Comparative effectiveness of congregation- versus clinic-based approach to prevention of mother-to-child HIV transmission: study protocol for a cluster randomized controlled trial

Implementation Science

Gbenga G Ogedegbe⁴  Chinenye O Ezeanolue⁵  Stephen K Obaro²  Wei Yang¹  Michael C Obiefune³  Echezona E Ezeanolue⁵ 

[1] School of Community Health Sciences, University of Nevada, Reno, Lombardi Building, Reno, NV 203MS 0274, USA;University of Nebraska Medical Center, 982165 Nebraska Medical Center, Omaha, Nebraska, USA;Prevention, Education, Treatment, Training and Research-Global Solutions-PeTR-GS, 7 Link Road, Independence Layout Enugu, Enugu State 400001, Nigeria;School of Medicine, New York University, 550 1st Ave, New York, NY, USA;Sunrise Foundation, Plot 358 New GRA, Enugu, Nigeria

关键词: Nigeria;    Comparative Effectiveness;    Church-based;    Community-based;    Congregation-based Approaches;    Prevention of Mother-to-child HIV Transmission (PMTCT);    HIV;   

Others  :  813597
DOI  :  10.1186/1748-5908-8-62

 received in 2013-04-03, accepted in 2013-06-04,  发布年份 2013

【 摘 要 】

Background

A total of 22 priority countries have been identified by the WHO that account for 90% of pregnant women living with HIV. Nigeria is one of only 4 countries among the 22 with an HIV testing rate for pregnant women of less than 20%. Currently, most pregnant women must access a healthcare facility (HF) to be screened and receive available prevention of mother-to-child HIV transmission (PMTCT) interventions. Finding new approaches to increase HIV testing among pregnant women is necessary to realize the WHO/ President's Emergency Plan for AIDS Relief (PEPFAR) goal of eliminating new pediatric infections by 2015.

Methods

This cluster randomized trial tests the comparative effectiveness of a congregation-based Healthy Beginning Initiative (HBI) versus a clinic-based approach on the rates of HIV testing and PMTCT completion among a cohort of church attending pregnant women. Recruitment occurs at the level of the churches and participants (in that order), while randomization occurs only at the church level. The trial is unblinded, and the churches are informed of their randomization group. Eligible participants, pregnant women attending study churches, are recruited during prayer sessions. HBI is delivered by trained community health nurses and church-based health advisors and provides free, integrated on-site laboratory tests (HIV plus hemoglobin, malaria, hepatitis B, sickle cell gene, syphilis) during a church-organized ‘baby shower.’ The baby shower includes refreshments, gifts exchange, and an educational game show testing participants’ knowledge of healthy pregnancy habits in addition to HIV acquisition modes, and effective PMTCT interventions. Baby receptions provide a contact point for follow-up after delivery. This approach was designed to reduce barriers to screening including knowledge, access, cost and stigma. The primary aim is to evaluate the effect of HBI on the HIV testing rate among pregnant women. The secondary aims are to evaluate the effect of HBI on the rate of HIV testing among male partners of pregnant women and the rate of PMTCT completion among HIV-infected pregnant women.

Discussion

Results of this study will provide further understanding of the most effective strategies for increasing HIV testing among pregnant women in hard-to-reach communities.

