Trial Outcomes & Findings for Task-shifted Adaptation of the WHO-PEN Intervention to Address Cardio-metabolic Complications in People Living With HIV in Zambia (NCT NCT05005130)
NCT ID: NCT05005130
Last Updated: 2024-01-30
Results Overview
Measured by an HIV RNA level of \<1000 copies per mL on the most recent measure and systolic blood pressure \<140 mmHg and/or diasystolic blood pressure \<90 mmHg. Dual control defined as HIV control (i.e., viral load \<1,000 c/mL for those with a documented viral load + evidence of 6MMD for those with missing viral load) + Hypertension control (SBP\<140 mmHg AND DBP\<90 mmHg)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1129 participants
Primary outcome timeframe
Baseline to 6 months
Results posted on
2024-01-30
Participant Flow
28 Healthcare Providers and 1101 patient participants were enrolled and 11 were excluded from the analysis. This 'mini' stepped wedge pilot had 2 clinic clusters to establish approach feasibility. In a stepped wedge fashion, participants at both clinics were surveyed at baseline and then one site was randomly selected to receive the intervention for 3 months. A midline survey was then conducted and the second site was switched to the intervention before an endline survey 3 months later.
Unit of analysis: Clinics
Participant milestones
| Measure |
Cluster 1 (George)
3 months without TASKPEN (Standard of Care (SOC)) and 6 months with TASKPEN.
During the control period, participants receive the current standard of care (SOC) in Zambia. Under the SOC in Zambian health facilities, the screening, diagnosis, and treatment of cardio-metabolic NCDs are generally unavailable in the clinical departments where most PLHIV seek and receive health services (i.e., ART and DSD clinics), and typically are only offered for hypertension in the general outpatient medical settings that provide urgent care-like services. Under the SOC, health worker capacity to diagnose and manage cardio-metabolic NCDs, including among non-physicians and community health workers, is severely limited and not protocolized like HIV services.
During the intervention period, participants receive TASKPEN package of integrated HIV/NCD services:
1. WHO PEN protocols, algorithm, \& training materials adapted for Zambia
2. Access to cardio-metabolic condition screening \& laboratory monitoring
3. Non communicable disease-focused electronic medical record module
4. Integrated non-communicable/HIV care ("one stop shop" for services)
5. Strengthened non-communicable disease (NCD) medication supply chain, including multi-month dispensing (MMD).
|
Cluster 2 (Chilenje)
6 months without TASKPEN (Standard of Care (SOC)) and 3 months with TASKPEN
During the control period, participants receive the current standard of care (SOC) in Zambia. Under the SOC in Zambian health facilities, the screening, diagnosis, and treatment of cardio-metabolic NCDs are generally unavailable in the clinical departments where most PLHIV seek and receive health services (i.e., ART and DSD clinics), and typically are only offered for hypertension in the general outpatient medical settings that provide urgent care-like services. Under the SOC, health worker capacity to diagnose and manage cardio-metabolic NCDs, including among non-physicians and community health workers, is severely limited and not protocolized like HIV services.
During the intervention period, participants receive TASKPEN package of integrated HIV/NCD services:
