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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.
Register: ClinicalTrials.gov
Last refreshed on: 22 February 2021
Main ID:  NCT02214875
Date of registration: 16/07/2014
Prospective Registration: No
Primary sponsor: Centre for Integrated Health Programs, Nigeria
Public title: Lafiyan Jikin Mata "Excellent Health for Mothers" LJM
Scientific title: Increasing Retention-in-care of HIV Positive Women in PMTCT Services Through Continuous Quality Improvement -Break Through Series in Primary & Secondary Health Care Facilities in Nigeria: A Cluster Randomized Controlled Trial
Date of first enrolment: July 14, 2014
Target sample size: 491
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02214875
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
Nigeria
Contacts
Name:     Bolanle Oyeledun, MASTERS
Address: 
Telephone:
Email:
Affiliation:  Center for Integrated Health Program(CIHP)
Key inclusion & exclusion criteria

Inclusion Criteria:

1. They must be pregnant women newly diagnosed for HIV during ANC

2. Clients must present with gestational age of 34weeks or less at ANC enrollment

3. They must accept in principle to take ARVs and remain in care.

4. They must be willing to participate until at least six months postpartum

5. Must be domiciled in the facility coverage area.

6. Previously diagnosed HIV positive pregnant women yet to start ART

Exclusion Criteria:

1. Clients requesting fee/remuneration for participation

2. Positive women already on ART.

3. Unbooked HIV positive pregnant woman coming in labour.

4. Positive pregnant women with gestational age more than 34 weeks.



Age minimum: N/A
Age maximum: N/A
Gender: Female
Health Condition(s) or Problem(s) studied
Retention
Intervention(s)
Other: CQI/BTS
Other: Control
Primary Outcome(s)
Proportion of HIV+ pregnant women in care 6 months postpartum [Time Frame: Six months post partum]
Secondary Outcome(s)
Proportion of HIV exposed infants with Dry Blood Spot (DBS) samples taken at 6-8 months of life [Time Frame: 2 months post delivery of exposed infant]
Secondary ID(s)
C6-TSA-037
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Foreign Affairs, Trade and Development, Canada
World Health Organization
Federal Ministry of Health, Nigeria
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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