Trial Outcomes & Findings for Home Link: Post Hospital Care to Reduce HIV Mortality in South Africa (NCT NCT04436289)
NCT ID: NCT04436289
Last Updated: 2024-01-09
Results Overview
Number of deaths from any cause.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
195 participants
Primary outcome timeframe
6 months after hospital discharge
Results posted on
2024-01-09
Participant Flow
Participant milestones
| Measure |
PLWH Home Link Study Arm
The Home Link intervention will be delivered by a home visit team including a primary care nurse and counselor trained in patient-centered counseling. A rotating hospital-based doctor will be available for pre-home visit clinical file review and post-visit discussion, via cell phone, for decision making and input on patient care during a household visit. We have termed this individual a "discharge officer". The discharge officer will be a Tshepong clinician who is working in the hospital. Supporting Home Link is expected to take \<30 minutes of the physician's time during the day. For study-specific concerns, the team will consult with a GCP-trained, PHRU research doctor based at Tshepong Hospital.
Home Link: In the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.
|
PLWH Care-as-usual (CAU) Study Arm
Participants will receive standard discharge care as provided at Tshepong Hospital during the study. This currently includes discharge counseling from a trained discharge counselor and will be provided with a follow-up return date (usually two weeks post-hospital). Discharge counseling will include a review of discharge medications and instructions regarding follow-up care visits.
|
PLWOH Home Link Study Arm
The Home Link intervention will be delivered by a home visit team including a primary care nurse and counselor trained in patient-centered counseling. A rotating hospital-based doctor will be available for pre-home visit clinical file review and post-visit discussion, via cell phone, for decision making and input on patient care during a household visit. We have termed this individual a "discharge officer". The discharge officer will be a Tshepong clinician who is working in the hospital. Supporting Home Link is expected to take \<30 minutes of the physician's time during the day. For study-specific concerns, the team will consult with a GCP-trained, PHRU research doctor based at Tshepong Hospital.
Home Link: In the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.
|
PLWOH Care as Usual (CAU) Study Arm
Participants will receive standard discharge care as provided at Tshepong Hospital during the study. This currently includes discharge counseling from a trained discharge counselor and will be provided with a follow-up return date (usually two weeks post-hospital). Discharge counseling will include a review of discharge medications and instructions regarding follow-up care visits.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
63
|
62
|
35
|
35
|
|
Overall Study
COMPLETED
|
55
|
51
|
30
|
31
|
|
Overall Study
NOT COMPLETED
|
8
|
11
|
5
|
4
|
Reasons for withdrawal
| Measure |
PLWH Home Link Study Arm
The Home Link intervention will be delivered by a home visit team including a primary care nurse and counselor trained in patient-centered counseling. A rotating hospital-based doctor will be available for pre-home visit clinical file review and post-visit discussion, via cell phone, for decision making and input on patient care during a household visit. We have termed this individual a "discharge officer". The discharge officer will be a Tshepong clinician who is working in the hospital. Supporting Home Link is expected to take \<30 minutes of the physician's time during the day. For study-specific concerns, the team will consult with a GCP-trained, PHRU research doctor based at Tshepong Hospital.
Home Link: In the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.
|
PLWH Care-as-usual (CAU) Study Arm
Participants will receive standard discharge care as provided at Tshepong Hospital during the study. This currently includes discharge counseling from a trained discharge counselor and will be provided with a follow-up return date (usually two weeks post-hospital). Discharge counseling will include a review of discharge medications and instructions regarding follow-up care visits.
|
PLWOH Home Link Study Arm
The Home Link intervention will be delivered by a home visit team including a primary care nurse and counselor trained in patient-centered counseling. A rotating hospital-based doctor will be available for pre-home visit clinical file review and post-visit discussion, via cell phone, for decision making and input on patient care during a household visit. We have termed this individual a "discharge officer". The discharge officer will be a Tshepong clinician who is working in the hospital. Supporting Home Link is expected to take \<30 minutes of the physician's time during the day. For study-specific concerns, the team will consult with a GCP-trained, PHRU research doctor based at Tshepong Hospital.
