REQUEST FOR PROPOSAL for a study on guidelines uptake, acceptability of formulation and patient pathway in South Africa regarding STIs
23 May 2024
ABOUT GARDP
The Global Antibiotic Research & Development Partnership (GARDP) accelerates the development and access of treatments for drug-resistant infections. Together with private, public and non-profit partners, GARDP works to preserve the power of antibiotics for generations to come.
GARDP is acting now to counter antibiotic resistance and save lives. Antimicrobial resistance (including antibiotic resistance) is one of the top 10 global health threats. In 2019, nearly 1.3 million people died as a result of drug-resistant bacterial infections, more than HIV (~860,000) or breast cancer (~700,000). If left unchecked, antibiotic resistance may kill as many as 10 million people each year from 2050.
Responding to a global health crisis: the story of GARDP
The headlines in 2015 were alarming. A deadly superbug was spreading in hospitals in Australia. An outbreak of drug-resistant gonorrhoea threatened public health in England. The superbug “NDM-1” had reached 70 countries. The BBC warned, “Antibiotic resistance: World on cusp of ‘post-antibiotic era’.”
For years, the problem had been growing. Even as bacteria were becoming more and more resistant to antibiotics, pharmaceutical companies were exiting the antibiotic development industry. The work had become more difficult and expensive, so now the risks outweighed the rewards. And the antibiotics that were being introduced were not particularly innovative—there had been no new class of antibiotics in about 30 years.
In this context, the World Health Assembly, the decision-making body of the World Health Organization (WHO), adopted the Global Action Plan on Antimicrobial Resistance (2015).
To deliver on this plan, GARDP was created in 2016 by the WHO and the Drugs for Neglected Disease initiative (DNDi). Like the WHO, GARDP drives a global response to antimicrobial resistance. Like DNDi, GARDP engages in public and private sector partnerships to research and develop new drugs that fit public health needs.
Following an initial incubation period in DNDi, GARDP was legally established in 2018 as a Swiss foundation (GARDP Foundation). Three years later, in 2021, the Swiss government granted GARDP legal privileges and immunities to facilitate GARDP’s collaboration with others working in the field of public health and in recognition of GARDP’s major role in the fight against antibiotic resistance.
Today, GARDP is a not-for-profit organization with over 50 staff. They are part of the GARDP global network, including GARDP North America Inc., representation in Australia, DNDi-GARDP Southern Africa NPC, the Drugs for Neglected Diseases initiative, and associated DNDi regional offices in India, Japan, South America, Southeast Asia and Kenya.
Together with essential support from donors and key research and development partnerships, the GARDP global network makes it possible to carry out global research and drug development trials, as well as expand access to antibiotics for appropriate use, in close connection with communities around the world.
GARDP R&D strategy for Neonatal sepsis aims at delivering, an affordable ’empirical’ treatment for neonatal sepsis and meningitis in settings with high resistance rates to the WHO first line empiric therapy of ampicillin and gentamicin, where the pathogenic bacteria have not been formally identified. The objective of the GARDP Neonatal sepsis project is to meet the public health needs to identify novel regimens from existing generic antibiotics that provide broader coverage against multi-drug resistant pathogens to improve clinical outcomes for neonatal sepsis globally.
PROJECT BACKGROUND
Management of Sexually Transmitted Infections (STIs) differs significantly among countries, and even within country depending on the level of care (i.e. STI or public health clinic, private practitioner, pharmacy). WHO issues treatment guidelines that are used as a basis for country recommendations although most LMICs adapt WHO STI guidance[2] to their specific circumstances.
Guideline implementation is an essential part of antibiotic stewardship but typically, it can take years for countries to update their guidelines following a change of WHO recommendations and longer still to implement new guidelines, even with donor and implementing partner support. In most LMIC countries guidelines are inconsistently used where there are no implementation strategies; poor implementation of evidence-based clinical practice guidelines can, in turn, lead to suboptimal care and inappropriate use of medicines.
