Randomized Controlled Trial on Sexually Transmitted Infections (STIs) and Reproductive Tract Sequelae in Non-Pregnant Women - Frequently Asked Questions (FAQs)

Eligibility

Who is eligible for grants?

• 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.
• We particularly encourage applications involving projects led by African PIs, women, early-career researchers, and practitioners seeking to innovate in women's health measurement, or from women-led organizations and applications from institutions based in LMICs.

Upon registration, applicants must provide information about the tax status of their organization as different terms and conditions may apply under the applicable tax laws. You should confirm your organization's tax status with the appropriate advisor or entity within your organization such as your grants or contracts department, finance, or office of sponsored research. Either funder may request additional information regarding your tax status. For information about tax statuses, you may check with your own advisors and review information on the applicable tax requirements.

Why sub-Saharan Africa only?
Sub-Saharan Africa has one of the highest estimated burdens of untreated STIs and the most significant gaps in representative data. A focused investment in this region will yield critical insights to support policy change and product development.

Is it allowable for persons with disabilities, including women with disabilities, to be part of the program?
Yes, absolutely. We encourage applications from anyone irrespective of disability.

Application Process

What must my application include?
Please refer to the Application Instructions document.

Does the max word count of 4000 include both the LOI Questionnaire and Supplemental Questionnaire?
Yes

What are the key considerations for competitive applications?

Design and objectives	Randomized controlled trial in sub-Saharan Africa Generate causal evidence for PID and related sequelae after STI Capture impact, cost, and cost-effectiveness of STI screening, treatment, and sequelae management Provide insight into timing of pathogenesis (e.g., frequent sample collection, testing intervals, symptom diaries) Enable stratified risk assessment by presence of symptoms, co-infection, and repeat infection Collect detailed sexual behavior data and STI incidence/duration
Feasibility	Applicants should demonstrate feasibility of the proposed design and recruitment strategy, including justification based on population STI prevalence and sample size
Stakeholder engagement & ethics	Meaningful community engagement Partnerships with in-country researchers and ethics boards Gender-responsive and ethically robust protocol design
Data & analysis	Strong governance across sites Monitoring for quality, adherence, and safety Real-time data analysis capability preferred Willingness to integrate additional foundation-prioritized outcomes (e.g., care-seeking behavior, menstrual health)

Am I able to edit my application once submitted?
Yes, you may edit your application up until the specified deadline. 

Do applicants need to be in consortiums, or can one institution apply?
This is an open call for all, including singular institutions with capacity to conduct the robust trial. Collaborations are encouraged.

Is partnership with academic institutions or ministries of health mandatory?
There are no such restrictions, as long as the design maintains scientific rigor. Contextualizing this research with local priorities is ideal, with an understanding of how the findings would contribute to decision-making.

Is it possible to submit more than one project?
While we welcome multiple submissions from each organization, the email address and PI should be distinct for each submission. PIs are welcome to be collaborators on multiple proposals.

What are the qualifications needed for the principal investigator / project lead?
Specific qualifications are not required for principal investigators if they can demonstrate they have the background and expertise to carry out the work and it's in alignment with the proposal they are submitting.

Are collaborations welcomed and how does this work?
We welcome and encourage collaboration. When creating an application, there is an option in the system for applicants to add collaborators to work on a joint proposal and submit. In this case, one organization would be the primary recipient of an award, and that awardee could potentially sub-grant to others, or collaborate informally, as it makes sense. We are not able to match organizations with one another during the application process.

Study Population and Scope

Is there a specific age group or target population based on vulnerability?
We encourage proposals focused on populations with the highest incidence of PID to ensure study feasibility.

Are adolescent girls and young women considered a key target group?
Yes.

Can non-pregnant women with HIV or other comorbidities be included?
Yes. Women with HIV or other comorbidities should not be excluded without clear justification.

Can the RCT be conducted in rural areas with limited telecommunications or infrastructure?
Yes, provided the feasibility of high-quality study implementation is demonstrated.

Can studies be conducted in conflict-affected or low-resource settings, such as Somalia, Ethiopia, Djibouti, or Liberia?
Yes. Such settings are encouraged as long as scientific rigor and diverse, representative populations are maintained.

Can an RCT be implemented in only one country, or must it span multiple countries?
Trials may be conducted in one or more countries.

Are multi-site trials required or would a single-site trial be considered?
A: Multi-site trials are preferred for generalizability, but single-site trials will be considered if they include a diverse population and adequate sample size. Collaborations are encouraged.

Design Study and Methodology

What are expectations for RCT design (e.g., cluster vs. individual randomization)?
Robust, prospective designs are expected, including options like varied screening intervals and frequent specimen collection for batch testing.

Is it acceptable to randomize participants when the control arm may withhold treatment?
Applications must clearly justify inclusion criteria and address ethical considerations.

