At-Home HIV Testing Kits Could Shed Stigma for Sex Workers, LGBT Community
Thirty-five million people around the world are HIV-positive, and 19 million of them don’t know it. That is a crisis, and there is work to be done. Global health-focused nonprofit Population Services International is on its way to making a big difference in Africa—specifically Malawi, Zambia, and Zimbabwe—where the organization will soon begin widespread distribution of oral-swab HIV self-test kits, paying close attention to what works.
“With the research that we are conducting, we will establish a body of evidence to demonstrate that HIV self-testing is acceptable, feasible, accurate, and if used by laypeople, safe, and ensures that people are linked to post-test support services,” says Karin Hatzold, director of HIV services at PSI.
The UNITAID/PSI HIV Self-Testing Project will try out several distribution models while evaluating the acceptance and feasibility of the HIV self-tests among key populations: female sex workers, men who are sexually active with men, and identifiable groups that have notable difficulty accessing HIV testing services.
Hatzold says the tests will be distributed through existing HIV testing clinics and retail pharmacies. Self-test users have the option of being assisted by a community health care worker at a testing facility or performing the test on their own in the privacy of their home.
“We are developing user instructions that can be easily understood by people who are not literate,” explains Hatzold. “We have also developed apps that show a demonstration video on how to perform the HIV self-test. These aids will help people to perform the test accurately on their own.”
Those who test positive will require confirmatory testing at a facility, and they will be fully informed of how and where they can access such services.
Malawi, Zambia, and Zimbabwe have been selected for the project owing to their high HIV prevalence, an issue the three governments are all eager to act on. While any kind of HIV testing services are significant, self-tests may prove to be the alternative opportunity these communities need. Many Africans in rural areas have not been tested because of stigma or limited access to health care facilities.
It’s a very, very big effort. While PSI remains the leading organization in the consortium behind the project, charged with implementation, demand creation, and dissemination of results, it is not working alone. The World Health Organization is responsible for global policy guidance and prequalification of HIVST kits, while the three countries’ health ministries will utilize the results and evidence to influence national policy.
A number of national and international research partners have also come on board—the London School of Hygiene and Tropical Medicine, the Liverpool School of Tropical Medicine, and University College London, with local research partners CeSHHAR Zimbabwe, MLW in Malawi, and ZAMBART in Zambia—all of which will ensure accuracy and quality, monitoring social harms, adverse events, data analysis, and engagement with policy makers. They will also be addressing the strategies’ effectiveness and the dissemination of findings.
To be as thorough and effective as possible, the project has been divided into two phases.
Phase One (years one and two) will be a collection and dissemination of the resulting public health evidence that will ultimately inform and influence international decision makers and national policy makers. This phase will decide how a potential HIVST scale-up could be executed effectively, ethically, and efficiently.
The efforts of Phase One should, in turn, reduce the wholesale price of HIVST kits as well, given that the project will support HIVST manufacturers interested in pursuing WHO-prequalified products or stringent regulatory authority approval and registration at the national level in the three countries. Interim results from impact evaluation will be presented at the end of Phase One, though it will continue in Phase Two.
In Phase One, the project will procure 822,495 HIVST kits and distribute 742,922.
Phase Two (years three and four) will begin pending PSI’s submission of an updated project proposal to the UNITAID board for review. Upon approval, the project will evolve from formative implementation science to full-impact evaluation of optimal HIVST distribution models and how they can achieve public health goals. The idea is to further catalyze the HIVST market by establishing high levels of consumer demand and strong country-level supply chains. A main focus is supporting the new manufacturers who enter the market in order to demonstrate the major impact that can then lead to full WHO recommendations that should inform and guide implementation on a global scale.
By the end of Phase Two, the project will have distributed a total of 1,920,578 HIVST kits.
The HIV crisis in Africa cannot be solved immediately—but it can be addressed effectively. This project is only a step in the long journey ahead, but it is one with strong footing and ready legs.