ACCELERATING THE GLOBAL SEXUALLY TRANSMITTED INFECTIONS RESPONSE

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T

ACCELERATING THE GLOBAL SEXUALLY TRANSMITTED

INFECTIONS RESPONSE

REPORT ON THE FIRST INFORMAL THINK-TANK MEETING

JUNE 2020

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JUNE 2020

GLOBAL SEXUALLY TRANSMITTED

INFECTIONS RESPONSE

REPORT ON THE FIRST INFORMAL THINK-TANK

MEETING

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The Global HIV, Hepatitis and Sexually Transmitted Infections Programmes (HHS) at the World Health Organization (WHO), Geneva, are grateful and would like to thank all individuals and organisations that contributed to the development of this document to make it relevant and responsive to the global public health needs in the area of sexually transmitted infections.

We appreciate the overall support of representatives of ministry of health, partners, donors, experts, community representatives, and staff members from regional offices who participated in the meeting. Meg Doherty, Director, WHO

Global HIV, Hepatitis and Sexually Transmitted Infections Programmes gave overall technical leadership and direction to the process. Other Secretariat staff who worked closely on organising and conducting the meeting and documenting the outcomes are Teodora Wi, Andy Seale, Melanie Taylor and Yamuna Mundade. WHO is grateful for the technical review, expert comments and edits provided by Francis Ndowa, expert peer-reviewer who provided support in editing this report.

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ABBREVIATIONS AND ACRONYMS

AMR antimicrobial resistance

ANC antenatal care

COVID coronavirus disease

EMTCT elimination of mother-to-child transmission

GAM Global AIDS Monitoring

Gavi The Vaccine Alliance

The Global Fund The Global Fund for AIDS, Tuberculosis and Malaria GHSS Global Health Sector Strategy

GLASS Global Antimicrobial Surveillance System GPHG Global Public Health Goods

GPW General Programme of Work

HHS Global HIV, Viral hepatitis and STIs programme

HIV human immunodeficiency virus

HPV human papillomavirus

HSV herpes simplex virus

HTLV human T-cell lymphotropic virus LMIC low- and middle-income countries

MNCH maternal, neonatal, child and adolescent health

MSM men who have sex with men

NSP National Strategic Plan

PADO Paediatric AIDS Drug Optimization POCT point-of-care test

PrEP pre-exposure prophylaxis SDGs Sustainable Development Goals

SRH sexual and reproductive health

SRHR sexual and reproductive health and human rights

STI sexually transmitted infection

UCN Division of communicable and noncommunicable diseases

UHC universal health coverage

UN United Nations

UNAIDS Joint United Nations Programme on HIV/AIDS

WHO World Health Organization

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According to estimates by WHO in 2016, about 1 million new sexually transmitted infections (STIs) are acquired every day for the four commonest curable STIs – Treponema pallidum, Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis. Ninety per cent of them occur in low- and middle-income countries (LMICs) (1). If not detected and treated in good time, these STIs cause severe complications, such as pelvic inflammatory disease, infertility and adverse pregnancy outcomes.

Of the two commonest viral STIs other than the human immunodeficiency virus (HIV), the human papillomavirus (HPV) is responsible for high morbidity, especially the high- risk genotypes of HPV, which are the main cause of cancers of the cervix, anus and penis, resulting in over 300 000 cervical cancer deaths globally per year (2). The other is the human herpes simplex virus (HSV), with an estimated adult population of 500 million living with the infection globally in 2016 (3).

Many STIs, both ulcerative and inflammatory, increase the risk of HIV acquisition and transmission. Failure to prevent and adequately treat STIs undermines efforts to end HIV globally (4–8). Expanded use of antiretroviral medicines for treatment and prevention of HIV transmission and acquisition, including pre-exposure prophylaxis (PrEP), has implications for the motivation to use condoms, with an observed increase in some STIs, such as syphilis and gonorrhoea in some settings, especially among men who have sex with men (MSM) (9–13).

Added to this is the global spread of antimicrobial resistance (AMR) in some sexually transmitted pathogens, especially N. gonorrhoeae, with the threat of untreatable gonococcal infection in view of the limited choices and classes of antibiotics available (14–15).

WHO’s 2019 progress report on HIV, viral hepatitis and STIs acknowledges that, “The global response to sexually transmitted infections is in crisis after years of neglect.

Opportunities to link with HIV and broader sexual and reproductive health services must be seized to resume progress” (16). The strategy on STIs has set ambitous targets that include reductions in the incidence of T. pallidum and N. gonorrhoeae by 90% by 2030, and STI services, or links to services, in all primary, HIV, reproductive health, family planning, and antenatal and postnatal care services by 2020 (17). Globally, adult STI incidence is not declining (1).

There are large gaps in domestic budgets and international funding for STI prevention and care, leading to limited and underresourced STI prevention and clinical care services, and surveillance.

On account of its high mortality, HIV has been one of the foremost global political priorities, but the other STIs have, over the years, lost such traction for resources. However, as the HIV and STI syndemics become better understood, and the burden of STIs more evident, more effort and opportunities must be harnessed to increase attention and identify resources to strengthen STI prevention and control. First, global estimates of STIs indicate sustained high incidence and recent country-level data demonstrate high STI prevalence among general populations such as pregnant women (18–

19) and women attending family planning services in some settings (20). Meanwhile, antenatal screening programmes are only slowing declines in congenital syphilis (21).Second, the alarming threat of untreatable gonorrhoea should (14–15) drive efforts at formulating policies to mitigate the global threat of AMR (22). Third, a recent review has highlighted a high STI prevalence at baseline screening and high incidence while taking PrEP for HIV (10). This suggests that PrEP could be an important gateway to and opportunity for improved STI testing and treatment in some key populations, including in

I. BACKGROUND

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LMICs (9). Fourth, research in new technologies, including vaccines (23) and point-of-care diagnostic tests (POCT) (24) for STIs, such as the dual HIV–syphilis rapid POCT (recently recommended by WHO as the first test in antenatal care settings (ANC) (25) offers progress for new prevention and diagnostic technologies. Fifth, the increasing rates of well-known STIs as well the emergence of newer outbreak- associated and neglected but re-emerging STIs such as human T-cell lymphotropic virus (HTLV)-1, and Zika and Ebola viruses demonstrate the need for aggressive prevention interventions (26). Finally, global initiatives to incorporate disease-specific care into a framework of universal health coverage (UHC) (27) offer opportunities to align STI interventions, such as partner services, for both HIV and STIs (24), within broader priorities for comprehensive health care.