Home Link: In the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.
|
PLWOH Care as Usual (CAU) Study Arm
Participants will receive standard discharge care as provided at Tshepong Hospital during the study. This currently includes discharge counseling from a trained discharge counselor and will be provided with a follow-up return date (usually two weeks post-hospital). Discharge counseling will include a review of discharge medications and instructions regarding follow-up care visits.
|
|---|---|---|---|---|
|
Overall Study
Death prior to hospital discharge
|
8
|
5
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
4
|
0
|
|
Overall Study
Extended hospital stay
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
1
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
PLWH Home Link Study Arm
n=55 Participants
The Home Link intervention will be delivered by a home visit team including a primary care nurse and counselor trained in patient-centered counseling. A rotating hospital-based doctor will be available for pre-home visit clinical file review and post-visit discussion, via cell phone, for decision making and input on patient care during a household visit. We have termed this individual a "discharge officer". The discharge officer will be a Tshepong clinician who is working in the hospital. Supporting Home Link is expected to take \<30 minutes of the physician's time during the day. For study-specific concerns, the team will consult with a GCP-trained, PHRU research doctor based at Tshepong Hospital.
Home Link: In the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.
|
PLWH Care-as-usual (CAU) Study Arm
n=56 Participants
Participants will receive standard discharge care as provided at Tshepong Hospital during the study. This currently includes discharge counseling from a trained discharge counselor and will be provided with a follow-up return date (usually two weeks post-hospital). Discharge counseling will include a review of discharge medications and instructions regarding follow-up care visits.
|
PLWOH Home Link Study Arm
n=35 Participants
The Home Link intervention will be delivered by a home visit team including a primary care nurse and counselor trained in patient-centered counseling. A rotating hospital-based doctor will be available for pre-home visit clinical file review and post-visit discussion, via cell phone, for decision making and input on patient care during a household visit. We have termed this individual a "discharge officer". The discharge officer will be a Tshepong clinician who is working in the hospital. Supporting Home Link is expected to take \<30 minutes of the physician's time during the day. For study-specific concerns, the team will consult with a GCP-trained, PHRU research doctor based at Tshepong Hospital.
Home Link: In the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.
|
PLWOH Care-as-usual (CAU) Study Arm
n=34 Participants
Participants will receive standard discharge care as provided at Tshepong Hospital during the study. This currently includes discharge counseling from a trained discharge counselor and will be provided with a follow-up return date (usually two weeks post-hospital). Discharge counseling will include a review of discharge medications and instructions regarding follow-up care visits.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=180 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=55 Participants
|
54 Participants
n=56 Participants
|
29 Participants
n=35 Participants
|
29 Participants
n=34 Participants
|
165 Participants
n=180 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=55 Participants
|
2 Participants
n=56 Participants
|
6 Participants
n=35 Participants
|
5 Participants
n=34 Participants
|
15 Participants
n=180 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=55 Participants
|
37 Participants
n=56 Participants
|
19 Participants
n=35 Participants
|
20 Participants
n=34 Participants
|
116 Participants
n=180 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=55 Participants
|
19 Participants
n=56 Participants
|
16 Participants
n=35 Participants
|
14 Participants
n=34 Participants
|
64 Participants
n=180 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
South Africa
|
55 Participants
n=55 Participants
|
56 Participants
n=56 Participants
|
35 Participants
n=35 Participants
|
34 Participants
n=34 Participants
|
180 Participants
n=180 Participants
|
|
HIV status at admission
HIV-negative
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
35 Participants
n=35 Participants
|
34 Participants
n=34 Participants
|
69 Participants
n=180 Participants
|
|
HIV status at admission
HIV-positive without reported prior knowledge
|
3 Participants
n=55 Participants
|
2 Participants
n=56 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
5 Participants
n=180 Participants
|
|
HIV status at admission
Known HIV-positive on admission
|
52 Participants
n=55 Participants
|
54 Participants
n=56 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
106 Participants
n=180 Participants
|
|
Advanced HIV at admission
No
|
13 Participants
n=55 Participants
|
19 Participants
n=56 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
32 Participants
n=180 Participants
|
|
Advanced HIV at admission
Yes
|
41 Participants
n=55 Participants
|
37 Participants
n=56 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
78 Participants
n=180 Participants
|
|
Advanced HIV at admission
N/A - HIV negative
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
35 Participants
n=35 Participants
|
34 Participants
n=34 Participants
|
69 Participants
n=180 Participants
|
|
Advanced HIV at admission
Missing
|
1 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
1 Participants
n=180 Participants
|
|
On ART at admission
No
|
26 Participants
n=55 Participants
|
15 Participants
n=56 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
41 Participants
n=180 Participants
|
|
On ART at admission
Yes
|
28 Participants
n=55 Participants
|
41 Participants
n=56 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
69 Participants
n=180 Participants
|
|
On ART at admission
Missing
|
1 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
1 Participants
n=180 Participants
|
|
On ART at admission
N/A - HIV negative
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
35 Participants
n=35 Participants
|
34 Participants
n=34 Participants
|
69 Participants
n=180 Participants
|
|
Most recent CD4 count (result within the last 6 months)
<50
|
14 Participants
n=55 Participants
|
13 Participants
n=56 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
27 Participants
n=180 Participants
|
|
Most recent CD4 count (result within the last 6 months)
50-199
|
16 Participants
n=55 Participants
|
12 Participants
n=56 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
28 Participants
n=180 Participants
|
|
Most recent CD4 count (result within the last 6 months)
200-349
|
6 Participants
n=55 Participants
|
7 Participants
n=56 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
13 Participants
n=180 Participants
|
|
Most recent CD4 count (result within the last 6 months)
350-499
|
9 Participants
n=55 Participants
|
13 Participants
n=56 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
22 Participants
n=180 Participants
|
|
Most recent CD4 count (result within the last 6 months)
Missing
|
10 Participants
n=55 Participants
|
11 Participants
n=56 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
21 Participants
n=180 Participants
|
|
Most recent CD4 count (result within the last 6 months)
N/A - HIV negative
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
35 Participants
n=35 Participants
|
34 Participants
n=34 Participants
|
69 Participants
n=180 Participants
|
|
Viral load result
<50
|
7 Participants
n=55 Participants
|
19 Participants
n=56 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
26 Participants
n=180 Participants
|
|
Viral load result
050-999
|
13 Participants
n=55 Participants
|
13 Participants
n=56 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
26 Participants
n=180 Participants
|
|
Viral load result
1000+
|
35 Participants
n=55 Participants
|
23 Participants
n=56 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
58 Participants
n=180 Participants
|
|
Viral load result
Missing
|
0 Participants
n=55 Participants
|
1 Participants
n=56 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
1 Participants
n=180 Participants
|
|
Viral load result
N/A - HIV negative
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
35 Participants
n=35 Participants
|
34 Participants
n=34 Participants
|
69 Participants
n=180 Participants
|
|
Food security
Food secure
|
22 Participants
n=55 Participants
|
47 Participants
n=56 Participants
|
20 Participants
n=35 Participants
|
31 Participants
n=34 Participants
|
120 Participants
n=180 Participants
|
|
Food security
Food insecure
|
33 Participants
n=55 Participants
|
9 Participants
n=56 Participants
|
15 Participants
n=35 Participants
|
3 Participants
n=34 Participants
|
60 Participants
n=180 Participants
|
|
Alcohol use
Never
|
30 Participants
n=55 Participants
|
42 Participants
n=56 Participants
|
24 Participants
n=35 Participants
|
22 Participants
n=34 Participants
|
118 Participants
n=180 Participants
|
|
Alcohol use
Monthly or less
|
12 Participants
n=55 Participants
|
9 Participants
n=56 Participants
|
9 Participants
n=35 Participants
|
9 Participants
n=34 Participants
|
39 Participants
n=180 Participants
|
|
Alcohol use
2-4 per month
|
4 Participants
n=55 Participants
|
1 Participants
n=56 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=34 Participants
|
9 Participants
n=180 Participants
|
|
Alcohol use
2-3 per week
|
2 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
3 Participants
n=180 Participants
|
|
Alcohol use
4 or more per week
|
7 Participants
n=55 Participants
|
4 Participants
n=56 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
11 Participants
n=180 Participants
|
|
HIV stigma scale
|
22 units on a scale
n=55 Participants • HIV stigma scale was assessed for participants living with HIV only. Data not collected from participants living without HIV
|
21 units on a scale
n=56 Participants • HIV stigma scale was assessed for participants living with HIV only. Data not collected from participants living without HIV
|
—
|
—
|
21 units on a scale
n=111 Participants • HIV stigma scale was assessed for participants living with HIV only. Data not collected from participants living without HIV
|
|
Modified social support (scaled score)
|
100 scaled score
n=55 Participants
|
100 scaled score
n=56 Participants
|
100 scaled score
n=35 Participants
|
100 scaled score
n=34 Participants
|
100 scaled score
n=180 Participants
|
|
CES-D 10
|
5 units on a scale
n=55 Participants
|
6 units on a scale
n=56 Participants
|
6 units on a scale
n=35 Participants
|
5 units on a scale
n=34 Participants
|
6 units on a scale
n=180 Participants
|
|
Duration of hospitalization
|
7 days
n=54 Participants • Two participants were missing records for the index admission. Thus duration of index hospitalization available for 178 of 180 participants.
