Implementation_framework_version1_2July2018_(1).docx

Table of contents

Abbreviations and acronyms

Foreword

Acknowledgements

Executive summary

Introduction

Country context

Objectives

Implementation focus areas

Leadership and governance

Site planning

Service delivery

Commodity security

Demand creation

Monitoring, evaluation, supervision and tools

Research and impact evaluation

Annexes

Abbreviations and acronyms:

PrEP Pre-exposure prophylaxis

STI Sexually Transmitted Infection

TDF Tenofovir

TWG Technical Working Group

WHO World Health Organization

Foreword

Acknowledgements

This framework is the product of collaboration between many experts, community organizations & networks, implementers, and partners from international organizations working within the country. The information presented is aligned with WHO’s 2017 consolidated guidelines on Pre-exposure prophylaxis.

We wish to thank the Disease Control Directorate that led a multi-partners’ technical working group that compiled this framework.

We thank the following institutions for technical and financial support during the development of this framework:

· Ministry of Health (Disease Control Directorate, Laboratory division, Pharmacy and Supply chain coordinating unit, Family Health Division)

· National AIDS Commission

· PEPFAR (USAID, CDC)

· UN agencies (WHO, UNAIDS)

· JHPIEGO

· Elizabeth Glazer Pediatric AIDS Foundation (EGPAF)

· Clinton Health Access Initiative (CHAI)

· Baylor College of Medicine

· Population Services International (PSI)

· EQUIP

· Lesotho National AIDS Support Organization (LENASO)

· Mothers to mothers

· Care for Basotho

· Chemonics

· The Lesotho Matrix organization

· Masters of Healing Foundation

Introduction

Pre-exposure Prophylaxis (PrEP) is a form of HIV prevention in which an HIV negative person at high risk of HIV infection takes daily antiretroviral medication to prevent HIV infection. Oral PrEP was first approved by the USA FDA in 2012 after which other countries followed.

Following the World Health Organization (WHO) recommendation[footnoteRef:1] in September 2015 that “oral pre-exposure prophylaxis (PrEP) be offered as an additional prevention choice for people at substantial risk of HIV infection as part of combination HIV prevention package,” Lesotho adopted PrEP as part of the national prevention strategy in 2016.[footnoteRef:2] [1: Guideline on when to start antiretroviral therapy and on pre-exposure prophylaxis for HIV. Geneva: World Health Organization; 2015 (http://www.who.int/hiv/pub/guidelines/earlyrelease-arv/en/).] [2: National Guidelines on the use of Antiretroviral therapy for HIV Prevention and Treatment, MOH Lesotho, 2016]

Across populations and PrEP regimens, PrEP significantly reduced the risk of HIV acquisition compared with placebo with higher PrEP effectiveness when PrEP use was more than 70%.[footnoteRef:3] PrEP does not, however, completely remove the risk of HIV infection and does not prevent sexual transmitted infections (STIs) or pregnancies. It should, therefore, be offered as part of a combination HIV prevention package that includes risk reduction counselling, social and behavioural change, correct and consistent condom use, voluntary medical male circumcision (VMMC), post-exposure prophylaxis (PEP), treatment as prevention, and the diagnosis and treatment of STIs and contraception. [3: Virginia A. Fonner, Sarah A. Dalglish, et al (2016). “Effectiveness and safety of oral HIV pre-exposure prophylaxis for all populations.”]

Lesotho offers PrEP as part of HIV combination prevention for people at substantial risk of HIV infection. The 2016 National guidelines on the use of antiretroviral therapy for HIV prevention and treatment provided the first guidance on PrEP use for HIV prevention. These revised guidelines emphasized the ‘Test and Treat’ approach and embraced the UNAIDS 90-90-90 global fast track targets for epidemic control. PrEP for HIV prevention was recommended to certain population groups regarded as being at high risk and therefore most likely to benefit from PrEP services. For rapid PrEP service scale up to occur, a structured and innovative implementation framework with the associated tools, communication strategies, and monitoring indicators is needed.

This framework for implementation of pre-exposure prophylaxis (PrEP) for HIV in Lesotho was developed to provide guidance for the roll out of PrEP services in Lesotho. Service roll out should ensure the provision of a holistic HIV prevention package that includes PrEP as an additional service within HIV combination prevention among the population and individuals at substantial risk of HIV infection. PrEP should not replace or compete with other effective and well-established HIV prevention interventions, but complement these in the fight to curb new infections. The target audience of the PrEP implementation framework includes policy makers, health program managers, regulatory authorities, health providers, potential PrEP users and the general population.