WHO has undergone a process of organizational change during 2020, during which time the STI components of programming, STI surveillance, normative guidance and mitigation of AMR in STI pathogens is now part of the WHO Department of HIV, Hepatitis and STI (HHS) in order to better operationalize opportunities for an integrated approach and link STIs with HIV and hepatitis. WHO HHS has now embarked on focused meetings with select STI partners to review and discuss the current epidemiology of STIs and a public health approach to STI service delivery at global and national levels.

HSS convened this informal consultation with partners to seek input on strengthening the global STI response. The meeting discussed the strengthening of political commitment, financing and delivery of STI services at the country level. It laid the groundwork for wider engagement of partners for global investment in STI control and forms the basis for a larger global STI stakeholder meeting projected for the end of 2020.

The meeting had the following objectives:

1. Strategize and identify a clear way forward to revitalize STI programming at the country level.

2. Identify opportunities to accelerate country-level implementation of the current and future Global Health Sector Strategy (GHSS) on Sexually Transmitted Infections.

3. Explore challenges and gaps that could form the basis for collaboration, including through global-level support and facilitation for achieving STI control in priority countries.

4. Present an update of the global epidemiology, the implementation of the current GHSS on STIs and plans for developing the next strategy for 2022–2030.

5. Share ideas and themes for a global STI stakeholders’

meeting scheduled for later in 2021, which could inform the 2022–2030 global STI strategy.

The agenda of the meeting and list of participants are in Annexes 1 and 2, respectively.

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A. Burden of Sexually Transmitted Infections

Based on the 2016 global estimates of 376 million new cases of curable STIs, WHO estimates that more than 1 million curable STIs comprising chlamydia, gonorrhoea, syphilis and trichomoniasis are acquired every day among those aged 15–

45 years (Fig. 1) (1). Addressing such an enormous burden of STIs will contribute significantly towards improving the health of billions of people to attain one of the goals of WHO’s Global Programme of Work 13 (GPW13) (28). Information from the six WHO regions for three of the curable STIs – gonorrhoea, chlamydia and trichomoniasis – show that there is a paucity of data to make accurate and more meaningful estimates as a limited number of countries report their data. Improving surveillance for STIs will be a priority to make data more reliable for countries to allocate commensurate resources for national impact.

STIs cause immense morbidity and mortality, particularly in the developing world. It is estimated that syphilis in pregnancy leads to over 230 000 fetal and neonatal deaths each year and, in 2016, placed an additional 400 000 infants at increased risk of early death (21). HPV infection is responsible for an estimated 530 000 cases of cervical cancer and 275 000 cervical cancer deaths each year (2).

N. gonorrhoeae and C. trachomatis infections are important causes of preventable infertility, especially in sub-Saharan

Africa. Additionally, STIs, such as syphilis, gonorrhoea, genital herpes simplex virus infection, greatly increase the risk of acquiring or transmitting HIV infection, by two- to threefold in some populations (4–8). Furthermore, the physical, psychological and social consequences of STIs have not been fully quantified, but severely compromise the quality of life of those infected and affected.

The emerging AMR in Neisseria gonorrhoeae and other organisms causing STIs is a major threat for the management and control of STIs. Many of the commonly used antibiotics have been rendered largely ineffective by AMR in N. gonorrhoeae. There is high-level resistance to fluoroquinolones, increasing resistance to azithromycin and emerging resistance to ceftriaxone and cefixime, the last class of recommended antibiotics for the treatment of gonorrhoea (14,15). High-level resistance is also reported in Mycoplasma genitalium, which complicates the treatment of urethral and cervical infections (29).

Future work will focus on strengthening gonococcal AMR surveillance, conserving the effectiveness of cephalosporins and potential new treatment options, increasing the pipeline of new antibiotics and facilitating the development of low-cost POCTs to identify gonorrhoea and chlamydial infections, AMR/

susceptibility testing and advocating for the development of gonococcal vaccines.

Fig. 1: Estimated 376 million new cases of curable STIs in 2016 (chlamydia, gonorrhoea, syphilis, trichomoniasis)

Source: Rowley et al. https://www.who.int/bulletin/volumes/97/8/18-228486.pdf?ua=1

II. THE CONTEXT

million

75

million

86

WHO Region of the Americas

million

34

million

23

million

51

108

million

WHO African Region WHO South-East Asia Region

WHO Western Pacific Region WHO Eastern Mediterranean Region WHO European Region

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Global estimates of herpesvirus infections were released in May 2020 and estimates of HPV prevalence among men and women are under way. Both the prevalence and incidence of these infections are based on modelling and projections.

There are approximately 500 million people living with genital herpes [3] and one in seven women are estimated to have prevalent HPV infection (30). If all the herpes and HPV infections are added to the estimated number of curable STIs, there is a huge and widespread burden of STIs.

The Spectrum-STI module was developed to generate country estimates of prevalence levels and time trends for active syphilis, gonorrhoea and chlamydia to support country-level estimation of these infections. Progress has been made in generating country-level syphilis estimates. The elimination of mother-to-child transmission (EMTCT) of syphilis and HIV have bolstered data availability around syphilis. Almost 1000 data points have been achieved between 2009 and 2016 for syphilis. The majority of countries provided maternal syphilis screening and treatment data from integration with maternal health. Currently, it takes four years to update global data for STIs. This needs to be thought through to see if STI data can be compiled as frequently as HIV data. Current reporting systems are inadequate and limited general population prevalence surveys are conducted to provide data for the Spectrum-STI model to generate national-level estimates.