1. WHO PEN protocols, algorithm, \& training materials adapted for Zambia
2. Access to cardio-metabolic condition screening \& laboratory monitoring
3. Non communicable disease-focused electronic medical record module
4. Integrated non-communicable/HIV care ("one stop shop" for services)
5. Strengthened non-communicable disease (NCD) medication supply chain, including multi-month dispensing (MMD).
|
|---|---|---|
|
Time Period 1 Baseline (T0)
STARTED
|
227 1
|
221 1
|
|
Time Period 1 Baseline (T0)
Healthcare Providers
|
20 1
|
0 0
|
|
Time Period 1 Baseline (T0)
COMPLETED
|
226 1
|
221 1
|
|
Time Period 1 Baseline (T0)
NOT COMPLETED
|
1 0
|
0 0
|
|
Time Period 2 Midline Survey (T1)
STARTED
|
188 1
|
188 1
|
|
Time Period 2 Midline Survey (T1)
COMPLETED
|
187 1
|
186 1
|
|
Time Period 2 Midline Survey (T1)
NOT COMPLETED
|
1 0
|
2 0
|
|
Time Period 3 Endline Survey (T2)
STARTED
|
158 1
|
119 1
|
|
Time Period 3 Endline Survey (T2)
Healthcare Providers
|
0 0
|
8 1
|
|
Time Period 3 Endline Survey (T2)
COMPLETED
|
152 1
|
118 1
|
|
Time Period 3 Endline Survey (T2)
NOT COMPLETED
|
6 0
|
1 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
These data not collected for Healthcare Providers.
Baseline characteristics by cohort
| Measure |
Standard of Care Patients
n=634 Participants
During the control period, participants receive the current standard of care (SOC) in Zambia. Under the SOC in Zambian health facilities, the screening, diagnosis, and treatment of cardio-metabolic NCDs are generally unavailable in the clinical departments where most PLHIV seek and receive health services (i.e., ART and DSD clinics), and typically are only offered for hypertension in the general outpatient medical settings that provide urgent care-like services. Under the SOC, health worker capacity to diagnose and manage cardio-metabolic NCDs, including among non-physicians and community health workers, is severely limited and not protocolized like HIV services.
|
TASKPEN Patients
n=456 Participants
During the intervention period, participants receive TASKPEN intervention services.
TASKPEN: The package of integrated HIV/NCD services:
1. WHO PEN protocols, algorithm, \& training materials adapted for Zambia
2. Access to cardio-metabolic condition screening \& laboratory monitoring
3. Non communicable disease-focused electronic medical record module
4. Integrated non-communicable/HIV care ("one stop shop" for services)
5. Strengthened non-communicable disease (NCD) medication supply chain, including multi-month dispensing (MMD)
|
Standard of Care Healthcare Providers
n=20 Participants
Healthcare Providers employed at either of the clinics who participated in study surverys.
|
TASKPEN Healthcare Providers
n=8 Participants
Healthcare Providers employed at either of the clinics who participated in study surverys.
|
Total
n=1118 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
Participants
|
46 years
n=634 Participants • These data not collected for Healthcare Providers.
|
45 years
n=456 Participants • These data not collected for Healthcare Providers.
|
—
|
—
|
45 years
n=1090 Participants • These data not collected for Healthcare Providers.
|
|
Age, Customized
Participant age between 18-29
|
41 Participants
n=634 Participants • These data not collected for Healthcare Providers.
|
32 Participants
n=456 Participants • These data not collected for Healthcare Providers.
|
—
|
—
|
73 Participants
n=1090 Participants • These data not collected for Healthcare Providers.
|
|
Age, Customized
Participant age between 30-44
|
246 Participants
n=634 Participants • These data not collected for Healthcare Providers.
|
185 Participants
n=456 Participants • These data not collected for Healthcare Providers.
|
—
|
—
|
431 Participants
n=1090 Participants • These data not collected for Healthcare Providers.
|
|
Age, Customized
Participant age between 45-59
|
284 Participants
n=634 Participants • These data not collected for Healthcare Providers.
|
187 Participants
n=456 Participants • These data not collected for Healthcare Providers.
|
—
|
—
|
471 Participants
n=1090 Participants • These data not collected for Healthcare Providers.
|
|
Age, Customized
Participant age between 60 and older
|
63 Participants
n=634 Participants • These data not collected for Healthcare Providers.
|
52 Participants
n=456 Participants • These data not collected for Healthcare Providers.
|
—
|
—
|
115 Participants
n=1090 Participants • These data not collected for Healthcare Providers.
|
|
Sex: Female, Male
Participants · Female
|
468 Participants
n=634 Participants • These data not collected for Healthcare Providers.
|
320 Participants
n=456 Participants • These data not collected for Healthcare Providers.
|
—
|
—
|
788 Participants
n=1090 Participants • These data not collected for Healthcare Providers.