Country context:

Lesotho has a generalized HIV epidemic with the second highest adult HIV prevalence in the world. The Lesotho Population-Based HIV Impact Assessment (LePHIA, 2017), a nationwide cross-sectional household survey, estimated HIV Prevalence among adults aged 15 to 59 years at 25.6% (30.4% females and 20.8% males); with the prevalence rising to as high as 49.9% among women aged 35-39. Approximately, 330,000 people live with HIV, and incidence is still high (1.47 which equates to more than 13000 new adult infections annually).[footnoteRef:4] The population-level viral load suppression (VLS) rates are estimated at 67.6%. Estimated at 2.1%4, pediatric (0 – 14 years) HIV prevalence is among the highest in the world. Heterogeneity is seen in the HIV prevalence by geographical regions with LePHIA results showing an adult HIV prevalence that ranges from 17.8% in Butha Buthe to a high 29.3% in Mohales’ hoek as shown in Figure 1. [4: Lesotho Population HIV Impact assessment, 2016/17]

Figure 1: Adult HIV prevalence by district in Lesotho (source LePHIA 2017)

Disparity exists in the HIV prevalence by gender with the most pronounced difference found among young adults aged 20-24. HIV prevalence among 20- to 24-year-olds is four times as high among females (16.7%) than males (4.0%) as shown in the figure 2 below. 4 Figure 2:

Surveys of key and vulnerable populations estimated prevalence at 79.1% among female sex workers, 43.3% among factory workers, 32.9% for MSM and 31% among inmates.[footnoteRef:5] [5: UNAIDS 2017, On the Fast Track to End AIDS.]

New infections continue to occur despite major strides in the national response, such as, the rapid expansion of access to antiretroviral therapy (ART). Certain population groups, for example, younger women and key populations have been reported to be at a much higher risk of HIV infection compared to the general populations with most new infections occurring among these groups. At present, over 25% of new HIV infections occur in adolescent girls and young women. In this male-dominated society, young women struggle to negotiate condom use with their (often older) male partners, and thus become susceptible to HIV immediately upon sexual debut.

With continuing high numbers of new infections and change in treatment guidelines to starting ART upon HIV diagnosis, there is a likelihood of massive pressure on available resources. This calls for new and innovative strategies to reduce new HIV infections. Evidence exists for PrEP as effective prevention strategy in diverse groups such as heterosexual men and women, people who inject drugs and men who have sex with men. Its roll out to groups of people that stand to benefit from its use needs to be fast-tracked.

The PrEP implementation journey in Lesotho:

The use of ART as a prophylactic intervention for HIV infection is already standard clinical practice in the HIV response in Lesotho as in many other countries. Anti-retroviral (ARV) prophylaxis was first used to prevent HIV transmission from mother to child during pregnancy and the perinatal period. It is still in use in a 28-day course of PEP, when either an occupational or a non-occupational risk exposure to HIV has been determined.

In 2015 WHO released its recommendations for oral PrEP among populations with incidence of 3% per year or higher. Following the World Health Organization WHO recommendation, Lesotho adopted PrEP as part of the national prevention strategy in 2016. A brief description of the intervention was included in the National guidelines on the use of antiretroviral therapy for HIV prevention and treatment that were developed in 2016. This included the priority population groups for PrEP and the regimen to be used for PrEP services. Among the priority populations for PrEP were;

· People who exchange sex for money

· People who paid for sex

· Men who have sex with men

· Transgender people

· People who inject drugs

· Incarcerated individuals

· Multiple concurrent sexual partners

· HIV-negative partner in a sero-discordant relationship if HIV-positive partner:

· Has a VL is above 1000 copies/mL

· Has an unknown VL

· Has been on ART for less than 12 months

· Is not on ART at all

Following the release of these ART guidelines, service provision of oral PrEP was however, limited, with a focus primarily on sero-discordant couples identified through facility-based services. In 2017, the Lesotho Ministry of Health committed to scaling-up the intervention among other populations groups at substantial risk across the country and to introduce PrEP services at the community level. This scale-up phase for PrEP in Lesotho began with planning and formulation of a national technical working group (TWG) that has enabled Lesotho to prepare for service scale up. The TWG was formed in September 2017 and was made up of 4 subcommittees namely:

· Implementation plan task team

· Clinical, Laboratory, counseling, Pharmacy and supply chain

· Communication and Social mobilization

· Monitoring and Evaluation Baseline facility assessments:

Prior to the first TWG meeting in September, 2017, rapid facility and community assessments had been carried out to assess readiness for PrEP implementation. The rapid facility baseline assessment was conducted between September 5th and September 15th, 2017. One hundred and twenty-one health facilities in five HIV-high burden districts of Lesotho were assessed. The results showed that PrEP was being provided for HIV-negative partners of PLHIV, pregnant women, adolescents, sex workers and MSM at 109 (90%) facilities. Facilities offering PrEP included government facilities, Christian Health Association of Lesotho (CHAL) facilities, other private facilities, and one correctional services clinic.

Health professionals prescribing PrEP included Medical Officers, Nurses, Nurse Clinicians, and Nursing Assistants. These health professionals were offering the service using guidance from the National guidelines on the use of Antiretroviral Therapy for HIV prevention and treatment (100%), clinical job aids (84%), senior clinicians (45%), ‘Test and Treat’ training materials (40%).

