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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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22 March 2021 |
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Main ID: |
NCT02249962 |
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Date of registration:
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11/09/2014 |
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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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Option B+: Study on Safety, Viral Suppression, and Survival on Second Line ART
S4 |
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Scientific title:
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Option B+: ART Safety and Durability During First and Subsequent Pregnancies |
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Date of first enrolment:
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May 2015 |
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Target sample size:
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12011 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02249962 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Malawi
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Contacts
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Name:
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Mina C Hosseinipour, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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UNC Project- Malawi |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Female age =16 (includes adults and emancipated minors)
- HIV positive by 2 rapid tests approved by the Malawi Ministry of Health
- Willingness to provide informed consent
Exclusion Criteria:
- Female <16 years
- HIV negative
- Incapable of providing informed consent
Age minimum:
16 Years
Age maximum:
50 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Infant Exposure to Efavirenz
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HIV
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Primary Outcome(s)
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Proportion of participants with failure on Option B+ first-line treatment
[Time Frame: Up to 36 months]
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Secondary Outcome(s)
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Family planning use and proportion of women with subsequent pregnancy by 36 months
[Time Frame: Up to 36 months]
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Pregnancy outcome assessment
[Time Frame: At time of pregnancy completion (birth, termination)]
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PHQ-9 evaluation
[Time Frame: baseline, months 6, 12, 18, 24, 30, 36]
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Laboratory serum markers
[Time Frame: baseline, months 3, 6, 9, 12, 18, 24, 30, 36]
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HIV antibody testing- infant
[Time Frame: age 1 year]
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Infant neuro-development assessment: Bayley score
[Time Frame: Age 3 weeks, months 3, 6, 12, 18, 24, 30, 36]
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ART Adherence: pill-count
[Time Frame: months 3, 6, 9, 12, 18, 24, 30, 36]
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Maternal CD4 count
[Time Frame: baseline, months 12, 24, 36 post-ART initiation]
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Micronutrient assessment
[Time Frame: Baseline, months 6, 12, 24, 36]
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HIV RNA level measurement
[Time Frame: baseline, months 3, 6, 12, 24, 36]
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Pharmacokinetic: progesterone level in women using contraceptive implant
[Time Frame: months 3, 6, 12, 24]
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Secondary ID(s)
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14-1633
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R01HD080485
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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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