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INTERVAL: Varying Intervals of ART to Improve Outcomes in HIV

NCT03101592 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9118

Last updated 2020-10-27

Study results available
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Summary

This is an unblinded cluster-randomized study to evaluate the effectiveness of two strategies for scripting/dispensing of antiretroviral therapy (ART) on retention, virologic suppression, and cost compared to the standard of care. The study will be conducted in Malawi and Zambia among approximately 8,200 HIV-1-infected adults (18 years or older) who are stable on ART. Clusters will be randomized to one of three study arms: (1) standard of care (SOC) ART scripting (varies by country, region, clinic, and/or provider), (2) three-month ART scripting, and (3) six-month ART scripting. 30 clusters will be selected for the study, 15 in Malawi and 15 in Zambia, and will be randomized to a study arm.

Conditions

Interventions

OTHER

Three-month ART dispensing

Patients enrolled in the three-month ART dispensing arm will receive a 90-day supply of ART from their provider for the duration of the study.

OTHER

Six-month ART dispensing

Patients enrolled in the six-month ART dispensing arm will receive a 180-day supply of ART from their provider for the duration of the study.

Sponsors & Collaborators

  • Boston University

    collaborator OTHER

  • Equip, Lesotho

    collaborator OTHER

  • Ministry of Health, Malawi

    collaborator OTHER_GOV

  • Ministry of Health, Zambia

    collaborator OTHER_GOV

  • Partners in Hope, Inc.

    collaborator INDUSTRY

  • Right to Care

    collaborator OTHER

  • United States Agency for International Development (USAID)

    collaborator FED

  • University of California, Los Angeles

    lead OTHER

Principal Investigators

  • Risa M Hoffman, MD, MPH · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-31
Primary Completion
2019-09-30
Completion
2020-08-10

Countries

  • Malawi
  • Zambia

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03101592 on ClinicalTrials.gov