Option B+ in Malawi: The Origins and Implementation of a Global Health Innovation

A Conversation with Dr Erik Schouten

When considering which public health intervention is best for a country or region for prevention of mother-to-child transmission (PMTCT) of HIV, the World Health Organization (WHO) provides a set of guidelines that provide options for various settings. When on-the-ground realities in Malawi prevented widespread implementation of either option A or option B “as written,” the government of Malawi took a bold step to better meet the needs of its population, in what they dubbed Option B+.

Touted at the XIX International AIDS Conference (AIDS 2012) as a viable option for prevention of mother-to-child transmission of HIV by UNICEF’s Dr. Chewe Luo, Option B+ calls for antiretroviral therapy (ART) for life for all HIV-positive pregnant women, regardless of CD4 levels.

This innovation of a public health intervention, in its early stages of implementation in Malawi, is building in popularity, and may prove to be replicable, scalable, cost-effective and efficacious for other countries.

MSH spoke with Dr Erik Schouten, principal technical advisor for HIV and project director supervisor for MSH’s Center for Health Services in Malawi, regarding the innovation and national scale-up of Option B+.

What are the origins of Option B+?

The Malawian government developed Option B+ in 2010 in response to the specific needs of its people, and the realization that the World Health Organization (WHO) guidelines on prevention of mother-to-child-transmission of HIV (PMTCT) weren’t practical in this setting. Malawi was having a hard time providing reliable CD4 count testing for HIV-positive women — nearly 70% of pregnant women go for antenatal care services at smaller health facilities where reliable CD4 counting is not available – and would not be available for years to come. The WHO guidelines were critically dependent on the availability of CD4 count testing and therefore not viable in Malawi. The government of Malawi elected to combine antiretroviral therapy (ART) with PMTCT in a new approach we dubbed Option B+, which offers lifelong treatment to all HIV-positive pregnant women, regardless of their CD4 levels.

What was your role in its development and who supported you?

I was one of the members of the team that proposed and developed the Option B+ policy. I supported the drug-need forecasting and costing of the approach, the development of integrated HIV clinical care guidelines, the training curriculum, and the implementation plan. I was supported to do this work by the MSH-led Basic Support for Institutionalizing Child Survival (BASICS) program, funded by USAID.

How is Malawi moving from the idea to the implementation of Option B+?

In June 2011 we began training health staff across the country; in 3 months over 3,500 staff were trained. The trainings last 5 days, and often we had 10 to 12 trainings running in parallel throughout the country. This was only possible through the engagement of a number of agencies, including national and international NGOs, most of them supported by the US government. MSH trained over 470 staff and supported the national coordination of all involved agencies. We started implementing Option B+ in Malawi in July 2011.

What are some of the successes and challenges of implementing Option B+ in Malawi?

In the first 9 months of the implementation, we saw a six-fold increase of the number of pregnant women starting ART. This is a fantastic start of the program. And, we hope that women who are initiated on ART will adhere to their treatment and remain in care.

The national roll out of option B+ is almost completed. Over 520 of the targeted 560 health facilities provide Option B+. We need a minimum of two trained health staff in a facility to start Option B+. This minimum number of health staff required is the main bottleneck to completing the roll out of Option B+.

Another challenge is public acceptance and community support for ARTs for life. Some women are afraid of disclosing their HIV status. The stigma and discrimination that can come with that has a negative impact on adherence and retention in care. We are involved in studies looking at the best implementation model for Option B+ and how adherence and retention can be best supported.

Has Option B+ received acceptance beyond Malawi, in the international health community?

Initially, Option B+ received a mix of positive and negative responses. It was not a WHO- accepted policy at first, and many feared that the costs of its implementation would be astronomically high. We wrote a view point for the Lancet (2011) and since then a PEPFAR team from the Office of the U.S. Global AIDS Coordinator visited the country (January 2012). Initial skepticism changed to strong support as others understood fully the limited capacity in the Malawian health sector, and our meticulous preparations of the implementation.

Then, in April 2012, the WHO published an addendum to the 2010 PMTCT guidelines, acknowledging that, in some circumstances, Option B+ is a good way to go. The international health community is increasingly taking interest in the approach, as was evidenced throughout the recent XIX International AIDS conference, including in a plenary speech by Dr Chewe Luo of UNICEF. Option B+ is becoming an internationally accepted standard.

Do you have recommendations for other countries considering Option B+?

Adoption of Option B+ requires a substantial amount of preparations. An increased number of health facilities need to be accredited to provide ART and more health staff at decentralized health facilities need to be trained and licensed to prescribe ART. In some countries, nurses are not allowed to prescribe ART and this could be an obstacle. The costs of the program will increase as many more pregnant women will start ART and funds will need to be secured.

Option B+ has many health system advantages and will help to get more women on ART, which will help to achieve the virtual elimination of pediatric HIV targets. There are also health benefits for the mother — reduced maternal mortality — and reduced HIV transmission to her discordant sexual partner(s).

Option B+ is not just a different approach to PMTCT, but since all pregnant HIV infected women are receiving ART for life, it is a way to decentralize ART to many more health facilities, bringing services closer to more people. It will also harmonize ART and PMTCT programs. In Malawi we combined ART and PMTCT guidelines into joint guidelines for clinical HIV care: we combined the training for PMTCT and ART, and integrated M&E tools, supervision and drug supply systems.

Option B+ is a game-changer in how we organize care and treatment for people living with HIV.

Related reading