PrEP services were being offered within ART clinics (96%), Maternal and Child health (MCH) clinics (56%), general outpatients departments (53%), Tuberculosis (TB) clinics (39%), outreach points (28%), adolescent health corners (22%), sexually transmitted infections clinics (7%), and men’s corners (6%).

Between June 2016 and August 2017, a total of 1051 clients were ever initiated on PrEP. Some of these stopped PrEP for various reasons such as: partner virally suppressed, separated from partner, migration to South Africa, and loss to follow-up. Two clients stopped due to seroconversion. At the end of August 2017, there were 853 clients continuing on PrEP. Onsite laboratory testing for serum creatinine and hepatitis B surface antigen was available at 11 facilities. The remaining facilities had a system in place for off-site laboratory testing. Once sent to the off-site laboratory, samples were being tracked by using telephone, physically going to the lab, mobile messaging or through an electronic system. There were no major anticipated laboratory testing and results delivery challenges with introduction of PrEP.

A supply chain management system was in place to monitor supply of medicines and supplies. All public health facilities had at least one member of staff trained in supply chain management.

Data reporting systems were in place being operated by Records Assistants, Nurses, Nursing Assistants and Receptionists. Monthly and quarterly reports were being submitted to the District Health Management Teams (DHMTs).

Interviewed facility staff highlighted their needs to enable smooth roll-out of PrEP. These included: availing PrEP registers, training staff on PrEP, provision of information, education and communication (IEC) material, availing job aids/SOPs and guidelines, and addressing health worker attitudes.

Working with the results of the baseline, the formulated subcommittees of the PrEP TWG started work on the national implementation framework. This document is a compilation of the work that was accomplished through a number of meetings in the four subcommittees of the TWG.

Defining “substantial HIV risk” Substantial risk of HIV infection is defined as an incidence of HIV infection typically considered to be higher than 3 per 100 person-years in the absence of PrEP. Epidemiologic research conducted through national surveys, clinical trials and cohort studies has shown that HIV incidence varies considerably between and within different population groups[footnoteRef:6]. It is particularly important that more costly HIV prevention interventions, such as PrEP, are focused on groups at high risk of HIV infection in order to reduce the costs of lifelong treatment for people who might otherwise acquire HIV. Delivering PrEP to those individuals at substantial risk would further increase the cost-effectiveness of PrEP. [footnoteRef:7] [6: On the Fast-track to end AIDS by 2030: Focus on location and population. UNAIDS 2015] [7: Rachel Baggaley, Shona Dalal, et al (2016). “Beyond the 90-90-90: refocusing HIV prevention as part of the global HIV response.”]

For maximum impact, focusing PrEP services in geographical areas with high HIV incidence (and prevalence) and within key and vulnerable subpopulations as well as among people at substantial individual risk (regardless of geography or population group), is necessary. With a clearly documented profile of Lesotho’s HIV epidemic by incidence, age group and other risk factors, groups that need to be targeted for PrEP services were delineated. Based on the epidemiologic background in Lesotho, which has a generalized HIV epidemic, people considered to be at substantial risk of HIV infection and therefore, requiring to be prioritized for PrEP services include:

• Adolescent girls and young women (15 -24 years):

HIV incidence is disproportionately higher among young women compared to their male counterparts with the incidence among 15 -19 year old females 3 to 4 times higher than males in the same age group4. There are also high rates of gender‐based violence with 38% of 18‐24 years old having experienced sexual violence during their lifetime. In addition, many women transition through well-defined periods of increased risk of HIV infection when condom use is not possible (e.g. when women want to conceive) or reject condoms for whatever reason (e.g. in adolescence). Other HIV prevention interventions such as voluntary medical male circumcision (VMMC) do not directly protect women from HIV acquisition.

• Men who have sex with men Globally, MSM have a higher burden of HIV infection due to the higher probability of HIV transmission during anal intercourse compared to vaginal intercourse[footnoteRef:8]. In Lesotho their HIV prevalence is estimated at 32.9 %. Studies have revealed inconsistent condom usage among this group. [8: Beyrer C, Stefan D, et al, Global epidemiology of HIV infection in men who have sex with men, Lancet. 2012; 380(9839): 367–377.]

• Commercial sex workers, people who engage in transactional sex, and their clients:

Female sex workers are a population at heightened risk of HIV infection due to biological, behavioural, and structural risk factors. In Lesotho, prevalence of HIV among FSW is estimated at 79.1 %. Condoms use with clients is one of the key ways of preventing HIV transmission within sex work. However, evidence has shown inconsistent use of condoms among sex workers with some of their clients/partners

• HIV-negative partner in a sero-discordant relationship:

In Lesotho, about 15% of couples are discordant (LDHS, 2014), which reveals the gravity of infections between the uninfected and infected partner. PrEP can protect the uninfected partner in a sero-discordant relationship with an HIV-infected partner who may have not yet enrolled on antiretroviral therapy (ART) or is on ART but still has a high viral load.

