Healthy Beginning Initiative (HBI)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Nevada, Reno
ClinicalTrials.gov Identifier:
NCT01795261
First received: February 15, 2013
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

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
HIV

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Nevada, Reno:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 5400
Study Start Date: September 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Lifestyle counseling
Prevention of mother to child transmission of HIV
Lifestyle counseling Male
male partners and PMTCT completion rate among HIV-infected pregnant women.

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).

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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.

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01795261

Locations
Nigeria
PeTR Global Solutions
Abuja, Maitama, Nigeria
Sponsors and Collaborators
University of Nevada, Reno
Investigators
Principal Investigator: Echezona Ezeanolue, MD University of Nevada, Reno
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Nevada, Reno
ClinicalTrials.gov Identifier: NCT01795261     History of Changes
Other Study ID Numbers: 1R01HD075050-01, 1R01HD075050-01
Study First Received: February 15, 2013
Last Updated: October 10, 2014
Health Authority: United States: Institutional Review Board
Nigeria: National Health Research Ethics Committee of Nigeria (NHREC)

Keywords provided by University of Nevada, Reno:
HIV

ClinicalTrials.gov processed this record on October 28, 2014