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As part of the Imagine2030 campaign we want to show that innovation is not just something for the future. Medical advances being made right now will shape how we fight diseases of poverty in the future, and are delivering changes every day. It will be these advances, and the organisations behind them, that will bring us closer to our goal: an end of diseases of poverty by 2030.

We shift our final focus of the campaign to maternal health and family planning ahead of World Contraception Day on September 26. Our partners at PATH are working on a new contraceptive method that can increase contraceptive access and choice for the women that need it the most.

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Subcutaneous depot medroxyprogesterone acetate (DMPA-SC) is a new, innovative injectable that opens up contraceptive access and choice to women at the “last mile” in low-income countries and promotes women’s empowerment and autonomy. Sayana^® Press, the DMPA-SC brand product currently available, combines the contraceptive drug and needle in the Uniject™ injection system.* This “all-in-one” contraceptive is small, light, and easy to use, making it especially suitable for community-based distribution—and for women to administer themselves through self-injection.

This simple but revolutionary contraceptive is the culmination of a 30-year journey. PATH originally developed the Uniject injection system in the 1990s as a way for minimally trained health workers to give lifesaving medicines and to keep syringes and needles from being reused, avoiding risk of transmitting bloodborne pathogens. PATH then licensed the technology to Becton Dickinson (BD), which began working with pharmaceutical companies to package medicines in the Uniject. Years later, Pfizer developed a new, lower-dose formulation of DMPA that could be delivered subcutaneously—just under the skin—instead of intramuscularly. In 2014, a price agreement between the Bill & Melinda Gates Foundation, Pfizer Inc., and the Children’s Investment Fund Foundation helped galvanize momentum for rollout of the product and ensured women in the world’s poorest countries would have access to Sayana Press. Recently, the price was reduced to US$0.85 per dose for qualified purchasers such as ministries of health, USAID, and UNFPA.

Working closely with ministries of health and local partners, PATH coordinated the first introductions of the currently available DMPA-SC product, Sayana Press, in Burkina Faso, Niger, Senegal, and Uganda starting in 2014. By early 2016, all four countries began moving to include the product at scale in their national family planning programs. Today, DMPA-SC is available in at least 15 FP2020 countries and more than 1 million doses have been delivered to women around the world.

 

Making a difference in the lives of women, adolescent girls, and communities

Wherever it’s been introduced, DMPA-SC has helped increase access for women and adolescents. Before DMPA-SC, injectables could only be given using a standard vial and syringe and were most often administered by medical workers. Long distances to clinics, long waits for service, and occasional stockouts of syringes meant too many women went home without receiving the family planning method of their choice. DMPA-SC, on the other hand, moves family planning provision closer to women. Trained lay health workers can inject family planning clients whenever and wherever it is convenient, even in the privacy of their homes.

The unique design of Sayana Press lends itself to easy and safe self-injection. The United Kingdom and several European Union countries approved self-injection with Sayana Press in 2015, and an increasing number of countries in other parts of the world have also approved the practice. And the World Health Organization has recommended self-injection of subcutaneous injectable contraceptives in settings where women have access to training and support.

Evidence exchange supports product introduction and scale

By advancing the long-term, sustainable availability of DMPA-SC as part of a broad contraceptive method mix, global partners have the potential to reach millions of women with an unmet need for family planning. To achieve this goal, countries are working together to share program implementation evidence and inform new country experiences and transitions.

Uganda in particular has been a leader in this space. Over the last year, delegations from Benin, Burkina Faso, Niger, Nigeria, Senegal, and many more countries have traveled to Uganda to observe the self-injection research studies and community-based distribution programs, meet with Village Health Team members (community health workers), and exchange information with governmental and nongovernmental partners regarding introduction and scale-up. During each visit, the country teams developed action plans for strengthening the quality of DMPA-SC programming and implementation in their own countries, informed by evidence and experience.

Building on research conducted in both Uganda and Senegal, PATH and implementing partners in Uganda are now assessing best practices for self-injection program design across multiple channels and plan to share results with other countries interested in introducing and scaling up self-injection.

Picture credits: PATH/Will Boase

*The information in this article is specific to Sayana Press, the currently available DMPA-SC brand product in FP2020 countries. Additional DMPA-SC products may be available in the future. Sayana Press is a registered trademark of Pfizer Inc. Uniject is a trademark of BD.

Learn more about PATH here.

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Go back to imagine2030.org

As part of the Imagine2030 campaign we want to show that innovation is not just something for the future. Medical advances being made right now will shape how we fight diseases of poverty in the future, and are delivering changes every day. It will be these advances, and the organisations behind them, that will bring us closer to our goal: an end of diseases of poverty by 2030.