|
6 days
n=56 Participants • Two participants were missing records for the index admission. Thus duration of index hospitalization available for 178 of 180 participants.
|
4 days
n=35 Participants • Two participants were missing records for the index admission. Thus duration of index hospitalization available for 178 of 180 participants.
|
6 days
n=33 Participants • Two participants were missing records for the index admission. Thus duration of index hospitalization available for 178 of 180 participants.
|
6 days
n=178 Participants • Two participants were missing records for the index admission. Thus duration of index hospitalization available for 178 of 180 participants.
|
PRIMARY outcome
Timeframe: 6 months after hospital dischargePopulation: Analysis population excludes those who were late exclusions from the primary trial due to death prior to discharge or an extended hospital stay
Number of deaths from any cause.
Outcome measures
| Measure |
PLWH Home Link Study Arm
n=55 Participants
The Home Link intervention will be delivered by a home visit team including a primary care nurse and counselor trained in patient-centered counseling. A rotating hospital-based doctor will be available for pre-home visit clinical file review and post-visit discussion, via cell phone, for decision making and input on patient care during a household visit. We have termed this individual a "discharge officer". The discharge officer will be a Tshepong clinician who is working in the hospital. Supporting Home Link is expected to take \<30 minutes of the physician's time during the day. For study-specific concerns, the team will consult with a GCP-trained, PHRU research doctor based at Tshepong Hospital.
Home Link: In the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.
|
PLWH Care-as-usual (CAU) Study Arm
n=56 Participants
Participants will receive standard discharge care as provided at Tshepong Hospital during the study. This currently includes discharge counseling from a trained discharge counselor and will be provided with a follow-up return date (usually two weeks post-hospital). Discharge counseling will include a review of discharge medications and instructions regarding follow-up care visits.
|
PLWOH Home Link Study Arm
n=35 Participants
The Home Link intervention will be delivered by a home visit team including a primary care nurse and counselor trained in patient-centered counseling. A rotating hospital-based doctor will be available for pre-home visit clinical file review and post-visit discussion, via cell phone, for decision making and input on patient care during a household visit. We have termed this individual a "discharge officer". The discharge officer will be a Tshepong clinician who is working in the hospital. Supporting Home Link is expected to take \<30 minutes of the physician's time during the day. For study-specific concerns, the team will consult with a GCP-trained, PHRU research doctor based at Tshepong Hospital.
Home Link: In the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.
|
PLWOH Care-as-usual (CAU) Study Arm
n=34 Participants
Participants will receive standard discharge care as provided at Tshepong Hospital during the study. This currently includes discharge counseling from a trained discharge counselor and will be provided with a follow-up return date (usually two weeks post-hospital). Discharge counseling will include a review of discharge medications and instructions regarding follow-up care visits.
|
|---|---|---|---|---|
|
Mortality at 6 Months
|
4 Participants
|
10 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 months after hospital dischargePopulation: Analysis population excludes those who were late exclusions from the primary trial due to death prior to discharge or an extended hospital stay
Number of deaths from any cause.
Outcome measures
| Measure |
PLWH Home Link Study Arm
n=55 Participants
The Home Link intervention will be delivered by a home visit team including a primary care nurse and counselor trained in patient-centered counseling. A rotating hospital-based doctor will be available for pre-home visit clinical file review and post-visit discussion, via cell phone, for decision making and input on patient care during a household visit. We have termed this individual a "discharge officer". The discharge officer will be a Tshepong clinician who is working in the hospital. Supporting Home Link is expected to take \<30 minutes of the physician's time during the day. For study-specific concerns, the team will consult with a GCP-trained, PHRU research doctor based at Tshepong Hospital.
Home Link: In the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.
|
PLWH Care-as-usual (CAU) Study Arm
n=56 Participants
Participants will receive standard discharge care as provided at Tshepong Hospital during the study. This currently includes discharge counseling from a trained discharge counselor and will be provided with a follow-up return date (usually two weeks post-hospital). Discharge counseling will include a review of discharge medications and instructions regarding follow-up care visits.
|
PLWOH Home Link Study Arm
n=35 Participants
The Home Link intervention will be delivered by a home visit team including a primary care nurse and counselor trained in patient-centered counseling. A rotating hospital-based doctor will be available for pre-home visit clinical file review and post-visit discussion, via cell phone, for decision making and input on patient care during a household visit. We have termed this individual a "discharge officer". The discharge officer will be a Tshepong clinician who is working in the hospital. Supporting Home Link is expected to take \<30 minutes of the physician's time during the day. For study-specific concerns, the team will consult with a GCP-trained, PHRU research doctor based at Tshepong Hospital.
