HIVINTEGRATE-RXNCT07711366
INTEGRATE-RX: Integrating Clinical Pharmacists in HIV Care to Mitigate Last-Mile Challenges and Reduce Cardiovascular Disease Burden
A study testing INTEGRATE-RX in people with HIV and Hypertension, run by Temple University at 2 sites in Kenya.
Trial summary
The risk of heart attacks and stroke is two times higher among people living with HIV (PLWH), as compared to the general population. Prevention and treatment of cardiovascular disease (CVD) risk factors, such as high blood pressure, high cholesterol, and diabetes, are important in the overall management and CVD risk… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HIV, Hypertension, Cardiovascular Disease Prevention
- What is being tested?
- INTEGRATE-RX
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 2 sitesKenya
- Study dates
- 1 Oct 2026to 31 Jul 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients 18 years or above
- Actively enrolled in the AMPATH HIV care program
- Screen positive for and confirmed to have hypertension through repeated blood pressure measurement (SBP ≥ 140 or diastolic BP (DBP) ≥ 90), or those who are already in care for hypertension
Who cannot join
- Hypertensive emergency requiring immediate medical attention
- Terminal illness
- Pregnancy
- Inability to provide informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya2 sites
Moi Teaching and Referral Hospital
Eldoret, Uasin Gishu County
Kitale County Referral Hospital
Kitale, Trans Nzoia County
About this study
The risk of heart attacks and stroke is two times higher among people living with HIV (PLWH), as compared to the general population. Prevention and treatment of cardiovascular disease (CVD) risk factors, such as high blood pressure, high cholesterol, and diabetes, are important in the overall management and CVD risk reduction among PLWH. Clinical pharmacists and their involvement in HIV care through comprehensive medication management have lead to improved medication adherence, undetectable HIV viral load, and continuity in care among PLWH. In addition, when pharmacists work with other health providers, they can also improve access to medications and management of major CVD risk factors like high blood pressure, high cholesterol, and diabetes. However, evaluation of the effectiveness, economic impact, and scalability of pharmacist-led interventions in combined HIV and CVD care in sub-Saharan Africa, where the burden of both HIV and CVD risk factors is high, are still understudied. Therefore, the objective of this study is to evaluate the effectiveness and cost-effectiveness of a pharmacist-led implementation strategy to prevent and manage cardiovascular disease in PLWH. The investigators hypothesize that a pharmacist-led intervention (INTEGRATE-RX) which includes - (1) integration of clinical pharmacists for CVD medication initiation and continuation, (2) pharmacist-coordinated access to CVD essential medicines, and (3) pharmacist-coordinated peer support for medication delivery and psychosocial counseling - will be clinically effective and cost-effective in improving CVD outcomes amongst PLWH.
Read the detailed description
Aim 1 will design a pharmacist-led HIV/CVD integrated care implementation strategy in western Kenya. Using a human-centered design approach, the investigators will refine a pharmacist-led multicomponent cardiovascular risk reduction intervention to enhance HIV/CVD care. The investigators will evaluate the acceptability and appropriateness of the implementation strategy amongst patients, pharmacists, physicians, other providers, peers, and administrators. Aim 2 will evaluate the clinical effectiveness by conducting an implementation hybrid type 2 stepped-wedge clustered randomized controlled trial comparing: INTEGRATE-RX implementation strategy and Usual Care. The primary clinical outcome will be one-year change in systolic blood pressure (SBP). The primary adherence outcome will be medication adherence. The primary implementation outcome will be fidelity. Secondary outcomes will include change in viral load, low-density lipoprotein (LDL), patient-reported quality of life, and RE-AIM metrics. Aim 3 will estimate the cost-effectiveness and budget impact of INTEGRATE-RX in terms of cost per patient with controlled hypertension and per disability-adjusted life year (DALY) saved. To assess the financial impact of adopting this high-value intervention, the investigators will estimate the incremental cost per unit reduction in SBP and per DALY saved, compared to Usual Care. The investigators will model the budget impact of increasing intervention coverage to 50% of the eligible population by 2030 to promote wider county-level adoption. This research is conducted by a transdisciplinary team of research investigators with diverse and complementary expertise. Data generated from this study will provide important policy guidance for countries trying to address the growing burden of CVD and CVD risk factors amongst the adult and aging population living with HIV. In addition, this study contributes rigorous evidence on the roles and effectiveness of clinical pharmacists in integrated communicable and non-communicable chronic disease management in sub-Saharan Africa and other resource-constraint settings in the US and globally.
