Study title: PROtecting Mothers and their Infants through Screening and Comprehensive Management of SExually Transmitted Infections in Antenatal Care in Zimbabwe

Lead Researcher(s)

Rashida Ferrand, Grant Murewanhema

Funder(s)

Medical Research Council

Partner(s)

London School of Hygiene and Tropical Medicine, Ministry of Health and Child Care Zimbabwe, Harare City Health

Background

Sexually transmitted infections (STIs) during pregnancy are associated with multiple adverse neonatal and maternal health outcomes. Despite the large burden and risk to maternal and infant health posed by STIs, in most countries, routine antenatal testing for chlamydia trachomatis (Ct), Neisseria gonorrhoeae (Ng), and trichomonas vaginalis (Tv) infections is not offered. In fact, STI management in the majority of low- and middle-income countries (LMIC) continues to be based on the WHO-endorsed syndromic management approach that has low sensitivity: more than >80% of curable STIs are asymptomatic and therefore not treated. The availability in recent years of STI diagnostics that are sensitive, specific, user-friendly, rapid, and do not require sophisticated infrastructure offers an immediate opportunity to transform STI management in LMIC and to achieve substantial public health impact. While these diagnostic platforms which do not require complicated laboratory infrastructure are available, there is a severe lack of evidence regarding their implementation and cost-effectiveness, which is needed to influence guidelines and subsequent integration into health systems. This is likely to be key to reducing rates of STIs in LMIC, and the WHO has called for evidence to inform replacement of syndromic management by diagnostic testing.

Study aim(s)

To conduct an individually randomised controlled trial to investigate the impact of diagnostic-led STI screening within antenatal care on newborn and maternal outcomes in Zimbabwe, a high HIV/STI prevalence setting in Africa.

Study design

PROMISE will recruit 8,280 women (4,140 per arm). The PROMISE trial will be conducted in Harare, Zimbabwe and recruiting from 15 antenatal clinics. The intervention will consist of testing for Ct, Ng, Tv, integrated with HIV and syphilis testing, at two points during a woman’s pregnancy (enrolment [≤22 weeks’ gestation], and during the third trimester [32-34 weeks’ gestation]). STI treatment and management in the intervention arm will be based on the test result if asymptomatic; women with symptoms will be treated following syndromic management guidelines. Management will include partner notification and treatment. The primary outcome (composite outcome of LBW, preterm birth, and stillbirth) will be assessed at a birth visit occurring within 72 hours of birth. Children and mothers will be followed up at 1- and 6-weeks postnatal to access secondary outcomes (small vulnerable newborn, small for gestational age, early and late neonatal death <7 and <28 days; neonatal conjunctivitis, pneumonia, sepsis, and prevalence of untreated STIs among mothers).

PROMISE will investigate the cost-effectiveness of the antenatal STI screening strategy and conduct a process evaluation to understand the operational and structural factors required for scalability.

Study dates

January 2025 -December 2027