Fig. 2. Estimated global congenital syphilis rates by WHO region

Source: Korenromp et al. PLoS One. 2019

Although the estimated total number of cases of congenital syphilis globally fell from 748 000 in 2012 to 661 000 in 2016, and cases of congenital syphilis per 100 000 live births fell from 539 to 473, global rates of congenital syphilis by region in 2012 and 2016 show that progress was rather limited in controlling transmission during these years. The rates of congenital syphilis were highest in the African Region and lowest in the European Region, reflecting variations in the respective regions’ maternal prevalence and service coverages (Fig. 2) (21). Of the 661 000 cases of congenital syphilis in 2016, over 350 000 occurred as adverse birth outcomes, including stillbirths and neonatal deaths (21).

WHO seeks to improve and increase the frequency of national and global estimates of the curable STIs, mainly chlamydia, gonorrhoea and trichomoniasis through promotion of prevalence surveys for these infections among general populations and improvement in case reporting through sentinel surveillance.

A more recent observation of concern is the increased incidence and prevalence of STIs among users of PrEP for prevention of HIV infection. The burden of STIs ranged from 10% to 20%

for infections such as gonorrhoea, chlamydia, trichomoniasis and that caused by Mycoplasma genitalium, with an equally increased incidence of infections. The pooled incidence from studies reporting the composite outcome of chlamydia,

Non-clinical CS 0 2012 200 1200

1000

400 600 800

Congenital Syphilis cases per 100,000 live births

Stillbirth due to CS Neonatal death due to CS Prematurity or LBW due to CS Liveborn with clinical CS 2016

AFR

2012 2016

AMR

2012 2016

EMR

2012 2016

EUR

2012 2016

SEAR

2012 2016

WPR

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gonorrhoea and early syphilis was 72.2 per 100 person-years (10). Of the 3325 citations identified, 88 articles were included (71 published, 17 unpublished). Data were from 26 countries – 70% were from high-income countries and 66% were from MSM-only programmes. In studies reporting a composite outcome of chlamydia, gonorrhoea and early syphilis, the pooled prevalence was 23.9% before starting PrEP. The prevalence of the STI pathogen by anatomical site showed that it was highest in the rectum (C. trachomatis: 8.5%, N. gonorrhoeae:

9.3%) compared to the genital tract (C. trachomatis: 4.0%, N.

gonorrhoeae: 2.1%) and oropharyngeal sites (C. trachomatis:

2.4%, N. gonorrhoeae: 4.9%) [10]. The incidence was higher

than the prevalence, which demonstrated that PrEP users have multiple instances of these infections per year (Table 1) (10).

Therefore, it is essential to provide STI care in PrEP interventions to reduce the acquisition and transmission of STIs (9).

In addition to key populations, several PrEP studies in young African women have also shown a high prevalence and incidence of STIs, with the majority of those asked about symptoms being asymptomatic (Table 2) (11–13). With undiagnosed and untreated STIs, these young women are at a higher risk of developing adverse reproductive health consequences, including pelvic inflammatory disease, ectopic pregnancy and infertility (11–13).

Table 1. High Sexually Transmitted Infection incidence and prevalence of Sexually Transmitted Infections among PrEP users (10)

Table 2. Sexually Transmitted Infection prevalence and incidence in young African women using PrEP (11–13)

Source: Ong JJ et.al. JAMA Netw Open. 2019

Prevalence Incidence

Pathogen Number of studies

pooled

Total sample size Prevalence (95% CI)

Number of studies pooled

Total sample size Incidence per 100PY (95% CI)

C. trachomatis (any site) 12 4918 10.8

(6.4-16.1)

14 6756 21.5

(17.9-25.8)

N. gonorrhoeae (any site) 14 6340 11.6

(7.6-16.2)

13 6462 37.1

(18.3-25.5)

T. pallidum* 22 9757 5.0

(3.1-7.4)

23 12459 11.6

(9.2-14.6)

Hepatitis B virus 4 4370 1.3

(0.1-3.5)

2 1353 1.2

(0.6-2.6)

Hepatitis C virus 4 2555 2.0

(0.8-3.7)

8 3786 0.3

(0.1-0.9)

M. genitalium 1 198 17.2

(12.2-23.2)

- - -

Trichomonas vaginalis 2 1379 5.9

(4.7-7.2)

1 50 0

Any C. trachomatis, N. gonorrhoeae or T. pallidum

16 8431 23.9

(18.6-29.6)

11 6301 72.2

(60.5-86.2)

CT prevalence (%) CT incidence (Per 100PY) GC prevalence (%) GC incidence (Per 100PY) VOICE

(South Africa, Uganda, Zimbabwe) N=5029 12 27 4 11

MTN-020/ASPIRE

(Malawi, South Africa, Uganda, Zimbabwe) N=2629 12 27 4 11

Plus Pills

(Cape Town) N=150 48 NA 6 NA

HPTN 082

(Cape Town, Johannesburg, Harare) N=427 29 33 8 14

POWER

(Cape Town, Johannesburg, Kisumu) N=1504 26 53 10 20

3P project

(Cape Town) N=200 25 42 11 14

Source: Ong et al. JAMA Netw Open. 2019

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B. The Sexually Transmitted Infection Strategy

The Department of HHS aims to achieve the targets of the GHSS for HIV, Hepatitis and STIs through GPW13, which includes promoting health around HIV and viral hepatitis, and control of STI to achieve the Sustainable Development Goals (SDGs). HHS is working towards country impact to achieve these targets.

The SDGs, GPW13 and the Triple Billion goals

The SDGs recognize health as a precondition for, and an outcome and indicator of, sustainable development and, thus, position global health as a political priority (31). GPW13 is clearly committed to supporting United Nations (UN) reform and the UN Secretary General’s proposal to work as

“One UN”(28). The UN reform is an opportunity to position health in the centre of the UN system’s work at country level for achieving the SDGs. At the “Leading Health through UN Reform” meeting held on the sidelines of the WHO Global Management meeting in Nairobi, Kenya, 10–12 December 2018, WHO committed to leading a transformative agenda that supports countries in reaching all health-related SDG

targets. Achieving the Triple Billion targets requires novel ways of working, not only within WHO but also alongside our partners for harnessing the capacities and potential of the whole UN system, leveraging civil society and the private sector, and mobilizing new technologies to address complex global health issues.

GPW13 2019−2023 sets out WHO’s 5-year strategic plan with the overarching goal of ensuring healthy lives and promoting well-being for all, at all ages, and a concrete and ambitious Triple Billion target (28). It is firmly based on the 2030 Agenda for Sustainable Development and aligned with the principles and purpose of UN reform, including the reinforcing of national ownership, development of responses specific to country contexts, and ensuring the effective delivery of results on the ground (Fig. 3).

GPW13 also sets out how WHO will achieve these goals by making some important strategic shifts, namely, stepping up leadership, driving impact in every country and focusing global public goods on impact. It places WHO’s country offices and their leaders at the forefront of ensuring that WHO and Member States together can achieve the Triple Billion targets by 2023.

Fig. 3. Overview of WHO’s Thirteenth General Programme of Work 2019−2023: strategic priorities and shifts (28)

Source: Thirteenth Global Programme of Work 2019–2023. Geneva: WHO; 2019 (https://apps.who.int/iris/bitstream/handle/10665/324775/WHO-PRP-18.1-eng.pdf, accessed 13 October 2020).

DRIVING PUBLIC HEALTH IMPACT IN EVERY COUNTRY

differentiated approach based on capacity and vulnerability

Mature health system Fragile health system

STRATEGIC PRIORITIES (AND GOALS)

STRATEGIC SHIFTS

Policy dialogue to develop systems of the future

Strategic support to build high

performing systems

Technical assistance

to build national institutions

Service delivery to fill critical

gaps in emergencies

FOCUSING GLOBAL PUBLIC GOODS ON IMPACT

normative guidance and agreements; data, research and innovation

ENSURING HEALTHY LIVES AND PROMOTING WELL-BEING FOR ALL AT ALL AGES BY:

PROMOTE HEALTH – KEEP THE WORLD SAFE – SERVE THE VULNERABLE

STEPPING UP LEADERSHIP diplomacy and advocacy;

gender equality, health equity and human rights;

multisectoral action; finance

ACHIEVING UNIVERSAL

HEALTH COVERAGE PROMOTING HEALTHIER

POPULATIONS 1 BILLION

more people enjoying better health and well-being

1 BILLION

more people better protected from health emergencies

1 BILLION

more people benefitting from universal health coverage

ADDRESSING HEALTH EMERGENCIES MISSION

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The Global Health Sector Strategies for HIV, Hepatitis and Sexually Transmitted Infections

Three interlinked GHSS were developed by WHO with the intention of addressing three major public health issues – HIV, viral hepatitis and STIs – for the period 2016 to 2021 (17).

All three strategies contribute to the attainment of the post- 2015 health goal, SDG 3, towards ensuring financial security, health equity and UHC. In 2016, the World Health Assembly approved the joint WHO GHSS on HIV, Hepatitis and STIs (WHA69.22) (17).

The GHSS on STIs aligns its goals, targets and objectives to the HIV and hepatitis strategies and to the 2030 Agenda for Sustainable Development. Its focus on ensuring financial security and health equity through a commitment to UHC links to the 2030 Agenda for Sustainable Development for the eradication of poverty and reduction of inequality. The STI Strategy aims to end STIs as a public health threat by 2030, within the context of ensuring healthy lives and promoting well-being for all, at all ages. The STI Strategy was developed around five pillars: (1) strategic information, (2) intervention for impact, including WHO’s global public health goods, (3) delivery for equity, (4) financing, and (5) innovation for acceleration (Fig. 4).

WHO’s current GHSS is till the end of 2021, but work is under way to develop a new strategy covering the period to the end of 2030. Thus, in the upcoming period, the department will undertake a broad consultative process for the development of the next strategy, as previously, but may need to be more streamlined during the period of the COVID-19 pandemic.

Commentaries and publications are being produced on how to address the political and programmatic contexts to be able to address barriers and explore opportunities.

An assessment was conducted in 2018 to evaluate the mid- term progress in implementing the GHSS 2016–2021 (16).

The assessment identified that the global response to STIs is in crisis after many years of suboptimal activities. STIs are not declining globally, except for slow declines in congenital syphilis. In several countries, STIs are increasing. The report warned that a complete reversal in trend would be required to achieve the targets by 2030. There were opportunities to link with HIV services and with broader efforts at sexual health services, which need to be capitalized on to achieve progress in controlling STIs.

Fig. 4. Global Health Sector Strategy on Sexually Transmitted Infections (STIs) 2016–2021 (17)

VISION, GOAL AND TARGETS

Frameworks for action: Universal health coverage; the continuum of services; and a public health approach

Strategy Implementation: Leadership, Partnership, Accountability, Monitoring & Evaluation Strategic

Direction 1:

Information for focused action

The who and the where

Strategic Direction 2:

Interventions for impact

The what

Delivering for equity

The how

Financing for sustainability The financing

Innovation for acceleration

The future

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C. WHO transformation

WHO has undergone a process of organizational change during 2020, referred to as Transformation (32). With this transformation, the STI programmatic agenda (surveillance, normative guidance, country support and programming) is now part of the WHO Department of HHS in order to better operationalize opportunities for integration with and linkages between STI, HIV, hepatitis and provision of country support, while increasing synergies with maternal, neonatal, child and adolescent health (MNCH).

HHS will leverage the WHO transformation as a process to increase coherence, reduce fragmentation and improve the overall efficiency of HIV–STI programmes and all joint work and collaborative efforts at country level. Reorganization of STI programmes at country level would also increase the chances of improved resource mobilization, better monitoring, better reporting and evaluation, and overall improved levels

of prioritization, leadership and governance. These collective efforts, well-coordinated and mutually supportive across the various WHO divisions at headquarters in Geneva and at all three levels of the Organization, should allow for greater effectiveness and efficiency of the HHS department’s work, delivered both individually and collectively. It is also expected to bring greater synergies at country level. By reshaping its organizational framework, it is expected that WHO will stimulate similar cross-pollination of efforts across multiple teams in the health departments and related ministries at country level (Fig. 5).