Home Link: In the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.
|
PLWOH Care-as-usual (CAU) Study Arm
n=34 Participants
Participants will receive standard discharge care as provided at Tshepong Hospital during the study. This currently includes discharge counseling from a trained discharge counselor and will be provided with a follow-up return date (usually two weeks post-hospital). Discharge counseling will include a review of discharge medications and instructions regarding follow-up care visits.
|
|---|---|---|---|---|
|
Mortality at 12 Months
|
7 Participants
|
12 Participants
|
8 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 52 weeks post-hospital dischargePopulation: Among participants with at least one clinic or home visit
Time to first clinic or home visit post-hospital discharge.
Outcome measures
| Measure |
PLWH Home Link Study Arm
n=53 Participants
The Home Link intervention will be delivered by a home visit team including a primary care nurse and counselor trained in patient-centered counseling. A rotating hospital-based doctor will be available for pre-home visit clinical file review and post-visit discussion, via cell phone, for decision making and input on patient care during a household visit. We have termed this individual a "discharge officer". The discharge officer will be a Tshepong clinician who is working in the hospital. Supporting Home Link is expected to take \<30 minutes of the physician's time during the day. For study-specific concerns, the team will consult with a GCP-trained, PHRU research doctor based at Tshepong Hospital.
Home Link: In the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.
|
PLWH Care-as-usual (CAU) Study Arm
n=45 Participants
Participants will receive standard discharge care as provided at Tshepong Hospital during the study. This currently includes discharge counseling from a trained discharge counselor and will be provided with a follow-up return date (usually two weeks post-hospital). Discharge counseling will include a review of discharge medications and instructions regarding follow-up care visits.
|
PLWOH Home Link Study Arm
n=32 Participants
The Home Link intervention will be delivered by a home visit team including a primary care nurse and counselor trained in patient-centered counseling. A rotating hospital-based doctor will be available for pre-home visit clinical file review and post-visit discussion, via cell phone, for decision making and input on patient care during a household visit. We have termed this individual a "discharge officer". The discharge officer will be a Tshepong clinician who is working in the hospital. Supporting Home Link is expected to take \<30 minutes of the physician's time during the day. For study-specific concerns, the team will consult with a GCP-trained, PHRU research doctor based at Tshepong Hospital.
Home Link: In the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.
|
PLWOH Care-as-usual (CAU) Study Arm
n=25 Participants
Participants will receive standard discharge care as provided at Tshepong Hospital during the study. This currently includes discharge counseling from a trained discharge counselor and will be provided with a follow-up return date (usually two weeks post-hospital). Discharge counseling will include a review of discharge medications and instructions regarding follow-up care visits.
|
|---|---|---|---|---|
|
Time (Days) to Any Non-acute Follow-up
|
13 days
Interval 11.0 to 19.0
|
28 days
Interval 15.0 to 64.0
|
13 days
Interval 11.0 to 25.0
|
31 days
Interval 27.0 to 90.0
|
SECONDARY outcome
Timeframe: Up to 52 weeks post-hospital dischargePopulation: Analysis population excludes those who were late exclusions from the primary trial due to death prior to discharge or an extended hospital stay
Number of outpatient follow-up care (clinic or home visit) encounters
Outcome measures
| Measure |
PLWH Home Link Study Arm
n=55 Participants
The Home Link intervention will be delivered by a home visit team including a primary care nurse and counselor trained in patient-centered counseling. A rotating hospital-based doctor will be available for pre-home visit clinical file review and post-visit discussion, via cell phone, for decision making and input on patient care during a household visit. We have termed this individual a "discharge officer". The discharge officer will be a Tshepong clinician who is working in the hospital. Supporting Home Link is expected to take \<30 minutes of the physician's time during the day. For study-specific concerns, the team will consult with a GCP-trained, PHRU research doctor based at Tshepong Hospital.
Home Link: In the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.
|
PLWH Care-as-usual (CAU) Study Arm
n=56 Participants
Participants will receive standard discharge care as provided at Tshepong Hospital during the study. This currently includes discharge counseling from a trained discharge counselor and will be provided with a follow-up return date (usually two weeks post-hospital). Discharge counseling will include a review of discharge medications and instructions regarding follow-up care visits.
|
PLWOH Home Link Study Arm
n=35 Participants
The Home Link intervention will be delivered by a home visit team including a primary care nurse and counselor trained in patient-centered counseling. A rotating hospital-based doctor will be available for pre-home visit clinical file review and post-visit discussion, via cell phone, for decision making and input on patient care during a household visit. We have termed this individual a "discharge officer". The discharge officer will be a Tshepong clinician who is working in the hospital. Supporting Home Link is expected to take \<30 minutes of the physician's time during the day. For study-specific concerns, the team will consult with a GCP-trained, PHRU research doctor based at Tshepong Hospital.