• Pregnant women and lactating mothers:

In HIV-negative women, pregnancy is a period of elevated risk of HIV infection. Infection acquired during pregnancy may be more likely to be transmitted to the fetus than a pre-existing infection because of high viral load soon after sero‐conversion.

Other population groups in Lesotho at substantial risk of acquiring HIV include:

• People with concurrent or a high number of sexual partners

• People who have another sexually transmitted infection (STI), and

• People who are incarcerated, factory workers, migrants and partner of migrants

• People who perceive themselves to be at risk Guiding principles of PrEP provision:

It is important to adopt a public health, human rights and people-centered approach when offering PrEP to those at “substantial risk of HIV”. Similar to other HIV prevention and treatment interventions, a human rights-based approach gives priority to issues concerning universal health coverage, gender equality and health-related rights including accessibility, availability, acceptability and quality of PrEP services.

The introduction of PrEP as an additional HIV prevention approach in Lesotho will, therefore, be governed by the following fundamental principles in line with public health and human rights-based approach to delivering universal health services.

Accessibility PrEP implementation must ensure that PrEP is accessible to those who need it. This includes people who currently have limited access to HIV prevention services, are at increased risk of HIV infection, and/or are vulnerable in accessing and using other HIV prevention methods.

Affordability Given that a majority of the target populations are classified as vulnerable, affordability of services is crucial. It will therefore be important that PrEP services including the provision of PrEP drugs are provided free of charge. In Lesotho PrEP services are provided free of charge in the public sector.

Involvement and participation Experience and research have shown that when services are brought closer to the target populations and are owned by the people through their full participation, then they are more acceptable. The service delivery modalities for PrEP should therefore ensure the involvement and participation of the beneficiaries.

Acceptability Provision of PrEP must be sensitive to the culture and way of life of the target populations and communities. This includes minimization of any approaches that subject people to stigma and discrimination. Efforts should therefore be made to ensure acceptability of services by the beneficiaries.

Safety of PrEP service delivery Taking PrEP services to the people in need requires the maintenance of strict quality assurance and compliance to the clinical monitoring guidance. Consequently measures will be put in place to support staff to understand and appropriately deliver PrEP services. Health care workers will be properly trained on assessing eligibility criteria for PrEP and screen for contra-indications and provide on-going support and monitoring for people taking PrEP. The quality of services being provided should be monitored routinely.

Integration of services PrEP service shall build on existing systems and networks, integrating PrEP activities within existing service delivery mechanisms. PrEP services should be delivered alongside other established services such as SRH and HIV services.

Informed Consent People accessing PrEP must give informed consent. Therefore, PrEP services should be offered to clients following provision of adequate and relevant information and counselling.

Confidentiality Provision of PrEP must be confidential and this includes confidentiality of health records by providers. However, facilitated disclosure to a partner, family members and/or peer should be promoted.

Linkages to other services Clients enrolled in PrEP services should be linked to other services they may require and appropriate systems developed to track and monitor.

Implementation focus areas:

Module 1: Leadership and governance:

This section will address issues regarding leadership and governance of the PrEP program to ensure ownership and coordination of the program at all levels.

Implementing PrEP poses challenges in planning, managing and funding because PrEP services should be regarded as a component of the combination HIV prevention package. However, its implementation offers new opportunities for accelerating the national HIV response. This calls for the involvement of leaders at all levels to join forces to systematically address important issues such as raising awareness of the benefits of PrEP, setting priorities for locations and populations for implementation, making services user-friendly and ensuring adherence.

Additionally, it is important for leaders to be aware that the implementation of PrEP involves more than just ensuring the supply of medicines. PrEP programmes also involve regular testing for HIV, screening for other STIs, adherence support, and linking clients to ART if they test HIV-positive while receiving PrEP services. This spectrum of services therefore need to be provided as part of the package for PrEP services.

Overall coordination of the PrEP response shall be a responsibility of the Ministry of Health led by the Disease Control Directorate. They will be responsible for policy formulation, adaptation of guidelines and will provide technical assistance to the districts in setting targets, operational planning, implementation, supervision, as well as monitoring and evaluation. This will be done with the support of the PrEP TWG and in consultation with the district health management teams (DHMTs). Through the supply chain coordinating unit at the central level, the Ministry of Health will also be responsible for ensuring commodity security through forecasting and quantification of required commodities for PrEP services.

The DHMTs will provide leadership in implementation planning, dissemination of guidelines and policies, capacity building, community engagements, coordination of stakeholders. They will also be responsible for monitoring and evaluation and ensuring quality of HIV services in the districts.

The country’s development partners such as PEPFAR, GFATM and the UN bodies will support service delivery, policy and guideline implementation and resource mobilization for PrEP services to be implemented.

