NCT03101592

Brief 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.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
9,118

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
terminated

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

March 18, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 5, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

May 31, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2020

Completed
3 months until next milestone

Results Posted

Study results publicly available

October 27, 2020

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

2.3 years

First QC Date

March 18, 2017

Results QC Date

August 26, 2020

Last Update Submit

October 4, 2020

Conditions

HIV-1-infection

Keywords

antiretroviral therapyretentionARTcost-effectivenessvirologic suppression

Outcome Measures

Primary Outcomes (1)

  • Retention in Care at 12 Months

    The primary outcome to be studied is whether scripting/dispensing of ART for intervals of six months is non-inferior to three months with respect to retention in care.

    12 months

Secondary Outcomes (2)

  • Virologic Suppression at 12 Months

    12 months

  • Provider Cost Per Patient by Outcome (USD) (Mean, 95% CI)

    12 months

Study Arms (3)

Standard of care ART dispensing

NO INTERVENTION

The standard of care arm will allow ART dispensing based on usual practice at the clinic. Standard of care is anticipated to have variability in how ART is dispensed, although the approach should be consistent with applicable country guidelines at the time of study.

Three-month ART dispensing

EXPERIMENTAL

Providers at facilities randomized to three-month ART dispensing will be expected to provide all enrolled patients with a 90-day supply of ART and associated HIV medications (cotrimoxazole and isoniazid if part of country guidelines). All other aspects of care will be as per standard of care for the enrolling clinic.

Other: Three-month ART dispensing

Six-month ART dispensing

EXPERIMENTAL

Providers at facilities randomized to six-month ART dispensing will be expected to provide all enrolled patients with a 180-day supply of ART and associated HIV medications (cotrimoxazole and isoniazid if part of country guidelines). All other aspects of care will be as per standard of care for the enrolling clinic.

Other: Six-month ART dispensing

Interventions

Three-month ART dispensingOTHER

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.

Three-month ART dispensing
Six-month ART dispensingOTHER

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.

Six-month ART dispensing

Eligibility Criteria

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

You may qualify if:

  • At least 18 years of age.
  • Willing and able to provide written informed consent for participation in this study.
  • Confirmed HIV-1 infection based on country standard of care for testing.
  • On antiretroviral treatment (ART) for at least six months.
  • On a first-line ART regimen as defined by country-specific guidelines.
  • No drug toxicity/tolerability issues with ART regimen within the prior six months.
  • No period of more than one month without ART medication possession within the last six months.
  • No active opportunistic infection suspected (including tuberculosis) and not treated for an opportunistic infection in the last 30 days.
  • No active comorbidity (including hypertension) and not treated for a comorbidity in the last 30 days.
  • No viral load of more than 1000 copies/ml (using standard assay) within the last six months.
  • Not currently pregnant.
  • At least six months postpartum if recently delivered a baby.
  • Not currently breastfeeding or planning to breastfeed.

You may not qualify if:

  • Under 18 years of age.
  • Viral load of 1000 copies/ml or greater (using standard assay) within the last six months.
  • On alternative first-line or second-line ART regimen.
  • One month or more without medication possession within the last six months.
  • Experienced an ART toxicity/tolerability issue within the last six months.
  • Currently receiving treatment for tuberculosis or receiving treatment for any other opportunistic infection or comorbidity (including hypertension).
  • Pregnant or less than six months postpartum.
  • Women who are breastfeeding.
  • Unwilling or unable to provide informed consent.
  • Previously enrolled in the study.
  • Currently enrolled in any other research study at the site that involves adherence/retention or alters delivery of HIV care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Partners in Hope

Lilongwe, Malawi

Location

EQUIP Zambia

Lusaka, Zambia

Location

Related Publications (3)

  • Hoffman RM, Moyo C, Balakasi KT, Siwale Z, Hubbard J, Bardon A, Fox MP, Kakwesa G, Kalua T, Nyasa-Haambokoma M, Dovel K, Campbell PM, Tseng CH, Pisa PT, Cele R, Gupta S, Benade M, Long L, Xulu T, Sanne I, Rosen S. Multimonth dispensing of up to 6 months of antiretroviral therapy in Malawi and Zambia (INTERVAL): a cluster-randomised, non-blinded, non-inferiority trial. Lancet Glob Health. 2021 May;9(5):e628-e638. doi: 10.1016/S2214-109X(21)00039-5.

    PMID: 33865471DERIVED

  • Phiri K, McBride K, Siwale Z, Hubbard J, Bardon A, Moucheraud C, Haambokoma M, Pisa PT, Moyo C, Hoffman RM. Provider experiences with three- and six-month antiretroviral therapy dispensing for stable clients in Zambia. AIDS Care. 2021 Apr;33(4):541-547. doi: 10.1080/09540121.2020.1755010. Epub 2020 May 4.

    PMID: 32363910DERIVED

  • Hoffman R, Bardon A, Rosen S, Fox M, Kalua T, Xulu T, Taylor A, Sanne I. Varying intervals of antiretroviral medication dispensing to improve outcomes for HIV patients (The INTERVAL Study): study protocol for a randomized controlled trial. Trials. 2017 Oct 13;18(1):476. doi: 10.1186/s13063-017-2177-z.

    PMID: 29029644DERIVED

Limitations and Caveats

As an implementation science study of service delivery, we faced limitations common in real-world interventions. Most participants did not have routine viral load tests and funding limitations reduced the follow-up period to one year.

Results Point of Contact

Title
Dr. Risa Hoffman, MD, MPH; Director of GHP; Associate Professor of Clinical Medicine
Organization
David Geffen School of Medicine at UCLA
rhoffman@mednet.ucla.edu
310 825-7225

Study Officials

  • Risa M Hoffman, MD, MPH

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The study will be a cluster randomized trial comparing three different antiretroviral therapy (ART) dispensing strategies. Clusters will be comprised of individual clinics in Malawi and Zambia. Enrolled individuals will receive standard of care at their site with the exception of the ART dispensing interval based on the assigned randomization. Outcomes will be assessed after 12 months.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Clinical Professor

Study Record Dates

First Submitted

March 18, 2017

First Posted

April 5, 2017

Study Start

May 31, 2017

Primary Completion

September 30, 2019

Study Completion

August 10, 2020

Last Updated

October 27, 2020

Results First Posted

October 27, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)MA(1)