Trial Registration

Clinicaltrials.gov, NCT01795261

【 授权许可】

   
2013 Ezeanolue et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】

• [1]World Health Organization: Global HIV/AIDS Response, Progress Report 2011. 2012. http://whqlibdoc.who.int/publications/2011/9789241502986_eng.pdf webcite. Accessed 23 January
• [2]Department of Public Health, National AIDS/STI Control Program, Federal Ministry of Health, Nigeria: National HIV Sero-prevalence Sentinel Survey. 2010. http://www.nigeria-aids.org/documents/2010_National%20HIV%20Sero%20Prevalence%20Sentinel%20Survey.pdf webcite Accessed 23 January 2012
• [3]Tubiana R, Le Chenadec J, Rouzioux C, Mandelbrot L, Hamrene K, et al.: 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, 50:585-596.
• [4]United States Centers for Disease Control and Prevention: Diagnoses of HIV infection by age. 2010. http://www.cdc.gov/hiv/topics/surveillance/basic.htm#hivaidsage webcite
• [5]European Collaborative Study: Mother-to-child transmission of HIV infection in the era of highly active antiretroviral therapy. Clin Infect Dis 2005, 40(3):458-465.
• [6]Morbidity and Mortality Weekly Report: Achievements in Public Health: Reduction in Perinatal Transmission of HIV Infection—United States. 1985–2005. MMWR 2006, 55(21):592-597.
• [7]World Health Organization: Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants: recommendations for a public health approach. Geneva; 2010. http://whqlibdoc.who.int/publications/2010/9789241599818_eng.pdf webcite
• [8]National Agency for Control of AIDS (NACA): Factsheet 2011, Update on the HIV/AIDS Epidemic and Response in Nigeria. http://naca.gov.ng/content/view/423/lang,en/ webcite
• [9]National Population Commission (NPC) [Nigeria] and ICF Macro: Nigeria Demographic and Health Survey 2008. Abuja, Nigeria; 2009.
• [10]Joint United Nations Programme on HIV/AIDS (UNAIDS): Global plan towards the elimination of new HIV infections among children by 2015 and keeping their mothers alive. Geneva; 2011.
• [11]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 and Behavior 2011, 15:1111-1120.
• [12]Nunn A, Zaller N, Cornwall A, Mayer KH, Moore E, Dickman S, Beckwith C, Kwakwa H: Low perceived risk and high prevalence among a predominantly African American population participating in Philadelphia’s rapid HIV testing program. AIDS Patient Care and STDs 2011, 25(4):229-235.
• [13]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, 13:21-35.
• [14]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, 12(1):26. BioMed Central Full Text
• [15]Kinuthia J, Kiariie JN, Farquhar C, Richardson BA, Nduati R, Mbori-Ngacha D, John-Stewart G: Uptake of prevention of mother-to-child transmission interventions in Kenya: Health systems are more influential than stigma. J Int AIDS Soc 2011, 14(1):61-70. BioMed Central Full Text
• [16]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, 5(11):e13891.
• [17]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.
• [18]Okunlola MA, Ayinde OA, Owonikoko KM, Omigbodun AO: Factors influencing gestational age at antenatal booking at the University College Hospital. Ibadan. J Obstet Gynecol 2006, 26(3):195-197.
• [19]Adegbola O: Gestational age at antenatal booking in Lagos University Teaching Hospital (LUTH). Nigerian Q J Hosp Med 2009, 19:162-164.
• [20]Losina E, Bassett IV, Giddy J, Chetty S, Regan S, Walensky RP, Ross D, Scott CA, Uhler LM, Katz JN, Holst H, Freedberg KA: The "ART" of linkage: pre-treatment loss to care after HIV diagnosis at two PEPFAR sites in Durban. South Africa. PLoS One 2010, 5(3):e9538.
• [21]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, 59(4):417-425.
• [22]Guthrie BL, De Bruyn G, Farquhar C: HIV-1-discordant couples in sub-Saharan Africa: explanations and implications for high rates of discordancy. Current HIV Research 2007, 5:416-429.
• [23]Dunkle KL, Stephenson R, Karita E, Chomba E, Kayitenkore K, Vwalika C, Greenberg L, Allen S: New heterosexually transmitted HIV infections in married or cohabiting couples in urban Zambia and Rwanda: an analysis of survey and clinical data. Lancet 2008, 371:2183-2191.
• [24]Eywo O, De Walque D, Ford N, Gakii G, Lester RT, Mills EJ: HIV status in discordant couples in sub-Saharan Africa: a systematic review and meta-analysis. Lancet Infectious Diseases 2010, 10:770-777.
• [25]Jasseron C, Mandelbrot L, Dollfus C, Trocme N, Tubiana R, Teglas JP, Faye A, Rouzioux C, Blanche S, Warszawski J: Non-disclosure of a pregnant woman’s HIV status to her partner is associated with non-optimal prevention of mother-to-child transmission. AIDS Behav 2013, 17(2):488-497.
• [26]Sagay AS, Musa J, Ekwempu CC, Imade GE, Babalola A, Daniyan G, Malu N, Idoko JA: Partner disclosure of HIV status among HIV positive mothers in Northern Nigeria. Afr J Med Sci 2006, 35:119-123.
