Sharing HIV/AIDS Responsibilities and Efforts

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02417636
• Date of registration: 18/02/2015
• Prospective Registration: No
• Primary sponsor: Infectious Diseases Institute
• Public title: Sharing HIV/AIDS Responsibilities and Efforts SHARE
• Scientific title: Impact of Task Shifting Type II for ART Delivery on Patient and Process Outcomes in Uganda
• Date of first enrolment: February 2015
• Target sample size: 1760
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02417636
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Uganda

Contacts

• Name: Elizabeth Bancroft, M.D., S.M.
• Affiliation: Centers for Disease Control and Prevention, Uganda

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

PUBLIC HEALTH EVALUATION

Intervention(s)

Other: Task Shifting

Primary Outcome(s)

Treatment-limiting events that could occur on first-line ART [Time Frame: 12 months]

Secondary ID(s)

ST/0111/15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ministry of Health, Uganda

Centers for Disease Control and Prevention