Implementing comprehensive prevention of mother-to-child transmission and HIV prevention for South African couples: study protocol for a randomized controlled trial

Abstract

BackgroundIn 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/designThe 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.DiscussionIt 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 registrationClinicalTrials.gov NCT02085356 (registration date: 10 March 2014).Electronic supplementary materialThe online version of this article (doi:10.1186/1745-6215-15-417) contains supplementary material, which is available to authorized users.

Self-Report and Dry Blood Spot Measurement of Antiretroviral Medications as Markers of Adherence in Pregnant Women in Rural South Africa

“…Details of the Protect Your Family study intervention have been previously described. (8) Participants were compensated with R100 (South African Rand or ZAR ~US$10) for their time and transportation to the assessment.…”

Psychosocial correlates of patient–provider family planning discussions among HIV-infected pregnant women in South Africa

“…26 A trained health care provider was designated and available at all clinics for respondents endorsing severe depression, suicidal ideation, and IPV. Clinic health care providers were trained to assess risk and provide triage for further assessment, hospitalization, or outpatient counseling/treatment by licensed psychiatric nurses, social workers, and mental health professionals at associated district hospitals.…”

Intimate partner violence among HIV positive pregnant women in South Africa

“…Participants were 673 HIV-positive pregnant women in South Africa recruited during the baseline phase of Protect Your Family, a clinic-randomised, controlled trial designed to test the effectiveness of a behavioural intervention aimed at increasing prevention-of-mother-to-child-transmission (PMTCT) uptake, family planning and male partner participation in the antenatal and postnatal process in 12 community health centres in Gert Sibande and Nkangala districts in Mpumalanga province, South Africa (Jones et al, 2014). Both newly diagnosed ( n = 365) and previously diagnosed women ( n = 308) were recruited (see Tables 1a and 1b).…”