WHO is now looking to reduce morbidities due to STIs under the UHC framework, in alignment with strategic shifts globally, so as to drive impact at the country level. While WHO focuses on leadership and excellent research and completion of global public health goods (GPHGs), it will simultaneously look to translate all outputs to diverse settings at the country level.

Fig. 5. Strategic framework for WHO HHS under GPW13 (28) Mission & Goal

Strategic shifts

O p e r a t i o n a l shifts

S t r a t e g i c frameworks S t r a t e g i c priorities

• Eliminate HIV, Viral Hepatitis and control STIs

• Reduce HIV and hepatitis deaths

• Prevent new HIV and hepatitis infections

• Reduce new STIs and morbidity

• Deliver coordinated and quality support in countries

• Emphasize operational and programmatic guidance

• Promote strong and vibrant synergies within WHO

• WHO 13^th General Programme of Work

• Agenda for Sustainable Development

• Universal health coverage

• Deliver integrated response

• Achieve UHC

• Address health emergencies

• Transform and expand partnerships

• Drive innovation

• Foster cultural change

• Global health sector strategies on HIV and Viral Hepatitis

• Promote healthier populations GPW 13 mission:

• Promote health – Keep the world Safe – Serve the vulnerable

Global leadership regarding service delivery efficiencies

and greater integration in support

of UHC

Focus global goods to achieve HIV and viral hepatitis impact – policy and guidance for priority interventions and

services Drive impact at country-level

Policy dialogue – to develop

systems for the future

Strategic support – to build high

performing systems

Technical assistance

– to build national institutions

Service delivery – to

fill critical gaps

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Following the transition and incorporation of STI programming into HHS, WHO is working with partners to identify opportunities to accelerate the global STI response. Although WHO started to address STIs within MNCH and sexual and reproductive health (SRH) programmes, including family planning, maternal health and infertility, these need to be further strengthened and integration operationalized. Targeting persons at high risk for STIs, including key populations, is expected to increase the impact. There is now an enormous opportunity to bring STI services within HIV prevention and care, and an even greater opportunity to prevent STIs within the newly initiated PrEP to prevent HIV infection among people who do not have HIV but are at very high risk of getting HIV. Within the framework of the WHO Antimicrobial Stewardship, work is ongoing on AMR in pathogens that are sexually transmitted, especially monitoring and reporting on resistant N. gonorrhoeae, along with partners working on the creation of treatment options and new molecules for the treatment of gonorrhoea and syphilis. WHO is also facilitating the development of low-cost POC STI diagnostics and exploring STI vaccines. Within the STI strategic approach, previous work on emerging STIs, such as Zika and Ebola virus diseases, will be integrated. Significant headway has been made around global initiatives such as the EMTCT of HIV and syphilis, and WHO is now taking up EMTCT of hepatitis B and cervical cancer to the elimination goals as well. Lastly, WHO is also looking into innovations around multiplex HIV and syphilis testing.

As HHS is preparing to update the GHSS on STIs, it is an opportune time now to plan for the acceleration of prevention and control of STIs in the upcoming GHSS, 2022–2030.

This should consider new areas of focus, reprioritize interventions and increase the use of the voice and support of key stakeholders for increasing advocacy and efforts towards the prevention and control of STIs. WHO has been using innovative approaches to leveraging HIV and AMR systems for STI surveillance, and collecting data and information with limited resources. Existing standard protocols for STI surveillance, prevalence surveys and systems, such as the Global Antimicrobial Surveillance System (GLASS), the Joint United Nations Programme on HIV/AIDS (UNAIDS)’

Global AIDS Monitoring (GAM) and Spectrum-STI model for estimating national STI rates have resulted in increased implementation and availability of some data, but more countries need to develop national strategic plans (NSPs) for STIs. Many of the service delivery opportunities at country level are yet to see full utilization, and more efforts are needed in these areas.

There are more than 30 pathogens that are sexually transmitted, but priority STIs have been identified following certain criteria, including high incidence and prevalence, serious adverse outcomes and existence of available tools to address these pathogens. Consequently, WHO has prioritized the following microorganisms as they cause curable STIs – Neisseria gonorrhoeae, Chlamydia trachomatis, Treponema pallidum and Trichomonas vaginalis. There are plans to add Mycoplasma genitalium to the list. Among the viral STIs, the priority pathogens are HIV, genital HSV, HPV and viral hepatitis (Fig.

6). Collaboration with the Cervical Cancer Elimination Initiative will be essential. HTLV-1 has been newly added because it is a cause of increasing concern in certain populations.

Fig. 6. Priority sexually transmitted pathogens (selection criteria)

Curable STIs

Neisseria gonorrhoeae

(antimicrobial resistance) HIV

Chlamydia trachomatis

(adolescent burden & infertility) Genital herpes simplex virus (high prevalence) Treponema pallidum

(EMTCT – congenital syphilis) Human papillomavirus

(cervical cancer) Trichomonas vaginalis

(highest prevalence) Hepatitis B

Mycoplasma genitalium

(increasing rates; AMR) HTLV-1

(increasing concern)

Viral infections

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D. Progress in the implementation of

Sexually Transmitted Infection interventions

The GHSS on STIs 2016–2021 has a series of milestones and targets that should be met by 2020 and 2030. Compared to the baseline in 2016, a 90% reduction in syphilis incidence, a 90% reduction in gonorrhoea incidence, and less than 50 cases of congenital syphilis per 100 000 live births should be reached by 2030. It is recognized that more data are needed to ensure reliable estimates to inform progress in achieving the milestones and targets. Effective responses at the right coverage are expected over the next year to make sure that the targets will be met by 2030 (Table 3 ).

While surveillance for syphilis has progressed well, substantive work is needed around the other STIs for which there is no established or reliable reporting system.

