NCT02417636

Brief Summary

PUBLIC HEALTH EVALUATION PROTOCOL on Impact of Task Shifting Type II for ART Delivery on Patient and Process Outcomes in Uganda

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,760

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

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

Study Start

First participant enrolled

February 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

January 10, 2018

Status Verified

January 1, 2018

Enrollment Period

2.6 years

First QC Date

February 18, 2015

Last Update Submit

January 9, 2018

Conditions

PUBLIC HEALTH EVALUATION

Outcome Measures

Primary Outcomes (1)

  • Treatment-limiting events that could occur on first-line ART

    The primary study outcome is a composite endpoint of possible treatment-limiting events that could occur on first-line ART. These include virologic failure (viral load measure of ≥ 1000 copies/ml after 6 months of treatment), toxicity failure, loss to follow up and all-cause mortality.

    12 months

Study Arms (2)

Nurse-initiated and monitored ART

EXPERIMENTAL

This is an experimental task shifting of ART initiation and monitoring from a clinician-led model to a nurse-led model. Participants will be screened for eligibility for ART and the study and then enrolled initiated on ART by a Nursing Officers and then followed and monitored for ART adherence on a monthly basis for 12months. Quarterly, sexual behavior and quality of life questionnaires will be administered. CBC, CD4, HIV-1 Viral load, renal and liver function test will be done biannually. Nursing Officers will be free to consult with clinicians on the management of patients.

Other: Task Shifting

Clinician - initiated and monitored ART

ACTIVE COMPARATOR

This is Standard of Care for the Uganda Ministry of Health to compared with the experimental task shifting. Participants will be screened for eligibility for ART and the study and then enrolled initiated on ART by a Clinicians (Clinical Officer or Medical Officer) and then followed and monitored for ART adherence on a monthly basis for 12months. Quarterly, sexual behavior and quality of life questionnaires will be administered. CBC, CD4, HIV-1 Viral load, renal and liver function test will be done biannually.

Other: Task Shifting

Interventions

Task ShiftingOTHER

Participants will be screened for eligibility for ART and the study and then enrolled initiated on ART by a Nursing Officers and then followed and monitored for ART adherence on a monthly basis for 12months. Quarterly, sexual behavior and quality of life questionnaires will be administered. CBC, CD4, HIV-1 Viral load, renal and liver function test will be done biannually. Nursing Officers will be free to consult with clinicians on the management of patients.

Clinician - initiated and monitored ARTNurse-initiated and monitored ART

Eligibility Criteria

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

You may qualify if:

  • Individuals will be eligible for the study if they:
  • are 18 years or older
  • have a confirmed HIV+ diagnosis at an accredited health facility according to the National HIV Testing Algorithm
  • are ART naive (except for short course mother-to-child transmission prophylaxis and post exposure prophylaxis not less than 6 months prior to study enrollment)
  • are clinically stable (no serious opportunistic infection, no other chronic condition)
  • are eligible for ART according to the Uganda National Treatment Guidelines

You may not qualify if:

  • Individuals will not be eligible for the study if they
  • have more than grade 3 laboratory results for renal function, liver enzymes and hematology according to the National Institutes of Health Division of AIDS toxicity grading scale
  • are unwilling to give informed consent
  • anticipate moving from their current residence in the subsequent 24 months and
  • reside outside of a 40km radius (or more than 1 hour drive) of the selected study site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mbale Regional Referral Hospital

Mbale, 256, Uganda

Location

Related Publications (1)

  • Sekiziyivu BA, Bancroft E, Rodriguez EM, Sendagala S, Nasirumbi MP, Najjengo MS, Kiragga AN, Musaazi J, Musinguzi J, Sande E, Brad B, Dalal S, Byakika-Jayne T, Kambugu A. Task Shifting for Initiation and Monitoring of Antiretroviral Therapy for HIV-Infected Adults in Uganda: The SHARE Trial. J Acquir Immune Defic Syndr. 2021 Mar 1;86(3):e71-e79. doi: 10.1097/QAI.0000000000002567.

    PMID: 33230029DERIVED

Study Officials

  • Elizabeth Bancroft, M.D., S.M.

    Centers for Disease Control and Prevention, Uganda

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 18, 2015

First Posted

April 15, 2015

Study Start

February 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

January 10, 2018

Record last verified: 2018-01

Locations

UG(1)