Community leadership remains key and there is need for extensive community engagement in the implementation of PrEP services. This includes the religious and community leaders, the private sector, media, people living with HIV and the potential PrEP users. This will allow for increased demand of services, identification and addressing of gaps in service delivery and ownership/adoption of PrEP in the community.

Module 2: Site planning:

This section guides managers and administrators involved in organizing PrEP services at implementing sites. It outlines the steps to be taken in planning to deliver PrEP services and gives suggestions for personnel, infrastructure and commodities (such as PrEP medicines and laboratory tests) that should be considered when implementing PrEP. The module further stipulates the minimum requirements for accreditation of a PrEP service delivery site that will guide routine service quality assessments.

Service points As much as possible, PrEP service shall build on existing systems and networks, integrating PrEP activities within existing service delivery mechanisms. This is in line with the WHO global strategy on people-centered and integrated health services, which has been adopted by Lesotho. In Lesotho, PrEP will be provided at both facility and community levels, each of which will have specific resource requirements according to the populations being offered PrEP and the service delivery model/approach used. Service sites will include; hospitals, health centers, health posts, and in the community at health facility outreach clinics, resource centers, and community service points.

Within the facility, PrEP services will be available at points where services for the following are being offered; Anti-retroviral therapy(ART), HIV testing services (HTS), Tuberculosis treatment, Maternal and child Health (MCH), Sexual and reproductive health (SRH), Adolescent and youth services, Male health services and Voluntary medical male circumcision (VMMC). The integration will make services more convenient for people who attend health facilities for other reasons and increase the uptake of HIV-specific services.

For community PrEP, services will be provided in non-medical settings to the fullest extent possible, leveraging on existing ‘safe spaces’ which include resource centers and mobile services targeted at strategic community locations. PrEP services will be offered through three distinct, but complementary service delivery approaches: mobile outreach PrEP services, fixed community-based resource centers, and flash mobilization events complimented by service provision. Services will be delivered at preferred settings and times. Set ‘fixed sites’ will be established with PrEP services available every day, and separate ‘mobile sites’ will be arranged based on demand for PrEP services. These sites will be visited every 2 weeks to provide services to clients continuing PrEP as well as to initiate new clients. For refills, clients will be able to either visit the nearest fixed site, or return to the mobile site location on a pre-arranged date to receive their refill.

Laboratory services:

All clinics and community sites that provide PrEP should be able to perform onsite HIV testing using rapid diagnostic tests. Sites providing PrEP services within hospitals shall be able to perform additional laboratory tests needed for offering PrEP, while sites operating at health centers, health posts and other community delivery points will collect samples to be tested at hospital laboratories.

Human resources Lesotho is faced with a continuing scarcity of skilled health workers. As a result, for successful implementation of PrEP, there is need to consider human resources for health approaches like task sharing/shifting and community based delivery approaches that will increase accessibility to PrEP. Task shifting involves the rational distribution of tasks among health workforce such that specific tasks are reassigned as appropriate from highly qualified to lesser qualified health workers to improve efficiencies and effectiveness in the use of the available workforce.

The package of service for PrEP clients will be provided by health professionals who have completed training on the national guidance for the use of ARVs for PrEP. These may include the following categories of health workers:

Experienced clinical provider (physicians, clinical officer[footnoteRef:9] or nurse clinicians) [9: Clinical officers are health professionals in parts of eastern and southern Africa. They are independent practitioners (unlike medical and nursing assistants), who are trained in the medical model to practise the full range of medical duties and provide routine care in many clinical settings. Clinical officers have been the backbone of HIV care and treatment programmes in Africa to date, enabling the rollout of ART across the continent.]

Provide general oversight of clinical services and be available to offer support for complex cases, including remotely (for example, via mobile phone text message, email, instant messaging, voice and video messaging, etc.).

Peer educators and community health workers

Support education programmes that provide basic information on PrEP and other HIV prevention options, and how to recognize HIV risk. Support demand creation for PrEP and strategies for adherence. They may provide services at the clinic site or through outreach services in the community

Provision of PrEP requires a prescription from doctors and nurses in all settings. Regardless of professional background, training for staff in providing PrEP is needed. The lay cadres (e.g. expert clients, HTS counsellors, peer outreach workers, community health workers) specifically in primary care clinics and mobile and fixed-site community settings will be trained to create demand and support adherence counselling. Training of these cadres on PrEP service delivery will be through existing mentoring and supervision activities.

Minimum requirements for a PrEP service delivery site

Module 3: Service delivery:

This section addresses issues regarding service provision approaches and operations around PrEP implementation including counseling, identification of PrEP clients, initiation and client follow-up mechanisms, capacity building and data management for program monitoring. Additionally, it details the critical procedures aimed at ensuring that PrEP is provided safely and effectively, including: screening for substantial risk of HIV; excluding acute HIV infection, performing appropriate testing before initiating someone on PrEP and while the person is taking PrEP; and how to follow up PrEP users and offer counselling on issues such as adherence.

