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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| self-injection | Active Comparator | Women randomized to this arm will be trained to self-inject Sayana Press at home every three months |
|
| provider injection | Active Comparator | Women randomized to this arm will received Sayana press from a family planning provider every three months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sayana Press | Drug | Sayana® Press is a subcutaneous formulation of depot medroxyprogesterone acetate (DMPA) in a prefilled, auto-disabled injection system called Uniject |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| To compare reported side effects between the two study groups | Women's reported side effects | up to 12 months |
| To compare pregnancy rates between the two study groups | Frequencies of pregnancies in the two groups reported during the final |
| Measure | Description | Time Frame |
|---|---|---|
| To describe experiences of women who self-inject Sayana Press | Self-injectors' reported experiences (e.g., using, storing, and disposing of Sayana Press) | 12 months |
| To describe experiences and recommendations of family planning providers who train women to self-inject Sayana Press |
Inclusion Criteria:
Age 18-40, inclusive
Exclusion Criteria:
Pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Holly Burke, Ph.D. | FHI 360 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College of Medicine, Department of Community Health | Blantyre | Malawi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32389457 | Derived | 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. | |
| 29526707 | Derived | Burke 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. |
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|
| 12 months |
Providers' reported experiences and recommendations |
| 12 months |