|
|
Sex: Female, Male
Participants · Male
|
166 Participants
n=634 Participants • These data not collected for Healthcare Providers.
|
136 Participants
n=456 Participants • These data not collected for Healthcare Providers.
|
—
|
—
|
302 Participants
n=1090 Participants • These data not collected for Healthcare Providers.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=634 Participants
|
0 Participants
n=456 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=1118 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
634 Participants
n=634 Participants
|
456 Participants
n=456 Participants
|
20 Participants
n=20 Participants
|
8 Participants
n=8 Participants
|
1118 Participants
n=1118 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=634 Participants
|
0 Participants
n=456 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=1118 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=634 Participants
|
0 Participants
n=456 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=1118 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=634 Participants
|
0 Participants
n=456 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=1118 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=634 Participants
|
0 Participants
n=456 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=1118 Participants
|
|
Race (NIH/OMB)
Black or African American
|
634 Participants
n=634 Participants
|
456 Participants
n=456 Participants
|
20 Participants
n=20 Participants
|
8 Participants
n=8 Participants
|
1118 Participants
n=1118 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=634 Participants
|
0 Participants
n=456 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=1118 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=634 Participants
|
0 Participants
n=456 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=1118 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=634 Participants
|
0 Participants
n=456 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=1118 Participants
|
|
Region of Enrollment
Zambia
|
634 Participants
n=634 Participants
|
456 Participants
n=456 Participants
|
20 Participants
n=20 Participants
|
8 Participants
n=8 Participants
|
1118 Participants
n=1118 Participants
|
|
Education
None
|
45 Participants
n=634 Participants • Data not collected for Healthcare Providers.
|
55 Participants
n=456 Participants • Data not collected for Healthcare Providers.
|
—
|
—
|
100 Participants
n=1090 Participants • Data not collected for Healthcare Providers.
|
|
Education
Primary
|
276 Participants
n=634 Participants • Data not collected for Healthcare Providers.
|
238 Participants
n=456 Participants • Data not collected for Healthcare Providers.
|
—
|
—
|
514 Participants
n=1090 Participants • Data not collected for Healthcare Providers.
|
|
Education
Secondary plus
|
313 Participants
n=634 Participants • Data not collected for Healthcare Providers.
|
163 Participants
n=456 Participants • Data not collected for Healthcare Providers.
|
—
|
—
|
476 Participants
n=1090 Participants • Data not collected for Healthcare Providers.
|
|
Marital Status
Never married
|
63 Participants
n=634 Participants • Data not collected for Healthcare Providers.
|
25 Participants
n=456 Participants • Data not collected for Healthcare Providers.
|
—
|
—
|
88 Participants
n=1090 Participants • Data not collected for Healthcare Providers.
|
|
Marital Status
Married or cohabitating
|
281 Participants
n=634 Participants • Data not collected for Healthcare Providers.
|
234 Participants
n=456 Participants • Data not collected for Healthcare Providers.
|
—
|
—
|
515 Participants
n=1090 Participants • Data not collected for Healthcare Providers.
|
|
Marital Status
Separated or Divorced or Widowed
|
290 Participants
n=634 Participants • Data not collected for Healthcare Providers.
|
197 Participants
n=456 Participants • Data not collected for Healthcare Providers.
|
—
|
—
|
487 Participants
n=1090 Participants • Data not collected for Healthcare Providers.
|
|
Body Mass Index (BMI)
Underweight
|
53 Participants
n=634 Participants • Data not collected for Healthcare Providers.
|
41 Participants
n=456 Participants • Data not collected for Healthcare Providers.
|
—
|
—
|
94 Participants
n=1090 Participants • Data not collected for Healthcare Providers.
|
|
Body Mass Index (BMI)
Healthy weight
|
257 Participants
n=634 Participants • Data not collected for Healthcare Providers.
|
246 Participants
n=456 Participants • Data not collected for Healthcare Providers.
|
—
|
—
|
503 Participants
n=1090 Participants • Data not collected for Healthcare Providers.