The last guidelines issued by WHO (“Guidelines for the management of symptomatic sexually transmitted infections”, 2021) recommended the use of ceftriaxone 250mg+ azithromycin 1g to treat uncomplicated gonorrhoeae (alternatively cefixime 400mg + azithromycin 1g), as part of a syndromic approach, following clinical or aetiological diagnosis. Azithromycin also treats chlamydia, which presents with the same symptoms as gonorrhoea. These guidelines did not change treatment recommendations already issued in 2017. For that reason, and in light of the increasing antimicrobial resistance worldwide, WHO will soon release new guidelines for the treatment of uncomplicated gonorrhoea, increasing the recommended dose for ceftriaxone to 1g.
In most countries it is unclear to what extent current guidelines (2021) have been (1) adopted or incorporated in National guidelines and (2) implemented across the different public and private health facilities and other treatment points like pharmacies. Also unknown is how successful the program has been as treatment cascade or patient outcome data is rarely recorded or analysed, including for people failing treatment (e.g. having unresolved symptoms), and there is rarely follow-up or tracking of partner therapy or transmission.guidelines are officially adopted, patients may seek care in pharmacies where current practice may differ from recommendations. Moreover, the recommendation of 1g IM injection of ceftriaxone may pose an additional barrier to implementation of these new guidelines.
Zoliflodacin, a new antibiotic developed by GARDP that recently reported positive phase 3 results, could be an oral alternative to ceftriaxone injection. Still, its formulation (sachet containing 3g powder for suspension) needs to be assessed in terms of acceptability by health care workers and patients.
The main objective of this study is, therefore, to assess guideline implementation and the perceived barriers to guideline adherence among GPs and other healthcare providers like nurses or pharmacists, to gather information on patient pathway, and to assess acceptability of an oral formulation.
PURPOSE OF THE RFP
The main objective of this study is to assess guideline implementation and the perceived barriers to guideline adherence among GPs and other healthcare providers like nurses or pharmacists in light of new treatments to be included in the guidelines, particularly zoliflodacin. Therefore, the current work also aims exploring preferences regarding administration oral vs injectable treatment among different groups. The project will be done in South Africa.
[1] Guidelines for the management of symptomatic sexually transmitted infections. Geneva: World Health Organization; 2021. An updated version is expected imminently but, due to a lack of alternatives on the market, types of antibiotics recommended will not change. Future guidelines may recommend zoliflodacin, once FDA-approved in about 2 years’ time.
CRITERIA FOR SELECTING SERVICE PROVIDERS
The decision to award any contract as a result of this RFP process will be based on Suppliers’ responses and any subsequent negotiations or discussions. The decision-making process will consider the ability of each supplier to fulfil GARDP’s requirements as outlined within this RFP and the total cost of the offer.
Proposals will be assessed against the main following criteria but not limited to:
Technical criteria
Technical criteria will weight maximum 70% of the award decision and are composed of criteria such as technical expertise, project experience, team structure, project plan proposal, project management capabilities, client recommendations, values and cultural fit.
Financial criteria
Financial criteria will weight minimum 30% of the award decision and are composed of criteria such as competitiveness and completeness of the offer, payment schedule based on deliverables, special discount for non for profit organization.
Proposals evaluation and bid defense meeting
Based on a pre-aligned selection grid, GARDD selection committee will evaluation all written proposals to determine which suppliers shall be invited to a virtual meeting with GARDP Selection committee.
The duration of each meeting will be around 1 hour, including follow-up questions and answers. Agenda and expectations/questions expected for the meeting will be shared together with the invitation to participate.
Value-add and Insight
Please list/describe any additional services that you feel would be have benefit to GARDP and associated costs if any.
Data Privacy
GARDP is committed to protecting and respecting your privacy in compliance with the European General Data Protection Regulation (GDPR). Our Privacy Notice (Annex 3) sets out the basis on which the personal data collected from you, or that you provide to us, will be processed by us in connection with your relationship with at GARDP, as vendors, suppliers or third parties. By responding to our RFP, you explicitly consent to our Data Privacy Notice and confirm your understanding on how your personal data will be stored and treated by GARDP.
If you are interested to participate, please send a request to: RFP_Procurement@gardp.org to receive complete documentation of this RFP
Due/closing date: June 21st 2024