• [27]Olagbuji BN, Ezeanochie MC, Agholor KN, Olagbuji YW, Ande AB, Okonufua FE: Spousal disclosure of HIV serostatus among women attending antenatal care in urban Nigeria. J Obstet Gynecol 2011, 31(6):486-488.
• [28]Larsson EC, Thorson A, Pariyo G, Conrad P, Arinaitwe M, Kemigisa M, Eriksen J, Tomson G, Ekström AM: Opt-out HIV testing during antenatal care: experiences of pregnant women in rural Uganda. Health Policy Plan 2012, 27(1):69-75.
• [29]Peltzer K, Jones D, Weiss SM, Shikwane E: Promoting male involvement to improve uptake and reduce antenatal HIV infection: a cluster randomized controlled trial protocol. BMC Public Health 2011, 11:778. BioMed Central Full Text
• [30]Farquhar C, Kiarie JN, Richardson BA, Kabura MN, John FN, Nduati RW, Mbori-Ngacha DA, John-Stewart GC: Antenatal couple counseling increases uptake of interventions to prevent HIV-1 transmission. J Acquir Immune Defic Syndr 2004, 37:1620-1626.
• [31]Falnes EF, Moland KM, Tylleskar T: Manuela de Paoli M, Msuya AE, Engebretsen IM: It is her responsibility: partner involvement in prevention of mother-to-child transmisiion of HIV programmmes, northern Tanzania. J Int AIDS Soc 2011, 14(1):1-12. BioMed Central Full Text
• [32]Bello FA, Ogunbode OO, Adesina OA, Olayemi O, Awonuga OM, Adewole IF: Acceptability of counseling and testing for HIV infection in women in labour at the University College Hospital, Ibadan, Nigeria. African Health Sciences 2011, 11:30-35.
• [33]Okonkwo KC, Reich K, Alabi AI, Umeike N, Nachman SA: An evaluation of awareness: attitudes and beliefs of pregnant Nigerian women toward voluntary counseling and testing for HIV. AIDS Patient Care STDs 2007, 21:252-260.
• [34]Oladokun RE, Awolude O, Brown BJ, Adesina O, Oladokun A, Roberts A, Odaibo G, Osinusi K, Olaleye D, Adewole IF, Kanki P: Service uptake and performance of the prevention of mother-to-child transmission (PMTCT) programme in Ibadan, Nigeria. Afr J Med Med Sci 2010, 39:81-87.
• [35]Onah HE, Ibeziako N, Nkwo PO, Obi SN, Nwankwo TO: Voluntary counseling and testing (VCT) uptake, nevarapine use and infant feeding options at the University of Nigeria Teaching Hospital. J Obstet Gynecol 2008, 28(3):276-279.
• [36]Sekandi JN, Sempeera H, List J, Mugerwa MA, Asiimwe S, Yin X, Whalen CC: High acceptance of home-based HIV counseling and testing in an urban community setting in Uganda. BMC Public Health 2011, 11-730.
• [37]Marinucci F, Medina-Moreno S, Paterniti AD, Wattleworth M, Redfield RR: Decentralization of CD4 testing in resource-limited settings: 7 years of experience in six African countries. Cytometry A 2011, 79(5):368-374.
• [38]Ciaranello AL, Perez F, Keatinge J, Park JE, Engelsmann B, Maruva M, Walensky RP, Dabis F, Chu J, Rusibamayila A, Mushavi A, Freedberg KA: What will it take to eliminate pediatric HIV? Reaching WHO target rates of mother-to-child HIV transmission in Zimbabwe: a model-based analysis. PLos 2012, 9(1):e1001156.
• [39]Filler SJ, Berruti AA, Menzies N, Berzon R, Ellerbrock TV, Ferris R, Blandford JM: Characteristics of HIV care and treatment in PEPFAR-supported sites. J Acquir Immune Defic Syndr 2011, 57(1):e1-e6.
• [40]Rujumba J, Tumwine JK, Tylleskar T, Neema S, Heggenhougen HK: Listening to health workers: lessons from Eastern Uganda for streghtening the programme for the prevention of mother-to-child transmission of HIV. BMC Health Serv Res 2012, 12(1):3. BioMed Central Full Text
• [41]Tomlinson M, Doherty T, Jackson D, Lawn JE, Ijumba P, Colvin M, Nkonki L, Daviaud E, Goga A, Sanders D, Lombard C, Persson LA, Ndaba T, Snetro G, Chopra M: An effective study of an integrated, community-based package for maternal, newborn, child and HIV care in South Africa: study protocol for a randomized controlled trial. Trials 2011, 12:236. BioMed Central Full Text
• [42]Partnership Framework on HIV/AIDS, 2010–2015: A Memorandum of Understanding between the Government of Nigeria and the United States Government to Fight HIV/AIDS in Nigeria. http://www.pepfar.gov/about/2010/africa/150622.htm webcite
• [43]Tolerance and Tension: Islam and Christianity in Sub-Saharan Africa http://www.pewforum.org/newassets/images/reports/sub-saharan-africa/sub-saharan-africa-full-report.pdf webcite
• [44]Study of worldwide rates of religiosity, church attendance 1997 http://www.ns.umich.edu/Releases/1997/Dec97/chr121097a.html webcite
• [45]Altman DG, Schulz KF, Monhar D: The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001, 134(8):668-694.
• [46]Donner A, Klar N: Design and Analysis of Cluster Randomization Trials in Health Research. London: Arnold; 2000.
• [47]SAS [computer program]: Version 9. Carey NC: SAS Institute INC; 2005.