Healthy Beginning Initiative - Full Text View

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:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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 2014
Estimated Primary Completion Date:	August 2014 (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

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

Contacts

Contact: Michael Obiefune	243-802-575-5567
Contact: Alice Osuji	090-810-62018

Locations

Nigeria
PeTR Global Solutions	Recruiting
Abuja, Maitama, Nigeria
Contact: Michael Obiefune 243-802-575-5567
Contact: Alice Osuji 090-810-62018
Principal Investigator: Eche Ezeanolue, MD

Sponsors and Collaborators

University of Nevada, Reno

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

More Information

Publications:

Tubiana R, Le Chenadec J, Rouzioux C, Mandelbrot L, Hamrene K, Dollfus C, Faye A, Delaugerre C, Blanche S, Warszawski J. Factors associated with mother-to-child transmission of HIV-1 despite a maternal viral load <500 copies/ml at delivery: a case-control study nested in the French perinatal cohort (EPF-ANRS CO1). Clin Infect Dis. 2010 Feb 15;50(4):585-96. doi: 10.1086/650005.

European Collaborative Study. Mother-to-child transmission of HIV infection in the era of highly active antiretroviral therapy. Clin Infect Dis. 2005 Feb 1;40(3):458-65. Epub 2005 Jan 7.

Centers for Disease Control and Prevention (CDC). Achievements in public health. Reduction in perinatal transmission of HIV infection--United States, 1985-2005. MMWR Morb Mortal Wkly Rep. 2006 Jun 2;55(21):592-7.

Turan JM, Bukusi EA, Onono M, Holzemer WL, Miller S, Cohen CR. HIV/AIDS stigma and refusal of HIV testing among pregnant women in rural Kenya: results from the MAMAS Study. AIDS Behav. 2011 Aug;15(6):1111-20. doi: 10.1007/s10461-010-9798-5.

Nunn A, Zaller N, Cornwall A, Mayer KH, Moore E, Dickman S, Beckwith C, Kwakwa H. Low perceived risk and high HIV prevalence among a predominantly African American population participating in Philadelphia's Rapid HIV testing program. AIDS Patient Care STDS. 2011 Apr;25(4):229-35. doi: 10.1089/apc.2010.0313. Epub 2011 Mar 15.

Monjok E, Smesny A, Essien EJ. HIV/AIDS-related stigma and discrimination in Nigeria: review of research studies and future directions for prevention strategies. Afr J Reprod Health. 2009 Sep;13(3):21-35. Review.

Hardon A, Vernooij E, Bongololo-Mbera G, Cherutich P, Desclaux A, Kyaddondo D, Ky-Zerbo O, Neuman M, Wanyenze R, Obermeyer C. Women's views on consent, counseling and confidentiality in PMTCT: a mixed-methods study in four African countries. BMC Public Health. 2012 Jan 11;12:26. doi: 10.1186/1471-2458-12-26.

Franca-Martins AM, Graubard Z, Holloway GA, Van der Merwe FJ. Placental haemangioma associated with acute fetal anemia in labour. Acta Med Port. 1990 May-Jun;3(3):187-9.

Youngleson MS, Nkurunziza P, Jennings K, Arendse J, Mate KS, Barker P. Improving a mother to child HIV transmission programme through health system redesign: quality improvement, protocol adjustment and resource addition. PLoS One. 2010 Nov 9;5(11):e13891. doi: 10.1371/journal.pone.0013891.

Ekouevi DK, Stringer E, Coetzee D, Tih P, Creek T, Stinson K, Westfall AO, Welty T, Chintu N, Chi BH, Wilfert C, Shaffer N, Stringer J, Dabis F. Health facility characteristics and their relationship to coverage of PMTCT of HIV services across four African countries: the PEARL study. PLoS One. 2012;7(1):e29823. doi: 10.1371/journal.pone.0029823. Epub 2012 Jan 20.

Okunlola MA, Ayinde OA, Owonikoko KM, Omigbodun AO. Factors influencing gestational age at antenatal booking at the University College Hospital, Ibadan, Nigeria. J Obstet Gynaecol. 2006 Apr;26(3):195-7.

Adegbola O. Gestational age at antenatal booking in Lagos University Teaching Hospital (LUTH). Nig Q J Hosp Med. 2009 Jul-Sep;19(3):162-4.

Jivegård L, Holm J, Bergqvist D, Björck CG, Björkman H, Brunius U, Claes G, Hammarsten J, Jernby B, Konrad P, et al. Acute lower limb ischemia: failure of anticoagulant treatment to improve one-month results of arterial thromboembolectomy. A prospective randomized multi-center study. Surgery. 1991 May;109(5):610-6.

Johnson LF, Stinson K, Newell ML, Bland RM, Moultrie H, Davies MA, Rehle TM, Dorrington RE, Sherman GG. The contribution of maternal HIV seroconversion during late pregnancy and breastfeeding to mother-to-child transmission of HIV. J Acquir Immune Defic Syndr. 2012 Apr 1;59(4):417-25. doi: 10.1097/QAI.0b013e3182432f27.

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:	March 20, 2013
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 May 23, 2013