About the Star Initiative

Catalytic funding
for HIV Self-Testing
Market development

STAR is a Unitaid-funded initiative launched in 2005 with three key goals: to catalyze the global market for HIV self-testing (HIVST), to generate evidence for decision-making, and to create an enabling environment for HIVST scale-up.

The Initiative is led by Population Services International (PSI) in partnership with the London School of Hygiene and Tropical Medicine (LSHTM), ministries of health, and local research partners and implementers, with technical support for research and policy development at country and global levels provided by the World Health Organization (WHO).

STAR’s work focuses on short-term catalytic investment for longer-term sustainable HIVST scale-up in high HIV burden countries.

By combining a targeted research agenda; global policy and guideline development; active market creation facilitated by donor commitments; and a rapid implementation timeline, the Initiative has already demonstrated laudable successes.

[STAR] combines a targeted research agenda; global policy and guideline development; active market creation; and a rapid implementation timeline.

The ultimate aim is to establish sustainable country-owned HIVST programs that enable countries to reach their HIV prevention goals and the UN 90-90-90 targets.

The Initiative’s work has progressed through three phases in the 5 years of its operations, expanding its geographical reach from three to thirteen countries, and shifting its focus from evidence generation to widespread implementation and scale-up, as the scientific evidence base for HIVST has expanded.

Click on the expandable sections below to learn more about each phase.

Star's Three Phases

Implemented initially in Malawi, Zambia and Zimbabwe, the first phase of the STAR Initiative was designed to quickly generate evidence that could support the development and implementation of guidelines for HIVST at the national and global level.

Given that the work began in the context of no normative standards or technical guidelines on HIVST from WHO, no policy framework, and only three countries in the world, all high income, offering self-testing of any kind, its rapid success was remarkable.

The research agenda at the core of STAR’s Phase 1, which involved international collaborations with world-leading research institutions including the London School of Hygiene and Tropical Medicine, the Liverpool School of Tropical Medicine and University College London, generated crucial scientific evidence about how to distribute HIVST products effectively, efficiently and ethically. This information was subsequently used to inform global guideline development and HIVST program design in other countries. 

The products of STAR’s research efforts have been published in international journals, presented at high-profile conferences, and incorporated into systematic reviews done by WHO (see resources page). 

The STAR Initiative’s second phase built on the evidence and experience generated in the first phase to scale up access to HIVST across sub-Saharan Africa. It expanded implementation to three additional countries: eSwatini (formerly Swaziland), Lesotho and South Africa. As with the first phase, Phase 2 included a research focus to generate evidence for further expansion of HIVST around the world, undertake detailed costing analysis of HIVST versus other testing options alone or in combination, and support countries to make informed choices about the distribution models and products that best meet their needs. Global efforts to create an enabling environment for HIVST focused on supporting WHO to produce normative guidelines and contributing to the assessment and prequalification of new HIVST products, as well as working with Unitaid to undertake HIVST market analysis reports.

Phase 3 is an 18-month intervention in seven new countries: Cameroon, Mozambique, Nigeria, Tanzania, and Uganda in Africa; and India and Indonesia in Asia. It is focused on addressing market barriers to HIVST roll out and establishing the structures, systems and oversight mechanisms necessary for long-term sustainability, using knowledge derived from the first two phases of STAR.

In keeping with STAR’s market development focus, it also aims to ensure that STAR-supported countries are sustainably transitioned to other funding sources for HIVST by the end of the 18-month time frame.

Alongside the focus on the seven countries where implementation is being rolled out, Phase 3 activities will also support the worldwide expansion and rollout of HIVST as a testing approach in non-STAR countries.

Targeted
Research Agenda

The STAR Initiative worked to build the evidence base for and inform the scale-up of HIV self-testing (HIVST). The Initiative’s research agenda spans key questions from the design of HIVST delivery to the effective scale-up HIVST within existing health systems.

Researchers within STAR countries are exploring the public health impact of HIVST compared to standard HIV testing, its cost and cost-effectiveness and appropriate methods for ensuring linkage to post-test services.

The research agenda covered the following research questions:

How can we best deliver HIVST?

  • What level of accuracy can be achieved by HIVST users?
  • How can social harm from introducing HIVST by anticipated, reported and addressed?
  • What are HIVST users’ preferences and how can demand for HIVST be maximized?

Can HIVST increase the public health impact of existing HIV testing?

  • Is HIVST reaching people who are currently not accessing HIV testing services (key populations, men, adolescents and other vulnerable populations)?
  • Does HIVST increase the frequency and coverage of HIV testing compared to current testing strategies? 

Linkage to Post-Test Care

  • Are interventions to improve linkage into post-test services (HIV care and VMMC) effective and cost-effective?
  • What are user preferences for the delivery of post-test services and how can demand for services be maximized? 

Cost and Cost-effectiveness of HIVST Introduction

  • What are the delivery costs of adding HIVST? How can we reduce them?
  • What is the population-level cost effectiveness of introducing HIVST?
  • Can community-led distribution models be used to maximize benefit and reduce costs? 

Effective Scale-Up of HIVST

  • Can accuracy, linkage to care and prevention be adequately estimated using routine program monitoring and evaluation?
  • How can HIVST be integrated into routine programmatic services?

HIVST
products

prequalified by WHO, as of June 2020

OraQuick

OraSure Technologies

Insti

bioLytical Laboratories

Mylan HIV Self-Test

Atomo Diagnostics

SURE CHECK

Chembio Diagnostic Systems

Global Policy
and Guideline Development

When STAR began there was no normative guidance for HIV Self-Testing. The Initiative therefore set out to reduce policy barriers to market entry for quality-assured HIVST products and support WHO to produce guidance for countries to design effective, ethical and evidence-based programs.

By the end of STAR Phase 1, 41 countries had developed HIVST policies and WHO had released its first normative guidance published in 2016.

Subsequent work with WHO led to the publication of an HIVST strategic framework (October 2018); three policy briefs (December 2016; November 2018; November 2019); and frequently asked questions documents for community organisations and testing providers. The 2018 guidelines were updated in November 2019.

Active Market Creation:
An Enabling Environment

Before STAR, there were no low cost and quality-assured HIV self-test products approved for public procurement in resource-limited settings. Together with Unitaid, the STAR Initiative therefore prioritized generating market intelligence supporting manufacturers to pursue WHO prequalification; and facilitating the establishment of regulatory frameworks both internationally and in STAR countries, as well as directly procuring almost 5 million test kits which helped to ensure demand.

These direct procurements and future purchases, facilitated by the successful mobilization of additional financing from the Global Fund to Fight AIDS, Tuberculosis and Malaria (GF), the US President’s Emergency Plan for AIDS Relief (PEPFAR) and national governments was intended to make  HIVST demand increasingly predictable for manufacturers, encouraging new market entrants and establishing supply volumes to facilitate market growth.

As evidence of the effectiveness of this approach, the number of HIVST products prequalified by WHO has grown from zero in 2015 to four in 2020.