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
- Conditions
- HIVNon Communicable Diseases
- Interventions
- Other: TASKPEN
- Registration Number
- NCT05950919
- Lead Sponsor
- University of North Carolina, Chapel Hill
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5620
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TASKPEN TASKPEN The TASKPEN intervention is a package of five evidence-based intervention (EBI) components that enhances WHO's Package of Essential Noncommunicable Disease Intervention for Primary Care (WHO-PEN) and includes a multi-faceted implementation strategy centred on service integration within routine HIV care settings. The EBI components and multi-faceted strategy have been adapted to the Zambian setting during recently completed formative work."
- Primary Outcome Measures
Name Time Method Percent of Participants with both HIV Viral Suppression and Control of Hypertension, Diabetes and Tobacco Use Month 12 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.
Number of Participants with both HIV Viral Suppression and Control of Hypertension, Diabetes and Tobacco Use Month 12 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.
- Secondary Outcome Measures
Name Time Method Percent of Participants with Improvement in 10-year ASCVD Risk Score up to 24 months 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.
Percent of Participants with Severe Hypertension 1, 12 and 24 months Systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥120 mmHg
Average Change in Haemoglobin A1c and Fasting Glucose Baseline up to 24 months Mean change in HgbA1c and/or fasting blood glucose from baseline at last assessment. Assessed at Baseline, 12 and 24 months.
Ideal Cardiovascular Health (CVH) 1, 12, and 24 months 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.Percent of Participants with HIV-1 Viral Suppression 0, 12, and 24 months To be assessed at empirically supported thresholds of \<1,000 c/mL, \<200 c/mL, and \<50 c/mL.
Number of Participants Retained in HIV Care 0, 12, and 24 months Number of participants with evidence of being retained in HIV care within the last \~180 days.
Variation of Medication Possession Ratio (MPR) ART 0, 12 and 24 months Number of days late for pharmacy refills by total days on treatment, and then subtracting that percentage from 100%--for antiretroviral therapy (ART).
Variation of Medication Possession Ratio (MPR) NCD Medications 0, 12 and 24 months Number of days late for pharmacy refills by total days on treatment, and then subtracting that percentage from 100%--for NCD medications.
Change in Blood Pressure Control from Baseline to Month 12 Baseline, Month 12 Average numerical change in systolic and diastolic blood pressure.
Change in Blood Pressure Control from Baseline to Month 24 Baseline, Month 24 Average numerical change in systolic and diastolic blood pressure.
Number of Participants with Severe Hypertension up to 24 months Systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥120 mmHg. Assessed at Baseline, 12 and 24 months.
Number of Participants with HIV-1 Viral Suppression 0, 12, and 24 months To be assessed at empirically supported thresholds of \<1,000 c/mL, \<200 c/mL, and \<50 c/mL.
Percent of Participants Retained in HIV Care 1, 12, and 24 months Percent of participants with evidence of being retained in HIV care within the last \~180 days.
Number of Participants with an Increase in Quality of Life (QOL) up to 24 months 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.Percent of Participants with an Increase in Quality of Life up to 24 months 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.
Trial Locations
- Locations (12)
Railway Urban Health Center
🇿🇲Lusaka, Zambia
Bauleni Health Center
🇿🇲Lusaka, Zambia
Chelstone Urban Health Center
🇿🇲Lusaka, Zambia
Chipata 1st Level Hospital
🇿🇲Lusaka, Zambia
Kamwala Urban Health Center
🇿🇲Lusaka, Zambia
Kanyama 1st Level Hospital
🇿🇲Lusaka, Zambia
Kalingalinga Urban Health Center
🇿🇲Lusaka, Zambia
Mtendere Health Center
🇿🇲Lusaka, Zambia
Ng'ombe Urban Health Center
🇿🇲Lusaka, Zambia
Chawama 1st Level Hospital
🇿🇲Lusaka, Zambia
Kabwata Urban Health Center
🇿🇲Lusaka, Zambia
Makeni Urban Health Center
🇿🇲Lusaka, Zambia