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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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12 December 2020 |
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Main ID: |
NCT03016546 |
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Date of registration:
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06/01/2017 |
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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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Integrating HIV and Depression Self-Care to Improve Adherence in Perinatal Women
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Scientific title:
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Integrating HIV and Depression Self-Care to Improve Adherence in Perinatal Women |
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Date of first enrolment:
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December 1, 2016 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03016546 |
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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: Supportive Care. 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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India
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Contacts
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Name:
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Nancy Reynolds |
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Address:
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Telephone:
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Email:
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Affiliation:
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Yale University School of Nursing |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Pregnant, HIV+ women, in third trimester (=28 weeks-delivery)
- Eligible for ART treatment or prophylaxis for the PMTCT, during pregnancy, peripartum
and postnatal transmission
- screen positive for depressive symptoms
- Speak English, Hindi or Kannada
- Able to provide informed consent.
Exclusion criteria:
- Unable to participate in study visits
- Any condition that, in the opinion of the site investigator, would compromise the
candidate's ability to participate.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Depression
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Intervention(s)
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Behavioral: Attention Control Condition
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Behavioral: BEST-maCARE
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Primary Outcome(s)
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the participant's medication adherence (self-report-ACTG Adherence Questionnaire)
[Time Frame: 6 weeks post-delivery]
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depression (self-report-EPDS -Edinburgh Postnatal Depression Scale)
[Time Frame: 6 weeks post-delivery]
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Program feasibility and acceptability composite
[Time Frame: 6 weeks post-delivery]
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viral load (serum HIV-1 RNA)
[Time Frame: 6 weeks post-delivery]
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Secondary ID(s)
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1204010141
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R21MH098667-01A1
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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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