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NCT03025165 Clinical Trial

A Comparison of Different Community Models of ART Delivery Amongst Stable HIV+ Patients in Two Urban Settings in Zambia

HIV Infections Clinical Trial

Official title:
A Comparison of Different Community Models of ART Delivery Amongst Stable HIV+ Patients in Two Urban Settings in Zambia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03025165
Other study ID # HPTN 071c
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date July 22, 2019

Study information
Verified date August 2022
Source HIV Prevention Trials Network
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the virological and clinical outcomes of patients participating in community models of ART delivery to the standard of care in an urban setting in Zambia.

Description:

The outcomes of this study will be measured in a prospective cohort of adult patients enrolled into ART care in two urban communities participating in the HPTN 071 (PopART) trial. The two community models are: 1) adherence clubs, groups of 20-25 stable patients who receive ART care in the community every 3 months, and 2) home-based ART delivery in which a community health worker delivers ART care to an individual at home every 3 months. The standard of care is delivery of ART care at the local clinic.

Recruitment information / eligibility
Status Completed
Enrollment 2526
Est. completion date July 22, 2019
Est. primary completion date July 22, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 18 years or older On first-line ART and retained in care for more than 6 months Virologically suppressed World Health Organization (WHO) stage I and II at time of screening Reside within the clinic catchment area Willing to provide written informed consent and accept Community HIV-care Provider (CHiPs) intervention Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Community Adherence Clubs
Provision of ART care in the community to a club of 20-25 HIV+ patients
• Home-Based ART Delivery
Provision of ART care to an individual at their home
• Standard of Care
Delivery of ART adherence support, symptom screening and dispensation of medications at the local clinic according to local guidelines.

Locations
Country Name City State
Zambia Zambart Lusaka

Sponsors (1)
Lead Sponsor Collaborator
HIV Prevention Trials Network

Country where clinical trial is conducted

Zambia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Viral Suppression Viral suppression at 12 months measured using the standard of care viral load testing equipment currently in place. Viral suppression will be defined according to National guidelines. One year after beginning participation in the program
Secondary Viral suppression at 24 months Undetectable HIV viral load 24 months after entry into the models of care. This will be done as part of routine laboratory monitoring and measured using routine programmatic data. Two years after beginning participation in the program
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