ContraceptionNCT02293694
Sayana® Press Self-injection Study in Malawi
A study testing Sayana Press in people with Contraception, run by FHI 360 at 1 site in Malawi.
Trial summary
The feasibility of Sayana Press self-injection and the potential for this practice to increase contraceptive continuation has never been assessed in family planning programs in low-resource settings. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Sayana Press
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 735 participants
- Where
- 1 siteMalawi
- Study dates
- 17 Sep 2015to 30 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-40, inclusive
- In general good health (participant verbally reports she feels well)
- Able to understand and willing to sign an informed consent document
- Willing to give contact information for follow-up
- Agree to have follow-up visits/interviews
- Willing to be randomized to the self-injection arm or provider-administered injection arm
- Menstrual period started within the past 7 days (for new DMPA users)
- Meet eligibility criteria for receiving DMPA per WHO Medical Eligibility Criteria (MEC)
Who cannot join
- 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) which in the opinion of the investigator would make study participation unsafe or would interfere with adherence to study requirements or complicate data interpretation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 12-month Open-label Randomized Controlled Trial to Evaluate Sayana® Press Suitability for at Home Subcutaneous Self-injection Procedures in Adult Women
The feasibility of Sayana Press self-injection and the potential for this practice to increase contraceptive continuation has never been assessed in family planning programs in low-resource settings. The Malawi Ministry of Health (MOH) and the United States Agency for International Development (USAID) Malawi Mission requested the Advancing Partners and Communities (APC) project to assess self-injection of Sayana Press to inform their decision-making for procurement of Sayana Press and distribution through the health system in Malawi.
Read the detailed description
Sayana® Press is a subcutaneous formulation of depot medroxyprogesterone acetate (DMPA) in a prefilled, auto-disabled injection system called Uniject (Pfizer, Inc., USA). Sayana Press was registered with the Medicines and Health Care Products Regulatory Agency (MHRA) and several other national regulatory agencies. The addition of this method is anticipated to aid in improving provision of family planning services in low-resource settings. As such, Sayana Press could be particularly useful in a country such as Malawi where injectable contraception is the most common method used. DMPA clients and providers are ready to explore the potential of self-injection of Sayana Press. A study conducted in a large family planning clinic in Edinburgh, Scotland found self-administration of DMPA-SC feasible and associated with similar continuation rates and satisfaction to clinician-administered DMPA-IM. A non-comparison study conducted in Planned Parenthood clinics in Florida found continuation of self-injected DMPA-SC high (74%) at the fourth injection. Participants in this study reported the injection to be easy and convenient and were likely to recommend self-administration to other women. Moreover, on September 29, 2014 Pfizer submitted a request to the MHRA to change the Sayana Press label to include self-injection.
If self-injection is found feasible, the results from this research will inform self-injection training materials, messages for providers and clients, and future scale-up efforts in Malawi and elsewhere in sub-Saharan Africa.
- Conditions
- Contraception
- Being tested
- Sayana Press
- Keywords
- DMPA-SC: depo medroxyprogesterone acetate sub-cutaneous, DMPA-IM: depo medroxyprogesterone acetate intramuscular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sayana PressDrug
Also called depot medroxyprogesterone acetate (DMPA)
Sayana® Press is a subcutaneous formulation of depot medroxyprogesterone acetate (DMPA) in a prefilled, auto-disabled injection system called Uniject
| Study group | Role | What they receive |
|---|---|---|
| self-injection | Active comparator | Women randomized to this arm will be trained to self-inject Sayana Press at home every three months Receives: Drug: Sayana Press |
| provider injection | Active comparator | Women randomized to this arm will received Sayana press from a family planning provider every three months. Receives: Drug: Sayana Press |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare continuation rates between women who self-inject Sayana Press compared to women who receive Sayana Press injection from a provider
Discontinuation of Sayana Press measured at enrollment and every three months through one year
Measured: up to 12 months
Secondary outcomes (2)
To compare reported side effects between the two study groups
Women's reported side effects
Measured: up to 12 months
To compare pregnancy rates between the two study groups
Frequencies of pregnancies in the two groups reported during the final
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study start17 Sep 2015
- Primary completion27 Jan 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 735 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Holly Burke, Ph.D., Study director, FHI 360
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293694
- Sponsor's protocol ID
- 631917-1
- Status last verified
- Sep 2017
- First submitted
- 10 Nov 2014
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Burke HM, Chen M, Packer C, Fuchs R, Ngwira B. Young Women's Experiences With Subcutaneous Depot Medroxyprogesterone Acetate: A Secondary Analysis of a One-Year Randomized Trial in Malawi. J Adolesc Health. 2020 Nov;67(5):700-707. doi: 10.1016/j.jadohealth.2020.03.038. Epub 2020 May 7.
PubMed 32389457Burke HM, Chen M, Buluzi M, Fuchs R, Wevill S, Venkatasubramanian L, Dal Santo L, Ngwira B. Effect of self-administration versus provider-administered injection of subcutaneous depot medroxyprogesterone acetate on continuation rates in Malawi: a randomised controlled trial. Lancet Glob Health. 2018 May;6(5):e568-e578. doi: 10.1016/S2214-109X(18)30061-5. Epub 2018 Mar 8.