Home Link: In the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.
|
PLWOH Care-as-usual (CAU) Study Arm
n=34 Participants
Participants will receive standard discharge care as provided at Tshepong Hospital during the study. This currently includes discharge counseling from a trained discharge counselor and will be provided with a follow-up return date (usually two weeks post-hospital). Discharge counseling will include a review of discharge medications and instructions regarding follow-up care visits.
|
|---|---|---|---|---|
|
Number of Outpatient Follow-up Care Encounters
|
11 visits
Interval 7.0 to 14.0
|
3.5 visits
Interval 1.5 to 7.0
|
7 visits
Interval 4.0 to 12.0
|
4 visits
Interval 0.0 to 6.0
|
SECONDARY outcome
Timeframe: Up to 52 weeks post-hospital dischargePopulation: Among those with at least one readmission
Number of nights spent in hospital post-initial discharge (among those with at least one readmission)
Outcome measures
| Measure |
PLWH Home Link Study Arm
n=21 Participants
The Home Link intervention will be delivered by a home visit team including a primary care nurse and counselor trained in patient-centered counseling. A rotating hospital-based doctor will be available for pre-home visit clinical file review and post-visit discussion, via cell phone, for decision making and input on patient care during a household visit. We have termed this individual a "discharge officer". The discharge officer will be a Tshepong clinician who is working in the hospital. Supporting Home Link is expected to take \<30 minutes of the physician's time during the day. For study-specific concerns, the team will consult with a GCP-trained, PHRU research doctor based at Tshepong Hospital.
Home Link: In the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.
|
PLWH Care-as-usual (CAU) Study Arm
n=24 Participants
Participants will receive standard discharge care as provided at Tshepong Hospital during the study. This currently includes discharge counseling from a trained discharge counselor and will be provided with a follow-up return date (usually two weeks post-hospital). Discharge counseling will include a review of discharge medications and instructions regarding follow-up care visits.
|
PLWOH Home Link Study Arm
n=17 Participants
The Home Link intervention will be delivered by a home visit team including a primary care nurse and counselor trained in patient-centered counseling. A rotating hospital-based doctor will be available for pre-home visit clinical file review and post-visit discussion, via cell phone, for decision making and input on patient care during a household visit. We have termed this individual a "discharge officer". The discharge officer will be a Tshepong clinician who is working in the hospital. Supporting Home Link is expected to take \<30 minutes of the physician's time during the day. For study-specific concerns, the team will consult with a GCP-trained, PHRU research doctor based at Tshepong Hospital.
Home Link: In the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.
|
PLWOH Care-as-usual (CAU) Study Arm
n=12 Participants
Participants will receive standard discharge care as provided at Tshepong Hospital during the study. This currently includes discharge counseling from a trained discharge counselor and will be provided with a follow-up return date (usually two weeks post-hospital). Discharge counseling will include a review of discharge medications and instructions regarding follow-up care visits.
|
|---|---|---|---|---|
|
Number of Nights of Hospital Readmission
|
9 nights
Interval 6.0 to 14.0
|
11.5 nights
Interval 6.0 to 21.0
|
10 nights
Interval 3.0 to 17.0
|
11.5 nights
Interval 6.5 to 20.5
|
SECONDARY outcome
Timeframe: Up to 52 weeks post-hospital dischargePopulation: Data not collected for specific study outcome
Participant-reported out-of-pocket costs for medical care
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 52 weeks post-hospital dischargePopulation: Intervention arm participants who completed in-depth interviews. Care-as-usual (CAU) arm participants were not interviewed.
Acceptability questionnaire and in-depth interviews with 7 acceptability domains for healthcare workers (HCWs) and participants and in-depth interviews for HCWs and participants. An a priori code book will be developed that reflects key analytic concepts of predisposing, enabling, and need characteristics from the Andersen Behavioral Model. During the process of reading and coding of transcripts using this initial coding scheme, additional codes may be added to document emerging themes of interest.
