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Sharing HIV/AIDS Responsibilities and Efforts (SHARE)

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ClinicalTrials.gov Identifier: NCT02417636
Recruitment Status : Completed
First Posted : April 15, 2015
Last Update Posted : January 10, 2018
Sponsor:
Collaborators:
Ministry of Health, Uganda
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Infectious Diseases Institute, Makerere University

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

Condition or disease Intervention/treatment Phase
PUBLIC HEALTH EVALUATION Other: Task Shifting Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1760 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Impact of Task Shifting Type II for ART Delivery on Patient and Process Outcomes in Uganda
Study Start Date : February 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Nurse-initiated and monitored ART
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
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.

Active Comparator: Clinician - initiated and monitored ART
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
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.




Primary Outcome Measures :
  1. Treatment-limiting events that could occur on first-line ART [ Time Frame: 12 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02417636


Locations
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Uganda
Mbale Regional Referral Hospital
Mbale, Uganda, 256
Sponsors and Collaborators
Infectious Diseases Institute
Ministry of Health, Uganda
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Elizabeth Bancroft, M.D., S.M. Centers for Disease Control and Prevention, Uganda

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Responsible Party: Infectious Diseases Institute, Principal Investigator, Makerere University
ClinicalTrials.gov Identifier: NCT02417636     History of Changes
Other Study ID Numbers: ST/0111/15
First Posted: April 15, 2015    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018