Decision Framework

ART Delivery

The Decision Framework is aimed at supporting the implementation of differentiated models of ART delivery. It provides a background to the principles and a menu of examples. A 5-step plan to guide ART programme managers is outlined and the key “elements” to consider are described along with the “building blocks” of service delivery. The Decision Framework gives guidance on how to prioritize differentiated care to address some of the common challenges of people living with HIV in a given setting. Further iterations of the Decision Framework will be developed to support other parts of the treatment cascade, specific sub-populations and other contexts. 

Children, adolescents and pregnant and breastfeeding women

A Decision Framework for differentiated antiretroviral therapy delivery for children, adolescents and pregnant and breastfeeding women draws purposeful attention to these specific populations. It is the second of the Decision Framework series. The 2017 Key considerations for differentiated antiretroviral therapy delivery for specific populations: children, adolescents, pregnant and breastfeeding women and key populations or Key Considerations (see WHO section below for more detail), advocates for providing access to differentiated ART delivery for specific populations. A Decision Framework for ART Delivery for children, adolescents and pregnant and breastfeeding women focuses on how to implement these recommendations. The framework is aimed at supporting HIV programme managers at the national and district level to adapt or build differentiated models of ART delivery. The document guides the reader through how to assess the data and identify priorities to address specific and local challenges.

Global Guidance

WHO

Guidance on operations and service delivery was introduced in Chapter 9 of the World Health Organization’s (WHO’s) 2013 consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. This chapter recommended decentralization of ART services to primary care settings, together with supportive task-shifting approaches, including non-physician initiation and maintenance of ART, and community health workers’ dispensing of ART refills between clinical visits.

After a consultative meeting on community ART delivery in December 2013, this chapter was supplemented in March 2014 by the addition of recommendations to strengthen facility-based models with out-of-clinic or community models of care that engaged community providers in ART delivery, adherence and psychosocial tasks. Examples of client- and health care worker-managed group and facility-based and out -of-facility individual models of ART delivery were provided.

In July 2016, WHO updated its consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations. It addresses overarching elements for effective HIV service delivery to these populations, including ART delivery in both facility- and community-based models.

WHO’s updated 2016 consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection include recommendations to improve the quality and efficiency of services to people living with HIV. It specifically recommends a differentiated care approach to address the diverse needs of people living with HIV, alternative strategies for community delivery of ART to accommodate the growing number of people on ART, and principles for improving the quality of care and providing client-centred care. Specific recommendations for clients stable on ART include reducing the frequency of ART refill and clinic visits to 3-6 monthly and confirming previous recommendations for trained and supervised lay providers to distribute ART.

At the time the 2016 WHO consolidated ARV guidelines were developed, there was limited evidence and experience around how these criteria should be applied to pregnant and breastfeeding women, children and adolescents and members of key populations. Since then, appreciation has been growing that these types of clients may also benefit from models of care specifically for clinically stable clients. The 2017 Key considerations for differentiated antiretroviral therapy delivery for specific populations: children, adolescents, pregnant and breastfeeding women and key populations outlines the rationale for and features of differentiated ART delivery for clinically stable clients in these populations. The document complements A Decision Framework for differentiated antiretroviral therapy delivery for children, adolescents and pregnant and breastfeeding women.  

The differentiated ART delivery recommendations were also expanded in the 2017 guidelines for managing advanced HIV disease and rapid initiation of antiretroviral therapy. This guideline adds recommendations for appropriate packages of care for clients presenting or returning to care with either advanced HIV disease or when clinically well. For those with advanced HIV, it recognizes the need for more intensified care initially and recommends a package of focused screening, prophylaxis for major opportunistic infections, rapid initiation and adapted adherence support including home visits if feasible. For those clinically well, it recognizes the need to simplify both clinical and adherence preparation processes and speed up ART initiation. The guideline recommends reducing preparation visits to enable rapid initiation within 7 days and also supports same day initiation where the client is willing and ready to start.  