PubMed 29526707
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-month Open-label Randomized Controlled Trial to Evaluate Sayana® Press Suitability for at Home Subcutaneous Self-injection Procedures in Adult Women
- ClinicalTrials.gov ID
- NCT02293694
- Acronym / sponsor ID
- 631917-1
- Conditions
- Contraception
- Keywords
- DMPA-SC: depo medroxyprogesterone acetate sub-cutaneous, DMPA-IM: depo medroxyprogesterone acetate intramuscular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 735 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Study start
- 17 Sep 2015 (actual)
- Primary completion
- 27 Jan 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 18 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The feasibility of Sayana Press self-injection and the potential for this practice to increase contraceptive continuation has never been assessed in family planning programs in low-resource settings. The Malawi Ministry of Health (MOH) and the United States Agency for International Development (USAID) Malawi Mission requested the Advancing Partners and Communities (APC) project to assess self-injection of Sayana Press to inform their decision-making for procurement of Sayana Press and distribution through the health system in Malawi.
Detailed description
Sayana® Press is a subcutaneous formulation of depot medroxyprogesterone acetate (DMPA) in a prefilled, auto-disabled injection system called Uniject (Pfizer, Inc., USA). Sayana Press was registered with the Medicines and Health Care Products Regulatory Agency (MHRA) and several other national regulatory agencies. The addition of this method is anticipated to aid in improving provision of family planning services in low-resource settings. As such, Sayana Press could be particularly useful in a country such as Malawi where injectable contraception is the most common method used. DMPA clients and providers are ready to explore the potential of self-injection of Sayana Press. A study conducted in a large family planning clinic in Edinburgh, Scotland found self-administration of DMPA-SC feasible and associated with similar continuation rates and satisfaction to clinician-administered DMPA-IM. A non-comparison study conducted in Planned Parenthood clinics in Florida found continuation of self-injected DMPA-SC high (74%) at the fourth injection. Participants in this study reported the injection to be easy and convenient and were likely to recommend self-administration to other women. Moreover, on September 29, 2014 Pfizer submitted a request to the MHRA to change the Sayana Press label to include self-injection.
If self-injection is found feasible, the results from this research will inform self-injection training materials, messages for providers and clients, and future scale-up efforts in Malawi and elsewhere in sub-Saharan Africa.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| self-injection | Active comparator | Drug: Sayana PressWomen randomized to this arm will be trained to self-inject Sayana Press at home every three months |
| provider injection | Active comparator | Drug: Sayana PressWomen randomized to this arm will received Sayana press from a family planning provider every three months. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 18-40, inclusive
- In general good health (participant verbally reports she feels well)
- Able to understand and willing to sign an informed consent document
- Willing to give contact information for follow-up
- Agree to have follow-up visits/interviews
Key exclusion criteria (4 listed)
- 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) which in the opinion of the investigator would make study participation unsafe or would interfere with adherence to study requirements or complicate data interpretation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sayana PressAlso: depot medroxyprogesterone acetate (DMPA)Sayana® Press is a subcutaneous formulation of depot medroxyprogesterone acetate (DMPA) in a prefilled, auto-disabled injection system called Uniject | Drug | provider injection, self-injection |
Primary outcome
To compare continuation rates between women who self-inject Sayana Press compared to women who receive Sayana Press injection from a provider
Time frame: up to 12 months
Discontinuation of Sayana Press measured at enrollment and every three months through one year
2 secondary outcomes
To compare reported side effects between the two study groups
Time frame: up to 12 months
To compare pregnancy rates between the two study groups
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- Derived from this study: PubMed 32389457Burke HM, Chen M, Packer C, Fuchs R, Ngwira B. Young Women's Experiences With Subcutaneous Depot Medroxyprogesterone Acetate: A Secondary Analysis of a One-Year Randomized Trial in Malawi. J Adolesc Health. 2020 Nov;67(5):700-707. doi: 10.1016/j.jadohealth.2020.03.038. Epub 2020 May 7.
- Derived from this study: PubMed 29526707Burke HM, Chen M, Buluzi M, Fuchs R, Wevill S, Venkatasubramanian L, Dal Santo L, Ngwira B. Effect of self-administration versus provider-administered injection of subcutaneous depot medroxyprogesterone acetate on continuation rates in Malawi: a randomised controlled trial. Lancet Glob Health. 2018 May;6(5):e568-e578. doi: 10.1016/S2214-109X(18)30061-5. Epub 2018 Mar 8.
- Individual participant dataSharing planned: No
Related trials for Contraception
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Recruiting
Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
Contraceptive Behavior, Self Administration
Not yet recruitingPhase 3
Evaluation of the Contraceptive Efficacy and Safety of a New Concentration of an Antiandrogenic Progestogen Combined With a Reduced-Dose Estrogen (LUNA)
Contraception
Recruiting
Prospective Multi-Center Trial for FemBloc Permanent Birth Control
Contraception
RecruitingObservational study
Primitive Immunodeficiency, Intrauterine Devices and Menstrual Hygiene Products
Primary Immune Deficiency Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holly Burke, Ph.D. study director
FHI 360
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sayana Press in people with Contraception, run by FHI 360 at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare continuation rates between women who self-inject Sayana Press compared to women who receive Sayana Press injection from a provider (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02293694, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2017.