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

Not Applicable

Completed

• Conditions: HIV Infections
• Interventions: Other: Home-Based ART Delivery; Other: Community Adherence Clubs; Other: Standard of Care

• Registration Number: NCT03025165
• Lead Sponsor: HIV Prevention Trials Network

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-19
• Study Start: 2017-05-01
• Primary Completion: 2019-07-22
• Study Completion: 2019-07-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2526

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home-Based ART Delivery	Home-Based ART Delivery	Individuals receive ART adherence support, symptom screening and dispensation of pre-packed medications by community health worker at their household every three months, with two clinic visits every year for clinical review and laboratory monitoring
Community Adherence Clubs	Community Adherence Clubs	ART adherence support, symptom screening and dispensation of pre-packed medications by community health worker to a club meeting of 20-25 HIV+ patients every three months, with two clinic visits every year for clinical review and laboratory monitoring
Standard of Care	Standard of Care	Delivery of ART adherence support, symptom screening and dispensation of medications at the local clinic according to local guidelines.

Primary Outcome Measures

Name	Time	Method
Viral Suppression	One year after beginning participation in the program	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.

Secondary Outcome Measures

Name	Time	Method
Viral suppression at 24 months	Two years after beginning participation in the program	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.

Trial Locations

Locations (1)

Zambart; 🇿🇲 Lusaka, Zambia