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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 March 2023 |
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Main ID: |
NCT02515370 |
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Date of registration:
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30/07/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Friends for Life Circles for Option B Plus
FLCs |
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Scientific title:
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Using Enhanced Peer Group Strategies to Support Prevention of Mother to Child HIV Transmission (PMTCT) Option B+ in Uganda |
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Date of first enrolment:
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May 2016 |
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Target sample size:
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540 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02515370 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Uganda
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Contacts
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Name:
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Philippa Musoke, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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MU-JHU CARE |
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Key inclusion & exclusion criteria
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Inclusion criteria
- Age >18 years
- Documentation of pregnancy through clinical assessment or pregnancy test
- Documentation of confirmed HIV-positive sero-status at the time of screening
- Accepting to receive option B+ for PMTCT
- Providing written informed consent to participate in the randomized trial.
- Agreeing to come the study clinic for scheduled appointments
- Agreeing to be home visited as needed to ensure follow up
- Residing within a 20 km radius around the study clinic
- Not planning to move out of the catchment area within the next 2 years
Exclusion criteria
- Social and other circumstances that may prevent the mother from coming back for follow up
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Human Immunodeficiency Virus
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Intervention(s)
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Other: Friends for Life Circles (FLCs).
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Primary Outcome(s)
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Adherence to Option B+ ARV drugs
[Time Frame: 2 years]
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Retention
[Time Frame: 2 years]
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Secondary Outcome(s)
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Assessing success and sustainability of FLCs group support activities and IGAs
[Time Frame: 2 years]
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Infant HIV Free survival
[Time Frame: 2 years]
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Secondary ID(s)
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Musoke-R01-080476-Option B+
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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