Outcome measures
| Measure |
PLWH Home Link Study Arm
n=33 Participants
The Home Link intervention will be delivered by a home visit team including a primary care nurse and counselor trained in patient-centered counseling. A rotating hospital-based doctor will be available for pre-home visit clinical file review and post-visit discussion, via cell phone, for decision making and input on patient care during a household visit. We have termed this individual a "discharge officer". The discharge officer will be a Tshepong clinician who is working in the hospital. Supporting Home Link is expected to take \<30 minutes of the physician's time during the day. For study-specific concerns, the team will consult with a GCP-trained, PHRU research doctor based at Tshepong Hospital.
Home Link: In the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.
|
PLWH Care-as-usual (CAU) Study Arm
Participants will receive standard discharge care as provided at Tshepong Hospital during the study. This currently includes discharge counseling from a trained discharge counselor and will be provided with a follow-up return date (usually two weeks post-hospital). Discharge counseling will include a review of discharge medications and instructions regarding follow-up care visits.
|
PLWOH Home Link Study Arm
n=8 Participants
The Home Link intervention will be delivered by a home visit team including a primary care nurse and counselor trained in patient-centered counseling. A rotating hospital-based doctor will be available for pre-home visit clinical file review and post-visit discussion, via cell phone, for decision making and input on patient care during a household visit. We have termed this individual a "discharge officer". The discharge officer will be a Tshepong clinician who is working in the hospital. Supporting Home Link is expected to take \<30 minutes of the physician's time during the day. For study-specific concerns, the team will consult with a GCP-trained, PHRU research doctor based at Tshepong Hospital.
Home Link: In the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.
|
PLWOH Care-as-usual (CAU) Study Arm
Participants will receive standard discharge care as provided at Tshepong Hospital during the study. This currently includes discharge counseling from a trained discharge counselor and will be provided with a follow-up return date (usually two weeks post-hospital). Discharge counseling will include a review of discharge medications and instructions regarding follow-up care visits.
|
|---|---|---|---|---|
|
Number of Participants Completing In-depth Interviews to Assess Acceptability of the Intervention
|
33 participants
|
—
|
8 participants
|
—
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: Among all screened participants who met eligibility criteria (pre-randomization).
Percentage of approached and eligible individuals who enroll.
Outcome measures
| Measure |
PLWH Home Link Study Arm
n=340 Participants
The Home Link intervention will be delivered by a home visit team including a primary care nurse and counselor trained in patient-centered counseling. A rotating hospital-based doctor will be available for pre-home visit clinical file review and post-visit discussion, via cell phone, for decision making and input on patient care during a household visit. We have termed this individual a "discharge officer". The discharge officer will be a Tshepong clinician who is working in the hospital. Supporting Home Link is expected to take \<30 minutes of the physician's time during the day. For study-specific concerns, the team will consult with a GCP-trained, PHRU research doctor based at Tshepong Hospital.
Home Link: In the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.
|
PLWH Care-as-usual (CAU) Study Arm
Participants will receive standard discharge care as provided at Tshepong Hospital during the study. This currently includes discharge counseling from a trained discharge counselor and will be provided with a follow-up return date (usually two weeks post-hospital). Discharge counseling will include a review of discharge medications and instructions regarding follow-up care visits.
|
PLWOH Home Link Study Arm
The Home Link intervention will be delivered by a home visit team including a primary care nurse and counselor trained in patient-centered counseling. A rotating hospital-based doctor will be available for pre-home visit clinical file review and post-visit discussion, via cell phone, for decision making and input on patient care during a household visit. We have termed this individual a "discharge officer". The discharge officer will be a Tshepong clinician who is working in the hospital. Supporting Home Link is expected to take \<30 minutes of the physician's time during the day. For study-specific concerns, the team will consult with a GCP-trained, PHRU research doctor based at Tshepong Hospital.
Home Link: In the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.
|
PLWOH Care-as-usual (CAU) Study Arm
Participants will receive standard discharge care as provided at Tshepong Hospital during the study. This currently includes discharge counseling from a trained discharge counselor and will be provided with a follow-up return date (usually two weeks post-hospital). Discharge counseling will include a review of discharge medications and instructions regarding follow-up care visits.
|
|---|---|---|---|---|
|
Feasibility of Clinical Trial as Assessed by Enrollment Percentage
|
195 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: Analysis population excludes those who were late exclusions from the primary trial due to death prior to discharge or an extended hospital stay
Feasibility of clinical trial will be determined by the percentage of participants with complete follow-up.