GFATM

The Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) released a toolkit in November 2015 to provide operational guidance to managers of health facilities on implementing differentiated care approaches. The toolkit covers three interrelated differentiated approach modules: screening and testing; treatment and care; and drug delivery. Each module contains brief operational guidance aimed at helping site managers identify differentiated care opportunities, sets out what options are available by exploring best practice models, and then provides guidance on how to proceed with implementation. Following the modules, the toolkit offers a selection of tools and further resources for developing differentiated approaches.

GFATM also released their HIV Information Note in December 2016 to provide guidance to applicants developing Global Fund funding requests for the 2017-2019 funding cycle. A core component of the 2017-2022 Global Fund Strategy is to mainstream programme quality. Differentiated care is described as a key strategy to achieve this and reach the UNAIDS fast track prevention and treatment targets. In addition to differentiated ART delivery, countries are encouraged to identify alternative service delivery modalities for other HIV-related programs. This includes differentiated service delivery interventions across the cascade from prevention and testing through to treatment. Differentiated service delivery strategies for key populations are also highlighted.

UNAIDS

UNAIDS partnered with Medécins Sans Frontières (MSF) in 2015 to release the first in a series of case studies highlighting the need to adapt ART delivery systems to meaningfully include community-based services. This report details MSF’s experiences with implementing community-based ART delivery models, specifically analytically summarizing the models previously described by MSF in its “Closer to Home” report. The report also describes the critical enablers for such models to function without introducing health system shortcomings into community care.

In July 2017, UNAIDS released the report "Ending AIDS: Progress Towards the 90-90-90 targets" which includes differentiated care. The report describes how the concept of differentiated care has emerged from pioneering efforts that engage communities and bring quality services to their homes and villages. It also recognizes that an increasing number of countries are using the differentiated care model to establish community-based systems for providing services across the cascade and making the 90–90–90 targets a reality. 

PEPFAR

In October 2015, the United States President’s Emergency Plan for AIDS Relief (PEPFAR) issued its recommendations regarding provision of ART for all persons living with HIV (“Test and START”). These specifically refer to the need to realize greater efficiencies, share lessons learnt from community-based models, and review alternate ART delivery locations. These recommendations were incorporated into the “PEPFAR Technical Considerations for COP/ROP 2016”, which placed emphasis on reconfiguring service delivery approaches. Table 1 specifically recommended implementation of differentiated models of ART delivery for stable patients with reduced visit frequency, annual viral load testing, and adoption of facility fast-track systems and community-based distribution models.

COP/ROP 2017 identifies differentiated models of ART delivery as a priority strategy requiring PEPFAR support for country policy development and implementation.  Attention is drawn to the need to include family (children, adolescents and pregnant and breastfeeding women) and key populations (pg 157-158).  Focus is also placed on the importance of human resources for health planning, specifically the use of community-based or lay cadres to facilitate such differentiated ART delivery models and decrease facility visits to once a year for stable clients (pg 170).

USAID's Supply Chain for Health team has put together an antiretroviral (ARV) planning tool to help countries consider their ARV procurement and supply chain planning for implementing i. “treat all” and ii. longer ART refills, also known as multi-month scripting (MMS). By inputting the i. the total number of newly identified HIV positive patients starting ART and ii. the number of stable patients (eligible for MMS) the tool determines the number of ART treatments needed to implement “treat all” and MMS over a three-year period.

MSF

Medécins Sans Frontières (MSF) released its first report in 2012 on community-based models of ART delivery that it had been piloting for stable patients in sub-Saharan African countries in partnership with country health authorities. The “Closer to Home” report sets out the rationale for such models and describes the first four piloted models with their outcomes: 

  1. Decentralizing from primary health clinics to health posts and increasing appointment spacing (facility-based individual model) in Malawi
  2. Community ART groups (client-managed group model) in Mozambique
  3. ART adherence clubs (health care worker-managed group model) in South Africa
  4. PODI community ART distribution (out-of-facility individual model) in the Democratic Republic of the Congo.