Can animal studies or mixed-methods studies be included?
Animal studies are excluded. Mixed-methods may be considered if well justified.

Would there be an opportunity to include secondary outcomes (e.g., time to pregnancy, antimicrobial susceptibility)?
Yes, if the feasibility of high-quality implementation can be demonstrated.

Will there be a standard questionnaire to ensure data comparability across countries?
No. Grantees are responsible for designing standardized tools to ensure data comparability if working across multiple sites.

What does the timeline and progression of the study look like?
Focus on high-STI-risk populations to ensure enough PID cases during the study. Sample sizes must be calculated using local data to ensure adequate power.

Diagnostic Tools and Criteria

What definition of PID diagnosis will be used for this RFP? Will STI positivity alone be sufficient?
No. A consistent, clinical PID definition based on recognized global or national standards is required. STI positivity alone is insufficient.

Is NAAT the gold standard testing for STIs, including for diagnosis of Trichomonas?
Yes. NAAT is recommended for Gonorrhea, Chlamydia, and Trichomonas, though other validated methods may be used.

Do diagnostic tools need to be prequalified, or can late-stage or locally approved products be used?
Use of diagnostics with stringent regulatory approval is strongly recommended. Novel or locally approved tools may be included if they don't compromise core objectives.

Interventions and Study Focus

Which STIs are included in the focus of this RFA? Is Mycoplasma genitalium or BV included?
The focus is on Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Inclusion of M. genitalium or BV must be justified and should not detract from the core objectives.

Can HPV be included in the study?
Yes. While not the primary focus, HPV is a Foundation priority and may be included if aligned with study objectives.

Can Female Genital Schistosomiasis (FGS) be included in the study?
Yes. Especially if FGS is prevalent in the study setting, assessing its diagnosis and sequelae is welcomed.

Is clinical PID (e.g., symptomatic) the primary focus, or will studies on subclinical (asymptomatic) PID be considered?
Clinical PID should remain the primary focus, but studies including subclinical PID are welcome if methodologically clear.

Can non-clinical interventions such as behavioral change strategies, youth-friendly services, or SBCC be included?
Yes, if clearly linked to improving understanding or prevention of PID.

Can proposals include diagnostic technologies or address co-infections such as HIV or HPV within RCTs?
Yes, if the primary outcome remains PID. Integrated care approaches are acceptable.

Ethics, Data Use, and Sustainability

What are the expectations for post-trial sustainability?
Applications should ideally engage with relevant stakeholders and community advisory boards to contextualize this research within local priorities.

Can results be used for future advocacy or program design?
Yes.

Is IRB approval required at the proposal stage?
No.

What are the expectations for informed consent in rural or traditional communities?
All ethical considerations should be addressed and justified.

What are the rules for data ownership?
Grantees own data resulting in foundation-funded grants. The foundation does, however, require that grant outputs be made widely available to the intended beneficiaries. The details of our Global Access policy, as well as frequently asked questions, are available on our website. https://www.gatesfoundation.org/about/policies-and-resources/global-access-statement

Review Process

How does the review process work?

Please refer to the Rules and Guidelines document.

Can I get a list of potential reviewers who might be assigned to my application?
No. We do not make public the roster of reviewers.

Can I request that my application not be reviewed by a specific individual?
No. However, we will ask reviewers to self-identify conflicts of interest and will not assign reviewers with conflicts.

Will I receive specific feedback on my application if it is not selected?
Due to the rapid proposal and review timelines applicable to this RFP, applicants with proposals that are not selected for award may receive a notification of decline without specific feedback.

Award Information

Are grant awards made directly to individuals?
No. All awards are made to the organization where the individual holds their primary appointment. Institutions must agree to the terms and conditions governing each grant award prior to award activation. 

How much money will each grant provide?
We will consider applications requesting awards ranging from $8 million to $10 million USD per project, with a grant duration of up to 48 months. Budgets should align with the scale and complexity of the proposed work. Indirect costs are allowable and should be included within the total requested funding. (subject to the Gates Foundation's indirect cost policy).

Is there a budget ceiling for early-stage trials?
The range is $8-10M.

Is cost-sharing required?
There are no such requirements.

Are in-kind contributions considered in evaluation?
All relevant contributions must be disclosed.

Technical Support

I forgot my password. How do I reset my password?
You can request to update your password within the application site. If you continue to have issues, please reach out to [email protected].

How will I know if my application was submitted?
Once an application is submitted, an email confirmation will be sent. 

I'm having trouble uploading my application file. What should I do?
If you are having issues submitting your application, we would encourage you to submit from a different browser. If the issue persists, please email the specifics of your problem to [email protected].

How often do you intend to update the Frequently Asked Questions, and do you plan to provide answers to all questions submitted?
We will periodically post answers to questions as they are submitted, but do not have a specific schedule. We will provide answers on this page that are of relevance and of general interest to potential applicants. For answers to specific questions that are not covered here, please email [email protected]