Some recent data from national strategic plans were reviewed to assess whether countries are on track for implementing and achieving the targets of the GHSS on STIs. Overall, the assessment revealed that countries are a long way from achieving the targets and that intensive and focused country support is required. Across the six WHO regions, the following were assessed: the presence of NSPs for STIs, the presence of a national EMTCT strategy, availability of STI treatment guidelines, active surveillance under way for AMR of gonorrhoea, and HPV vaccination under national vaccination programmes. Only 112 out of 191 (58%) countries responded to the survey. In the future, more rigorous follow up with countries will be required. This assessment identified priority areas of the GHSS on STIs where more efforts are needed and ensure that this is reflected in NSPs, including in the HIV, SRH and MNCH strategic plans of countries.

Table 3. Global Health Sector Strategy (GHSS) on Sexually Transmitted Infections: interventions, indicators and targets (17)

2030 targets Baseline 2016 Status – 2019/2020

Impact Indicators 90% reduction in syphilis incidence 6.3 M 90% reduction in gonorrhoea incidence 86.9 M

≤ 50 cases/100,000 live births in 80 countries 473 (385-561) congenital syphilis cases / 100 000 live births

Service coverage by 2020

70% of countries with STI surveillance system 135 /185 countries reporting syphilis data 97/ 110 countries STI surveillance 70% of countries have 95% of pregnant women

screened and treated for HIV/syphilis

18 (9%) countries screened and treated at least 95% of pregnant women

103/ 111 (93%) with policies for ANC screen and treat

70% of key population have full access to HIV/STI services including condoms

No data No data

70% of countries provide STI services or link to PHC, HIV, FP, ANC

Major gaps exist

On track: Only global surveillance of antimicrobial resistance and momentum on tackling cervical cancer

PHC: 88%; HIV: 91%

RHS: 84%; FP: 77%

ANC: 89%

70% of countries report on AMR in gonorrhoea 60 (31%) countries monitor AMR in gonorrhoea , 2017

57/89 countries monitor AMR gonorrhoea 2019

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A majority of countries have prioritized the EMTCT of HIV and syphilis. This is followed by interventions such as STI screening among people with HIV, STI screening among high-risk groups such as MSM and sex workers, and condom distribution.

Other interventions such as HPV vaccination, STI syndromic

management, STI prevention, surveillance and monitoring, provision of STI services for adolescents, and monitoring for AMR are at a lower priority than expected and need to be paid more attention (Fig. 7).

Fig. 7: Prioritization of opportunities for accelerating the Sexually Transmitted Infection response

Address STIs in SRH – adolescents, FP and

maternal health – Scale up and coverage

Emerging outbreaks – Zika, Ebola – address prevention

Cross-cutting engagement: gender and human rights, stigma and discrimination, behavioural and social factors, wellness and wellbeing

Increasing STIs in PrEP – STI services for KP

Global initiatives – EMTCT of HIV, syphilis, cervical cancer, Universal Health

Coverage, – Leverage resources

Attention to AMR – Improved surveillance, new

treatment and diagnosis

Tools and innovations – HPV vaccine, dual HIV

syphilis – STI diagnostics

U S

R V

E I

L L

A N

C E

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E. Challenges in Sexually Transmitted Infection control programmes

The prevention and control of STIs is made difficult by many issues, among which are the following.

• Most STIs are asymptomatic.

• Surveillance for STIs is limited.

• There are limited tools for effective interventions such as affordable STI POCT resulting in syndromic management approaches in many countries and settings.

• Effective interventions are not implemented to scale to make an impact, mostly due to limited financial and human resources.

• AMR has emerged in some sexually transmitted pathogens over the years, thus limiting the range of affordable, effective antibiotics.

• There are limited activities to control and mitigate the emergence of AMR in Neisseria gonorrhoeae and other organisms that cause STIs.

• Numerous human behavioural factors that increase the risk of STIs, including multiple sex partners, inadequate use of condoms, are difficult to change.

• Stigma and discrimination against persons with STIs impact on the provision of STI services by governments, resulting in limited access to health care for many persons, including adolescents, sex workers, MSM and other key populations.

• Competing priorities with other equally important public health infections and diseases, and emerging infections such as COVID-19, mean that funding for STIs is not a priority most of the time.

To refine and refocus its leadership in the area of STI prevention and control, WHO needs partner inputs as it moves the agenda to 2030. There are GPHGs, including guidelines for the prevention and control of STIs, surveillance of STIs and diagnostic approaches to the detection of STIs, and some more are being updated and consolidated. These will require to be readily available to countries for implementation.

However, despite the existence of such tools, minimal achievements have been made in the provision of technical support to countries to ensure implementation. Building on the GPW13 strategic shift and WHO core function, there needs to be advocacy for policy options that countries can adapt through the GHSS on STIs. WHO already has some tools to assess implementation of the GHSS on STIs. Furthermore, WHO needs to emphasize the issues of gender, equity and human rights in all its programmes, and facilitate access for all who need STI services, including young women, young men, sex workers and MSM. Value for money to guide investments in prevention and control of STIs needs to be integrated into the UHC framework, with more understanding and commitment by countries to pay for services. Additionally, more advocacy is needed for countries to support funding for STI services within international funding mechanisms, such as the Global Fund to Fights AIDS, Tuberculosis and Malaria (Global Fund) and work towards a sustainable approach to controlling STIs.

These multiple strategic shifts and functions should come together to achieve a better impact at country level.

WHO will work across the three levels of the Organization – headquarters, regional offices and WHO country offices – to achieve impact at the country level. If cross-cutting areas of work at WHO headquarters are examined, it will be evident that STIs are enmeshed in several of the programmes, such as AMR, primary health care, MNCH, SRH, essential medicines (MHT) and vaccines (IVB). It is imperative that HHS programmes and the core STI team strengthen interdepartmental collaboration to integrate the STI workplan across all these cross-cutting areas.

The immediate undertaking in this regard will be to develop a global action plan to accelerate the STI response within the following priority areas of work.

• Strengthen surveillance to generate data for advocacy and programming.

• Advocate for support to STI prevention and control.

• Identify opportunities for, and increase engagement with, community partners for a sustained STI response.

• Mobilize resources to support implementation of the GHSS on STIs.

