Effects of a Package of Evidence-based Interventions and Implementation Strategies Based on WHO PEN for People Living With HIV and Cardio-metabolic Conditions in Lusaka, Zambia

HIV Clinical Trial

— TASKPEN UH3  

Official title:

Z 32201 - Effects of a Package of Evidence-based Interventions and Implementation Strategies Based on WHO PEN for People Living With HIV and Cardio-metabolic Conditions in Lusaka, Zambia: A Type II Hybrid Effectiveness-implementation Stepped Wedge Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05950919
• Other study ID #: 22-2252
• Secondary ID: 4UH3HL156389-03
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: June 2023
• Source: University of North Carolina, Chapel Hill
• Contact: Chilambwe Mwila, MSc
• Phone: 260 966 608354
• Email: Chilambwe.Mwila[@]cidrz.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effects of a multi-level intervention known as "TASKPEN," adapted from the World Health Organization (WHO) Package of Essential Noncommunicable Disease Interventions (WHO-PEN) for the Zambian public health system, on clinical and implementation outcomes for persons living with HIV (PLHIV) with co-morbid cardio-metabolic conditions in Lusaka, Zambia.

Description:

This hybrid effectiveness-implementation stepped wedge trial will be used to evaluate the clinical effectiveness and implementation outcomes and strategies. Investigators will evaluate the effects of TASKPEN on the primary clinical effectiveness outcome of dual HIV/ cardio-metabolic non-communicable diseases (NCD) control at 12 months, and the secondary implementation outcome of intervention reach in the clinic population. Other secondary outcomes will include longitudinal changes in the Atherosclerotic Cardiovascular Disease (ASCVD) Risk Estimator, changes in quality of life per the WHOQOL-HIV-Bref, modification of grade III hypertension, and HIV viral suppression at different accepted thresholds (i.e., <1,000 c/mL, <200 c/ml, <50 c/ml). A cluster will be defined as one health facility and their associated catchment area population (i.e., together a study site). Sequential crossover of sites will take place, from control to intervention, until all 12 clusters (i.e., all 12 sites) are exposed to the intervention before the end of the study. Trained and experienced study staff will conduct a bio-behavioral survey at baseline with approximately 1,020 participants across all study sites before introduction of the TASKPEN intervention. After this baseline survey is completed, four randomly selected clusters (i.e., 4 facilities) will be switched to the TASKPEN intervention (the first orange shaded step in Figure 3) over a ~4-week introduction/ "wash out" period, and then continue with TASKPEN implementation until the end of the trial. Six months later, another survey with 1,020 participants who have not participated previously will be done across all 12 sites at time T1 right before a second block of two clusters (i.e., clusters 5 and 6) are switched to the TASKPEN intervention. After another 6 months, the survey will be repeated, this time as a midline survey, and another two clusters (i.e., clusters 7 and 8) will be switched to the TASKPEN intervention after survey completion. Six months later, at time T3, another survey will be completed with 1,020 participants who have not volunteered previously right before the final four randomly selected clusters (i.e., clusters 9 through 12) switch to the TASKPEN intervention. After all facilities/ sites have received the intervention for at least 6 months, a final "end-line survey" will be administered at time T4. Once the end-line survey is completed, a total of approximately 5,100 participants will have completed a survey.

To overcome the limitations inherent to cross-sectional assessments of patient outcomes, and to facilitate collection of more detailed longitudinal data, a "nested cohort," will be embedded in the larger trial reflecting a representative sample of approximately 320 survey participants with co-morbid cardio-metabolic NCDs identified through study surveys to carefully follow longitudinal clinical outcomes in PLHIV with these conditions.

Embedded in the trial will be concurrent mixed methods data collection to assess implementation outcomes and to understand the mechanisms by which the evidence-based intervention package and associated implementation strategies did, or did not, achieve their intended effects or acted through the conceptual model of change.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5620
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Objective 1:

Cross-sectional patient surveys (n=5100): all HIV-infected adults aged 18 years and older who seek HIV services at the study sites.

Following the baseline survey, investigators will exclude anyone who previously participated in a study survey. Investigators will also exclude people who present for one time services or who plan to transfer their HIV care to another site. Finally, people unwilling or unable to provide written informed consent will be excluded.