MSF updated this report in December 2013. “Reaching Closer to Home” reports on MSF’s progress with designing, implementing and evaluating alternative models for ART delivery. This report explains the importance of different strategies for different contexts. The report explains adaptations made to the previously described models when implementing in other contexts, such as Zimbabwe and Lesotho. Lastly, the report focuses attention on the minimum requirements and enabling factors for implementation.

National Policies

Kenya

In May 2016, the Kenyan Ministry of Health, through the National AIDS & STI Control Programme (NASCOP), released: its updated “Guidelines on use of antiretroviral drugs for treating and preventing HIV infection in Kenya”; and its practical handbook for HIV managers and service providers on differentiated care, entitled “Improving the quality and efficiency of health services in Kenya”. 

The guidelines specifically recognize and outline a differentiated care approach for the ART initiation period and ART delivery thereafter. It stipulates the building blocks of a model of care from ART initiation throughout the first year on ART for well clients versus clients with advanced HIV disease (pg 24-27). It similarly outlines the building blocks of a model of care for stable versus unstable patients after their first year on ART (pg 28-32). Each differentiation category is clearly defined with the package of care, location of services, service provider, frequency of services and a summary of clinical and laboratory monitoring outlined for each group. It further provides flexibility in choice of ART delivery model for stable patients, allowing for facility and community distribution variations, and includes examples. It sets out the criteria that must be met before implementing community-based distribution, which includes already having a facility-based fast-track system in place (pg 32).

The practical handbook recognizes the need for differentiated care, and takes the approach of describing a collection of differentiated care models throughout the HIV cascade, mostly from Kenya and also drawing from best practice examples in other sub-Saharan African contexts. It focuses on differentiated model implementation using a quality improvement framework approach. It provides examples of differentiation approaches for ART delivery for stable patients including: decentralized drug delivery at peripheral clinics and fast-track drug refills (facility-based individual models); facility-based distribution groups (health care worker-managed group model); decentralized drug delivery by health staff in communities (out-of-facility individual model); and community-based drug delivery where drugs are delivered by patient groups (client-managed group model). It also provides examples of longer drug refills (up to four months) resulting in increased appointment spacing.  

To accompany the guidelines and practical handbook, the Kenyan Ministry of Health, through NASCOP, released a Differentiated Care Operational Guide in January 2017. The guide is a healthcare worker handbook designed to equip service delivery providers with strategies for implementing differentiated care as described in the Guidelines on Use of Antiretroviral Drugs for Treating and Preventing HIV Infection in Kenya (2016 Edition). It provides step by step guidance and details country and facility level planning approaches, implementation strategies and how to monitor and evaluate differentiated care. Focus is placed on categorizing patients based on clinical characteristics and the guide includes tools and job aids for implementing differentiated care.

Malawi

Malawi’s MoH revised its 2014 clinical HIV management guidelines in May 2016 (3rd edition). These guidelines retain stable patient service differentiation, which was introduced in the previous guideline. ART refill periods are aligned with clinical reviews, which take place 3 monthly for adults and children on 1st-line regimens (with the option of considering 6-12 month ART refills in special circumstances, such as long distance travel) and 2 monthly for stable clients on 2nd-line regimens. ART refill collection by persons other than the client is limited to registered guardians or treatment supporters. Viral load monitoring is done at 6 months on ART, 2 years on ART and every 2 years thereafter. Only health care workers and pharmacy personnel are allowed to dispense ART, and that ART cannot be distributed outside of certified ART health facilities. IPT and CPT refill periods are aligned with ART refill periods.

Mozambique

In 2013, the Mozambican Ministry of Health released its “HIV and AIDS Response Acceleration Plan 2013-2015”, which was later extended to 2017. The document presents a detailed and coordinated operational strategy that brings together available resources to achieve the following objectives by 2017: increase the percentage of eligible adults and children receiving antiretroviral treatment (ART) to 80%, reduce the number of newly acquired HIV infections by 50%, and reduce the rate of mother-to-child transmission to less than 5%. It presents specific interventions that aim to increase access to evidence-based prevention strategies, care and treatment services, as well as improve retention and quality of services.

