Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2026-03-02 @ 4:05 AM
Study NCT ID:
NCT02293694
Status:
COMPLETED
Last Update Posted:
2017-09-18
First Post:
2014-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sayana® Press Self-injection Study in Malawi
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 735}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-15', 'studyFirstSubmitDate': '2014-11-10', 'studyFirstSubmitQcDate': '2014-11-14', 'lastUpdatePostDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To describe experiences of women who self-inject Sayana Press', 'timeFrame': '12 months', 'description': "Self-injectors' reported experiences (e.g., using, storing, and disposing of Sayana Press)"}, {'measure': 'To describe experiences and recommendations of family planning providers who train women to self-inject Sayana Press', 'timeFrame': '12 months', 'description': "Providers' reported experiences and recommendations"}], 'primaryOutcomes': [{'measure': 'To compare continuation rates between women who self-inject Sayana Press compared to women who receive Sayana Press injection from a provider', 'timeFrame': 'up to 12 months', 'description': 'Discontinuation of Sayana Press measured at enrollment and every three months through one year'}], 'secondaryOutcomes': [{'measure': 'To compare reported side effects between the two study groups', 'timeFrame': 'up to 12 months', 'description': "Women's reported side effects"}, {'measure': 'To compare pregnancy rates between the two study groups', 'timeFrame': '12 months', 'description': 'Frequencies of pregnancies in the two groups reported during the final'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['DMPA-SC: depo medroxyprogesterone acetate sub-cutaneous', 'DMPA-IM: depo medroxyprogesterone acetate intramuscular'], 'conditions': ['Contraception']}, 'referencesModule': {'references': [{'pmid': '32389457', 'type': 'DERIVED', 'citation': "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."}, {'pmid': '29526707', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIf 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge 18-40, inclusive\n\n* In general good health (participant verbally reports she feels well)\n* Able to understand and willing to sign an informed consent document\n* Willing to give contact information for follow-up\n* Agree to have follow-up visits/interviews\n* Willing to be randomized to the self-injection arm or provider-administered injection arm\n* Menstrual period started within the past 7 days (for new DMPA users)\n* Meet eligibility criteria for receiving DMPA per WHO Medical Eligibility Criteria (MEC)\n\nExclusion Criteria:\n\nPregnancy\n\n* Plans to become pregnant in the next 12 months\n* Plans to relocate outside the study area in the next 12 months\n* 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'}, 'identificationModule': {'nctId': 'NCT02293694', 'briefTitle': 'Sayana® Press Self-injection Study in Malawi', 'organization': {'class': 'OTHER', 'fullName': 'FHI 360'}, 'officialTitle': 'A 12-month Open-label Randomized Controlled Trial to Evaluate Sayana® Press Suitability for at Home Subcutaneous Self-injection Procedures in Adult Women', 'orgStudyIdInfo': {'id': '631917-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'self-injection', 'description': 'Women randomized to this arm will be trained to self-inject Sayana Press at home every three months', 'interventionNames': ['Drug: Sayana Press']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'provider injection', 'description': 'Women randomized to this arm will received Sayana press from a family planning provider every three months.', 'interventionNames': ['Drug: Sayana Press']}], 'interventions': [{'name': 'Sayana Press', 'type': 'DRUG', 'otherNames': ['depot medroxyprogesterone acetate (DMPA)'], 'description': 'Sayana® Press is a subcutaneous formulation of depot medroxyprogesterone acetate (DMPA) in a prefilled, auto-disabled injection system called Uniject', 'armGroupLabels': ['provider injection', 'self-injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Blantyre', 'country': 'Malawi', 'facility': 'College of Medicine, Department of Community Health', 'geoPoint': {'lat': -15.78499, 'lon': 35.00854}}], 'overallOfficials': [{'name': 'Holly Burke, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'FHI 360'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FHI 360', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}