NCT03025165

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,526

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

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

January 17, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2019

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

2.2 years

First QC Date

January 17, 2017

Last Update Submit

March 20, 2025

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Viral suppression at 24 months

    Two years after beginning participation in the program

Study Arms (3)

Community Adherence Clubs

EXPERIMENTAL

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

Other: Community Adherence Clubs

Home-Based ART Delivery

EXPERIMENTAL

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

Other: Home-Based ART Delivery

Standard of Care

OTHER

Delivery of ART adherence support, symptom screening and dispensation of medications at the local clinic according to local guidelines.

Other: Standard of Care

Interventions

Community Adherence ClubsOTHER

Provision of ART care in the community to a club of 20-25 HIV+ patients

Community Adherence Clubs
Home-Based ART DeliveryOTHER

Provision of ART care to an individual at their home

Home-Based ART Delivery
Standard of CareOTHER

Delivery of ART adherence support, symptom screening and dispensation of medications at the local clinic according to local guidelines.

Standard of Care

Eligibility Criteria

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zambart

Lusaka, Zambia

Location

Related Publications (2)

  • Limbada M, Macleod D, Situmbeko V, Muhau E, Shibwela O, Chiti B, Floyd S, Schaap AJ, Hayes R, Fidler S, Ayles H; HPTN 071 (PopART) study team. Rates of viral suppression in a cohort of people with stable HIV from two community models of ART delivery versus facility-based HIV care in Lusaka, Zambia: a cluster-randomised, non-inferiority trial nested in the HPTN 071 (PopART) trial. Lancet HIV. 2022 Jan;9(1):e13-e23. doi: 10.1016/S2352-3018(21)00242-3. Epub 2021 Nov 26.

    PMID: 34843674DERIVED

  • Limbada M, Bwalya C, Macleod D, Floyd S, Schaap A, Situmbeko V, Hayes R, Fidler S, Ayles H; HPTN 071 (PopART) Study Team. A comparison of different community models of antiretroviral therapy delivery with the standard of care among stable HIV+ patients: rationale and design of a non-inferiority cluster randomized trial, nested in the HPTN 071 (PopART) study. Trials. 2021 Jan 12;22(1):52. doi: 10.1186/s13063-020-05010-w.

    PMID: 33430928DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Mohammed Limbada, MBCHB, MScID

    Zambart

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 17, 2017

First Posted

January 19, 2017

Study Start

May 1, 2017

Primary Completion

July 22, 2019

Study Completion

July 22, 2019

Last Updated

March 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)