Healthy Beginning Initiative (HBI)
|ClinicalTrials.gov Identifier: NCT01795261|
Recruitment Status : Unknown
Verified November 2015 by University of Nevada, Reno.
Recruitment status was: Active, not recruiting
First Posted : February 20, 2013
Last Update Posted : December 2, 2015
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||5400 participants|
|Observational Model:||Case Control|
|Official Title:||Comparative Effectiveness of Congregation and Clinic Based Approaches to Prevention of Mother to Child Transmission of HIV|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||September 2016|
Prevention of mother to child transmission of HIV
Lifestyle counseling Male
male partners and PMTCT completion rate among HIV-infected pregnant women.
- Analysis of HIV testing rates in pregnant women and their male partners in a congregation based approach compared to a health facility based approach. [ Time Frame: One year ]We need to have 1,313 pregnant women in each arm of the study and follow them through pregnancy and up to 6 weeks post-delivery. Since pregnant women will be recruited at different stages of pregnancy, we will need to end recruitment 5 months after the study is open to recruitment and allow time to follow last recruited pregnant women through 9 months of pregnancy and up to 6 weeks post-delivery (approximately 11 months).
- Associations between HIV Test and Interventions and other covariates (risk factors) at individual- and community (church)-level will also be analyzed. [ Time Frame: one year ]Variables include age, household income, education level, previous HIV testing, last menstrual period, marital status, and employment status. HIV testing and PMTCT completion: will be assessed using a one-page investigator-administered questionnaire completed by pregnant women during the baby reception.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01795261
|PeTR Global Solutions|
|Abuja, Maitama, Nigeria|
|Principal Investigator:||Echezona Ezeanolue, MD||University of Nevada, Reno|