Provision of PrEP services:

Pre-exposure prophylaxis (PrEP) is the use of antiretroviral medication by HIV-negative people to prevent them from acquiring HIV. The provision of PrEP is relatively complex when compared with other biomedical HIV prevention tools such as condoms. PrEP is expensive, requires high adherence among users and long-term client monitoring through laboratory tests and repeated HIV testing. On very rare occasions, PrEP may cause serious adverse events.

In many settings, the most feasible way to consider implementing PrEP is to integrate PrEP within existing services, for example within services for key populations – such as men who have sex with men, sex workers, people who inject drugs and transgender people – or those that provide HIV testing, STI screening, condoms and other family planning services. Some PrEP service delivery points may not have onsite laboratory services. In this case, the health care workers should collect biological samples, such as blood samples for creatinine testing, and send them to external laboratories for testing and ensure that follow-up schedules are maintained for all persons initiating PrEP. In the community service delivery points, point of care testing may be used (e.g for creatinine testing) and where available, this will improve turn-around times and efficiency of services.

PrEP will be delivered using community-based and facility-based delivery models. While both models can serve as identification points for potential PrEP candidates, service delivery points initiating clients on PrEP must meet minimum set criteria listed in the module on site planning above. At entry points where only identification is possible, providers will be equipped to link identified clients to PrEP service delivery points. As much as possible, service delivery models need to be aligned to the specific client typologies, while providing a comprehensive minimum package of services for these beneficiaries. The figure 3 below summarizes the link between the various aspects of the PrEP program and the service points:

Figure 3: PrEP service delivery models:

Community:

· Resource centers (youth resource centers, KP resource centers)

· Drop in centers

· Flash mobilization events

Clinical protocols and standard operating procedures Clinical protocols, job aides, and standard operating procedures have been developed to guide health care workers in the provision of PrEP services. As part of quality improvement, these documents will be periodically reviewed and revised to address issues as they arise.

The MOH, with support from the clinical subcommittee of the TWG, has led the development of protocols for training and supervising new staff at all levels. Staff will receive training on PrEP service provision. In addition, clinics will ensure that the necessary guidelines and SOPs for PrEP are in place, including protocols for the ordering of required medicines and laboratory and clinical supplies.

The following 2-sided pocket card summarizes the basics on PrEP that are elaborated further in this module.

Figure 4: Example of a pocket card for PrEP users: (source WHO implementation guide) Lesotho Clinical PrEP Basics Indications for PrEP

· HIV-negative.

· Documented HIV negative result on day of initiation on PrEP. AND (by history over the past 6 months):

· Sexual partner with HIV who is not virally supressed including

· Sexual partner who has been on ART for more than 6 months but is not virally suppressed.

· Sexual partner with HIV is not ART`

· Sexual partner who has been on ART for less than 6 months OR Sexually active in AND any of the following:

· Vaginal or anal sexual intercourse without condoms with more than one partner, OR

· A sexual partner with one or more HIV risk factors (these may include; having unprotected anal or vaginal sex; having a sexually transmitted infection such as syphilis, herpes, chlamydia, gonorrhea, and bacterial vaginosis; sharing contaminated needles, syringes and other injecting equipment and drug solutions when injecting drugs list some risk factors), OR

· A history of a sexually transmitted infection (STI) by lab testing or self-report or syndromic STI treatment, OR

· Requesting PrEP – refer to 2017 PrEP job aides/guidelines for further guidance Contraindications:

· HIV-positive

· Estimated creatinine clearance <60 ml/min

· Signs/symptoms of acute HIV infection, probable recent exposure to HIV

· Allergy or contraindication to any medicine in the PrEP regimen.

· Adolescents and adults weighing less than 35 kg.

Recommended regimen: TDF 300 mg + 3TC 300mg PO daily .

Counselling: Link tablet use with a daily routine.

Develop a plan for contraception or safer conception and for STI prevention.

Key effectiveness messages:

PrEP is highly effective for preventing HIV infection when used as prescribed.

PrEP does not prevent pregnancy or STIs Side-effects:

Nausea, abdominal cramps, headache; these are usually mild and resolve over the first month of taking PrEP.

Creatinine elevation (typically reversible if stop PrEP).

Loss of bone mineral density; recovers after stopping PrEP.

Initial tests: HIV test, Creatinine Clearance, HBsAg (Hepatitis B surface Antigen), STIs symptom screening and VDRL/RPR, consider HCV for MSM where available.

One month after PrEP initiation: HIV test Every 3 months: HIV test, check STIs. Every 6 months: Cr, check STIs, assess PrEP indications and use.

Special situations:

· Exposure to HIV in the past 72 hours: Use PEP for 28 days, then start PrEP if indicated.

· Acute viral syndrome

· Do not start PrEP

· Do DNA PCR if results will be available in less than 1 month

· Retest after 1 month with rapid test, if DNA PCR is not available

· Pregnancy and breastfeeding: PrEP can be offered and continued.