|
|
Body Mass Index (BMI)
Overweight
|
178 Participants
n=634 Participants • Data not collected for Healthcare Providers.
|
107 Participants
n=456 Participants • Data not collected for Healthcare Providers.
|
—
|
—
|
285 Participants
n=1090 Participants • Data not collected for Healthcare Providers.
|
|
Body Mass Index (BMI)
Obese
|
146 Participants
n=634 Participants • Data not collected for Healthcare Providers.
|
56 Participants
n=456 Participants • Data not collected for Healthcare Providers.
|
—
|
—
|
202 Participants
n=1090 Participants • Data not collected for Healthcare Providers.
|
|
Body Mass Index (BMI)
Missing data
|
0 Participants
n=634 Participants • Data not collected for Healthcare Providers.
|
6 Participants
n=456 Participants • Data not collected for Healthcare Providers.
|
—
|
—
|
6 Participants
n=1090 Participants • Data not collected for Healthcare Providers.
|
|
Alcohol Consumption
Yes
|
288 Participants
n=634 Participants • Data not collected for Healthcare Providers.
|
186 Participants
n=456 Participants • Data not collected for Healthcare Providers.
|
—
|
—
|
474 Participants
n=1090 Participants • Data not collected for Healthcare Providers.
|
|
Alcohol Consumption
No
|
346 Participants
n=634 Participants • Data not collected for Healthcare Providers.
|
270 Participants
n=456 Participants • Data not collected for Healthcare Providers.
|
—
|
—
|
616 Participants
n=1090 Participants • Data not collected for Healthcare Providers.
|
|
History of Hypertension
Yes
|
151 Participants
n=634 Participants • Data not collected for Healthcare Providers.
|
129 Participants
n=456 Participants • Data not collected for Healthcare Providers.
|
—
|
—
|
280 Participants
n=1090 Participants • Data not collected for Healthcare Providers.
|
|
History of Hypertension
No
|
483 Participants
n=634 Participants • Data not collected for Healthcare Providers.
|
327 Participants
n=456 Participants • Data not collected for Healthcare Providers.
|
—
|
—
|
810 Participants
n=1090 Participants • Data not collected for Healthcare Providers.
|
|
History of Type II Diabetes
Yes
|
23 Participants
n=634 Participants • Data not collected for Healthcare Providers.
|
10 Participants
n=456 Participants • Data not collected for Healthcare Providers.
|
—
|
—
|
33 Participants
n=1090 Participants • Data not collected for Healthcare Providers.
|
|
History of Type II Diabetes
No
|
603 Participants
n=634 Participants • Data not collected for Healthcare Providers.
|
445 Participants
n=456 Participants • Data not collected for Healthcare Providers.
|
—
|
—
|
1048 Participants
n=1090 Participants • Data not collected for Healthcare Providers.
|
|
History of Type II Diabetes
Don't know
|
8 Participants
n=634 Participants • Data not collected for Healthcare Providers.
|
1 Participants
n=456 Participants • Data not collected for Healthcare Providers.
|
—
|
—
|
9 Participants
n=1090 Participants • Data not collected for Healthcare Providers.
|
|
Time on ART
Less Than 5 Years
|
139 Participants
n=634 Participants • Data not collected for Healthcare Providers.
|
87 Participants
n=456 Participants • Data not collected for Healthcare Providers.
|
—
|
—
|
226 Participants
n=1090 Participants • Data not collected for Healthcare Providers.
|
|
Time on ART
5-9 Years
|
141 Participants
n=634 Participants • Data not collected for Healthcare Providers.
|
111 Participants
n=456 Participants • Data not collected for Healthcare Providers.
|
—
|
—
|
252 Participants
n=1090 Participants • Data not collected for Healthcare Providers.
|
|
Time on ART
10 Years or more
|
354 Participants
n=634 Participants • Data not collected for Healthcare Providers.
|
258 Participants
n=456 Participants • Data not collected for Healthcare Providers.