• Strengthen support to countries.

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1. Sexually Transmitted Infection strategy:

governance and leadership

There is a need to develop a compelling message and strategy to advocate for STI support. There are multiple issues to be addressed. STI case management should be strengthened by moving from syndromic to etiological management of STIs.

This will require affordable and accessible diagnostic tests.

Additional leadership from WHO is needed to integrate STI management at many levels of care – at ANC, at PrEP centres, fertility centres, etc. There needs to be a change in the framing of STIs to elevate this area of work within the country and global agenda. It may not be ideal to equate STIs with HIV as HIV programmes have existed for many decades and have been fairly successful. However, lessons learned from the HIV response can inform efforts to accelerate the STI response.

Strengthening leadership and governance within WHO is the first step in elevating STI work in the developmental agenda.

Policy-makers at the country level look to WHO’s level of prioritization of public health problems to guide their priorities and actions. Donor partners look to WHO for identifying public health priorities to direct their funding allocations. If STIs are not prioritized by WHO, it would be difficult for managers at the country level to provide leadership for STI control. In many HIV programmes in the African Region, STIs are an essential component of HIV programmes. This is an opportune time to improve governance of STI programmes by better planning, programming, monitoring and reporting.

From a wide spectrum of STIs caused by multiple pathogens, for efficiency, it is important to focus on high-burden STIs.

WHO and countries should prioritize curable STIs and ensure that treatment and diagnostics are available and accessible.

Targeted STI interventions are crucial for greater impact. Key populations with the greatest risk should be reached for STI interventions. Work on the next GHSS has been initiated. WHO/

HHS is exploring approaches for inclusion of STI activities into the Global Fund concept notes of countries, using experience from hepatitis programmes, which have no vertical funding.

There is a need to work with countries to integrate STIs as an essential package in primary care and UHC frameworks.

Building an investment case for STIs remains a challenge because mortality rates attributable to STIs are minimal.

Traditionally, global health aid effectiveness has been centred around the concept of preventing mortality. Specifically, crafted impact indicators such as “years of life saved” have been highlighted when donors evaluate disease programmes for aid effectiveness. Current cost–effectiveness models and investment cases are centred on mortality reduction as a central assumption. In the case of STIs, mortality is

negligible, but morbidity and its scale at which it occurs are comparatively large. There is also the risk of complications and sequelae. There is a need to develop new cost–effectiveness models, where the assumptions are focused on morbidity and prevention of complications and disabling sequelae instead of mortality reduction.

2. Sexually Transmitted Infection surveillance

2.1 Currently, STI surveillance faces the following challenges:

i. difficulty in conducting robust surveillance when laboratory testing is not available to understand the etiology of these infections;

ii. some of the infections are asymptomatic; therefore, a significant burden of the disease is missed without the tools to conduct diagnostic testing;

iii. there is limited linking of laboratory data to epidemiological data; and

iv. the representativeness of data can be challenged as reach and access to screening and diagnosis is poor.

It is yet to be figured out how some of the estimates can be validated with real data to see what the actual burden of STIs is by undertaking sentinel approaches in appropriate sentinel areas.

2.2 Surveillance is the backbone of public health. There is a need to strengthen ongoing STI surveillance. The need for surveillance has been highlighted during the work done in countries to create disease burden estimates. Surveillance improves when surveillance data are utilized. Countries should use surveillance data for planning and programming, but this is not being done. Instead of periodic STI estimations, a move should be made towards the generation of regular annual estimates to inform programming.

2.3 There are ways to get national data on a sentinel-site basis without setting up a completely new surveillance programme (which may not be feasible in some countries). The etiology of STIs has changed from bacterial to predominantly viral over the past few decades, especially in the past 10–15 years.

Genital herpes is the commonest cause of genital ulcers and not syphilis and chancroid as earlier, based on studies in Africa, Europe and the United States of America (34–36) Had such studies not been conducted, it would not have been possible to capture this epidemiological shift in causes of genital ulcers. Therefore, it is imperative that sentinel site studies be conducted on a regular basis to document the prevailing causative pathogens of STIs, including the detection of emerging and re-emerging infections.

III. DISCUSSION

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2.4 The complications of STIs are another component that adds to the disease burden. Routine STI surveillance should incorporate monitoring of STI complications within STI management reporting. STI surveillance in key populations remains fundamental, as the STI prevalence in these populations remains a major driver of the STI epidemic. For this, the collaboration of nongovernmental organizations (NGOs) is essential. Routine surveillance based on systematic surveillance and screening of key populations would be more relevant in key populations than occasional surveillance that rarely results in any intervention.

2.5 Capacity-building is required for surveillance and monitoring and evaluation at regional and national levels. It is suggested to take data frameworks, data capture and data collection to subregional levels to build new STI estimates for countries. This will enable a better understanding of disease epidemiology and will encourage countries to become more proactive as they will be empowered to own their national data and take responsibility for these. Capacity at the Regional Office is limited. Better data monitoring systems and capacity- building for staff are needed at the regional level.

2.6 The syndromic approach is widely used in STI country programmes. STI surveillance was originally intended to be an integral part of the syndromic approach but, over the course of many years, most country programmes have become restricted to the use of only the syndromic approach and have lost the element of concomitant surveillance on the etiology of syndromes, due to the lack of financial resources. Currently, the only ongoing surveillance taking place with the syndromic approach is the reporting on case notification. However, the data generated under notification have shortcomings due to under- or over-notification and non-compliance with case definitions. It is not possible to know which microbe is the cause of a given syndrome if prescribed therapeutic protocols are not adhered to and ongoing surveillance of drug resistance is not conducted.

Gonococcal antimicrobial sentinel surveillance may have failed in some countries due to non-compliance of health professionals.

2.7 Going forward, there could be two potential solutions for ongoing surveillance of AMR.

i. Maintain the syndromic approach and simultaneously conduct periodic etiological studies of syndromes.

Conduct ongoing monitoring for gonococcal AMR.

For this, countries need funds and resources.

ii. The development of another management approach via the use of POCT will make AMR programmes more cost effective, as only those who test positive for gonorrhoea will be further followed up and tested for AMR.