We shift our final focus of the campaign to maternal health and family planning ahead of World Contraception Day on September 26. Our partners at FHI360 are working on understanding the real issues that affect women when it comes to contraceptive use, and how best to use data to shape research projects and new products to respond to these issues. This article originally appeared on the Contraceptive Health Technology Exchange

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Contraceptive product development efforts, to date, have largely been premised on the notion that if we build it, they will come. Primary attention has been paid to making products that work, with the assumption that if women want to avoid pregnancy, they will use them. While the desire to avoid pregnancy is an extremely powerful motivator, it is not enough. For many women, the fear of contraceptive side effects or the challenge associated with accessing and using contraceptives is greater than the burden of another pregnancy.

Some argue that to improve uptake and continuation rates, we need to improve provider counseling around contraceptive side effects and address socio-cultural barriers, such as inequitable gender norms, that prevent women from using contraceptives. These efforts—while essential—are still insufficient. Even the most informed and empowered women can have unintended pregnancies when they don’t have access to acceptablecontraceptives—methods that meet their particular needs in their particular life stage and context.

As researchers, how do we shift the model of contraceptive development to focus first on what users want from an ideal contraceptive? From large population surveys, such as the country-level Demographic and Health Surveys (DHS), we already have some insight into what they don’t want. In those surveys, non-contraceptive users who say they don’t want to become pregnant are asked why they aren’t using a method. Their most frequent response is “side effects and health concerns.”  Qualitative studies have explored in more detail the particular side effects and other concerns that contribute to non-use.

Knowing what is potentially unacceptable to users is a great start, but it doesn’t tell us everything. We also need to know what users desire from their contraceptives. What characteristics could make them not only easier, but maybe even desirable to use?  What non-contraceptive benefits might they confer? Soliciting this kind of information is not easy. Responses to hypothetical questions about whether one would use a new method are not especially reliable. The correlation between what people say they are going to do and what they actually do is notoriously weak.

Product preference questions are especially challenging within the time and space constraints of a quantitative survey. Questions usually have a set of pre-coded response options which inevitably do not encompass the entirety of perspectives; moreover, standardized product descriptions can limit understanding. Translation of complex or unfamiliar concepts into the local language of the study population also presents challenges. How does one describe “hormone” in Mossi, the predominant local language in Burkina Faso? Also, surveys can run the risk of social desirability bias where the respondent gives an answer she thinks the interviewer wants to hear or is the “right” answer.

But… by asking a lot of different questions in different ways, we can begin to see patterns. By using different data collection methods, we can triangulate our findings. As part of the Contraceptive Technology Innovation Initiative, we did just that in a recently completed study in Uganda and Burkina Faso. The study assessed potential user preferences for six, long-acting methods currently in various stages of development or introduction:  a new single-rod implant, a biodegradable implant, a longer-acting injectable, a method of non-surgical permanent contraception, a new copper intrauterine device (IUD), and the levonorgestrel intra-uterine system (LNG-IUS).

To start, we added a set of 11 questions to one round of the Performance Monitoring and Accountability 2020 (PMA2020) survey in each country. Women were asked what method characteristics were most important to them when choosing a contraceptive, how long they wanted their method to last, and whether they would consider using any of these six methods, if available. The great thing about the PMA2020 platform is that it offers a nationally representative sample of women, so we can have some reassurance that findings are generalizable to the broader population.

To supplement the survey data, we held focus group discussions with women and men and conducted in-depth interviews with family planning providers.  We explored user preferences, attitudes, and decision-making drivers related to the six methods specifically and to contraceptive use generally.

In all, more than 5,000 women responded to the PMA2020 survey questions and over 500 women, men, and providers participated in focus groups and interviews. We learned, for example, that women in Uganda and Burkina Faso are particularly concerned about irregular and heavy menstrual bleeding caused by some contraceptives. While some respondents said they would use a method that induces amenorrhea (absence of bleeding), others were concerned that stopping menstruation would have negative health effects.

Some women said they wouldn’t want a method inserted into the uterus, while providers noted that many of their clients would not use a method that delayed their ability to get pregnant after discontinuing use. Across several lines of inquiry, we found that the biggest complaints about existing methods were directly related to what makes many of them work – contraceptive steroids. We will need to identify new, non-hormonal contraceptive targets to increase chances of future product method acceptability.

In the end, our research confirmed the urgency for a broader range of family planning methods to meet widely varying needs and desires of women worldwide – a range that includes new choices with fewer side effects to enhance acceptability and reduce health-related fears that deter use. There is nothing hypothetical about that.

