Addressing HyperteNsion and Diabetes Through Community-Engaged Systems in Puno, Peru (ANDES Study)

NCT05524987 | Active Not Recruiting DMC

• 2 other identifiers: 104372UG3HL152371
• Study Type: interventional
• Target: 1,068
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertension (HTN) has become the largest driver of morbidity and mortality (M\&M) worldwide, affecting nearly 1 billion persons, the vast majority living in low- and middle-income countries (LMICs). While clinical research has identified highly-efficacious and inexpensive options to control HTN, rates of awareness, treatment and control of HTN are abysmally low. Implementation strategies that can effectively reach and engage patient populations while feasible within the constraints of frail health systems are urgently needed. In Peru, less than 10% of those with HTN are optimally controlled and thus avoidable M\&M continues to increase at unacceptable levels. In the proposed ANDES strategy, ANDES research team will study a vulnerable, impoverished indigenous Andean population that has a high prevalence of HTN (18.5%) and Type 2 Diabetes (T2D) (7.4%); living at high altitude. The study has two phases: UG3/UH3. During the formative UG3 phase (ended 12/31/22) we completed 3 aims, including: a) adapting community-based service delivery models for detection/control of HTN/T2D using stakeholder-engaged approaches; and b) assessed short-term implementation and service outcomes of pilot Health Fairs to detect HTN/T2D and a CHW-led model for engagement and treatment of HTN/T2D in two communities. A number of stakeholder in-depth interviews revealed significant limitations to HTN control. Discrete Choice Experiments (DCEs) surveys helped understand attributes for a community health worker (CHW)-led HTN care program that patients would value. Human-Centered Design was used to refine CHWs manual prototype, frequency and content of training sessions on patients, training CHW, supervision and integration into the healthcare system; facility-based health worker training content and approaches; identified opportunities for CHWs to improve health care system by helping to promote hypertension diagnosis, treatment and control. All these activities were used to refine the protocol that was tested in the pilot study where 1,079 subjects underwent blood pressure monitoring under a Standard Operating Procedure using electronic tablets to construct a REDCap database. The UH3 phase will test the adapted ANDES strategy. ANDES is a two-arm, individually randomized superiority trial with parallel assignment. The overall objective of ANDES is to evaluate the effectiveness of a home-based Health Agent-led intervention in reducing blood pressure and improving diabetes control in patients from under-resourced communities in Puno, Peru. Potential ANDES study participants will be identified, screened, and recruited via 2 different mechanisms: 1) community health fairs and 2) healthcare facility-based enrollment. Health fair planning, will be conducted in collaboration with DIRESA \& EsSalud and local healthcare facility leaders. All health fair attendees will be screened for blood pressure measurements. ANDES research study staff will do screening at tents in the health facilities after doctors refer patients (or for any patients to visit who want) to inquire about their willingness for an in-person screening visit at their home. Recruitment will be rolling over 24 months during which 1068 participants in total (534 participants per arm) will be enrolled. To detect a difference in systolic blood pressure of 2.5 mmHg between intervention and control arms with 95% confidence, 90% power and a standard deviation of 12 mmHg, ANDES research team would need 485 participants per arm. Assuming a conservative lost-to-follow-up of 10% at 12 months, ANDES research team would need to randomize 1068 participants in total (534 participants per arm). The primary outcome is to determine if the ANDES intervention impacts SBP in comparison to the usual care arm 12 months after randomization. ANDES participants will initiate one of two care pathways according to the randomization assignment. Participants in the usual care group will be referred to their local healthcare facility for evaluation and/or to receive medical therapy per typical standard of care and at the discretion of the treating physician for the entirety of the ANDES study. Participants in the ANDES intervention group will receive the ANDES implementation package consisting of health agent home visits for 12 consecutive months. Implementation package delivery will end after month 12, at which time intervention participants will be advised to obtain standard care from their local healthcare facility. Study outcome measures will be obtained in both the usual care and ANDES intervention group at months 12 and 18 post-randomization. All participants will receive visits at baseline, 12 and 18 months for study outcome assessments. Intervention participants will additionally receive a total of 12 visits by health agents as part of the intervention package, for a total of 18 visits for those assigned to the intervention group.