2.8 For syphilis, given that there is routine maternal screening and trend estimation at country level, the Spectrum-STI model may now be used more frequently. Systems and processes for country STI estimates are established using maternal syphilis trend estimates (from the Spectrum-STI model) and, with the WHO congenital syphilis estimation tool to estimate the incidence of congenital syphilis as a basis for EMTCT validation.

These need to be strengthened and scaled up, linked with STI workshops that are often conducted by UNAIDS for regional HIV estimation. Other curable STIs lack routine prevalence data to make more frequent estimation productive.

2.9 A new syphilis impact modelling tool was developed by WHO (Region of the Americas, Western Pacific Region, headquarters) in 2019, in collaboration with Avenir Health, to assist countries in prioritizing syphilis interventions, such as screening key populations, treating symptomatic infection, and partner management to support the elimination of syphilis beyond EMTCT. Country STI NSPs, investment cases and the GHSS could benefit from this model. Early results highlight the importance of sex partner tracing, and of understanding and reaching key populations with screening. Combining clinical treatment, sex partner tracing with targeted screening and behavioural risk reduction in key populations is required to eliminate syphilis. This model is being piloted in Papua New Guinea and Peru. At the regional level, the syphilis impact modelling tool may be used to explore scenarios of what is required to accelerate declines in the incidence and prevalence of syphilis and achieve a 90% reduction by 2030.

3. Sexually Transmitted Infection testing:

innovation and access

3.1 One of the bottlenecks in STI programmes is the lack of access to diagnostic tests for STIs. Partners such as the Foundation for Innovative New Diagnostics (FIND) are trying to work on feedback from countries on what is needed to get countries to take up easy-to-use, cheap POCT for gonorrhoea and chlamydia when the tests become available. The finding from countries is that they struggle to implement STI activities if such activities are not already in the existing funding plans or in upcoming Global Fund concept notes. Inclusion of new diagnostic tests for STIs in future STI or HIV plans to scale up these health products will be a good way forward.

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3.2 Due to limited access to and high cost of existing diagnostic tests for STIs, especially for gonococcal and chlamydial infections, and in the absence of rapid STI diagnostic tests to carry out etiological diagnoses for STIs, innovative STI testing approaches should explored before universal STI screening can be implemented. STI testing could be implemented initially in sentinel clinics to provide data for surveillance and in services providing STI care for key populations. Through such approaches, background information on asymptomatic infection would be captured. Moreover, countries with limited resources and those still implementing syndromic case management should conduct periodic surveys of the etiology of prevailing STI syndromes at least every two years.

These surveys will inform country-specific syndromic case management algorithms as well as give some insight into the burden of STIs.

3.3 In order to have a more efficient approach to implementing STI testing, the use of the same diagnostic platform and the same samples should be an important consideration. The sample type used for testing can be a decisive factor in increasing access to STI testing. Although focusing on developing POCT is important, test samples that can be collected non-invasively, such as urine and saliva, are important to ensure increased uptake of testing, particularly among asymptomatic clients.

3.4 In the context of COVID-19, it is expected that after a few months, there will be a vaccine against COVID-19 and there might be a once-in-a-lifetime opportunity where health systems will test and vaccinate a large portion of the human population. If a relatively simple STI test is ready and available at that point, it would be a great opportunity to test for STIs.

Other diseases that can be eliminated can be included in such an effort.

3.5 In the background of COVID-19, there has been a lot of expansion of testing technologies in the US. In several other high-income countries, self-collection of specimens and sending specimens by courier for STI testing are being implemented. Several PrEP and sexual health clinics for key populations are implementing these approaches. Lessons learnt from these interventions can be adapted in resource- constrained settings.

3.6 Collaboration and discussions with the private sector to drive down the prices of diagnostic tests and other new products is one of the issues for WHO to put into operation as it seeks to increase access to diagnostic tests for STIs in countries.

4. Sexually Transmitted Infection treatment:

innovation and access

4.1 Developing new antibiotics is an extremely long and costly process. It takes over ten years to get a drug on the market and there are significant risks, such as attrition of drugs from the time they are discovered to the time the drug is registered.

It is not a matter of looking in isolation at the new STI drug being developed, but about how that newly developed drug can be integrated into a much broader public health framework.

As it is, big pharmaceutical companies have withdrawn from research into new antibiotics. A few small companies develop antibiotics and even fewer focus on antibiotics for STIs such as gonorrhoea. Therefore, partnerships are needed to make sure that any antibiotics that come out of this dry pipeline are taken up and made accessible in order to impact on STI control.

4.2 The spectre of the threat of shortage of benzathine benzylpenicillin calls for the need for collaboration and judicious planning. In 2015, at the launch of the GHSS 2016–2021, there was a call by Member States to address the shortage of penicillin, but the problem has continued.

Planning for a global mechanism to minimize shortage and ensure quality is required.

Work is under way with the Access to Medicines and Health Products (MHP) and AMR divisions of WHO to ensure the availability of quality benzathine benzylpenicillin through prequalifying companies manufacturing the active product ingredients. Reintegrating a focus on this in the new STI and HIV strategy is needed.

4.3 Surveillance brings a lot of understanding about the disease burden and development of resistance. This knowledge is important while developing new antibiotics.

4.4 Conservation of antibiotics is important, but the primary agenda should be to look at how technologies such as newly developed drugs can be preferably combined with diagnostic approaches. Contradictions or conflicts around this needs to be resolved. The challenge for product development partners is on funding – how is this really going to function on resources and prioritization. On the technology side, more effort could put into increasing collaboration in the development of diagnostics, therapeutics and vaccines, given that all these elements can benefit from basic science as well as modelling studies to shape the implementation and marketing of these products that relate to STIs and other conditions.

4.5 Another important milestone in terms of HIV prevention is the potential use of the injectable PrEP that can be given every eight weeks. The time when patients come for medication may also be an opportune time to screen for STIs.

ACCELERATING THE GLOBAL SEXUALLY TRANSMITTED INFECTIONS RESPONSE

T