Optimizing PMTCT service delivery in rural North-Central Nigeria: protocol and design for a cluster randomized study

Abstract

Nigeria has more HIV-infected women who do not receive needed services for the prevention of mother-to-child transmission of HIV (PMTCT) than any other nation in the world. To meet the UNAIDS/WHO goal of eliminating mother-to-child HIV transmission by 2015, multiple interventions will be required to scale up PMTCT services, especially to lower-level, rural health facilities. To address this, we are conducting a cluster-randomized controlled study to evaluate the impact and cost-effectiveness of a novel, family-focused integrated package of PMTCT services. A systematic re-assignment of patient care responsibilities coupled with the adoption of point-of-care CD4 + cell count testing could facilitate the ability of lower-cadre health providers to manage PMTCT care, including the provision and scale-up of antiretroviral therapy (ART) to pregnant women in rural settings. Additionally, as influential community members, male partners could support their partners' uptake of and adherence to PMTCT care. We describe an innovative approach to scaling up PMTCT service provision that incorporates considerations of where and from whom women can access services (task-shifting), ease of obtaining a CD4 + cell count result (point-of-care testing), the degree of HIV service integration for HIV-infected women and their infants, and the level of family and community involvement (specifically male partner involvement). This systematic approach, if proven feasible and effective, could be scaled up in Nigeria and similar resource-limited settings as a means to accelerate progress toward eliminating mother-to-child transmission of HIV and help women with HIV infection take ART and live long, healthy lives (Trial registration: NCT01805752).

Keywords: Cluster-randomized clinical trial; Male participation/involvement; Point-of-care CD4+ cell count; Prevention of mother-to-child HIV transmission; Task shifting.

Figure 1

Google^™ map of North Central Nigeria showing location of Vanderbilt University/Friends in Global Health-supported study intervention clinics (green dotted icons), control/standard of care clinics (yellow plain icons) and referral sites (cross icons).

Figure 2

Power analysis for 12 clinics (6 matched-pairs) based on estimates of coefficient of variation (CV) derived from prior program data, North Central Nigeria