This 3-month injectable contraceptive could be a game changer for women and their families in developing countries. This powerpoint is an illustration research primary and secondary objectives, study findings, study design in Malawi of a 12-month open-label randomized controlled trial to evaluate Sayana Press suitability for at home subcutaneous self-injection procedures in adult women.

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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)

7. 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

8. Clients’ main reason for choosing Sayana Press
Uganda
n=98
Senegal
n=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

9. 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

10. Providers’ reasons for preferring Sayana Press

11. 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

12. 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

13. 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

14. 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)

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

16. 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

17. 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)

18. Eligibility Criteria
INCLUSION:
• 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

19. Enrollment Visit for Self-Injection Group
• Providers will train participants to self-inject Sayana
Press
• 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

20. 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

21. Project Timeline
2014 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

22. 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