· If HBsAg negative Offer Hepatis B vaccination if available.

· If HBsAg positive: assess HBV treatment indications; consider risk of flare if PrEP stopped.

· Adolescents: may benefit from more frequent appointments e.g. monthly visits.

More information: http://www.who.int/hiv/topics/prep/en/

Training for PrEP providers PrEP is a prescription only drug and hence has restrictions. PrEP will be prescribed and dispensed by trained health care providers, including doctors, nurse clinicians, nurses and pharmacists. Peer educators, community health workers, youth groups among others will promote PrEP use at community level.

The development of a PrEP curriculum and training programme was completed prior to the scale up phase. Training of health workers will be conducted to ensure all staff are informed and kept up-to-date on PrEP. An initial training of trainers’ (ToT) course for all DHMTs will be conducted to help sensitize district health leaders to HIV prevention by presenting the rationale for offering PrEP and the supporting evidence as well as the needs of specific populations. The ToT shall be followed by step-down trainings in all districts that shall target all health workers and other staff at facilities including the community health workers. The providers shall be trained on; the evidence regarding the benefits of PrEP, the role of PrEP in the country’s epidemic control efforts, relevant tests before initiating PrEP, monitoring tests conducted among PrEP users, counselling tools and approaches and the monitoring and evaluation of PrEP services. The training will also equip the service providers with skills to forecast and quantify their facilities’ stocks of PrEP medicines and monitoring tests. Additional specialized training, for example, in the form of knowledge seminars, CMEs or on-job-training using case scenarios aimed at staff involved in the provision of PrEP services, will be provided where updates to the developed training curriculum become available. The training programme would also include mentoring, support, supervision and refresher training.

PrEP is not a standalone intervention and hence PrEP will subsequently be incorporated in other HIV training programs including HIV testing, care and treatment, key populations, VMMC and PMTCT following the first phase of trainings (national ToT and district step-down trainings to cover all facilities in the country).

Clinical management of PrEP:

To provide PrEP safely and effectively, certain steps must be followed including: client counseling, screening for substantial risk of HIV; performing appropriate testing before initiating someone on PrEP and while the person is taking PrEP; and how to follow up PrEP users and offer counselling on issues such as adherence. PrEP will be offered to sexually active HIV-negative individuals who are at high risk of acquiring HIV infection and after thorough assessment to establish eligibility, readiness for effective use and commitment to adhere and contraindications ruled out.

Counselling Counselling, which is a critical element of combination HIV prevention, is an integral part of PrEP service provision. PrEP is both a biomedical and bio-behavioural and social intervention. Counselling can include important information on PrEP use, behavioural disinhibition, coping with side-effects and adherence, sexual health, relationship issues, drug and alcohol matters, and screening and support for gender-based violence. Patients should also be counseled at initiation that full protection is not obtained until 20 days after initiating PrEP. Since adherence is a critical predictor of the effectiveness of PrEP, counselling is an important opportunity to offer key messages around adherence and psycho-social support to PrEP users.

Those who counsel PrEP users may be lay, peer or professional counsellors and healthcare workers, including nurses, clinical officers and doctors. Importantly these cadres or any others used for this service must have undergone training to provide counselling. Ongoing training, supervision, mentorship and refresher training will be provided to health professionals offering counselling services to PrEP clients. Adherence counselling is key in provision of PrEP and will be emphasized.

Identification of PrEP clients:

For PrEP services to reach populations in an effective and acceptable way, community educators and advocates are needed to increase awareness about PrEP in their communities. Health education sessions will be done at the facilities and at community level to inform potential clients about PrEP with the intention of creating awareness of the availability of PrEP services and increasing uptake of PrEP as part of combination prevention package.

HIV testing service points (at community and facility level) will serve as the main points through which potential PrEP benefactors are identified. With HIV testing as the gateway to PrEP initiation, novel approaches such as the use of HIV self-testing will be promoted as a strategy to provide an additional strategy for identification of eligibility for PrEP. Individuals testing HIV-positive should be offered assisted partner notification services for all their sexual partners, and if they are in a serodiscordant relationship PrEP could be considered for the HIV-seronegative partner until the HIV-positive partner achieves viral suppression. Sites such as antenatal or ART clinics that identify or have had serodiscordant couples referred can consider offering PrEP to the HIV-negative partner if the HIV-positive partner is not yet virally suppressed.

Given the high HIV incidence among adolescent girls and young women, PrEP services should be offered in facilities that provide family planning or other reproductive health services such as STI clinics or clinics providing services for women in tertiary education. PrEP could be offered as part of antenatal and postnatal services to women at substantial risk.

As awareness about the benefits of PrEP grows, people who consider themselves to be at substantial risk of HIV acquisition may self-select and seek to obtain PrEP from their regular healthcare provider. Ultimately, PrEP should be available as an additional choice to those who want and need it as part of a comprehensive combination HIV prevention package.

