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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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16 December 2017 |
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Main ID: |
NCT02403583 |
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Date of registration:
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24/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Jamii Bora: A Home-Based Couples Intervention
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Scientific title:
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Jamii Bora: A Home-based Couples Intervention |
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Date of first enrolment:
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August 1, 2014 |
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Target sample size:
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233 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02403583 |
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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: Prevention. 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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Kenya
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Contacts
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Name:
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Janet M Turan, 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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University of Alabama at Birmingham |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- (a) 18 years of age or older (b) 36 weeks of pregnancy or less (c) has been offered
HIV testing at ANC, (d) is currently in a stable relationship (married or cohabiting)
with a male partner of duration of at least 6 months (e) is currently living with a
male partner who will be in residence at least one night a week at the home during the
study period, (f) has not yet participated in couple HIV counseling and testing during
this pregnancy (g) has not disclosed current HIV status to male partner (h) does not
know with certainty the HIV-positive status of her male partner.
Exclusion Criteria:
- (a) Currently pregnant (b) Greater than 36 weeks of pregnancy (c) Less than 18 years
of age (d) Not currently in a stable relationship of at least 6 months (e) Does not
currently live with male partner at least one night a week at the home (f) Has not
been offered HIV testing (g) Has received CHCT with current male partner (h) has
disclosed current HIV status to male partner (i) Knows with certainty current male
partner is HIV-positive
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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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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Behavioral: Intervention- Home Visits
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Primary Outcome(s)
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Use of PMTCT interventions (for HIV+ women only)
[Time Frame: 3 months after the expected due date of the baby]
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Utilization of maternal and child health (MCH) services (outcome for all couples in the study)
[Time Frame: 3 months after the expected due date of the baby]
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Secondary ID(s)
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X140304009
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1R34MH102103-01A1
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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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