|
—
|
—
|
612 Participants
n=1090 Participants • Data not collected for Healthcare Providers.
|
|
History of Dyslipidemia
Yes
|
1 Participants
n=634 Participants • Data not collected for Healthcare Providers.
|
2 Participants
n=456 Participants • Data not collected for Healthcare Providers.
|
—
|
—
|
3 Participants
n=1090 Participants • Data not collected for Healthcare Providers.
|
|
History of Dyslipidemia
No
|
631 Participants
n=634 Participants • Data not collected for Healthcare Providers.
|
454 Participants
n=456 Participants • Data not collected for Healthcare Providers.
|
—
|
—
|
1085 Participants
n=1090 Participants • Data not collected for Healthcare Providers.
|
|
History of Dyslipidemia
Don't know
|
2 Participants
n=634 Participants • Data not collected for Healthcare Providers.
|
0 Participants
n=456 Participants • Data not collected for Healthcare Providers.
|
—
|
—
|
2 Participants
n=1090 Participants • Data not collected for Healthcare Providers.
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPopulation: Eleven patient participants with incomplete data were excluded.
Measured by an HIV RNA level of \<1000 copies per mL on the most recent measure and systolic blood pressure \<140 mmHg and/or diasystolic blood pressure \<90 mmHg. Dual control defined as HIV control (i.e., viral load \<1,000 c/mL for those with a documented viral load + evidence of 6MMD for those with missing viral load) + Hypertension control (SBP\<140 mmHg AND DBP\<90 mmHg)
Outcome measures
| Measure |
Standard of Care
n=634 Participants
During the control period, participants receive the current standard of care (SOC) in Zambia. Under the SOC in Zambian health facilities, the screening, diagnosis, and treatment of cardio-metabolic NCDs are generally unavailable in the clinical departments where most PLHIV seek and receive health services (i.e., ART and DSD clinics), and typically are only offered for hypertension in the general outpatient medical settings that provide urgent care-like services. Under the SOC, health worker capacity to diagnose and manage cardio-metabolic NCDs, including among non-physicians and community health workers, is severely limited and not protocolized like HIV services.
|
TASKPEN
n=456 Participants
During the intervention period, participants receive TASKPEN intervention services.
TASKPEN: The package of integrated HIV/NCD services:
1. WHO PEN protocols, algorithm, \& training materials adapted for Zambia
2. Access to cardio-metabolic condition screening \& laboratory monitoring
3. Non communicable disease-focused electronic medical record module
4. Integrated non-communicable/HIV care ("one stop shop" for services)
5. Strengthened non-communicable disease (NCD) medication supply chain, including multi-month dispensing (MMD)
|
|---|---|---|
|
Change in Percent of Participants With Dual HIV and Blood Pressure Control
|
52 percentage of participants
|
60 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsAdoption measured based on Reach Evaluation Adoption Implementation and Maintenance (RE-AIM) and Consolidated Framework for Implementation Research (CFIR) which are implementation-oriented and empirically supported frameworks for adapting, introducing, and evaluating evidence-based interventions in routine practice settings. The number of facilities initiating TASKPEN intervention integrated care at approximately 6 months after TASKPEN introduction.
Outcome measures
| Measure |
Standard of Care
n=2 Clinics
During the control period, participants receive the current standard of care (SOC) in Zambia. Under the SOC in Zambian health facilities, the screening, diagnosis, and treatment of cardio-metabolic NCDs are generally unavailable in the clinical departments where most PLHIV seek and receive health services (i.e., ART and DSD clinics), and typically are only offered for hypertension in the general outpatient medical settings that provide urgent care-like services. Under the SOC, health worker capacity to diagnose and manage cardio-metabolic NCDs, including among non-physicians and community health workers, is severely limited and not protocolized like HIV services.
|
TASKPEN
n=2 Clinics
During the intervention period, participants receive TASKPEN intervention services.
TASKPEN: The package of integrated HIV/NCD services:
1. WHO PEN protocols, algorithm, \& training materials adapted for Zambia
2. Access to cardio-metabolic condition screening \& laboratory monitoring
3. Non communicable disease-focused electronic medical record module
4. Integrated non-communicable/HIV care ("one stop shop" for services)
5. Strengthened non-communicable disease (NCD) medication supply chain, including multi-month dispensing (MMD)
|
|---|---|---|
|
Number of Clinics That Adopted the Intervention (Intervention Adoption)
|
1 Clinics
|
1 Clinics
|
SECONDARY outcome
Timeframe: During 2 weeks prior to initiation of TASKPENPopulation: The number of healthcare workers analyzed reflects the overall total number who were trained at the clinics and may include overlap from the Healthcare Providers enrolled to participate in the study survey.
Number of healthcare providers working at the pilot clinic antiretroviral therapy (ART), differentiated service delivery (DSD), and outpatient departments who were trained in the implementation of the TASKPEN intervention package.
Outcome measures
| Measure |
Standard of Care
n=34 Participants
During the control period, participants receive the current standard of care (SOC) in Zambia. Under the SOC in Zambian health facilities, the screening, diagnosis, and treatment of cardio-metabolic NCDs are generally unavailable in the clinical departments where most PLHIV seek and receive health services (i.e., ART and DSD clinics), and typically are only offered for hypertension in the general outpatient medical settings that provide urgent care-like services. Under the SOC, health worker capacity to diagnose and manage cardio-metabolic NCDs, including among non-physicians and community health workers, is severely limited and not protocolized like HIV services.
|
TASKPEN
n=95 Participants
During the intervention period, participants receive TASKPEN intervention services.
TASKPEN: The package of integrated HIV/NCD services:
1. WHO PEN protocols, algorithm, \& training materials adapted for Zambia
2. Access to cardio-metabolic condition screening \& laboratory monitoring
3. Non communicable disease-focused electronic medical record module
4. Integrated non-communicable/HIV care ("one stop shop" for services)
5. Strengthened non-communicable disease (NCD) medication supply chain, including multi-month dispensing (MMD)
|
|---|---|---|
|
Number of Trained Healthcare Providers (Intervention Reach)
|
29 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Data are reported for all patient participants with viral load test results available.
Measured by the percent of patient participants with HIV RNA suppression (defined as \<1,000 copies/mL)
Outcome measures
| Measure |
Standard of Care
n=542 Participants
During the control period, participants receive the current standard of care (SOC) in Zambia. Under the SOC in Zambian health facilities, the screening, diagnosis, and treatment of cardio-metabolic NCDs are generally unavailable in the clinical departments where most PLHIV seek and receive health services (i.e., ART and DSD clinics), and typically are only offered for hypertension in the general outpatient medical settings that provide urgent care-like services. Under the SOC, health worker capacity to diagnose and manage cardio-metabolic NCDs, including among non-physicians and community health workers, is severely limited and not protocolized like HIV services.
|
TASKPEN
n=406 Participants
During the intervention period, participants receive TASKPEN intervention services.
TASKPEN: The package of integrated HIV/NCD services:
1. WHO PEN protocols, algorithm, \& training materials adapted for Zambia
2. Access to cardio-metabolic condition screening \& laboratory monitoring
3. Non communicable disease-focused electronic medical record module
4. Integrated non-communicable/HIV care ("one stop shop" for services)
5. Strengthened non-communicable disease (NCD) medication supply chain, including multi-month dispensing (MMD)
|
|---|---|---|
|
Changes in HIV Disease Control, as Measured by the Percent of Patient Participants With HIV RNA Suppression (Defined as <1,000 Copies/mL)
|
85 percentage of participants
|
89 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsThe "Intervention appropriateness measure (IAM)" among healthcare providers. The minimum score is 1 and maximum is 5. Higher scores indicate greater appropriateness.
