Integrating Hypertension and Cardiovascular Diseases Care Into Existing HIV Services Package in Botswana (InterCARE)

NCT05414526 | Active Not Recruiting DMC

• 1 other identifier: InterCARE project
• Study Type: interventional
• Target: 4,655
• Locations: 1 country
• Sites: 3

Brief Summary

The InterCARE research project proposes to leverage a successful national ART program to develop an effective package to improve the uptake of established effective hypertension and CVD risk factors management interventions among PLWHIV in Botswana and other low- and middle-income countries. Being the first project of its kind in Botswana, if successful, the InterCARE package could be readily rolled out to health facilities nationwide to diagnose, treat, track, and support the estimated 25-30% Batswana with hypertension.

Conditions

HIV Infections; Hypertension

Outcome Measures

Primary Outcomes (2)

• Effectiveness

  Proportion of PLWHIV with diagnosed hypertension receiving anti-hypertensive medication with controlled blood pressure

  Every 6 months for 2 years

• Implementation

  Proportion of clinic encounters in electronic health records where anti-hypertensive medications are prescribed if indicated, as attained from electronic health records

  Every 6 months for 2 years

Secondary Outcomes (11)

• Reach

  Every 6 months for 2 years

• Effectiveness

  Every 12 months for 2 years

• Adoption

  Every 6 months for 2 years

• Reach

  Every 6 months for 2 years

• Maintenance

  Every 6 months for 2 years

Study Arms (1)

InterCARE package

EXPERIMENTAL

The type 2 hybrid effectiveness-implementation study will be cluster randomized trial with 1:1 paired randomization (Intervention arm vs Control arm )Using the coin flip randomization method, one clinic will be randomized to the intervention condition, and one to the control condition.

Other: InterCARE package

Interventions

InterCARE package OTHER

The InterCARE package includes: 1. Healthcare Provider HTN/CVD Curriculum A new HTN curriculum will be developed in collaboration with local stakeholders using KITSO Master trainer program documents (Healthcare provider HIV curriculum), Primary Care Guidelines, HTN/CVD curriculum/protocols trialled in Kweneng District and the CDC Prevention Hypertension Management Curriculum. 2. Adaptation of HIV care EHR for HTN/CVD care EHR modifications will be done to enhance data collection around HTN/CVD care, with input from MoH. 3. Patient and treatment partner sessions Clinic staff will provide in-clinic education and counselling on HTN/CVD to all PLWHIV with a diagnosis of hypertension during their routine HIV clinic visit. All patients will be provided a take-home easy-to-read pamphlet on HTN/CVD risk factor management. All PLWHIV will be asked to bring a treatment partner from their social network at the 2nd study visit so that they can practice role-plays with each other.

InterCARE package

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 20-75 years old
• Documented HIV-infection on ART
• Confirmed diagnosis of hypertension or elevated blood pressure \>140/90mmHg versus \>130/80mmHg if they have underlying Diabetes Mellitus or Chronic Kidney Disease
• Receiving regular care at the selected clinics

You may not qualify if:

• ● Positive for HIV-related dementia
• Adults aged 18 years of age or older
• Selected to be a treatment partner by participant.

Sponsors & Collaborators

• University of Botswana: lead

Study Sites (3)

14 Infectious Diseases Care centres (IDCCs) nationwide

Gaborone, 0000, Botswana

Location

Phitsane-Molopo IDCC Clinic

Pitsane, Botswana

Location

Tonota IDCC Clinic

Tonota, Botswana

Location

Related Publications (3)

• Youssouf N, Mogaetsho GE, Moshomo T, Gaolathe T, Ponatshego P, Ramotsababa M, Molefe-Baikai OJ, Dintwa E, Kiki T, Van Pelt AE, Steger-May K, Bogart LM, Jaffar S, Gala P, Wang D, Seipone K, Bennett K, Hurwitz KW, Kebotsamang K, Hirschhorn LR, Mosepele M. Designing an implementation science clinical trial to integrate hypertension and cardiovascular diseases care into existing HIV services package in Botswana (InterCARE). Trials. 2024 Jul 29;25(1):510. doi: 10.1186/s13063-024-08333-0.

  PMID: 39075506 DERIVED

• Moshomo T, Gaolathe T, Ramotsababa M, Molefe-Baikai OJ, Mogaetsho E, Dintwa E, Gala P, Ponatshego P, Bogart LM, Youssouf N, Seipone K, Van Pelt AE, Bennett K, Jaffar S, Ilias M, Tonwe V, Hurwitz KW, Kebotsamang K, Steger-May K, Hirschhorn LR, Mosepele M. Quantitative outcomes of a type 2 single arm hybrid effectiveness implementation pilot study for hypertension-HIV integration in Botswana. Implement Sci Commun. 2024 Jul 22;5(1):80. doi: 10.1186/s43058-024-00620-w.

  PMID: 39039609 DERIVED

• Gala P, Ponatshego P, Bogart LM, Youssouf N, Ramotsababa M, Van Pelt AE, Moshomo T, Dintwa E, Seipone K, Ilias M, Tonwe V, Gaolathe T, Hirschhorn LR, Mosepele M. A mixed methods approach identifying facilitators and barriers to guide adaptations to InterCARE strategies: an integrated HIV and hypertension care model in Botswana. Implement Sci Commun. 2024 Jun 20;5(1):67. doi: 10.1186/s43058-024-00603-x.

  PMID: 38902846 DERIVED

MeSH Terms

Conditions

HIV Infections; Hypertension

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mosepele Mosepele, MD

  University of Botswana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: InterCARE is the name of the package of implementation strategies proposed by the investigators that are intended to integrate cardiovascular care services into existing HIV care systems in Botswana. The InterCARE package includes 3 main interventions: 1. a tailored inter-professional training curriculum on management of CVD risk and HIV 2. adaptation of the existing electronic health records (PIMS) 3. adoption of a treatment partner support system.

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: June 10, 2022
• Study Start: January 31, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BO (3)