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N/A Completed N=448 Randomized Other

Task-shifted Adaptation of the WHO-PEN Intervention to Address Cardio-metabolic Complications in People Living With HIV in Zambia

Source: ClinicalTrials.gov NCT05005130 ↗
Enrolled (actual)
448
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcomePrimary: Change in Percent of Participants With Dual HIV and Blood Pressure Control — 52; 60 percentage of participants

Summary

This mixed-methods formative research study aims to adapt the WHO Package of Essential Noncommunicable Disease Interventions (WHO-PEN) approach for the Zambian public health system, and pilot test an adapted, streamlined, and task-shifted package of integrated HIV Noncommunicable Disease (NCD) services, collectively called "TASKPEN".

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Percent of Participants With Dual HIV and Blood Pressure Control
52; 60
SECONDARY
Number of Clinics That Adopted the Intervention (Intervention Adoption)
1; 1
SECONDARY
Number of Trained Healthcare Providers (Intervention Reach)
29; 60
SECONDARY
Changes in HIV Disease Control, as Measured by the Percent of Patient Participants With HIV RNA Suppression (Defined as <1,000 Copies/mL)
85; 89
SECONDARY
Change in Intervention Appropriateness
4.69; 4.18
SECONDARY
Change in Intervention Acceptability
4.7; 4.34
SECONDARY
Change in Intervention Feasibility
4.66; 4.16
SECONDARY
Intervention Cost Per Patient
352.53; 287.5

Eligibility Criteria

Objective 1

Focus group discussion participants/implementation survey participants:

Inclusion:

  • 18 years of age or older
  • non-physician professional or lay/peer health care worker (HCW) involved with HIV and/or NCD service delivery.

Key Informant Interview (KII) participants:

  • 18 years of age or older
  • a senior Ministry of Health (MOH) policy maker or health official working at national level in Zambia involved in managing, coordinating, and/or overseeing health services for non-communicable diseases in Zambia.

In-depth interview participants:

  • emancipated HIV-infected adults 18 years of age or older have a documented cardio-metabolic condition

Exclusion:

  • any potential IDI, FGD, or KII participant if they are unwilling or unable to provide informed consent.

Objective 2:

Cross-sectional assessments:

Inclusion:

  • HIV-infected
  • aged 18 years and older
  • seeking care at either of the two ACHIEVE-supported pilot sites who are screened for and/or found to have evidence of one or more of the cardio-metabolic conditions or risk factors.

Nested cohort participants:

Inclusion:

  • documented HIV infection
  • aged 18 years or older
  • have one or more cardio-metabolic conditions or risk factors:
  • obesity (defined as BMI > 30 kg/m^2);
  • any current tobacco smoking;
  • hypertension as defined by WHO PEN (i.e., systolic blood pressure (SBP) = 140 mmHg and/or diastolic blood pressure (DBP) = 90 mmHg);
  • diabetes mellitus as defined by WHO PEN (i.e. random plasma glucose = 11.1 mmol/L, fasting plasma glucose = 7 mmol/L, and/or haemoglobin A1c = 48 mmol/mol);
  • prediabetes (defined as having impaired fasting glucose of 6.1 to 6.9 mmol/L, impaired glucose tolerance with a two-hour, post-oral glucose tolerance test glucose =7.8 mmol/L but 4 mmol/L or low density lipoprotein =6 mmol/L); and/or 7) personal history or medication use for heart disease, heart failure, stroke, or other cardio-metabolic complication (including but not limited to coronary artery disease, cerebrovascular disease, myocardial infarction, stroke, or peripheral vascular disease).

IDI participants:

  • HIV-infected
  • 18 years of age who were enrolled in the nested cohort and had documented exposure to the TASKPEN intervention at a pilot site.

FGD participants:

  • 18 years of age or older
  • a non physician health care worker (NPHW) or community health worker (CHW)/ lay health provider involved with TASKPEN or integrated HIV/NCD service delivery generally familiar with HIV and/or NCD service delivery at their facility.

KII participants:

  • 18 years of age or older
  • a facility-level antiretroviral therapy (ART) or out-patient department (OPD) clinic 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.

Exclusion criteria

For the nested cohort component, investigators will exclude:

  • adults who have no documented evidence of having established HIV care at the sites.
  • people unlikely to remain at the site to the completion of the study follow-up.
  • any potential IDI, FGD, or KII participant if they are unwilling or unable to provide written informed consent.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05005130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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