Outcome measures
| Measure |
Standard of Care
n=20 Participants
During the control period, participants receive the current standard of care (SOC) in Zambia. Under the SOC in Zambian health facilities, the screening, diagnosis, and treatment of cardio-metabolic NCDs are generally unavailable in the clinical departments where most PLHIV seek and receive health services (i.e., ART and DSD clinics), and typically are only offered for hypertension in the general outpatient medical settings that provide urgent care-like services. Under the SOC, health worker capacity to diagnose and manage cardio-metabolic NCDs, including among non-physicians and community health workers, is severely limited and not protocolized like HIV services.
|
TASKPEN
n=8 Participants
During the intervention period, participants receive TASKPEN intervention services.
TASKPEN: The package of integrated HIV/NCD services:
1. WHO PEN protocols, algorithm, \& training materials adapted for Zambia
2. Access to cardio-metabolic condition screening \& laboratory monitoring
3. Non communicable disease-focused electronic medical record module
4. Integrated non-communicable/HIV care ("one stop shop" for services)
5. Strengthened non-communicable disease (NCD) medication supply chain, including multi-month dispensing (MMD)
|
|---|---|---|
|
Change in Intervention Appropriateness
|
4.69 score on a scale
Standard Deviation 0.44
|
4.18 score on a scale
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsMeasured by the "Acceptability of Intervention measure (AIM)" among health care providers. The minimum score is 1 and maximum is 5. Higher scores indicate greater acceptability.
Outcome measures
| Measure |
Standard of Care
n=20 Participants
During the control period, participants receive the current standard of care (SOC) in Zambia. Under the SOC in Zambian health facilities, the screening, diagnosis, and treatment of cardio-metabolic NCDs are generally unavailable in the clinical departments where most PLHIV seek and receive health services (i.e., ART and DSD clinics), and typically are only offered for hypertension in the general outpatient medical settings that provide urgent care-like services. Under the SOC, health worker capacity to diagnose and manage cardio-metabolic NCDs, including among non-physicians and community health workers, is severely limited and not protocolized like HIV services.
|
TASKPEN
n=8 Participants
During the intervention period, participants receive TASKPEN intervention services.
TASKPEN: The package of integrated HIV/NCD services:
1. WHO PEN protocols, algorithm, \& training materials adapted for Zambia
2. Access to cardio-metabolic condition screening \& laboratory monitoring
3. Non communicable disease-focused electronic medical record module
4. Integrated non-communicable/HIV care ("one stop shop" for services)
5. Strengthened non-communicable disease (NCD) medication supply chain, including multi-month dispensing (MMD)
|
|---|---|---|
|
Change in Intervention Acceptability
|
4.7 score on a scale
Standard Deviation 0.44
|
4.34 score on a scale
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsMeasured by the "Feasibility of Intervention Measure (FIM)" among Healthcare providers. The minimum score is 1 and maximum is 5. Higher scores indicate greater feasibility.
Outcome measures
| Measure |
Standard of Care
n=20 Participants
During the control period, participants receive the current standard of care (SOC) in Zambia. Under the SOC in Zambian health facilities, the screening, diagnosis, and treatment of cardio-metabolic NCDs are generally unavailable in the clinical departments where most PLHIV seek and receive health services (i.e., ART and DSD clinics), and typically are only offered for hypertension in the general outpatient medical settings that provide urgent care-like services. Under the SOC, health worker capacity to diagnose and manage cardio-metabolic NCDs, including among non-physicians and community health workers, is severely limited and not protocolized like HIV services.
|
TASKPEN
n=8 Participants
During the intervention period, participants receive TASKPEN intervention services.
TASKPEN: The package of integrated HIV/NCD services:
1. WHO PEN protocols, algorithm, \& training materials adapted for Zambia
2. Access to cardio-metabolic condition screening \& laboratory monitoring
3. Non communicable disease-focused electronic medical record module
4. Integrated non-communicable/HIV care ("one stop shop" for services)
5. Strengthened non-communicable disease (NCD) medication supply chain, including multi-month dispensing (MMD)
|
|---|---|---|
|
Change in Intervention Feasibility
|
4.66 score on a scale
Standard Deviation 0.56
|
4.16 score on a scale
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: These data were collected only at one study site. These data reflect out-of-pocket expenditures for participants living with HIV and at least one non-communicable disease co-morbidity.
Measured by cost per patient and reported in Zambian Kwacha. The analysis focused on the expenditures paid out of pocket for HIV and hypertension care. These data were collected from one site only (Chilenje).
Outcome measures
| Measure |
Standard of Care
n=18 Participants
During the control period, participants receive the current standard of care (SOC) in Zambia. Under the SOC in Zambian health facilities, the screening, diagnosis, and treatment of cardio-metabolic NCDs are generally unavailable in the clinical departments where most PLHIV seek and receive health services (i.e., ART and DSD clinics), and typically are only offered for hypertension in the general outpatient medical settings that provide urgent care-like services. Under the SOC, health worker capacity to diagnose and manage cardio-metabolic NCDs, including among non-physicians and community health workers, is severely limited and not protocolized like HIV services.
|
TASKPEN
n=18 Participants
During the intervention period, participants receive TASKPEN intervention services.
TASKPEN: The package of integrated HIV/NCD services:
1. WHO PEN protocols, algorithm, \& training materials adapted for Zambia
2. Access to cardio-metabolic condition screening \& laboratory monitoring
3. Non communicable disease-focused electronic medical record module
4. Integrated non-communicable/HIV care ("one stop shop" for services)
5. Strengthened non-communicable disease (NCD) medication supply chain, including multi-month dispensing (MMD)
|
|---|---|---|
|
Intervention Cost Per Patient
|
352.53 Kwacha (ZMW)
Standard Error 23.81
|
287.5 Kwacha (ZMW)
Standard Error 101.02
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 158 other events
Deaths: 4 deaths
TASKPEN
Serious events: 0 serious events
Other events: 222 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard of Care
n=636 participants at risk
During the control period, participants receive the current standard of care (SOC) in Zambia. Under the SOC in Zambian health facilities, the screening, diagnosis, and treatment of cardio-metabolic NCDs are generally unavailable in the clinical departments where most PLHIV seek and receive health services (i.e., ART and DSD clinics), and typically are only offered for hypertension in the general outpatient medical settings that provide urgent care-like services. Under the SOC, health worker capacity to diagnose and manage cardio-metabolic NCDs, including among non-physicians and community health workers, is severely limited and not protocolized like HIV services.
|
TASKPEN
n=465 participants at risk
During the intervention period, participants receive TASKPEN intervention services.
TASKPEN: The package of integrated HIV/NCD services:
1. WHO PEN protocols, algorithm, \& training materials adapted for Zambia
2. Access to cardio-metabolic condition screening \& laboratory monitoring
3. Non communicable disease-focused electronic medical record module
4. Integrated non-communicable/HIV care ("one stop shop" for services)
5. Strengthened non-communicable disease (NCD) medication supply chain, including multi-month dispensing (MMD)
|
|---|---|---|
|
Cardiac disorders
Hypertension
|
22.5%
143/636 • Number of events 143 • From the time of signing informed consent through completion of each survey period, a combined total of 6 months.
Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 November 2014. Adverse events were not collected for Healthcare Providers.
|
42.6%
198/465 • Number of events 198 • From the time of signing informed consent through completion of each survey period, a combined total of 6 months.
Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 November 2014. Adverse events were not collected for Healthcare Providers.
|
|
Endocrine disorders
Out of Range Glucose
|
2.4%
15/636 • Number of events 15 • From the time of signing informed consent through completion of each survey period, a combined total of 6 months.
Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 November 2014. Adverse events were not collected for Healthcare Providers.
|
5.2%
24/465 • Number of events 24 • From the time of signing informed consent through completion of each survey period, a combined total of 6 months.
Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 November 2014. Adverse events were not collected for Healthcare Providers.
|
Additional Information
Michael Herce, MD, MPH, MSc
University of North Carolina at Chapel Hill
Phone: 919-966-2537
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place