In many situations, people who proactively ask for PrEP will already consider themselves to be at risk, and may have determined that PrEP is an appropriate prevention option. As such, they may be motivated to take PrEP and benefit from it. In general, providers should consider offering PrEP to people who request it because, although these persons may recognize their own risk, they may not be able or willing to discuss this risk – either due to stigma or a reticence to talk to providers about sexual and drug-using behaviour.

Considerations for where PrEP implementing sites should be established Consideration should also be given to where PrEP services could be established, including assessing the existing capacity and infrastructure of health facilities and community-based setting and factors that enable or inhibit access to and provision of services. It will usually not be appropriate to develop a standalone service for providing PrEP; rather, PrEP should be integrated into existing services. Examples of services that could integrate PrEP include; TB clinics, adolescent health corners, MCH clinics, VMMC clinics, factory/ workplace clinics. Irrespective of location, sites that offer PrEP should cater and be easily accessible to populations that may benefit from PrEP. For example, in areas where there is a high HIV incidence or prevalence among young women, PrEP services could be integrated into settings that are conveniently located for adolescent girls and young women to access, demonstrate cultural sensitivity towards women and offer additional services sought by women, such as contraception and reproductive health services, and health services associated with tertiary education establishments.

For community PrEP, set ‘fixed sites’ will be established with PrEP services available every day, and separate ‘mobile sites’ will be arranged based on demand for PrEP services. These sites will be visited every 2 weeks to provide services to clients continuing PrEP as well as to initiate new clients. For refills, clients will be able to either visit the nearest fixed site, or return to the mobile site location on a pre-arranged date to receive their refill.

Special considerations for offering PrEP to adolescent girls and young women Adolescent girls and young women have significantly higher HIV incidence than adolescent boys and young men. Young men who have sex with men and young transgender women may have substantial HIV risk in many settings. Therefore, it will usually be more appropriate to consider these groups for PrEP services. It is important for providers to sensitively and non-judgmentally engage in a discussion with young people about their sexual partners, possibly including transactional sex, and recognize and minimize risks of intimate partner violence while assessing HIV prevention options. The age of consent for HIV testing and receiving prescription medicines is a likely barrier to providing services. The provision of health services to adolescents in a safe environment without the involvement of law enforcement is important to enable adolescent girls, young men who have sex with men and transgender people and young people who inject drugs to access HIV testing and ART if diagnosed HIV-positive or prevention services, including PrEP, if HIV-negative. Concerns about potential HIV exposure may be more emotionally challenging for adolescents, particularly where partnership dynamics are unequal. The potential loss of social and economic support, or the loss of a partner, may be especially difficult for adolescents, particularly if the partner is older and/or has more power in the relationship. Adolescents whose behaviours are criminalized or stigmatized – such as those who engage in transactional sex, men who have sex with men, who inject drugs and transgender people – may be even more vulnerable to exploitation and may have difficulty in accessing services. Providers should consider appropriate ways of engaging with adolescents to encourage them to access health facilities as well as support services should they be required.

Ensuring adherence to PrEP among adolescents may also be more challenging than among adults due to developmental, legal, economic or social factors that may affect their ability to access services. It should also be noted that adolescence is a period of experimentation and rebelliousness. This may also affect adherence to services such as PrEP. Creating an enabling environment such as having flexible hours, peer support groups and appointing PrEP champions, with sensitization training for staff on how to provide youth-friendly and inclusive services at facilities and community settings offering PrEP, is a first step. Ensuring that the requirements for providing PrEP (such as repeat laboratory testing and regular follow-ups) are possible and understood by adolescents will also be important. Creative solutions may be required to enable adolescents to access services and successfully initiate PrEP. These may include mobile phone text message-based adherence support, varied clinic hours, or other youth-friendly technology-based services and outreach services. More frequent follow-up of adolescents taking PrEP may also be necessary.

Experience also shows that offering stand-alone HIV services restricts who seeks services and compounds stigma and discrimination, especially among key populations. To minimize any missed opportunities and provide a ‘one-stop shop’ community model, oral PrEP will be offered as part of a minimum package of services as supported by WHO, which includes HTS, STI screening and treatment, provision of condoms and lubricants, referral for care and treatment, etc. In addition, given the target AGYW population who have the highest pregnancy rate and are least likely to seek health services, he minimum package will be expanded to include Family Planning, risk reduction counseling, and provision of condoms. TB screening will be offered for everyone.

Assessing individual risk for HIV infection Ultimately, people who could be offered PrEP are those who are considered to be at substantial individual risk of HIV acquisition regardless of geographical residence or population group. The provision of PrEP to all persons at substantial risk will maximize its impact at a population level. However, not all members of an identified population will be at substantial risk, and others at substantial risk will be in non-priority populations and geographies.

Health care workers need to be able to identify individuals at substantial HIV risk who may benefit from taking PrEP. The simplest means of doing this is through conversations between clinicians and clients as part of a consultation.