For the nested cohort, inclusion (n=320) participants will need to have been enrolled in a study survey and have evidence of one or more of the following cardio-metabolic conditions or risk factors at the time of the survey:

• Any current tobacco use (any tobacco use within 30 days of the survey, whether daily or non-daily use);

• Hypertension as defined by WHO PEN/ HEARTS (i.e., systolic blood pressure (SBP) =140 mmHg and/or diastolic blood pressure (DBP) =90 mmHg);

• Diabetes mellitus as defined by WHO PEN/ HEARTS (i.e., random plasma glucose = 11.1 mmol/L, fasting plasma glucose = 7 mmol/L, and/or hemoglobin A1c = 48 mmol/mol or =6.5%; and/or compatible clinical diagnosis);

• Prediabetes (defined as having impaired fasting glucose of 6.1 to 6.9 mmol/L and/or haemoglobin A1c 42 to 48 mmol/mol or between 6.0-6.4%); and/or

• Dyslipidaemia (defined as total cholesterol =5.2 mmol/L or low-density lipoprotein =3.4 mmol/L).

• Investigators will exclude adults who have no documented evidence of HIV infection, or who do not have a cardio-metabolic NCD or risk factor of interest. Investigators will also exclude people who did not participate in a patient survey, plan to transfer their HIV care to another site, or are unwilling/ unable to provide written informed consent.

Objective 2 Participant inclusion criteria

In-depth interview (IDI) participants must be

• HIV-positive adults

• =18 years of age

• survey and/or cohort participants and

• had received HIV and/or NCD services at a TASKPEN study site.

Focus group discussion (FGD) participants must be:

• =18 years of age;

• a non-physician health care worker (NPHW) or community health worker (CHW)/ lay health provider involved with TASKPEN or integrated HIV/NCD service delivery; and

• generally familiar with HIV and/or NCD service delivery at their facility.

Key informant interview (KII) participants must be:

• =18 years of age;

• a facility-level ART, DSD, out-patient department (OPD), or relevant clinic leader/ manager/ in-charge, or policy maker at district, provincial, or national level in Zambia; and

• generally familiar with HIV and/or NCD-related issues in their community.

Implementation questionnaire participants must be:

• HIV-positive adults

• =18 years of age

• who had exposure to the TASKPEN intervention at a study site OR

• =18 years of age,

• a facility-level healthcare provider or manager at district, provincial, or national level in Zambia, and

• familiar with the TASKPEN intervention.

Costing study participants must be:

• HIV-positive adults

• =18 years of age

• who had received HIV and/or NCD services at a TASKPEN study site OR

• =18 years of age and

• a facility-level healthcare provider or manager at facility, district, provincial, or national level in Zambia, and generally familiar with HIV and/or NCD-related issues.

Participant exclusion criteria

• Investigators will exclude adult IDI participants who have no evidence of having received HIV and/or NCD services at the sites during the study period, adult implementation questionnaire

• participants who were not exposed/ familiar with the TASKPEN intervention, as well as
• people unwilling or unable to provide written informed consent.

• Investigators will exclude any potential IDI, FGD, or KII study participant if they are unwilling or unable to provide written informed consent.

Related Conditions & MeSH terms

• HIV
• Non Communicable Diseases
• Noncommunicable Diseases

Intervention

Other:
• TASKPEN
The package of integrated HIV/NCD services: Integrated non-communicable/HIV care ("one stop shop" for services) WHO PEN protocols, algorithm, & training materials adapted for Zambia Access to cardio-metabolic condition screening & laboratory monitoring Non-communicable disease-focused electronic medical record module Strengthened NCD medication supply chain

Locations

Country	Name	City	State
Zambia	Bauleni Health Center	Lusaka
Zambia	Chawama 1st Level Hospital	Lusaka
Zambia	Chelstone Urban Health Center	Lusaka
Zambia	Chipata 1st Level Hospital	Lusaka
Zambia	Kabwata Urban Health Center	Lusaka
Zambia	Kalingalinga Urban Health Center	Lusaka
Zambia	Kamwala Urban Health Center	Lusaka
Zambia	Kanyama 1st Level Hospital	Lusaka
Zambia	Makeni Urban Health Center	Lusaka
Zambia	Mtendere Health Center	Lusaka
Zambia	Ng'ombe Urban Health Center	Lusaka
Zambia	Railway Urban Health Center	Lusaka

Sponsors (6)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Centre for Infectious Disease Research in Zambia, Fogarty International Center of the National Institute of Health, Ministry of Health, Zambia, National Heart, Lung, and Blood Institute (NHLBI), University of Zambia

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Reached	Number of PLHIV at the clinic (i.e., with documented receipt of ART/ HIV care services at a study site) screened for hypertension at 0, 12, and 24 months from TASKPEN introduction	0, 12, and 24 months
Other	Percent of Participants Reached	Percent of PLHIV at the clinic (i.e., with documented receipt of ART/ HIV care services at a study site) screened for hypertension at 0, 12, and 24 months from TASKPEN introduction	0, 12, and 24 months
Other	Number of Facilities Adopting TASKPEN	Number of facilities and providers initiating TASKPEN intervention/ integrated care at 0, 12, and 24 months	0, 12, and 24 months
Other	Percent of Facilities Adopting TASKPEN	Percent of facilities and providers initiating TASKPEN intervention/ integrated care at 0, 12, and 24 months	0, 12, and 24 months
Other	Level of Adherence to Implementation	Percent of nurses and other non-physician health workers at each site that supported intervention/ integrated care implementation at least once at 0, 12 and 24 months	0, 12, and 24 months
Other	Mean Acceptability of Intervention Score	Average (mean) Acceptability of Intervention Measure (AIM) score after TASKPEN implementation at =6 months from TASKPEN introduction The "Acceptability of Intervention Measure (AIM)" is a 4-item instrument measuring the acceptability of an evidence-based practice or intervention. A scale can be created for this measure by averaging responses from each item.; Scale values range from 1 (completely disagree) to 5 (completely agree). Higher scores indicate greater acceptability, feasibility, or appropriateness on the AIM, FIM, or IAM, respectively. No items need to be reverse coded.	6 months
Other	Mean Feasibility of Intervention Score	Average (mean) Feasibility of Intervention Measure (FIM) score after TASKPEN implementation at =6 months from TASKPEN introduction The "Feasibility of Intervention Measure (FIM)" is a 4-item instrument measuring the feasibility of an evidence-based practice or intervention. A scale can be created for this measure by averaging responses from each item.; Scale values range from 1 (completely disagree) to 5 (completely agree). Higher scores indicate greater acceptability, feasibility, or appropriateness on the AIM, FIM, or IAM, respectively. No items need to be reverse coded.	6 months
Other	Mean Appropriateness of Intervention Score	Average (mean) Intervention Appropriateness Measure (IAM) score after TASKPEN implementation at =6 months from TASKPEN introduction The "Intervention Appropriateness Measure (IAM)" is a 4-item instrument measuring the appropriateness of an evidence-based practice or intervention. A scale can be created for this measure by averaging responses from each item.; Scale values range from 1 (completely disagree) to 5 (completely agree). Higher scores indicate greater acceptability, feasibility, or appropriateness on the AIM, FIM, or IAM, respectively. No items need to be reverse coded.	6 months
Other	Cost-effectiveness of intervention	Incremental cost-effectiveness ratios (ICERs) at 0, 12 and 24 months	0, 12, and 24 months
Primary	Percent of Participants with both HIV Viral Suppression and Control of Hypertension, Diabetes and Tobacco Use	Dual control of HIV and cardio-metabolic NCDs is defined as: HIV RNA <1,000 copies/mL on most recent measure AND absence of the following: 1) uncontrolled systolic and diastolic hypertension; 2) uncontrolled diabetes mellitus; and 3) current tobacco smoking.	Month 12
Primary	Number of Participants with both HIV Viral Suppression and Control of Hypertension, Diabetes and Tobacco Use	Dual control of HIV and cardio-metabolic NCDs is defined as: HIV RNA <1,000 copies/mL on most recent measure AND absence of the following: 1) uncontrolled systolic and diastolic hypertension; 2) uncontrolled diabetes mellitus; and 3) current tobacco smoking.	Month 12
Secondary	Percent of Participants with Improvement in 10-year ASCVD Risk Score	Participants who experience numerical improvement in 10-year ASCVD risk score and experience improvement in risk category (for example, change from high risk to intermediate risk, high to borderline risk, borderline to low risk, etc.). Assessed at 12 and 24 months.	up to 24 months
Secondary	Change in Blood Pressure Control from Baseline to Month 12	Average numerical change in systolic and diastolic blood pressure.	Baseline, Month 12
Secondary	Change in Blood Pressure Control from Baseline to Month 24	Average numerical change in systolic and diastolic blood pressure.	Baseline, Month 24
