A 12-month open-label randomized controlled trial to evaluate Sayana® Press suitability for at home

subcutaneous self-injection procedures in adult women

Holly McClain Burke, PhD, MPH

October 7, 2014

SAYANA® PRESS

• 3-month contraceptive injectable

•104 mg/0.65 mL of DMPA

•Prefilled

•Single dose, single package

•Non-reuseable

•Subcutaneous injection

•Compact size

•Easy to use

•Approved by EMA

Why is Sayana Press a “game changer”?

• Specifically developed to address logistics and safety challenges of widespread distribution in low-resource settings

• Potential for self-injection, which may:– increase user autonomy and lower discontinuation rates

– decrease operational costs, improve efficient use of providers’ time, expand CHWs’ role

– reduce opportunity costs for users

FHI 360 PK Study Findings

• Injection of Depo-SubQ Provera 104™ in the upper arm provided sufficient MPA levels for contraceptive protection for 3 months (13 weeks)

• Uptake and metabolism of MPA when injected in the upper arm may be different from the abdomen and thigh

• Important because ≥ 90% of client participants in the FHI 360 acceptability studies chose to receive Sayana Press in the upper arm

FHI 360 Acceptability Study Findings

• Acceptability studies in Uganda and Senegal completed in 2013

• Most clients (≥80%) prefer Sayana Press over DMPA IM

• Most providers, including CHWs, preferred Sayana Press

• Sayana Press can be safely introduced into programs and administered by CHWs

• Providers spontaneously discussed self-injection

• After trying Sayana Press, 45% of clients in Uganda and 22% in Senegal would be willing to self-inject the method

Acceptability Study Research Objectives

1. Measure the acceptability of Sayana Press among family planning clients using DMPA IM

2. Measure the acceptability of Sayana Press among family planning providers—both clinic-based and community health workers (CHWs)

FHI 360 Acceptability Study Findings

• Acceptability studies in Uganda and Senegal completed in 2013

• Most clients (≥80%) prefer Sayana Press over DMPA IM

• Most providers, including CHWs, preferred Sayana Press

• Sayana Press can be safely introduced into programs and administered by CHWs

• Providers spontaneously discussed self-injection

• After trying Sayana Press, 45% of clients in Uganda and 22% in Senegal would be willing to self-inject the method

Clients’ main reason for choosing Sayana Press

Ugandan=98

Senegaln=192

Experienced no problems/fewer side effects 39 56

General statements about liking Sayana Press 39 37

No or less pain 8 20

Beneficial menstruation effects 8 6

Fast administration -- 30

Method effectiveness -- 18

Other 4 25

FHI 360 Acceptability Study Findings

• Acceptability studies in Uganda and Senegal completed in 2013

• Most clients (≥80%) prefer Sayana Press over DMPA IM

• Almost all (98%) providers, including CHWs, preferred Sayana Press

• Sayana Press can be safely introduced into programs and administered by CHWs

• Providers spontaneously discussed self-injection

• After trying Sayana Press, 45% of clients in Uganda and 22% in Senegal would be willing to self-inject the method

Providers’ reasons for preferring Sayana Press

FHI 360 Acceptability Study Findings

• Acceptability studies in Uganda and Senegal completed in 2013

• Most clients (≥80%) prefer Sayana Press over DMPA IM

• Most providers, including CHWs, preferred Sayana Press

• Sayana Press can be safely introduced into programs and administered by CHWs

• Providers spontaneously discussed self-injection

• After trying Sayana Press, 45% of clients in Uganda and 22% in Senegal would be willing to self-inject the method

Adverse Events (AEs)

• No pregnancies reported

• Total of 34 AEs reported by 25 clients

• One serious (malaria), but unrelated to SP

• 10 AEs possibly or definitely related to SP

– All mild or moderate in severity

– 3 AEs related to skin irritation at injection site

– 7 AEs are known side effects of DMPA

FHI 360 Acceptability Study Findings

• Acceptability studies in Uganda and Senegal completed in 2013

• Most clients (≥80%) prefer Sayana Press over DMPA IM

• Most providers, including CHWs, preferred Sayana Press

• Sayana Press can be safely introduced into programs and administered by CHWs

• Providers spontaneously discussed self-injection

• After trying Sayana Press, 45% of clients in Uganda and 22% in Senegal would be willing to self-inject the method

HSI Study Setting: Malawi

• 33% of injectables users discontinue while still needing FP

• 6 MOH FP clinics in Mangochi District

• 20 clinic-based providers (i.e., nurses and/or midwives)

• 20 Health Surveillance Assistants (HSAs)

Primary Objective

• To compare continuation rates between women who self-inject Sayana Press compared to women who receive Sayana Press injection from a provider

Secondary Objectives

• Compare between the two groups:

– reported side effects

– pregnancy rates

• Describe experiences of women who self-inject Sayana Press

• Describe experiences and recommendations of family planning providers who train women to self-inject Sayana Press

Study Design

• Open-label randomized controlled trial

• Eligible women randomized to:1. Receive Sayana Press from a provider, including HSAs, or

2. Receive training on how to self-inject Sayana Press and the opportunity to self-inject the method at home

• Participants will be followed for up to 1 year

• Interviews every 3 months shortly after re-injection date

• Measure: continuation status, acceptability, adverse events, experiences with side effects (including pain and injection site reactions), and pregnancy (at last interview only)

Eligibility CriteriaINCLUSION:

• Age 18-40, inclusive

• In general good health

• Willing and able to give informed consent

• Willing to give contact information for follow-up

• Agree to have follow-up visits/interviews

• Willing to be randomized

• Meet eligibility criteria for receiving DMPA per WHO Medical Eligibility Criteria

• Menstrual period started within the past 7 days (for new DMPA users)

EXCLUSION:

• Pregnancy

• Plans to become pregnant in the next 12 months

• Plans to relocate outside the study area in the next 12 months

• Any condition (social or medical) that would make study participation unsafe or would interfere with adherence to study

Enrollment Visit for Self-Injection Group

• Providers will train participants to self-inject SayanaPress

• Participants will self-inject Sayana Press under supervision

• Participants will be given 3 Sayana Press units to take home

• Community-Based Distribution Agents (CBDAs) will support self-injection in their communities

Additional Data Collection

• Track number of women who: were informed about the study, self-injected at enrollment, and self-injected on-time during year

• In-depth interviews with a small group of randomly selected self-injectors to understand strategies for remembering when to re-inject, fidelity to injection, storage and waste disposal procedures

• In-depth interviews with a small group of randomly selected providers to describe their techniques and recommendations for training and supporting women to self-inject

Project Timeline2014 2015 2016

July – Dec Jan –

March

April -

June

July - Sept Oct - Dec Jan –

March

April -

June

July - Sept Oct - Dec

Study Start-Up X

Enroll Participants X X

Follow-up Visits X X X X X

Conduct IDIs with

providers

X

Conduct IDIs with

self-injectors

X

Data Analysis X X X

Dissemination X

Project Impact

• Inform decision-making for commodity procurement, placement, and distribution of Sayana Press

• Inform self-injection training materials, messages for providers and clients, and future scale-up efforts

• Sayana Press and self-injection may increase access to family planning and expand method mix at the primary and community levels