To guide key stakeholders in the nationwide implementation of Community Adherence and Support Groups (CASG), the Mozambican Ministry of Health also released a “Community Adherence and Support Groups Strategy” in 2015. CASGs are a client-managed group model where clients, who are both stable and unstable on ART, form groups of up to six. On a rotating basis, one CASG group member collects ART medication at the health facility for all group members and distributes the medication to the other members in the community. Clients also visit their health facility biannually to receive clinical services. The document describes in detail the model, eligibility criteria, patient flow and monitoring and evaluation procedures. CASGs are an example of client-managed groups. For more details on client-managed groups, click here.

South Africa

The South African National Department of Health launched the National Strategic Plan (NSP) for HIV, TB and STIs 2017-2022 on March 31st 2017. The full version of the NSP promotes enabling increased access to health services through differentiated care approaches that are tailored for the populations served. The NSP states that all people living with one or more of the three diseases covered by the NSP will have access to differentiated service delivery, including facilities that are friendly and suitable for children, adolescents, young people, men, people with disabilities and survivors of sexual assault. Differentiated ART delivery for stable patients is also highlighted, including a minimum of 3 months drug supply and optimised prescription periods to meet the needs of key and vulnerable populations and improve adherence. A document summarizing the goals and objectives of the new NSP with the theme ‘Let Our Actions Count’ was also released. This summary highlights differentiated care as a ‘game-changer’.

The National Department of Health released its Adherence Guidelines for HIV, TB and NCDs in February 2016, which recognize the need for the health system to systematically address the problem of non-adherence and its impact on client outcomes and health system costs. The first section of the guidelines describes the evidence base for adherence strategies; the second sets out a minimum package of interventions to support linkage, adherence and retention in care that should be implemented in all facilities in South Africa. The minimum package includes interventions throughout the continuum of HIV care with Step 6 focusing on stable clients during the treatment consolidation and maintenance phase.

The guidelines require phased implementation at each ART facility of one or more alternative repeat prescription collection strategies, with a choice between spaced and fast lane appointment system (facility-based individual model), adherence clubs (health care worker-managed group model) and the central chronic medicine dispensing and distribution (CCMDD) system (out-of-facility individual model). Annexure 3-5 to the guidelines, together with the standard operating procedures, set out the eligibility criteria, guiding principles, roles and responsibilities of health staff and clients, procedures, tracing and monitoring requirements for each model. ART refill and clinical visit frequency differs by model with ART refill 1-2 monthly and clinical visit either bi-annually (fast lane and CCMDD) or annually (clubs). The guidelines also provide for additional adherence strategies that have been considered and can be implemented. These include community ART groups (client-managed group model), outreach and after-hours facility services.

The Southern African HIV Clinicians Society published guidelines in 2017 recommending strategies to support adolescents and young adults in achieving and maintaining viral suppression. These are the first in sub-Saharan Africa to recognize the need to differentiate service delivery models appropriate for stable or unstable adolescents and young adults in either their first year of treatment or thereafter. In chapter 4, it provides guidance on visit frequency (when), service location (where), service provider (who) and package of care (what) for clinical consultations, ART refills and psychosocial support for each of these 4 groups of adolescents and young adults. The guideline goes on to provide examples of ART delivery models from Southern Africa. It has a specific chapter providing service delivery guidance for adolescents and young adults that are pregnant or breastfeeding or members of key populations or disabled. Lastly, it also addresses transitioning issues and how differentiated ART delivery models can support transition from paediatric services into adolescent and young adult services and thereafter into adult services. 

Swaziland

The Swaziland National AIDS Programme’s National Policy Guidelines for Community-centred Models of ART Service Delivery (June 2016) recognize the need for differentiation throughout the treatment pathway but specifically provide guidance for stable client management. The guidelines recommend a defined package of care reducing clinical (6 monthly) and ART refill (3 monthly) visit frequency, provide for community-based care, and recommend a stop to CD4 count monitoring where viral load is available. 