Secondary	Number of Participants with Severe Hypertension	Systolic blood pressure =180 mmHg and/or diastolic blood pressure =120 mmHg. Assessed at Baseline, 12 and 24 months.	up to 24 months
Secondary	Percent of Participants with Severe Hypertension	Systolic blood pressure =180 mmHg and/or diastolic blood pressure =120 mmHg	1, 12 and 24 months
Secondary	Average Change in Haemoglobin A1c and Fasting Glucose	Mean change in HgbA1c and/or fasting blood glucose from baseline at last assessment. Assessed at Baseline, 12 and 24 months.	Baseline up to 24 months
Secondary	Ideal Cardiovascular Health (CVH)	Average change in Ideal CVH score on a 0-7 point Likert scale The Ideal CVH is based on the following factors: (1) Smoking: never or former smoker; (2) Body mass index<23 kg/m^2; (3) Physical activity: =150 min/wk of moderate-intensity physical activity, =75 min/wk of vigorous intensity physical activity, or =150 min/wk of moderate or vigorous intensity physical activity; (4) Diet: 4 or 5 healthy dietary components as defined below; (5) Total cholesterol <200 mg/dL; (6) Blood pressure <120/80 mm Hg; (7) Fasting glucose <100 mg/dL. For diet, the ideal metric is determined based on intake of fruits and vegetables (=450 g/d), fish (=198 g/wk), fiber-rich whole grains (=85 g/d), sodium (<1500 mg/d), sugar-sweetened beverages (=1 liter/wk).; To calculate the ideal CVH score, each metric is given 1 point and the number of ideal CVH metrics is added up for each participant. The range of scores is 0 to 7 inclusive with higher scores indicating better cardiovascular health.	1, 12, and 24 months
Secondary	Number of Participants with HIV-1 Viral Suppression	To be assessed at empirically supported thresholds of <1,000 c/mL, <200 c/mL, and <50 c/mL.	0, 12, and 24 months
Secondary	Percent of Participants with HIV-1 Viral Suppression	To be assessed at empirically supported thresholds of <1,000 c/mL, <200 c/mL, and <50 c/mL.	0, 12, and 24 months
Secondary	Number of Participants Retained in HIV Care	Number of participants with evidence of being retained in HIV care within the last ~180 days.	0, 12, and 24 months
Secondary	Percent of Participants Retained in HIV Care	Percent of participants with evidence of being retained in HIV care within the last ~180 days.	1, 12, and 24 months
Secondary	Variation of Medication Possession Ratio (MPR) ART	Number of days late for pharmacy refills by total days on treatment, and then subtracting that percentage from 100%--for antiretroviral therapy (ART).	0, 12 and 24 months
Secondary	Variation of Medication Possession Ratio (MPR) NCD Medications	Number of days late for pharmacy refills by total days on treatment, and then subtracting that percentage from 100%--for NCD medications.	0, 12 and 24 months
Secondary	Number of Participants with an Increase in Quality of Life (QOL)	Number of participants with an increase in quality of life score. Assessed at 12 and 24 months.; A version of the World Health Organization (WHO)QOL-HIV BREF will be used with 31 questions over 6 domains adapted to the Zambia context. We will present an overall score where a higher score indicate a higher quality of life. Most items are scaled in a positive direction, but some domains (i.e., #1, #2, #3, and #6) are scaled in a negative direction and will be recoded (as 6 minus question score) such that high scores reflect better quality of life. The mean score of items within each domain will be used to calculate a domain score. The means scores will then multiplied by 4 to make domain scores comparable with the overall scores used in the WHOQOL, so that scores range between 4 and 20. An overall average score across all 6 domains will be reported.	up to 24 months
Secondary	Percent of Participants with an Increase in Quality of Life	Percent of participants with an increase in quality of life score. Assessed at 12 and 24 months.; A version of the WHOQOL-HIV BREF will be used with 31 questions over 6 domains adapted to the Zambia context. We will present an overall score where a higher score indicate a higher quality of life. Most items are scaled in a positive direction, but some domains (i.e., #1, #2, #3, and #6) are scaled in a negative direction and will be recoded (as 6 minus question score) such that high scores reflect better quality of life. The mean score of items within each domain will be used to calculate a domain score. The means scores will then multiplied by 4 to make domain scores comparable with the overall scores used in the WHOQOL, so that scores range between 4 and 20. An overall average score across all 6 domains will be reported.	up to 24 months