Ignite Creation Date:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2026-01-08 @ 2:14 AM
Study NCT ID:
NCT01795261
Status:
UNKNOWN
Last Update Posted:
2015-12-02
First Post:
2013-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy Beginning Initiative
Sponsor:
University of Nevada, Reno
Organization:
Study Overview
Official Title:
Comparative Effectiveness of Congregation and Clinic Based Approaches to Prevention of Mother to Child Transmission of HIV
Status:
UNKNOWN
Status Verified Date:
2015-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HBI
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.
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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01HD075050-01 | NIH | None | https://reporter.nih.gov/quic… | View |