RecruitingNot ApplicableNCT05950919

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

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


Sponsor

University of North Carolina, Chapel Hill

Enrollment

5,620 participants

Start Date

May 30, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria36

  • 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.
  • 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.

Exclusion Criteria3

  • 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.

Interventions

OTHERTASKPEN

The package of integrated HIV/NCD services: 1. Integrated non-communicable/HIV care ("one stop shop" for services) 2. WHO PEN protocols, algorithm, \& training materials adapted for Zambia 3. Access to cardio-metabolic condition screening \& laboratory monitoring 4. Non-communicable disease-focused electronic medical record module 5. Strengthened NCD medication supply chain


Locations(12)

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, Zambia

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NCT05950919


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