HBIComparative Effectiveness of Congregation and Clinic Based Approaches to Prevention of Mother to Child Transmission of HIV
Data Collection
Collected from today forward - ProspectiveCase-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
Study start date: September 1, 2012
Actual date on which the first participant was enrolled.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).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.5400 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 40 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location