INTEGRATE-RX: Integrating Clinical Pharmacists in HIV Care to Mitigate Last-Mile Challenges and Reduce Cardiovascular Disease Burden (INTEGRATE-RX)
2026年7月14日 更新者：Temple University
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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
450
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Dan Tran, PharmD
- 電話番号：215-707-6014
- メール：tran.nk.tina@temple.edu
研究連絡先のバックアップ
- 名前：Erica Maier, BA
- 電話番号：215-707-9809
- メール：erica.maier@temple.edu
研究場所
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Trans Nzoia County
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Kitale、Trans Nzoia County、ケニア
- Kitale County Referral Hospital
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Uasin Gishu County
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Eldoret、Uasin Gishu County、ケニア
- Moi Teaching and Referral Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- Hypertensive emergency requiring immediate medical attention
- Terminal illness
- Pregnancy
- Inability to provide informed consent
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Usual care
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.
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実験的：INTEGRATE-RX
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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mean change in systolic blood pressure
時間枠：Baseline, Month 6, Month 12
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Mean change in systolic blood pressure from Baseline to Month 6 and Month 12
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Baseline, Month 6, Month 12
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Adherence to medications
時間枠：Baseline, Month 6, Month 12
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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).
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Baseline, Month 6, Month 12
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Implementation fidelity
時間枠：Baseline, Month 6, and Month 12
|
Level of adherence and consistency to each of the implementation strategy component
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Baseline, Month 6, and Month 12
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Viral load
時間枠：Baseline and Month 12
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HIV viral load at baseline and Month 12
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Baseline and Month 12
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Mean change in Low Density Lipoprotein (LDL)
時間枠：Baseline and Month 12
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Mean change in Low Density Lipoprotein (LDL) from Baseline to Month 12
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Baseline and Month 12
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Change in patient-reported Quality of Life (QOL)
時間枠：Baseline and Month 12
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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.
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Baseline and Month 12
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Reach (RE-AIM)
時間枠：Baseline
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Number of enrolled participants as a proportion of eligible individuals; Representativeness of participants
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Baseline
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Implementation (RE-AIM)
時間枠：Up to 12 months
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Adaptations made to the implementation strategy, patient satisfaction, cost-effectiveness analysis, budget impact analysis
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Up to 12 months
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Adoption (RE-AIM)
時間枠：Baseline and Month 12
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Proportion of clinics who agree to implement; Proportion of health facilities that implement INTEGRATE RX
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Baseline and Month 12
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Maintenance (RE-AIM)
時間枠：6 months after the intervention completion period
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Continuity of intervention during the follow-up period
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6 months after the intervention completion period
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
協力者
捜査官
- 主任研究者：Benson Njuguna, MPharm, MPH, MPP、Moi Teaching and Referral Hospital
- 主任研究者：Dan Tran, PharmD、Temple University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月1日
一次修了 (推定)
2029年9月30日
研究の完了 (推定)
2030年7月31日
試験登録日
最初に提出
2026年6月29日
QC基準を満たした最初の提出物
2026年7月14日
最初の投稿 (実際)
2026年7月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月17日
QC基準を満たした最後の更新が送信されました
2026年7月14日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 32418
- 1R01HL179904-01 (米国 NIH グラント/契約)
- 3R01HL179904-01S1 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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.
IPD 共有時間枠
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD 共有アクセス基準
The investigator who proposed to access and use the data will be granted access upon reasonable request and a methodologically sound proposal.
Requests should be directed to Tran.nk.tina@temple.edu.
To gain access, data requestors will need to sign a data access agreement.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
高血圧症の臨床試験
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University of Sao Paulo General Hospitalまだ募集していませんCOPD | 肺疾患および/または低酸素症に続発する肺高血圧症 | Pulmnary Hypertension
INTEGRATE-RXの臨床試験
-
Abbott Medical Devices完了
-
Vielight Inc.完了