The guidelines recommend three models of ART delivery for stable clients, and also describe mainstream care and mobile outreach for hard-to-reach communities. These are: facility fast-track models; facility-based treatment clubs (health care worker-managed group model) (specifically including teen and family club variants); and community-based ART groups (client-managed group model). The guidelines, together with the standard operating procedures for each model, set out the eligibility criteria and describe the services that take place at the ART refill visit versus the clinical visit, including when, by whom and where these services are provided with indications for up referral. 

Lastly, the guidelines deal with the strengthening of drug supply and laboratory systems to achieve scale up of community ART services, and set out the appropriate indicators required for monitoring and evaluation.

Tanzania

In a joint effort, the Tanzanian Ministry of Health, Community Development, Gender, Elderly and Children (MoHCDGEC) and International Training and Education Centre for Health (I-TECH) released “HIV Service Delivery Models: Mapping HIV Service Delivery Strategies in Tanzania” in 2017. This report describes the findings of a literature review on service delivery models across the HIV care and treatment cascade globally and in Tanzania. In addition, a mapping of current challenges and successful service delivery models implemented in both public facilities and by implementing partners is presented.

Reported common challenges that impact both access to testing and HIV care include stigma, long waiting times at clinics and specific access challenges for key and vulnerable populations. Differentiated care strategies to address these challenges are described using the elements and building blocks approach. These include provision of HIV testing services at specific times and locations for specific populations, longer refills, fast-tracking approaches, and adolescent clinics outside of school hours.

Based on these findings, recommendations for differentiated service delivery models have been incorporated into the 2017 National Guidelines for the Management of HIV and AIDS and will be used with the documented best practices to develop an operational guide for service delivery in Tanzania.

Zambia

The Zambian Ministry of Health (MoH) released Consolidated Guidelines for Treatment and Prevention of HIV Infection in 2016. It outlines a differentiated care framework characterized by four delivery components: location of service delivery, infrastructure available, trained human resources to task shift services, logistic management of commodities and the need for monitoring and evaluation. The guidelines support decentralized ART services to be more client focused and improve retention in HIV care. Less frequent clinical visits (3–6 months) and medication pickups (3–6 months) are recommended for stable clients on ART. Models of differentiated care described include Adherence Groups, Community ART distribution, Streamlined ART with multi-month scripting and Fast-track ART initiation. Piloting of differentiated models of community ART delivery in Zambia is ongoing.

Zimbabwe

The Zimbabwe Ministry of Health and Child Care (MoHCC) released an updated Operational and Service Delivery Manual for the Prevention, Care and Treatment of HIV in Zimbabwe (OSDM) in February 2017. This is the second edition of the manual originally developed in 2015. It sets out ‘how’ to implement WHO’s 2016 clinical guidelines, including differentiated service delivery across the entire HIV cascade from testing through to suppression. Chapter 2 describes the range of differentiated testing, prevention, initiation and ART delivery strategies that will be considered. For each strategy, the four building blocks addressing the “when, where, who and what” are described along with special considerations for specific populations, including pregnant and breastfeeding women, men, children and adolescents, key and vulnerable populations, people in prisons and people living with disabilities. The manual also includes standard operating procedures (SOPs) and outlines the five step process for deciding how to differentiate service delivery at a district level.

To accompany the manual, the Zimbabwe MoHCC also developed the Consolidated HIV and AIDS Job Aide that includes checklists, clinical algorithms and educational tools to support implementation. It provides a reference guide to key clinical and service delivery SOPs for HIV testing, prevention and ART delivery for children, adolescents and adults (including pregnant and breastfeeding women). The Job Aide gives detailed information to doctors, clinical officers, nurses, counsellors, pharmacists, health information officers, health promotion officers, community health workers and community-based organisations (CBOs) providing HIV prevention, care and treatment services to children, adolescents and adults (including pregnant and breastfeeding women). It describes eligibility criteria and frequency of follow up for stable adult clients, and outlines options available for differentiated ART delivery, including for children and adolescents and pregnant and breastfeeding women.