Healthy Beginning Initiative (HBI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Nevada, Reno
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Nevada, Reno
ClinicalTrials.gov Identifier:
NCT01795261
First received: February 15, 2013
Last updated: August 25, 2014
Last verified: February 2013

February 15, 2013
August 25, 2014
September 2012
August 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01795261 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Healthy Beginning Initiative
Comparative Effectiveness of Congregation and Clinic Based Approaches to Prevention of Mother to Child Transmission of HIV

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.

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).

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

HIV
Not Provided
  • Lifestyle counseling
    Prevention of mother to child transmission of HIV
  • Lifestyle counseling Male
    male partners and PMTCT completion rate among HIV-infected pregnant women.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5400
September 2014
August 2014   (final data collection date for primary outcome measure)

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.

Both
18 Years to 40 Years
Yes
Contact: Michael Obiefune 243-802-575-5567
Contact: Alice Osuji 090-810-62018
Nigeria
 
NCT01795261
1R01HD075050-01, 1R01HD075050-01
Yes
University of Nevada, Reno
University of Nevada, Reno
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Echezona Ezeanolue, MD University of Nevada, Reno
University of Nevada, Reno
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP