Trial Outcomes & Findings for Extending HIV Care Beyond the Rural Health Center (NCT NCT00371540)
NCT ID: NCT00371540
Last Updated: 2016-12-20
Results Overview
Number of Subjects Lost to follow-up
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
208 participants
Primary outcome timeframe
12 months
Results posted on
2016-12-20
Participant Flow
Participant milestones
| Measure |
I Routine Care
Routine care in the clinic
|
II Home Visits
Follow-up in clinic every 3 months, home visits monthly
Home visit by community care coordinators: Decrease in patient visits to the clinic from the standard of once per month to every 3 months with home visits monthly.
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
96
|
|
Overall Study
COMPLETED
|
102
|
87
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Extending HIV Care Beyond the Rural Health Center
Baseline characteristics by cohort
| Measure |
I Routine Care
n=112 Participants
Routine care in the clinic
|
II Home Visits
n=96 Participants
Follow-up in clinic every 3 months, home visits monthly
Home visit by community care coordinators: Decrease in patient visits to the clinic from the standard of once per month to every 3 months with home visits monthly.
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
112 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Gender
Female
|
81 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Gender
Male
|
31 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Region of Enrollment
Kenya
|
112 participants
n=5 Participants
|
96 participants
n=7 Participants
|
208 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsNumber of Subjects Lost to follow-up
Outcome measures
| Measure |
I Rountine Care
n=112 Participants
|
II Home Visits
n=96 Participants
|
|---|---|---|
|
Lost to Follow-up
|
5 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 12 monthsDetectable VL at 12 months
Outcome measures
| Measure |
I Rountine Care
n=96 Participants
|
II Home Visits
n=86 Participants
|
|---|---|---|
|
Viral Load
|
13 participants
|
9 participants
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
I Rountine Care
n=112 Participants
|
II Home Visits
n=96 Participants
|
|---|---|---|
|
Death
|
0 participants
|
1 participants
|
Adverse Events
I Rountine Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
II Home Visits
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
I Rountine Care
n=112 participants at risk
|
II Home Visits
n=96 participants at risk
|
|---|---|---|
|
Injury, poisoning and procedural complications
Death
|
0.00%
0/112
|
1.0%
1/96 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Kara Wools-Kaloustian
Indiana University School of Medicine
Phone: 317-274-7936
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place