Outcome measures
| Measure |
PLWH Home Link Study Arm
n=55 Participants
The Home Link intervention will be delivered by a home visit team including a primary care nurse and counselor trained in patient-centered counseling. A rotating hospital-based doctor will be available for pre-home visit clinical file review and post-visit discussion, via cell phone, for decision making and input on patient care during a household visit. We have termed this individual a "discharge officer". The discharge officer will be a Tshepong clinician who is working in the hospital. Supporting Home Link is expected to take \<30 minutes of the physician's time during the day. For study-specific concerns, the team will consult with a GCP-trained, PHRU research doctor based at Tshepong Hospital.
Home Link: In the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.
|
PLWH Care-as-usual (CAU) Study Arm
n=56 Participants
Participants will receive standard discharge care as provided at Tshepong Hospital during the study. This currently includes discharge counseling from a trained discharge counselor and will be provided with a follow-up return date (usually two weeks post-hospital). Discharge counseling will include a review of discharge medications and instructions regarding follow-up care visits.
|
PLWOH Home Link Study Arm
n=35 Participants
The Home Link intervention will be delivered by a home visit team including a primary care nurse and counselor trained in patient-centered counseling. A rotating hospital-based doctor will be available for pre-home visit clinical file review and post-visit discussion, via cell phone, for decision making and input on patient care during a household visit. We have termed this individual a "discharge officer". The discharge officer will be a Tshepong clinician who is working in the hospital. Supporting Home Link is expected to take \<30 minutes of the physician's time during the day. For study-specific concerns, the team will consult with a GCP-trained, PHRU research doctor based at Tshepong Hospital.
Home Link: In the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.
|
PLWOH Care-as-usual (CAU) Study Arm
n=34 Participants
Participants will receive standard discharge care as provided at Tshepong Hospital during the study. This currently includes discharge counseling from a trained discharge counselor and will be provided with a follow-up return date (usually two weeks post-hospital). Discharge counseling will include a review of discharge medications and instructions regarding follow-up care visits.
|
|---|---|---|---|---|
|
Feasibility of Clinical Trial as Assessed by Percentage of Participants With Complete Follow-up
|
55 Participants
|
51 Participants
|
30 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Feasibility of the intervention assessed among intervention arm participants only. This outcome not assessed among CAU participants.
The number of intervention arm participants with home visit #1 completed, completion of the 12 week follow-up, and vital status ascertainment at 6 months.
Outcome measures
| Measure |
PLWH Home Link Study Arm
n=55 Participants
The Home Link intervention will be delivered by a home visit team including a primary care nurse and counselor trained in patient-centered counseling. A rotating hospital-based doctor will be available for pre-home visit clinical file review and post-visit discussion, via cell phone, for decision making and input on patient care during a household visit. We have termed this individual a "discharge officer". The discharge officer will be a Tshepong clinician who is working in the hospital. Supporting Home Link is expected to take \<30 minutes of the physician's time during the day. For study-specific concerns, the team will consult with a GCP-trained, PHRU research doctor based at Tshepong Hospital.
Home Link: In the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.
|
PLWH Care-as-usual (CAU) Study Arm
Participants will receive standard discharge care as provided at Tshepong Hospital during the study. This currently includes discharge counseling from a trained discharge counselor and will be provided with a follow-up return date (usually two weeks post-hospital). Discharge counseling will include a review of discharge medications and instructions regarding follow-up care visits.
|
PLWOH Home Link Study Arm
n=35 Participants
The Home Link intervention will be delivered by a home visit team including a primary care nurse and counselor trained in patient-centered counseling. A rotating hospital-based doctor will be available for pre-home visit clinical file review and post-visit discussion, via cell phone, for decision making and input on patient care during a household visit. We have termed this individual a "discharge officer". The discharge officer will be a Tshepong clinician who is working in the hospital. Supporting Home Link is expected to take \<30 minutes of the physician's time during the day. For study-specific concerns, the team will consult with a GCP-trained, PHRU research doctor based at Tshepong Hospital.
Home Link: In the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.
|
PLWOH Care-as-usual (CAU) Study Arm
Participants will receive standard discharge care as provided at Tshepong Hospital during the study. This currently includes discharge counseling from a trained discharge counselor and will be provided with a follow-up return date (usually two weeks post-hospital). Discharge counseling will include a review of discharge medications and instructions regarding follow-up care visits.
|
|---|---|---|---|---|
|
Feasibility of Intervention as Assessed by Participant Program Completion
|
50 Participants
|
—
|
27 Participants
|
—
|
Adverse Events
PLWH Home Link Study Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 15 deaths
PLWH Care-as-usual (CAU) Study Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 17 deaths
PLWOH Home Link Study Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths
PLWOH Care-as-usual (CAU) Study Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 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