title: Evaluation of a community health worker intervention and the World Health Organization's Option B versus Option A to improve antenatal care and PMTCT outcomes in Dar es Salaam, Tanzania: study protocol for a cluster-randomized controlled health systems implementation trial.
abstract: BACKGROUND
  Mother-to-child transmission of HIV remains an important public health problem in sub-Saharan Africa. As HIV testing and linkage to PMTCT occurs in antenatal care (ANC), major challenges for any PMTCT option in developing countries, including Tanzania, are delays in the first ANC visit and a low overall number of visits. Community health workers (CHWs) have been effective in various settings in increasing the uptake of clinical services and improving treatment retention and adherence. At the beginning of this trial in January 2013, the World Health Organization recommended either of two medication regimens, Option A or B, for prevention of mother-to-child transmission of HIV (PMTCT). It is still largely unclear which option is more effective when implemented in a public healthcare system. This study aims to determine the effectiveness, cost-effectiveness, acceptability, and feasibility of: (1) a community health worker (CWH) intervention and (2) PMTCT Option B in improving ANC and PMTCT outcomes.
  
  
  METHODS
  This study is a cluster-randomized controlled health systems implementation trial with a two-by-two factorial design. All 60 administrative wards in the Kinondoni and Ilala districts in Dar es Salaam were first randomly allocated to either receiving the CHW intervention or not, and then to receiving either Option B or A. Under the standard of care, facility-based health workers follow up on patients who have missed scheduled appointments for PMTCT, first through a telephone call and then with a home visit. In the wards receiving the CHW intervention, the CHWs: (1) identify pregnant women through home visits and refer them to antenatal care; (2) provide education to pregnant women on antenatal care, PMTCT, birth, and postnatal care; (3) routinely follow up on all pregnant women to ascertain whether they have attended ANC; and (4) follow up on women who have missed ANC or PMTCT appointments.
  
  
  BACKGROUND
  ClinicalTrials.gov: EJF22802. Registration date: 14 May 2013.
authors.forename: David
authors.initials: D
authors.lastname: Sando
authors.forename: Pascal
authors.initials: P
authors.lastname: Geldsetzer
authors.forename: Lucy
authors.initials: L
authors.lastname: Magesa
authors.forename: Irene Andrew
authors.initials: IA
authors.lastname: Lema
authors.forename: Lameck
authors.initials: L
authors.lastname: Machumi
authors.forename: Mary
authors.initials: M
authors.lastname: Mwanyika-Sando
authors.forename: Nan
authors.initials: N
authors.lastname: Li
authors.forename: Donna
authors.initials: D
authors.lastname: Spiegelman
authors.forename: Ester
authors.initials: E
authors.lastname: Mungure
authors.forename: Hellen
authors.initials: H
authors.lastname: Siril
authors.forename: Phares
authors.initials: P
authors.lastname: Mujinja
authors.forename: Helga
authors.initials: H
authors.lastname: Naburi
authors.forename: Guerino
authors.initials: G
authors.lastname: Chalamilla
authors.forename: Charles
authors.initials: C
authors.lastname: Kilewo
authors.forename: Anna Mia
authors.initials: AM
authors.lastname: Ekström
authors.forename: Wafaie W
authors.initials: WW
authors.lastname: Fawzi
authors.affiliation: Department of Global Health and Population, Harvard School of Public Health, Huntington Avenue, Boston, Massachusetts 02115, USA. tbaernig@hsph.harvard.edu.
authors.forename: Till W
authors.initials: TW
authors.lastname: Bärnighausen
mesh_terms: D019380:Anti-HIV Agents / Q000627:therapeutic use*; D001071:Appointments and Schedules; D003153:Community Health Services / Q000592:standards*; D003150:Community Health Workers / Q000592:standards*; D005260:Female; D015658:HIV Infections / Q000453:epidemiology / Q000517:prevention & control* / Q000635:transmission; D007722:Health Knowledge, Attitudes, Practice; D006302:Health Services Research; D006308:Health Systems Plans; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D010043:Outcome and Process Assessment, Health Care / Q000592:standards*; D010342:Patient Acceptance of Health Care; D010353:Patient Education as Topic; D018743:Perinatal Care / Q000592:standards*; D011247:Pregnancy; D058996:Quality Improvement / Q000592:standards*; D019984:Quality Indicators, Health Care / Q000592:standards*; D012107:Research Design; D013636:Tanzania / Q000453:epidemiology; D013997:Time Factors; D016896:Treatment Outcome; D014944:World Health Organization
chemical_list: D019380:Anti-HIV Agents