NCT05609513

Brief Summary

Effective, cost-effective, scalable, sustainable, and equitable implementation strategies to improve care for people living with HIV and co-morbid hypertension in sub-Saharan Africa are urgently needed. Our study will compare the effectiveness, scalability, and cost-effectiveness of a lower-resource intensive vs. a higher resource intensive strategy to integrate hypertension care into HIV clinics in Uganda.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87,421

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

February 6, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2025

Completed
Last Updated

January 14, 2026

Status Verified

June 1, 2024

Enrollment Period

2.5 years

First QC Date

November 1, 2022

Last Update Submit

January 13, 2026

Conditions

HIV/AIDSHypertension

Outcome Measures

Primary Outcomes (2)

  • Population blood pressure control

    Proportion (%) of the entire clinic population in care (\>18 years old) with a documented BP \<140mmhg systolic AND \<90mmhg diastolic.

    Year 3-5

  • Hypertension patient BP control

    Proportion (%) of patients with hypertension with a documented BP \<140mmhg systolic AND \<90mmhg diastolic. \<140/90 mmHg

    Year 3-5

Secondary Outcomes (1)

  • cost-effectiveness

    Year 3-5

Study Arms (3)

8 HIV clinics randomized to HTN BASIC

EXPERIMENTAL

The HTN-BASIC intervention will consist of providing consistent access to diagnostic equipment and evidence-based antihypertensive drugs at no cost to the hypertensive patients. Access to a consistent supply of three anti-hypertensive drugs (amlodipine 5, 10mg; valsartan 80, 160mg; and hydrochlorothiazide 12.5, 25mg) will be supplied to each clinic in the trial.

Other: HTN-BASIC

8 HIV clinics randomized to HTN PLUS

EXPERIMENTAL

In addition to receiving all the components of HTN-BASIC, HTN-PLUS sites will receive an enhanced, more human-resource intensive package of interventions that have been developed in consultation with key stakeholders during our human-centered design phase. The intervention components will include four broad categories- (1) hypertension training, (2) differentiated service delivery and (3) remote patient monitoring for hypertension and (4) Performance Improvement Program. Uptake of all components will be assessed on a monthly basis during the intervention period. These interventions will by nature cost more, and so cost data will be rigorously collected as well.

Other: HTN-PLUS

Control Period for all 16 clinics

NO INTERVENTION

Outcome data will be collected during the control period prior to intervention roll-out in all 16 clinics.

Interventions

HTN-BASICOTHER

The HTN-BASIC intervention will consist of providing consistent access to diagnostic equipment and evidence-based antihypertensive drugs at no cost to the hypertensive patients. Access to a consistent supply of three anti-hypertensive drugs (amlodipine 5, 10mg; valsartan 80, 160mg; and hydrochlorothiazide 12.5, 25mg) will be supplied to each clinic in the trial.

8 HIV clinics randomized to HTN BASIC
HTN-PLUSOTHER

In addition to receiving all the components of HTN-BASIC, HTN-PLUS sites will receive an enhanced, more human-resource intensive package of interventions that have been developed in consultation with key stakeholders during our human-centered design phase. The intervention components will include four broad categories- (1) hypertension training, (2) differentiated service delivery and (3) remote patient monitoring for hypertension and (4) Performance Improvement Program. Uptake of all components will be assessed on a monthly basis during the intervention period. These interventions will by nature cost more, and so cost data will be rigorously collected as well.

8 HIV clinics randomized to HTN PLUS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) All patients over 18 years of age receiving care at participating HIV clinics will contribute data for the effectiveness outcomes

You may not qualify if:

  • \) Patients who are not diagnosed with HIV receiving care at participating HIV clinics and are under the age of 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Butabika

Kampala, Uganda

Location

Kawala

Kampala, Uganda

Location

Kisenyi

Kampala, Uganda

Location

Kitebi

Kampala, Uganda

Location

Komamboga

Kampala, Uganda

Location

Mengo Hospital

Kampala, Uganda

Location

Naguru

Kampala, Uganda

Location

Nsambya

Kampala, Uganda

Location

Bweyogerere

Wakiso, Uganda

Location

Entebbe RRH

Wakiso, Uganda

Location

Kakiri

Wakiso, Uganda

Location

Kawanda

Wakiso, Uganda

Location

Nakawuka HCIII

Wakiso, Uganda

Location

Nsangi HCIII

Wakiso, Uganda

Location

Nurture Africa

Wakiso, Uganda

Location

Saidina

Wakiso, Uganda

Location

Related Publications (2)

  • Longenecker CT, Kiggundu JB, Ayebare F, Muddu M, Kayima J, Mutungi G, Ssinabulya I, Schwartz JI, Spiegelman D, Tong G, Nugent R, Aifah A, Kagoya F, Cameron DB, Hutchinson B, Kamya MR, Katahoire AR, Semitala FC. Implementation strategies to integrate HIV and hypertension care in Kampala and Wakiso districts, Uganda: study protocol for a stepped wedge cluster randomized trial (PULESA-Uganda). BMC Health Serv Res. 2025 Aug 11;25(1):1060. doi: 10.1186/s12913-025-13281-9.

    PMID: 40790739DERIVED

  • Kiggundu JB, Semitala FC, Lipoto CF, Giibwa L, Twine R, Mwaka S, Ayebare F, Kiwala C, Magambo EN, Mutungi G, Ssinabulya I, Spiegelman D, Kayima J, Muddu M, Schwartz JI, Katahoire AR, Longenecker CT. Early findings from the integration of hypertension care into differentiated service delivery models for HIV in Uganda: a mixed-method study. J Int AIDS Soc. 2025 Jul;28 Suppl 3(Suppl 3):e26499. doi: 10.1002/jia2.26499.

    PMID: 40622382DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHypertension

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Fred C. Semitala, MBChB, MMED

    INFECTIOUS DISEASES RESEARCH COLLABORATION

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: This is a stepped wedge cluster randomized trial. Sixteen clinics will be randomized to the order in which they will begin intervention, with two clinics initiating the intervention every 2 months after a 2-month run-in period. Sites will be additionally randomized to receive the HTN-BASIC package only or the enhanced HTN-PLUS intervention. We will collect clinic data during the control period, run-in period and the intervention phase.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2022

First Posted

November 8, 2022

Study Start

February 6, 2023

Primary Completion

August 5, 2025

Study Completion

October 3, 2025

Last Updated

January 14, 2026

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

De-identified data can be made available upon request.

Locations

UG(16)