Score Related to Psychosocial Factors: Perceived Health6 Month Follow-UpGood/Very Good16 Participants
Primary

Total Number of Clinic Visits Per Participant (Incl. CCLAD Visits)

All clinic and CCLAD visits per participant

Time frame: 6 months

Population: As this was the pilot study/feasibility trial, the study design was not intended to compare the intervention group to a control group. This pilot study did not have a control group. Data was not collected from the Non Early CCLAD Participants

ArmMeasureValue (MEAN)
Early CCLAD ParticipantsTotal Number of Clinic Visits Per Participant (Incl. CCLAD Visits)5.1 visits

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026