N/A
Completed N=448
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
| Outcome | Result | p-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.
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.