Trial Outcomes & Findings for Early Community Client-LED ART Delivery in Nakivale Refugee Settlement (NCT NCT04736316)
NCT ID: NCT04736316
Last Updated: 2023-07-11
Results Overview
Attendance in one Early CCLAD group meeting (yes/no)
COMPLETED
NA
92 participants
Within 90 days of study initiation excluding the day of diagnosis
2023-07-11
Participant Flow
Participant milestones
| Measure |
Early CCLAD Participants
Subjects receiving Early CCLAD intervention
|
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 data to compare pilot study participants to non-participants, not as a control group.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
61
|
|
Overall Study
COMPLETED
|
31
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Community Client-LED ART Delivery in Nakivale Refugee Settlement
Baseline characteristics by cohort
| Measure |
Early CCLAD Participants
n=31 Participants
Subjects receiving CCLAD intervention
|
Non Early CCLAD Participants
n=61 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.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
35.4 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
31.9 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
33.1 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
31 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Refugees
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Education
No School
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Education
Some Primary School
|
17 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Education
Completed Primary School
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Education
Beyond Primary School
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Willingness to particpate in an Early CCLAD group, n(%)
|
31 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Mental Health Conditions
Anxiety
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Mental Health Conditions
Depression
|
15 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Mental Health Conditions
Low Social Support
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Mental Health Conditions
PTSD
|
20 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Self-Reported Health Status
Fair/Poor
|
16 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Self-Reported Health Status
Good/Very Good
|
15 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 90 days of study initiation excluding the day of diagnosisPopulation: Data was not collected from the "Non Early CCLAD Participants"
Attendance in one Early CCLAD group meeting (yes/no)
Outcome measures
| Measure |
Early CCLAD Participants
n=31 Participants
Subjects receiving Early CCLAD intervention
|
|---|---|
|
Number of Participants in HIV Care (Linkage) Among the Early CCLAD Participants
|
31 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Data was not collected from the "Non 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
Outcome measures
| Measure |
Early CCLAD Participants
n=31 Participants
Subjects receiving Early CCLAD intervention
|
|---|---|
|
Number of Early CCLAD Group Visits Attended (Retention) Among Early CCLAD Participants
|
3.3 Early CCLAD group visits
Interval 2.0 to 5.0
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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"
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
Outcome measures
| Measure |
Early CCLAD Participants
n=31 Participants
Subjects receiving Early CCLAD intervention
|
|---|---|
|
ART Initiation
|
31 Participants
|
PRIMARY outcome
Timeframe: 6 month periodPopulation: 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"
Viral suppression defined by \<1000 copies/mL or CD4 count \>250 cells/mm3 as documented in the HIV clinic records
Outcome measures
| Measure |
Early CCLAD Participants
n=31 Participants
Subjects receiving Early CCLAD intervention
|
|---|---|
|
Clinical Outcomes: Number of Participants With Viral Suppression
Virally Suppressed (VL <1000 or CD4>250)
|
20 Participants
|
|
Clinical Outcomes: Number of Participants With Viral Suppression
Not Virally Suppressed (VL≥1000 or CD4≤250)
|
3 Participants
|
|
Clinical Outcomes: Number of Participants With Viral Suppression
Missing Clinical Data
|
8 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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"
All clinic and CCLAD visits per participant
Outcome measures
| Measure |
Early CCLAD Participants
n=31 Participants
Subjects receiving Early CCLAD intervention
|
|---|---|
|
Total Number of Clinic Visits Per Participant (Incl. CCLAD Visits)
|
5.1 visits
Interval 4.0 to 6.0
|
PRIMARY outcome
Timeframe: baseline survey and 6 month follow-up surveyPopulation: 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"
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.
Outcome measures
| Measure |
Early CCLAD Participants
n=21 Participants
Subjects receiving Early CCLAD intervention
|
|---|---|
|
Survey Score Related to Psychosocial Factors: Perceived Health
Baseline · Fair/Poor
|
11 Participants
|
|
Survey Score Related to Psychosocial Factors: Perceived Health
Baseline · Good/Very Good
|
10 Participants
|
|
Survey Score Related to Psychosocial Factors: Perceived Health
6 Month Follow-Up · Fair/Poor
|
5 Participants
|
|
Survey Score Related to Psychosocial Factors: Perceived Health
6 Month Follow-Up · Good/Very Good
|
16 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 month surveysPopulation: 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"
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.
Outcome measures
| Measure |
Early CCLAD Participants
n=21 Participants
Subjects receiving Early CCLAD intervention
|
|---|---|
|
Survey Score Related Factors: Screened Positive for Depression
Baseline
|
10 Participants
|
|
Survey Score Related Factors: Screened Positive for Depression
6 Month Follow-Up
|
4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: 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"
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.
Outcome measures
| Measure |
Early CCLAD Participants
n=21 Participants
Subjects receiving Early CCLAD intervention
|
|---|---|
|
Survey Score Related Factors: Screened Positive for Anxiety
6 Month Follow-Up
|
6 Participants
|
|
Survey Score Related Factors: Screened Positive for Anxiety
Baseline
|
9 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 month surveysPopulation: 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"
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.
Outcome measures
| Measure |
Early CCLAD Participants
n=21 Participants
Subjects receiving Early CCLAD intervention
|
|---|---|
|
Survey Score Related Factors: Screening Positive for PTSD
Baseline
|
12 Participants
|
|
Survey Score Related Factors: Screening Positive for PTSD
6 Month Follow-Up
|
9 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 month surveysPopulation: 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"
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.
Outcome measures
| Measure |
Early CCLAD Participants
n=21 Participants
Subjects receiving Early CCLAD intervention
|
|---|---|
|
Survey Score Related Factors: Screening Positive for Low of Social Support
6 month survey
|
2 Participants
|
|
Survey Score Related Factors: Screening Positive for Low of Social Support
baseline
|
4 Participants
|
Adverse Events
Early CCLAD Participants
Non Early CCLAD Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place