NCT04027153

Brief Summary

The investigators hypothesize that routing algorithm based ART delivery will be acceptable, efficient and improve health outcomes, specifically through meeting client needs, retaining HIV-positive persons in care, and achieving high ART resupply and viral suppression. They also hypothesize that a fee for home delivery will improve retention and viral suppression among persons willing to pay a fee for ART delivery. The investigators propose to test ART delivery using routing science and fee for home delivery as strategies that could be scaled-up to sustain lifelong ART.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

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

June 17, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 7, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2021

Completed
Last Updated

March 4, 2022

Status Verified

March 1, 2022

Enrollment Period

1.2 years

First QC Date

June 17, 2019

Last Update Submit

March 2, 2022

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

  • Number of participants in the Fee arm that paid for delivery

    Paying a fee for home delivery of ART demonstrates feasibility and increases the proportion of HIV-positive persons achieving viral suppression, through simplifying resupply and monitoring, and is cost neutral.

    6 months

Study Arms (2)

Fee Arm

EXPERIMENTAL

Participants in this arm will pay a fee (based on an income sliding scale) to have their medication delivered to their location of choice.

Other: Fee based delivery

Standard of Care Arm

ACTIVE COMPARATOR

Participants in this arm will pick up their medication refill at the local clinic

Other: Fee based delivery

Interventions

Fee based deliveryOTHER

Testing willingness to pay for services to simplify delivery is innovative as the strategy could increase funds for HIV care making home delivery cost neutral.

Fee ArmStandard of Care Arm

Eligibility Criteria

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

You may qualify if:

  • HIV infected and clinically stable
  • Eligible for ART according to national guidelines
  • Willingness to reside in study community for duration of follow up
  • Able and willing to sign the informed consent form
  • Willing to pay for medication delivery
  • Not known to be pregnant

You may not qualify if:

  • No separate criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HSRC Sweetwaters

Sweetwaters, KwaZulu-Natal, South Africa

Location

Related Publications (2)

  • Tseng AS, Mugwanya KK, Szpiro AA, van Heerden A, Ntinga X, Schaafsma TT, Barnabas RV. Estimating the Effect of COVID-19 Pandemic Restrictions on Self-reported Antiretroviral Therapy Use and Late Refill Visits Among People Living With HIV in Rural South Africa. J Acquir Immune Defic Syndr. 2024 Aug 1;96(4):318-325. doi: 10.1097/QAI.0000000000003431.

    PMID: 38916425DERIVED

  • Barnabas RV, Szpiro AA, Ntinga X, Mugambi ML, van Rooyen H, Bruce A, Joseph P, Ngubane T, Krows ML, Schaafsma TT, Zhao T, Tanser F, Baeten JM, Celum C, van Heerden A; Deliver Health Study Team. Fee for home delivery and monitoring of antiretroviral therapy for HIV infection compared with standard clinic-based services in South Africa: a randomised controlled trial. Lancet HIV. 2022 Dec;9(12):e848-e856. doi: 10.1016/S2352-3018(22)00254-5. Epub 2022 Nov 3.

    PMID: 36335976DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

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 Diseases

Study Officials

  • Ruanne V Barnaba, MBChB, DPhil

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: one to one on an individual level
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, School of Medicine: Global Health

Study Record Dates

First Submitted

June 17, 2019

First Posted

July 19, 2019

Study Start

October 7, 2019

Primary Completion

December 31, 2020

Study Completion

March 6, 2021

Last Updated

March 4, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)