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This article was written by FHI 360 guest bloggers Rebecca Callahan, PhD, a scientist in the Contraceptive Technology Innovation department and Aurélie Brunie, PhD, a scientist in Health Services Research.

For more information about Imagine2030, visit imagine2030.org

As part of the Imagine2030 campaign we want to show that innovation is not just something for the future. Biomedical advances being made right now will shape how we fight diseases of poverty in the future, and are delivering changes every day. It will be these advances, and the organisations behind them, that will bring us closer to our goal: an end of diseases of poverty by 2030.

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As part of the Imagine2030 campaign we want to show that innovation is not just something for the future. Biomedical advances being made right now will shape how we fight diseases of poverty in the future, and are delivering changes every day. It will be these advances, and the organisations behind them, that will bring us closer to our goal: an end of diseases of poverty by 2030.

For our focus on Tuberculosis in February 2017, the CEO of TB Alliance, Dr. Mel Spigelman, shares his views on how we are progressing in the fight against the disease, and his hopes for 2030. Take a look at the video, and read the dispatch fro the forefront of the fight against TB underneath!

TB Alliance: New hope for simpler TB treatment, even for the most drug-resistant cases

There are very few diseases left that are curable but still require months and months if not years of treatment. Tuberculosis (TB) is one of them, and over 10 million people are sickened by it each year.

Today’s tuberculosis treatments were developed 50 years ago. They need to be modernized. Basic treatment for TB infections that are not drug resistant lasts six months and consists of four potent antibiotics. For infections that are resistant to any or all of these four drugs, treatment is longer and much more complicated—up to thousands of pills plus injections for up to two years or more, and horrible side effects. Drug-resistant TB is a major source of antimicrobial resistance, which has emerged as an urgent global health challenge.

Current treatment doesn’t always work. According to the World Health Organization (WHO), only one fifth of those needing treatment for multi-drug resistant (MDR) TB receive it, and only half of those with who receive treatment are cured. Those with extensively drug-resistant (XDR) TB have it worse—just over one quarter of those who receive treatment are cured.

New treatments in development

Today, however, there are two experimental drug regimens that have the potential to simplify everything. Late-stage clinical trial results, presented at the Conference on Retroviruses and Opportunistic Infections in Seattle, Washington this month, gave patients and their caregivers hope for improved, shorter and simpler treatments for all types of TB, including the most difficult to treat cases.

Two new drugs—pretomanid (Pa) and bedaquiline (B)—form the backbone of these regimens. When combined with moxifloxacin (M) and pyrazinamide (Z), the BPaMZ regimen, studied in TB Alliance’s NC-005 clinical trial, shows the potential to cure all but the most drug-resistant forms of TB within six months.

When the backbone is combined with linezolid (L), the BPaL regimen, studied in TB Alliance’s Nix-TB clinical trial, shows the potential to reduce treatment time for XDR-TB from two years or more to six months—the amount of time currently needed to cure the simplest version of the disease. Expanded study of the BPaL regimen is expected later in 2017.

These results need to be confirmed in expanded studies. If the new clinical trials verify that the new treatments work, health professionals around the world will only need two versions of TB treatment—both with a simple set of daily pills to be taken for no longer than six months.

TB killed almost 2 million people in 2015. By 2030, we can solve this deadly killer.

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Learn more about TB Alliance here.

Go back to imagine2030.org

As part of the Imagine2030 campaign we want to show that innovation is not just something for the future. Biomedical advances being made right now will shape how we fight diseases of poverty in the future, and are delivering changes every day. It will be these advances, and the organisations behind them, that will bring us closer to our goal: an end of diseases of poverty by 2030.

For our celebration of World AIDS Day, and the role innovation has to play in fighting the disease, we profile an ongoing project by our colleagues at IS Global, the Barcelona Institute for Global Health, ISGlobal, which is an innovative alliance between academic, government, and philanthropic institutions to address the challenges in global health. Innovation is not just new products or medicines. Sometimes it is also finding new ways of doing things, improving access and using research to improve health care delivery.

Their “TESFAM” project is looking at how to keep people living with HIV in contact with health care in Mozambique. TESFAM is a collaborative project between ISGlobal and the CISM (Centro de Investigação em Saúde da Manhiça), a leading African HIV research centre, in alliance with Fundação Ariel Glaser contra o SIDA Pediátrico.

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Mozambique is a country with a particularly high HIV prevalence in adults. Estimated at 10.6%, it is said to be the eighth highest in the world. In 2014, according to UNAIDS, an estimated 1.5 million people were living with HIV in the country and the mother-to-child transmission of HIV was around 12%. In Manhiça District, an area in Maputo Province in southern Mozambique, it is estimated that 40% of all adults and close to 29% of pregnant women are infected with HIV. Many of these individuals receive lifesaving antiretroviral therapy (ART), which has been available in Mozambique since 2004, due in large part to international support.

