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Healthy Beginning Initiative (HBI)

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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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Nevada, Reno

Brief Summary:
The purpose of this study is to determine if providing free laboratory test to pregnant women and their spouses at churches, in addition to laboratories or hospitals, will increase the number of pregnant women and their spouses who get screened for HIV, malaria, sickle cell trait, hemoglobin levels, syphilis, and hepatitis B. These tests are necessary to keep mothers healthy during pregnancy and lead to healthy babies. This research is taking place in 40 churches in Nigeria.

Condition or disease

Detailed Description:
We are conducting a randomized trial to evaluate the comparative effectiveness of a congregation-based Healthy Beginning Initiative (HBI) delivered by lay health advisors (Intervention Group; IG), versus a Facility Based Approach (Control Group; CG) on the HIV testing rate and PMTCT completion among 2,700 pregnant women. Four dioceses with forty churches nested in the dioceses, will be randomly assigned to either the IG (N=2; n=20) or the CG (N=2; n=20). The HBI combines a family educational game show and an integrated on-site laboratory testing in the context of a baby shower. Monthly prayer sessions for pregnant women will be used for recruitment and a baby reception following infant baptisms will be used for follow up after delivery. The primary outcome is difference in testing rate among pregnant women in IG compared to CG. The secondary outcomes are HIV testing rate among male partners and PMTCT completion among HIV-infected pregnant women. Pregnant women will complete an investigator-administered questionnaire at the baby reception to collect information on HIV testing and PMTCT completion. Data will be confirmed with Health Facilities and on-site testing data. This proposal is a collaboration among Partners for Prevention, education, Training, Treatment and Research (PeTR-Global Solutions)/AIDSRelief (our PEPFAR-funded partner in Nigeria responsible for training, HIV testing, linkage to treatment and local oversight of the project); New York University School of Medicine (program evaluation and shares oversight with PI), Board of Regents, NSHE, obo University of Nevada, Reno (provide overall oversight, data management and evaluation of program effectiveness).

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Study Type : Observational
Estimated Enrollment : 5400 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Lifestyle counseling
Prevention of mother to child transmission of HIV
Lifestyle counseling Male
male partners and PMTCT completion rate among HIV-infected pregnant women.

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women and their male partners who are 18 years and older and attend one of the 40 churches in the Enugu state of Nigeria will be eligible to participate in the study. All participation is voluntary.

Inclusion Criteria:

  • Pregnant females 18 years and older;
  • Male partners of pregnant females 18 years and older;
  • Subjects must attend church at one of the participating diocese

Exclusion Criteria:

- Subjects will be excluded if they are not pregnant women or their male partners or are younger than 18 years old.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01795261

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PeTR Global Solutions
Abuja, Maitama, Nigeria
Sponsors and Collaborators
University of Nevada, Reno
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Echezona Ezeanolue, MD University of Nevada, Reno

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Nevada, Reno
ClinicalTrials.gov Identifier: NCT01795261    
Other Study ID Numbers: 1R01HD075050-01 ( U.S. NIH Grant/Contract )
1R01HD075050-01 ( U.S. NIH Grant/Contract )
First Posted: February 20, 2013    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Keywords provided by University of Nevada, Reno: