Creating Policies, Plans and Budgets

Consider exploring the impact of introducing PrEP incrementally to existing prevention programs—and evaluate the cost of this for different populations.

Costing Guidelines and Rollout Analysis

• PrEP Costing Guidelines

Oral PrEP Specific Materials

• Oral PrEP Introduction Zimbabwe Rollout Analysis
• Oral PrEP Introduction Kenya Rollout Analysis

Modelling Summary | PrEP and microbicide modelling study literature review

• Literature review of studies, reviews and analyses focused on the impact, cost, cost-effectiveness, drug resistance and other parameters of both PrEP and microbicides
• Modeling literature review bibliography

Cost-Effectiveness and Impact Studies

Cost-Effectiveness Studies

• Comparative effectiveness and cost-effectiveness of antiretroviral therapy and pre-exposure prophylaxis for HIV prevention in South Africa
• Estimating the cost-effectiveness of pre-exposure prophylaxis to reduce HIV-1 and HSV-2 incidence in HIV-serodiscordant couples in South Africa
• What do we know about the cost–effectiveness of HIV preexposure prophylaxis, and is it affordable?

Sample PrEP Impact Studies

• Tailored combination prevention packages and PrEP for young key populations
• Using geospatial modelling to optimize the rollout of antiretroviral-based pre-exposure HIV interventions in Sub-Saharan Africa

Dapivirine Ring Specific Resources

Several modeling efforts have demonstrated the potential impact, and in some cases the cost and cost-effectiveness, of a monthly dapivirine ring.

• Dapivirine Vaginal Ring for HIV Prevention: modeling health outcomes, drug resistance and cost‐effectiveness (May 2019) — an article published in the Journal of the International AIDS Society
• Dapivirine Ring: The Case for Action (OPTIONS, 2017) — lays out next steps for the ring as it nears a regulatory decision and the field prepares for product introduction
• Dapivirine Ring Modeling Literature Review and Bibliography (OPTIONS, 2017) — a review of cost and impact modeling on the dapivirine ring

Biomedical HIV prevention products take various paths to regulatory approval, and in examining the experience of oral PrEP (both Truvada and Descovy) and the dapivirine vaginal ring these differences are highlighted.

Oral PrEP Specific Resources

In 2012, the US FDA approved the use of TDF/FTC (brand name Truvada) for HIV prevention in all populations, and WHO guidance was developed based on data from randomized controlled trials of TDF/FTC and TDF (a generic option). Similarly, F/TAF (brand name Descovy) was approved by the FDA in October 2019, as safe and effective HIV prevention option for cisgender men and transgender women. However, due to a lack of data in cisgender women, additional data will be needed before use of F/TAF is approved for this group.

Dapivirine Ring Specific Resources

IPM, the ring’s developer, applied to the European Medicines Agency (EMA) for review of the ring under Article 58. This procedure allows the EMA, in cooperation with the World Health Organization (WHO), to provide a scientific opinion on the safety, efficacy and quality of medicines that would be marketed exclusively outside of the European Union—specifically in low- and middle-income countries—for diseases of major public health interest.

In July of 2020, the EMA gave a positive scientific opinion on the public health benefits of the ring for use by women in low- and middle-income countries outside of the European Union. The positive opinion also said there should be a commitment to do a post-authorization efficacy study. This study would enroll cisgender women aged 18-25 to better understand efficacy, and to complement existing data on potential drug resistance. The EMA’s positive opinion helps move the ring from a research product to a real tool that women can use.

Next Steps

The WHO has convened a guideline development committee to review the dapivirine vaginal ring as part of its HIV/AIDS treatment and prevention guidelines with possible recommendations on the ring’s use. WHO may also now begin to “prequalify” the ring, a process to evaluate whether a medicine meets global standards for quality, safety and efficacy. WHO prequalification can facilitate national regulatory review and guideline development. Many African national regulatory agencies use WHO prequalification to determine which new products they approve.

IPM also plans to submit regulatory applications to the US Food & Drug Administration (FDA) and to various African regulatory bodies. For the latest information, visit IPM’s website.

Click to see next steps in the regulatory plan.

A positive opinion from the EMA can facilitate registration in priority African countries. An Article 58 review can also shorten the timeline for possible WHO prequalification, a process through which WHO evaluates whether a medicine meets global standards for quality, safety and efficacy.

For many countries, an opinion from a stringent regulatory authority such as the EMA along with WHO guidelines and prequalification will help advance national-level regulatory decision-making. For more information on the regulatory process, access the Dapivirine Ring Market Introduction Considerations deck.

Understanding country-level questions and interest in any biomedical HIV prevention product is a critical part of planning. For this reason, strategic design and implementation of demonstration projects in-country are a critical first step to bringing a product to market.

Oral PrEP Specific Resources

Beginning in 2013, the Bill & Melinda Gates Foundation supported seven early oral PrEP demonstration projects. The Prevention Market Manager project aggregated and analyzed the project results to inform oral PrEP rollout and new product demonstration projects. Click here for the findings.

Dapivirine Ring Specific Resources

For the ring, learning from the introduction of and experiences with HIV prevention products or other types of vaginal rings and family planning products can also inform planning.

• Vaginal ring acceptability and related preferences among women in low- and middle-income countries: A systematic review and narrative synthesis (OPTIONS, Nov 2019) — this systematic review provides an overview of women’s experience with and opinions for a wide variety of vaginal rings used to address various sexual health needs. The review includes an overview of women’s reported concerns and preferences, and suggests that most users of vaginal rings in low- and middle-income countries have a positive view that increases with familiarity of use
• The Dapivirine Ring: Key learnings from like-product introductions (OPTIONS, Oct 2019) — analyses of the introductions of other products that share similar characteristics provide useful lessons to inform planning for rollout of the dapivirine ring. This paper provides information for planners, implementers, funders, researchers, trainers, providers of technical assistance and others to build an agenda for introducing the dapivirine ring that addresses these two challenges
• Dapivirine Ring Early Introduction Considerations (OPTIONS, 2018) — The OPTIONS Consortium conducted secondary research and interviews with key stakeholders in several countries to understand questions about the ring that could inform demonstration and processes for introducing new biomedical HIV prevention products
• Lessons Learned from PrEP Rollout for the Dapivirine Ring (Sept 2018) — presented by AVAC’s Elizabeth Gardiner at a HOPE Protocol Team Meeting

In this step, you begin to assess which populations should be prioritized for PrEP introduction. This involves understanding the context of the epidemic, the characteristics of end users, and the size of the potential end user population. This is typically an iterative process that starts with collecting and understanding available data before developing new research.

You don’t need all the answers before moving ahead with the next steps for introduction. Now is the time to gather available information and identify gaps. Other questions include whether members of priority populations are willing and likely able to use PrEP consistently and, where applicable, to pay for it.

Identify Priority Populations

• Examples of situational analyses: South Africa, Kenya, Zimbabwe
• Step 2 of the OPTIONS Plan 4 PrEP Toolkit defines scenarios for oral PrEP rollout in different counties/districts or to different populations. The full toolkit is also available.
• Building Evidence to Guide PrEP introduction for Adolescent Girls and Young Women (Population Council, 2016)
• Addressing Gender to Ensure Effective PrEP Introduction

Technical working groups will help drive strategic decision making for PrEP introduction. For guidance on setting up a TWG, click here.

In this step you synthesize the information gathered in the previous activities and use it to develop a road map for when and where PrEP will first be introduced, and how access will scale up over time. This timeline shows PrEP moving from a proof-of-concept to rollout.

Oral PrEP Specific Resources

Country Implementation Plans

• Implementation Plan for HIV Pre-Exposure Prophylaxis in Zimbabwe 2018-2020
• Framework for the Implementation of Pre-Exposure Prophylaxis in Kenya (2017)

Interactive Oral PrEP Implementation Timelines

• Kenya
• South Africa

Dapivirine Ring Specific Resources

The Common Agenda for the Dapivirine Vaginal Ring

The Common Agenda serves as a shared guide for stakeholders working on activities required for the introduction of the dapivirine vaginal ring. The Common Agenda is designed to streamline and accelerate collective efforts.

In addition, this document — What’s Up with The Dapivirine Vaginal Ring: Understanding next steps after the EMA opinion — helps advocates to navigate the steps that can and must be taken now that the EMA has provided its opinion. It suggests advocacy priorities for civil society groups to consider in ensuring community members play a leading role in setting priorities, country planning for rollout, trial design for implementation research and getting resources allocated where they’re needed.

PrEP programs are supported by a range of documents. Ensuring you have the needed framework in place is an ongoing process in this initial phase of planning. Things to consider and plan for include guidelines – national-level documents that give a high-level recommendation for how PrEP should be used. Many countries are now including PrEP in their ARV guidelines, that also address how ART should be used in people living with HIV. These guidelines do not provide the detail needed for a program implementer, clinician, or service provider.

Global guidelines

• In June 2016, the WHO issued its consolidated guidelines on the use of antiretrovirals for prevention and treatment. This is the overarching global document that is guiding country adoption of PrEP and immediate offer of ART.
• For additional related documents developed by WHO, PEPFAR and UNAIDS, click here.

Policies

Policies (also called guidance) offer more specific information about how a country’s PrEP program should look, including eligibility criteria, clinical considerations, components of the minimum package of services that should be associated with PrEP introduction, etc.

Oral PrEP Specific Resources

National policies and guidelines from a number of countries are available here.

• National Policies and Guidelines
• Clinical Guidelines
• Oral PrEP Template Guidelines (English/French)

Kenya is one example of a country with a range of documents shaping the PrEP policy. These include: the Kenyan HIV Prevention Revolution Roadmap, and Kenya National Strategic Framework (KASF). Specific guidance on how PrEP should be delivered is found in the Guidelines on use of ARV drugs for treating and preventing HIV infections in Kenya – 2016 edition.

OPTIONS Plan 4 PrEP

The Plan 4 PrEP Toolkit supports national planning for the rollout of oral PrEP. Implementers may use all the steps to guide the entire planning process or use specific sections. Policy makers, technical working groups, implementing partners or advocates at the national or sub-national level will find tools informed by experiences in PrEP rollout from South Africa, Kenya and Zimbabwe.

• Plan 4 PrEP Toolkit: Facility Readiness Assessment (OPTIONS 2019)
• Greater Than the Sum of its Parts: Blended finance roadmap for global health (USAID 2019)

Oral PrEP Specific Resources

Assessment of Opportunities to Deliver Oral PrEP for Women Through Private Sector Health Care (OPTIONS 2017)

• Summary of Research Findings
• Kenya Research Findings
• South Africa Research Findings
• Zimbabwe Research Findings