- Conditions
- HIV, Hypertension, Cardiovascular Disease Prevention
- Being tested
- INTEGRATE-RX
- Keywords
- clinical pharmacist, integrated HIV and cardiovascular disease care, implementation science, HIV, cost effectiveness analysis, budget impact analysis, stepped-wedge cluster randomized trial, hybrid type 2 effectiveness-implementation trial, human centered design, clinical pharmacy, cardiovascular disease prevention, medication adherence, cardiovascular disease risk factors, peer navigators
- Medical subject headings
- Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTEGRATE-RXBehavioural
PLWH will be managed by the clinical pharmacist based on the established clinical care protocols that include comprehensive risk reduction strategies that incorporate counselling on diet and lifestyle, screening for, and management of other cardiovascular disease (CVD) risk factors, including but not limited to dyslipidemia and dysglycemia. The core components of the INTEGRATE-RX strategy will be: 1) integration of clinical pharmacists for CVD medication initiation and maintenance, (2) pharmacist-coordinated access to CVD essential medicines, and (3) pharmacist-coordinated peer support for medication delivery and psychosocial counselling.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | During usual care, patient living with HIV with comorbid hypertension, diabetes, or hyperlipidemia do not interact with clinical pharmacists. The usual care phase of the intervention will be delivered by physicians, clinical officers, and nurses, with medications dispensed by pharmaceutical technologists. |
| INTEGRATE-RX | Experimental | INTEGRATE-RX intervention includes (1) integration of clinical pharmacists for CVD medication initiation and continuation, (2) pharmacist-coordinated access to CVD essential medicines, and (3) pharmacist-coordinated peer support for medication delivery and psychosocial counseling. Receives: Behavioral: INTEGRATE-RX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in systolic blood pressure
Mean change in systolic blood pressure from Baseline to Month 6 and Month 12
Measured: Baseline, Month 6, Month 12
Adherence to medications
Adherence to non-HIV medications using the Voils DOSE-Nonadherence questionnaire (responses are scored on a 5-point Likert scale with 1 = perfectly adherent and 5 = non-adherent) and to HIV medications using the AIDS Clinical Trials Group (ACTG) Adherence questionnaire (responses are expressed as mean 4-day adherence ratio of 0 through 1 with 1 = perfect adherent and 0 = non-adherent).
Measured: Baseline, Month 6, Month 12
Implementation fidelity
Level of adherence and consistency to each of the implementation strategy component
Measured: Baseline, Month 6, and Month 12
Secondary outcomes (3)
Viral load
HIV viral load at baseline and Month 12
Measured: Baseline and Month 12
Mean change in Low Density Lipoprotein (LDL)
Mean change in Low Density Lipoprotein (LDL) from Baseline to Month 12
Measured: Baseline and Month 12
Change in patient-reported Quality of Life (QOL)
Change in patient-reported quality of life using the World Health Organization Quality of Life Brief Questionnaire in HIV population (WHOQOL-HIV BREF). The questionnaire items are grouped into six domains, with each domain rated on a 5-point Likert scale, where 1 indicates low quality of life and 5 indicates a positive high quality of life.
Measured: Baseline and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a stepped-wedge cluster randomized trial (SW-CRT). SW-CRT design offers a rigorous method of evaluation of the effectiveness of an intervention in pragmatic settings. Briefly, at pre-defined regular intervals, one cluster will be randomized to cross from receiving usual care (control group) to the intervention. This process then continues until all clusters are exposed to the intervention. Data collection occurs throughout the entire study, and each cluster contributes observations under both control and intervention periods. In this study, randomization will occur at the cluster level, each of which is represented by a distinct HIV clinic (also known as HIV module) within the AMPATH catchment area. There will be a total of 5 clusters. Each participating cluster will start with a Usual Care phase and are block-randomized to receive INTEGRATE-RX intervention in 5 steps, with one clinic per step.
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Purdue University, Brown University, Duke University, NYU Langone Health, Moi Teaching and Referral Hospital
- Responsible party
- Sponsor
- Investigators
- Benson Njuguna, MPharm, MPH, MPP, Principal investigator, Moi Teaching and Referral HospitalDan Tran, PharmD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711366
- Sponsor's protocol ID
- 32418
- Other IDs
- 1R01HL179904-01, 3R01HL179904-01S1
- Acronym
- INTEGRATE-RX
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Quantitative and qualitative data will be shared in the form of de-identified data sets. The de-identified participant data from the final research datasets used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication, or as required by a condition of awards and agreements supporting the research. All shared data must abide by a data use agreement that is fully executed between the requesting research investigator with Temple University. Requests of data use proposals may be directed to: Tran.nk.tina@temple.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.