NCT05642858

Brief Summary

The overall objective is to evaluate the efficacy of educational text messages to reduce cardiovascular risk among persons living with HIV (PLWH).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable hiv

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 8, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

March 12, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

June 8, 2025

Status Verified

June 1, 2025

Enrollment Period

2.7 years

First QC Date

November 18, 2022

Last Update Submit

June 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants with controlled blood pressure

    Proportion of participants with blood pressure \< 130/80 mmHg as recorded in the electronic health record (EHR).

    6 months

Secondary Outcomes (11)

  • Number of cardiovascular risk factors controlled

    6 months

  • Self-perceived cardiovascular risk

    6 months

  • Systolic blood pressure

    6 months

  • Cholesterol

    6 months

  • Physical activity

    6 months

  • +6 more secondary outcomes

Study Arms (2)

Intervention Arm

EXPERIMENTAL

The intervention arm will receive education about HIV and heart disease risk via mobile phone text messages for up to 6 months. They will receive the text messages 3-5 times per week. The messages will include information about HIV and risk of heart disease and information about how to reduce heart disease risk. The intervention arm will also receive brief monthly surveys via a digital research platform.

Behavioral: Digital Educational Messaging

Control Arm

NO INTERVENTION

The control arm will not receive the educational text messages. They will receive brief monthly surveys via a digital research platform.

Interventions

Education via mobile phone text messages for up to 6 months.

Intervention Arm

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV positive
  • At least 40 years of age
  • English-speaking

You may not qualify if:

  • Existing clinical atherosclerotic cardiovascular disease (ASCVD)
  • Pregnant
  • Unwilling/unable to provide informed consent
  • Does not own a smartphone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94115, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeCardiovascular DiseasesAtherosclerosis

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 DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Megan McLaughlin, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan McLaughlin, MD, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2022

First Posted

December 8, 2022

Study Start

March 12, 2023

Primary Completion

December 1, 2025

Study Completion

July 1, 2026

Last Updated

June 8, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations