Trial Outcomes & Findings for Retention in HIV Care for Hispanic Immigrants (NCT NCT03484117)
NCT ID: NCT03484117
Last Updated: 2022-12-23
Results Overview
A dichotomized outcome (yes/no) with yes defined as at least one visit to HIV clinic at both time periods (week 1-16 and week 17-32), and no defined as no HIV visit from at least one time period. Responses determined by review of the medical record for evidence of attended HIV clinic visits.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
32 weeks
Results posted on
2022-12-23
Participant Flow
Participant milestones
| Measure |
Treatment as Usual
Participants in this arm will receive bilingual written materials on healthy living with HIV at the baseline visit. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants.
|
Community Health Worker
Participants in the intervention arm will receive 5 one-on-one sessions over 24 weeks with a Spanish-speaking CHW. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants
Community Health Worker: Participants will receive 5 one-on-one sessions with a CHW over 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
35
|
|
Overall Study
COMPLETED
|
30
|
31
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Treatment as Usual
Participants in this arm will receive bilingual written materials on healthy living with HIV at the baseline visit. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants.
|
Community Health Worker
Participants in the intervention arm will receive 5 one-on-one sessions over 24 weeks with a Spanish-speaking CHW. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants
Community Health Worker: Participants will receive 5 one-on-one sessions with a CHW over 24 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Declined participation in exit assess
|
1
|
1
|
Baseline Characteristics
Number of individuals analyzed were the total number of participants with available laboratory data.
Baseline characteristics by cohort
| Measure |
Treatment as Usual
n=32 Participants
Participants in this arm will receive bilingual written materials on healthy living with HIV at the baseline visit. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants.
|
Community Health Worker
n=35 Participants
Participants in the intervention arm will receive 5 one-on-one sessions over 24 weeks with a Spanish-speaking CHW. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants
Community Health Worker: Participants will receive 5 one-on-one sessions with a CHW over 24 weeks.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-25 years
|
1 Participants
n=32 Participants
|
3 Participants
n=35 Participants
|
4 Participants
n=67 Participants
|
|
Age, Customized
>=26 years
|
31 Participants
n=32 Participants
|
32 Participants
n=35 Participants
|
63 Participants
n=67 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=32 Participants
|
18 Participants
n=35 Participants
|
28 Participants
n=67 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=32 Participants
|
17 Participants
n=35 Participants
|
39 Participants
n=67 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
32 Participants
n=32 Participants
|
35 Participants
n=35 Participants
|
67 Participants
n=67 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=32 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=67 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=32 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=67 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=32 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=67 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=32 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=67 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=32 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=67 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=32 Participants
|
4 Participants
n=35 Participants
|
8 Participants
n=67 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=32 Participants
|
3 Participants
n=35 Participants
|
8 Participants
n=67 Participants
|
|
Race (NIH/OMB)
More than one race
|
19 Participants
n=32 Participants
|
22 Participants
n=35 Participants
|
41 Participants
n=67 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=32 Participants
|
6 Participants
n=35 Participants
|
10 Participants
n=67 Participants
|
|
HIV Viral suppression
|
27 Participants
n=31 Participants • Number of individuals analyzed were the total number of participants with available laboratory data.
|
31 Participants
n=35 Participants • Number of individuals analyzed were the total number of participants with available laboratory data.
|
58 Participants
n=66 Participants • Number of individuals analyzed were the total number of participants with available laboratory data.
|
|
Baseline CD4 cell count
0-200 cells/mm^3
|
1 Participants
n=31 Participants • Number of participants analyzed were the total number of participants with available laboratory data.
|
3 Participants
n=35 Participants • Number of participants analyzed were the total number of participants with available laboratory data.
|
4 Participants
n=66 Participants • Number of participants analyzed were the total number of participants with available laboratory data.
|
|
Baseline CD4 cell count
201-500 cells/mm^3
|
11 Participants
n=31 Participants • Number of participants analyzed were the total number of participants with available laboratory data.
|
7 Participants
n=35 Participants • Number of participants analyzed were the total number of participants with available laboratory data.
|
18 Participants
n=66 Participants • Number of participants analyzed were the total number of participants with available laboratory data.
|
|
Baseline CD4 cell count
>500 cells/mm^3
|
19 Participants
n=31 Participants • Number of participants analyzed were the total number of participants with available laboratory data.
|
25 Participants
n=35 Participants • Number of participants analyzed were the total number of participants with available laboratory data.
|
44 Participants
n=66 Participants • Number of participants analyzed were the total number of participants with available laboratory data.
|
PRIMARY outcome
Timeframe: 32 weeksA dichotomized outcome (yes/no) with yes defined as at least one visit to HIV clinic at both time periods (week 1-16 and week 17-32), and no defined as no HIV visit from at least one time period. Responses determined by review of the medical record for evidence of attended HIV clinic visits.
