Clinical trial NCT05950919: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Non Communicable Diseases
Keywords: HIV
cardio-metabolic conditions
TASKPEN
Non Communicable Diseases
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Centre for Infectious Disease Research in Zambia
name: University of Zambia
name: Ministry of Health, Zambia
name: Fogarty International Center of the National Institute of Health
First posted: 2023-07-18
Enrollment: 5620
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: hybrid effectiveness-implementation stepped wedge trial
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent of Participants with both HIV Viral Suppression and Control of Hypertension, Diabetes and Tobacco Use
timeFrame: Month 12
measure: Number of Participants with both HIV Viral Suppression and Control of Hypertension, Diabetes and Tobacco Use
timeFrame: Month 12
Secondary outcomes:
measure: Percent of Participants with Improvement in 10-year ASCVD Risk Score
timeFrame: up to 24 months
measure: Change in Blood Pressure Control from Baseline to Month 12
timeFrame: Baseline, Month 12
measure: Change in Blood Pressure Control from Baseline to Month 24
timeFrame: Baseline, Month 24
measure: Number of Participants with Severe Hypertension
timeFrame: up to 24 months
measure: Percent of Participants with Severe Hypertension
timeFrame: 1, 12 and 24 months
measure: Average Change in Haemoglobin A1c and Fasting Glucose
timeFrame: Baseline up to 24 months
measure: Ideal Cardiovascular Health (CVH)
timeFrame: 1, 12, and 24 months
measure: Number of Participants with HIV-1 Viral Suppression
timeFrame: 0, 12, and 24 months
measure: Percent of Participants with HIV-1 Viral Suppression
timeFrame: 0, 12, and 24 months
measure: Number of Participants Retained in HIV Care
timeFrame: 0, 12, and 24 months
measure: Percent of Participants Retained in HIV Care
timeFrame: 1, 12, and 24 months
measure: Variation of Medication Possession Ratio (MPR) ART
timeFrame: 0, 12 and 24 months
measure: Variation of Medication Possession Ratio (MPR) NCD Medications
timeFrame: 0, 12 and 24 months
measure: Number of Participants with an Increase in Quality of Life (QOL)
timeFrame: up to 24 months
measure: Percent of Participants with an Increase in Quality of Life
timeFrame: up to 24 months
Other outcomes:
measure: Number of Participants Reached
timeFrame: 0, 12, and 24 months
measure: Percent of Participants Reached
timeFrame: 0, 12, and 24 months
measure: Number of Facilities Adopting TASKPEN
timeFrame: 0, 12, and 24 months
measure: Percent of Facilities Adopting TASKPEN
timeFrame: 0, 12, and 24 months
measure: Level of Adherence to Implementation
timeFrame: 0, 12, and 24 months
measure: Mean Acceptability of Intervention Score
timeFrame: 6 months
measure: Mean Feasibility of Intervention Score
timeFrame: 6 months
measure: Mean Appropriateness of Intervention Score
timeFrame: 6 months
measure: Cost-effectiveness of intervention
timeFrame: 0, 12, and 24 months
Locations:
city: Lusaka
country: Zambia
facility: Bauleni Health Center
city: Lusaka
country: Zambia
facility: Chawama 1st Level Hospital
city: Lusaka
country: Zambia
facility: Chelstone Urban Health Center
city: Lusaka
country: Zambia
facility: Chipata 1st Level Hospital
city: Lusaka
country: Zambia
facility: Kabwata Urban Health Center
city: Lusaka
country: Zambia
facility: Kalingalinga Urban Health Center
city: Lusaka
country: Zambia
facility: Kamwala Urban Health Center
city: Lusaka
country: Zambia
facility: Kanyama 1st Level Hospital
city: Lusaka
country: Zambia
facility: Makeni Urban Health Center
city: Lusaka
country: Zambia
facility: Mtendere Health Center
city: Lusaka
country: Zambia
facility: Ng'ombe Urban Health Center
city: Lusaka
country: Zambia
facility: Railway Urban Health Center
Study officials:
affiliation: University of North Carolina
name: Michael Herce, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Infectious Disease Research in Zambia
name: Wilbroad Mutale, MBChB, MPhil, PhD
role: PRINCIPAL_INVESTIGATOR
References: