Clinical trial NCT01795261: Healthy Beginning Initiative
Official title: Comparative Effectiveness of Congregation and Clinic Based Approaches to Prevention of Mother to Child Transmission of HIV
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV
Keywords: HIV
Lead sponsor: University of Nevada, Reno
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2013-02-20
Enrollment: 5400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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).

Eligibility 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.

Primary outcomes:
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.
timeFrame: One year
Secondary outcomes:
measure: Associations between HIV Test and Interventions and other covariates (risk factors) at individual- and community (church)-level will also be analyzed.
timeFrame: one year
Other outcomes:
Locations:
city: Abuja
country: Nigeria
facility: PeTR Global Solutions
state: Maitama
Study officials:
affiliation: University of Nevada, Reno
name: Echezona Ezeanolue, MD
role: PRINCIPAL_INVESTIGATOR
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