Optimised Postpartum PMTCT Testing for Infants and their Mothers (OPPTIM)

The prevention of mother-to-child transmission of HIV (PMTCT) is the most successful HIV prevention intervention globally. In 2015 South Africa adopted the WHO’s “Option B+” PMTCT strategy: lifelong antiretroviral therapy (ART) for all HIV-positive pregnant and breastfeeding women, regardless of CD4 count. However the early effectiveness of PMTCT, especially in low resource settings, is largely centered on pregnant women and early infant diagnosis with less emphasis on preventing transmission to infants born to HIV-positive women further along the PMTCT cascade. For example, in the City of Johannesburg (CoJ), despite the recommendation in the South African National Department of Health (SANDoH) guidelines for an integrated approach to maternal and child health, maternal HIV re-testing postpartum, infant testing beyond 10 weeks and maternal viral load testing are currently not well integrated into the Expanded Programme for Immunisation (EPI). These interventions are intended to reduce postpartum HIV transmission, as the postpartum period is a recognised high risk period for poor maternal adherence to ART and subsequent transmission of HIV to infants. There are few studies that have evaluated this integrated approach, mainly reporting on EPI coverage rates and maternal and infant testing rates, but not evaluating additional maternal care such as adherence to ART and viral load testing. Current programme indicators on infant HIV testing, beyond early infant testing, are difficult to interpret because of difficulties with data quality and accurate denominators. It is important to note that there are currently no postpartum programme indicators on maternal re-testing or maternal viral load monitoring. Poor implementation of postpartum HIV testing and monitoring of HIV-infected women and/or recording of these activities has resulted in a void of information on the maternal and infant HIV incidence in the postpartum period in this high maternal HIV prevalence setting.

Primary Objectives

To compare viral load suppression rates (viral load

<1000 copies/ml) between HIV-positive postpartum women on first line ART, receiving a package of enhanced viral load monitoring with viral load point of care testing to those receiving standard of care lab-based viral load monitoring

Stud Population

The study population will comprise of consenting mother-infant pairs from three urban primary health care clinics, Hillbrow Community Health Centre, Malvern clinic and Yeoville clinic in sub-district F, City of Johannesburg, an HIV burden among the highest in South Africa (73).
For the primary objective, all HIV-positive postpartum women (aged ≥14 years) on first line ART, who have given birth to a live infant and who are attending an EPI clinic for a 6-, 10- or 14-week immunization visit with their infant at one of the three study sites will be considered for inclusion.
For the secondary objective, all HEU infants of the mothers enrolled for the primary objective, attending an EPI clinic at 6-, 10- or 14-weeks at the study sites. Women may be enrolled independently, even if their infant is not enrolled on the study for whatever reason; including refusal of consent for infant participation or death of an infant after study enrolment.

Investigators

Dr Lee Fairlie, Prof Gayle Sherman, Shobna Sawry, Natasha Davies, Nomathemba Chandiwana, Diantha Pillay, Maria Escobar, Dr Saiqa Mullick, Dr Candice Fick, Dr Oluwafemi Adeagbo and Dr Pedro Pisa

Latest Update: 15 February 2021

For more on OPPTIM please email rhicomms@wrhi.ac.za