Health systems struggling with impact of HIV & AIDS

However, the magnitude of the HIV epidemic and the fact that ever more effective guidelines recommend earlier initiation of ART mean that immediate sustainability is unlikely without a huge effort to strengthen health systems countrywide. Indeed, very few health systems in the world could cope with the logistics and costs of the clinical management of 40% of the population needing lifelong care and treatment. Consequently, international collaboration and integrated efforts are essential if we are to reach the target set by the Global Health Sector Strategies for HIV, which stipulate that, by 2020, 90% of all people living with HIV will know their status, 90% of people diagnosed will be on antiretroviral therapy, and 90% of people receiving antiretroviral therapy will be virally suppressed, with the ultimate goal of eradicating AIDS by 2030.

In Mozambique, ART coverage for those who need it is currently estimated at approximately 50% in adults and 39% in children, according to UNAIDS country report. These figures illustrate the sheer number of people dependent on the health system for HIV prevention and care. Despite the rapid expansion in coverage seen in recent years, over a quarter of a million adults who are eligible for ART are not receiving treatment. Stigma, overburdened health systems and poverty present daily challenges to retention in care and treatment.

TESFAM – getting people care they need

The objective of the Tesfam study, which focuses on the Manhiça district, is to give more people access to HIV testing, link them to care, and retain them in care and treatment. The study compared clinic-based and home-based HIV testing and counselling approaches, comparing rates of linkage to care and cost-effectiveness. Ultimately, the hope is that the findings of Tesfam will optimize HIV counselling and testing strategies, leading to the engagement of as many people as possible in the care cascade. 

 

Over the course of the study, approximately 16,000 adults were offered HIV testing. Of those eligible for the study, almost 15% already knew their HIV-positive serostatus. The 1,122 adults identified as new HIV diagnoses were enrolled for follow up. A key step in the cascade from testing to treatment is the CD4 test to determine eligibility for ART. In the Tesfam study, at 3 months post diagnosis, only 43.7% of those enrolled had undergone CD4 testing  (see Figure 2).

Despite increased rates of HIV testing, loss to follow up at each step in the HIV care cascade is very common in both resource-constrained settings and in more resource-rich countries. The reasons why patients drop out of the HIV care cascade are very complex and are influenced by multiple factors relating to the healthcare system and the individual, including socioeconomic profile. Standard of care in many sub-Saharan African settings does not include routine patient tracing, and the fate of individuals lost to follow-up is largely unknown. Since the HIV-infected population is especially vulnerable to illness and early death, it is important that these patients are traced and re-engaged into care. The design of the Tesfam study included home visits and counselling for the 850 individuals who abandoned treatment at different phases of the cascade. While some had migrated or died, the home visit was very effective at re-engaging a large proportion of the 468 patients who received this additional visit. Moreover, these patients were interviewed to ascertain why they had dropped out of the study.

Raising awareness of HIV treatment – community engagement

One of the main contributions of the Tesfam project in Manhiça was that it raised awareness in the community of HIV and HIV treatment through organised community events and presentations at public markets to discuss the obstacles and solutions relating to accessing HIV/AIDS care and treatment. These sessions are dynamic and enriching discussions led by an experienced counsellor. Community members actively participate by presenting their concerns and offering suggestions on ways the barriers to adherence to care for HIV-positive patients could be overcome. These events bring the community together to discuss the best approaches to HIV/AIDS care and treatment and health-seeking behaviour and to emphasise the importance of HIV testing, prevention and transmission mechanisms. The discussions brought to light various reasons why people do not go to the hospital for testing or treatment, such as a lack of time and the fact that they do not feel comfortable with the hospital staff.

Finally, community participation can reduce stigma and give people an opportunity to share their views on HIV/AIDS programmes and contribute to their improvement.  In this respect, the Tesfam project clearly identified a need for a better understanding of the barriers and facilitators of retention in care. Local leaders were also shown to have considerable influence on the behaviour of members of their communities.

In the future, more efforts aimed at retaining and re-engaging patients in care will be crucial. A few weeks could mean the difference between life and death. In addition, there is a great need to train health care workers to create a non-judgmental enabling environment. There is no one-size-fits-all approach, and in order to achieve the 90-90-90 target we must adapt our strategies to different settings and cultures so that all HIV-positive individuals are diagnosed, linked and retained in care. This challenge can only be met by intervening at various stages of the HIV care cascade.

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Learn more about IS Global here.

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