Publication: Implementing comprehensive prevention of mother-to-child transmission and HIV prevention for South African couples: study protocol for a randomized controlled trial
3
Issued Date
2014
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eng
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Mahidol University
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BioMed Central
Bibliographic Citation
Trials. Vol.15, (2014), 417
Suggested Citation
Jones, Deborah, Peltzer, Karl, Weiss, Stephen M, Sifunda, Sibusiso, Dwane, Ntabozuko, Ramlagan, Shandir, Cook, Ryan, Matseke, Gladys, Maduna, Vincent, Spence, Andrew Implementing comprehensive prevention of mother-to-child transmission and HIV prevention for South African couples: study protocol for a randomized controlled trial. Trials. Vol.15, (2014), 417. Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/2895
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Implementing comprehensive prevention of mother-to-child transmission and HIV prevention for South African couples: study protocol for a randomized controlled trial
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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/design: 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.
Discussion: 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.
Trial registration: ClinicalTrials.gov NCT02085356 (registration date: 10 March 2014).