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

Abstract

BackgroundA 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.MethodsThis 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.DiscussionResults 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 RegistrationClinicaltrials.gov, NCT01795261

Prevalence of Sickle Cell Trait and Reliability of Self-Reported Status among Expectant Parents in Nigeria: Implications for Targeted Newborn Screening

“…Sample collection for HBI was randomly selected, as detailed in [20], and was designed to be representative for the population in southeastern Nigeria to minimize selection bias and increase generalizability. Furthermore, for HBI and consequently this cohort study, churches were used as convenience venues in the community to identify pregnant women, implement intervention, and conduct post-delivery follow up.…”

“…HBI is a large, cluster-randomized, controlled study designed to determine the effectiveness of a congregation-based intervention in increasing HIV testing among pregnant women and their male partners in southeast Nigeria. The study design details of HBI have been described previously [20]. In summary, 40 churches were selected from 40 communities across seven local government areas in Enugu State, southeast Nigeria.…”

“…In summary, 40 churches were selected from 40 communities across seven local government areas in Enugu State, southeast Nigeria. Sample collection was randomly selected, as detailed in [20], and was designed to be representative for the population to minimize selection bias and increase generalizability. Church-organized prayers sessions for pregnant women were used to recruit participants early in their pregnancy.…”

“…We conducted a nested cohort study by integrating sickle cell screening within an existing and community-accepted HIV testing infrastructure, the Healthy Beginning Initiative (HBI). HBI is a cluster-randomized trial designed to increase HIV testing of pregnant women and their male partners [20]. It is a congregation-based program in Enugu State, southeast Nigeria, which was created with heavy participation and leadership from the local community.…”

Prevention of Mother-to-Child Transmission of HIV in Delta State of Nigeria: Evaluation of the Early Infant Diagnosis Program

“…Second is the level of negative results (i.e., efficiency).While 4.4% of infants on ART tested positive at first test with indication of reduction at 18 th month (Table 2), up to 83% of the subpopulation of 'mother-and-child' who were suspected to miss early start of PMTCT (i.e., indicated by not being on ART) tested positive at both initial and 18 th month tests. Other studies have previously acknowledged or implied the effectiveness of PMTCT services in Nigeria [33][34][35][36] , and availability of the service in Delta State 16 . What this report adds to the body of literature is evidence of efficiency of the EID program in Delta State.…”