Conditions

Hypertension; Diabetes

Keywords

Hypertension; Diabetes; Task shifting; Community Health Worker; Puno-Peru

Outcome Measures

Primary Outcomes (1)

• Effectiveness outcome: Systolic Blood Pressure

  Systolic blood pressure (SBP) (mmHg) at 12 months after randomization.

  12 months

Secondary Outcomes (3)

• Effectiveness outcome: Diastolic blood pressure

  12 months

• Effectiveness outcome: Controlled hypertension

  12 months

• Effectiveness outcome: HbA1c

  12 months

Other Outcomes (6)

• Implementation outcome: Fidelity of the implementation strategy

  12 months

• Acceptability of implementation strategy

  12 months

• Participant acceptability of the ANDES implementation strategy

  12 months

Study Arms (2)

INTERVENTION

EXPERIMENTAL

Participants in the ANDES intervention group will receive the ANDES implementation package consisting of health agent home visits for 12 consecutive months. Implementation package delivery will end after month 12, at which time intervention participants will be advised to obtain standard care from their local healthcare facility. ANDES is an adaptation of the World Health Organization (WHO) HEARTS package and consists of the following components: A. Health agent-managed home care * BP monitoring * Health coaching * Health system navigation * Medication adherence support B. Text message-based health coaching Specifically, the ANDES strategy is aligned with four WHO HEARTS technical package components.

Behavioral: ANDES INTERVENTION

CONTROL

NO INTERVENTION

Participants in the usual care group will be referred to their local healthcare facility for evaluation and/or to receive medical therapy per typical standard of care and at the discretion of the treating physician for the entirety of the ANDES study.

Interventions

ANDES INTERVENTION BEHAVIORAL

ANDES intervention group will receive the ANDES implementation package consisting of health agent home visits for 12 consecutive months

INTERVENTION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of HTN, defined as one or more of the following:
• Physician-prescribed use of antihypertensive medications, and SBP≥130 mmHg and/or DBP≥80 mmHg
• Physician diagnosed hypertension defined as a hypertensive blood pressure measurement (SBP≥140 mmHg and/or DBP≥90 mmHg) documented or measured on two or more separate occasions.
• Willing and available to receive health agent home visits monthly for the next year.
• Receiving healthcare through MINSA or EsSalud healthcare systems

You may not qualify if:

• Less than 18 years old;.
• Has a SBP less than 140 mmHg and DBP less than 90 mmHg and is not currently taking medication;
• Has a SBP less than 130 mmHg and DBP less than 80 mmHg if currently taking hypertension medication;
• Unwilling, unable, or or not cognitively capable of providing informed consent;
• Pregnant or plan to become pregnant in the next 18 months;
• Plan to move out of the study area in the next 18 months;
• Are not ambulatory, particularly if bedridden;
• Currently receives home medical visits;
• Life expectancy less than 6 months.
• Lives more than approximately 1 hour from Puno city center;
• Plan to travel for more than 3 months in the next year;
• Another ANDES participant already lives in their home;
• Patients on dialysis or expecting to start dialysis within the next 12 months;
• Patients with liver failure (meeting Child-Pugh B or C criteria)

Sponsors & Collaborators

• Universidad Peruana Cayetano Heredia: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Washington University School of Medicine: collaborator
• Johns Hopkins University: collaborator
• Asociacion Benefica Prisma: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

PRISMA

Puno, Puno, Peru

Location

Related Publications (29)

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Related Links

• HEARTS Technical Package (accessed 1 June 2022)

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Stella Hartinger, PhD

  Universidad Peruana Cayetano Heredia

  PRINCIPAL INVESTIGATOR

• Victor Dávila-Román, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• William Checkley, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be done at the conclusion of the study
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A randomized, two-arm intervention individually randomized trial with parallel assignment

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 1, 2022
• Study Start: March 20, 2023
• Primary Completion: March 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

PE (1)