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Global Grand Challenges: Randomized Controlled Trial on Sexually Transmitted Infections (STIs) and Reproductive Tract Sequelae in Non-Pregnant Women

Gates (Bill & Melinda) Foundation

Sexually active young women in low- and middle-income countries (LMICs) experience a high incidence of sexually transmitted infections (STIs), limited access to screening and treatment, and poorly characterized but significant reproductive tract morbidity from untreated infection. Global estimates put the prevalence of gonorrhea and chlamydia among women at 0.8% and 4.0%, respectively, with incidence rates of 1.9 and 3.6 cases per 100 person-years. [1] However, these estimates are limited by sparse data, with few sources providing representative measures of disease frequency, including asymptomatic infections. Studies among young women in LMICs interested in HIV pre-exposure prophylaxis have measured incidence rates per 100 person-years of 12-53 for chlamydia, 6-20 for gonorrhea, and 6-7 for trichomoniasis. [2] Due to the asymptomatic nature of most infections and reliance on syndromic management, most STIs in women go undetected. Untreated STIs have been linked to a range of poor health outcomes, including pelvic inflammatory disease (PID), chronic pelvic pain, infertility, and ectopic pregnancy. However, these estimates of association are imprecise and draw primarily from cross-sectional, case-control, and retrospective cohort studies, mostly conducted in high-income countries. Gaps in available data limit our ability to draw robust inferences on the risk of sequelae following an infection, the timing of pathogenesis, or how factors such as the presence of symptoms or repeat infection may modify these risks.

Better data on the risk of PID and related sequelae are critical to inform prevention and treatment guidelines, motivate funding for product development and provision of services, and shift care-seeking and care-provision behaviors. Research on the prevalence and risk of PID in LMICs has been challenging due to a lack of accurate and scalable diagnostic methods for PID along with funding gaps that limit consistent and comprehensive diagnosis. Although diagnosing subclinical PID remains challenging, targeted research is critical to better understand the risk of developing clinical PID and to evaluate the effectiveness of STI screening and treatment in preventing reproductive tract complications. Strengthening the evidence base in this area will not only advance our understanding of STI-related morbidity but may also stimulate the development and application of improved diagnostic tools to reduce the burden of PID and related outcomes.

This Grand Challenge on Randomized Controlled Trial on Sexually Transmitted Infections (STIs) and Reproductive Tract Sequelae in Non-Pregnant Women aims to fill critical gaps in understanding of the risk of PID and related sequelae attributable to STIs and to evaluate the impact of etiologic STI screening and treatment on morbidity. With this Grand Challenge we welcome letters of intent (LOIs) from organizations to conduct a randomized controlled trial (RCT) in sub-Saharan Africa comparing STI screening and standard of care syndromic management. The primary outcome of this study should be PID, with secondary outcomes possibly including chronic pelvic pain, ectopic pregnancy, and infertility. The study should provide insight into the risk of outcomes following infection with gonorrhea, chlamydia, and/or trichomoniasis and the impact and cost-effectiveness of etiologic screening to prevent morbidity.

We are planning a webinar to provide more information and answer your questions on June 17 from 7:00-8:00 AM Pacific Time. To participate, please register and submit your questions ahead of time.

Deadline: July 7, 2025

Specialties

International Opportunities

Medical - Clinical Science

Medical

Social Sciences

Eligibility Requirements

This initiative is open to nonprofit organizations, for-profit companies, international organizations, government agencies, and academic institutions.
Study design must be randomized controlled trial or comparable, robust prospective in Sub-Saharan African settings.
We encourage groups to build upon existing and/or complimentary projects/studies/trials and to collaborate with other institutions.

Sponsor Details

Sponsor Institute/Organizations: Gates (Bill & Melinda) Foundation

Sponsor Type:

Address: 2099 Pennsylvania Ave, NW Suite 200 Washington DC 20006 USA

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