Outcome measures
| Measure |
Treatment as Usual
n=32 Participants
Participants in this arm will receive bilingual written materials on healthy living with HIV at the baseline visit. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants.
|
Community Health Worker
n=35 Participants
Participants in the intervention arm will receive 5 one-on-one sessions over 24 weeks with a Spanish-speaking CHW. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants
Community Health Worker: Participants will receive 5 one-on-one sessions with a CHW over 24 weeks.
|
|---|---|---|
|
Retention in Care - Yes Responses
|
19 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: From baseline to week-24Population: HIV viral load laboratory data at week-24 available for a total of 66 participants.
Participants with HIV viral load \<200 copies/ml
Outcome measures
| Measure |
Treatment as Usual
n=31 Participants
Participants in this arm will receive bilingual written materials on healthy living with HIV at the baseline visit. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants.
|
Community Health Worker
n=35 Participants
Participants in the intervention arm will receive 5 one-on-one sessions over 24 weeks with a Spanish-speaking CHW. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants
Community Health Worker: Participants will receive 5 one-on-one sessions with a CHW over 24 weeks.
|
|---|---|---|
|
Number of Participants With HIV Viral Load Suppression up to Week-24
|
30 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: From baseline to week-24Population: CD4 count laboratory data at week-24 available for 66 participants.
Change in CD4 T-cell count from baseline to week-24 post-randomization
Outcome measures
| Measure |
Treatment as Usual
n=31 Participants
Participants in this arm will receive bilingual written materials on healthy living with HIV at the baseline visit. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants.
|
Community Health Worker
n=35 Participants
Participants in the intervention arm will receive 5 one-on-one sessions over 24 weeks with a Spanish-speaking CHW. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants
Community Health Worker: Participants will receive 5 one-on-one sessions with a CHW over 24 weeks.
|
|---|---|---|
|
Change in CD4 T-cell Count Over 24 Weeks
|
6.0 1000 cells/uL
Standard Deviation 174.8
|
25.7 1000 cells/uL
Standard Deviation 137.0
|
SECONDARY outcome
Timeframe: Baseline to week-48Population: HIV viral load laboratory data at week-48 available for 59 participants.
Number of participants with HIV RNA \<200 copies/ml
Outcome measures
| Measure |
Treatment as Usual
n=28 Participants
Participants in this arm will receive bilingual written materials on healthy living with HIV at the baseline visit. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants.
|
Community Health Worker
n=31 Participants
Participants in the intervention arm will receive 5 one-on-one sessions over 24 weeks with a Spanish-speaking CHW. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants
Community Health Worker: Participants will receive 5 one-on-one sessions with a CHW over 24 weeks.
|
|---|---|---|
|
Number of Participants With HIV Viral Load Suppression up to 48 Weeks.
|
27 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Baseline to week-48Population: CD4 count laboratory data at week-48 available for 59 participants.
Change in CD4 T-cell count from baseline to week-48 post-randomization
Outcome measures
| Measure |
Treatment as Usual
n=28 Participants
Participants in this arm will receive bilingual written materials on healthy living with HIV at the baseline visit. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants.
|
Community Health Worker
n=31 Participants
Participants in the intervention arm will receive 5 one-on-one sessions over 24 weeks with a Spanish-speaking CHW. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants
Community Health Worker: Participants will receive 5 one-on-one sessions with a CHW over 24 weeks.
|
|---|---|---|
|
Change in CD4 T-cell Count Over 48 Weeks.
|
-2.4 1000 cells/uL
Standard Deviation 179.4
|
29.6 1000 cells/uL
Standard Deviation 184.6
|
Adverse Events
Treatment as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Community Health Worker
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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