Contraception Clinical Trial
Official title:
'A Randomized Controlled Trial of Safety and Effectiveness of Depo Provera Intramuscular and Subcutaneous Administration Comparing Lay Lady Health Workers With Clinically-trained Family Welfare Workers in Pakistan
Verified date | March 2021 |
Source | FHI 360 |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized controlled trial comparing lay Lady Health Workers (Lay Health Workers) with Family Welfare Workers (Clinically- trained Health Workers) on quantitative measures of safety and effectiveness of Depo Provera and Sayana Press provision in a clinic setting. This comparative trial will test the non-inferiority hypothesis that Lady Health Workers are just as competent as clinically-trained Family Welfare Workers in screening and counseling first-time injectable users. These first time users will also be randomly assigned to receive intramuscular or subcutaneous injections of DMPA.
Status | Completed |
Enrollment | 460 |
Est. completion date | July 23, 2018 |
Est. primary completion date | July 15, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 15 Years to 49 Years |
Eligibility | Inclusion Criteria: - Women who voluntarily accept DMPA Exclusion Criteria: - Women unable to provide informed consent - Women with contraindications to DMPA - Women who are pregnant |
Country | Name | City | State |
---|---|---|---|
Pakistan | Aga Khan University | Karachi | Sindh |
Lead Sponsor | Collaborator |
---|---|
FHI 360 | Aga Khan University, Jhpiego, Population Welfare Department, Government of Sindh, Pakistan, United States Agency for International Development (USAID) |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants That Were Appropriately Screened for Contraceptive Use | Number of participants that were appropriately screened for injectable contraceptive use in both rural and urban settings in Pakistan. | 3 months from randomization | |
Primary | Number of Participants That Were Appropriately Counseled for DMPA Use. | Number of participants that were appropriately counseled by both types of providers in both urban and rural settings. | 3 months from randomization | |
Secondary | Proportion of Clients Providers Who Report Satisfaction With the DMPA Method Received From the Provider | DMPA clients served by both types of providers in both urban and rural settings will report whether or not they were satisfied with the DMPA method provided to them. | 3 months from randomization | |
Secondary | Proportion of Clients Who Report Satisfaction With Provider Services | Clients who received intramuscular or subcutaneous DMPA injections will report whether or not they were satisfied with the services provided to them by their provider. | 3 months from randomization |
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