title: Implementing comprehensive prevention of mother-to-child transmission and HIV prevention for South African couples: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  In rural South Africa, only two-thirds of HIV-positive pregnant women seeking antenatal care at community health centers took full advantage of 'prevention of mother-to-child transmission' (PMTCT) services in 2010. Studies generally support male involvement to promote PMTCT, but the nature and impact of that involvement is unclear and untested. Additionally, stigma, disclosure and intimate partner violence pose significant barriers to PMTCT uptake and retention in care, suggesting that male involvement may be 'necessary, but not sufficient' to reduce infant HIV incidence. This study expands on a successful United States President's Emergency Plan for AIDS Relief (PEPFAR)-supported PMTCT couples intervention pilot study conducted in the Mpumalanga province, targeting HIV-positive pregnant women and their partners, the primary objective being to determine whether male partner involvement plus a behavioral intervention will significantly reduce infant HIV incidence.
  
  
  METHODS
  The study follows a cluster randomized controlled design enrolling two cohorts of HIV-positive pregnant women recruited from 12 randomly assigned Community Health Centers (CHC) (six experimental, six control). The two cohorts will consist of women attending without their male partners (n = 720) and women attending with their male partners (n = 720 couples), in order to determine whether the influence of male participation itself, or combined with a behavioral PMTCT intervention, can significantly reduce infant HIV infection ante-, peri- and postnatally.
  
  
  CONCLUSIONS
  It is our intention to significantly increase PMTCT participation from current levels (69%) in the Mpumalanga province to between 90 and 95% through engaging women and couples in a controlled, six session ante- and postnatal risk-reducing and PMTCT promotion intervention addressing barriers to PMTCT (such as stigma, disclosure, intimate partner violence, communication, infant feeding practices and safer conception) that prevent women and men from utilizing treatment opportunities available to them and their infants. Based upon the encouraging preliminary results from our pilot study, successful CHC adoption of the program could have major public health policy implications for containing the epidemic among the most vulnerable populations in rural South Africa: HIV-positive pregnant women and their infants.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02085356 (registration date: 10 March 2014).
authors.forename: Deborah
authors.initials: D
authors.lastname: Jones
authors.affiliation: HIV/AIDS, STIs and TB (HAST) Research Programme, Human Sciences Research Council (HSRC), Private Bag X41, Pretoria 0001, South Africa. KPeltzer@hsrc.ac.za.
authors.forename: Karl
authors.initials: K
authors.lastname: Peltzer
authors.forename: Stephen M
authors.initials: SM
authors.lastname: Weiss
authors.forename: Sibusiso
authors.initials: S
authors.lastname: Sifunda
authors.forename: Ntabozuko
authors.initials: N
authors.lastname: Dwane
authors.forename: Shandir
authors.initials: S
authors.lastname: Ramlagan
authors.forename: Ryan
authors.initials: R
authors.lastname: Cook
authors.forename: Gladys
authors.initials: G
authors.lastname: Matseke
authors.forename: Vincent
authors.initials: V
authors.lastname: Maduna
authors.forename: Andrew
authors.initials: A
authors.lastname: Spence
mesh_terms: D001521:Behavior Therapy; D002985:Clinical Protocols; D005260:Female; D015658:HIV Infections / Q000453:epidemiology / Q000517:prevention & control* / Q000523:psychology / Q000635:transmission*; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D015994:Incidence; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D008297:Male; D010349:Patient Compliance; D010353:Patient Education as Topic; D011247:Pregnancy; D011295:Prenatal Care; D012107:Research Design; D019035:Rural Health Services; D012944:Social Support; D013019:South Africa / Q000453:epidemiology; D018454:Spouses / Q000523:psychology*; D013997:Time Factors; D016896:Treatment Outcome