Early Phase 1
Completed N=460
Clinical Study of Depo Provera Comparing Lay Health Workers and Clinically-trained Health Workers
Contraception
Source: ClinicalTrials.gov NCT03255941 ↗
Enrolled (actual)
460
Serious AEs
—
Results posted
Apr 2021
Primary outcomePrimary: Number of Participants That Were Appropriately Screened for Contraceptive Use — 155; 136; 49; 51 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Were Appropriately Screened for Contraceptive Use |
155; 136; 49; 51; 21; 40 | — |
| PRIMARY Number of Participants That Were Appropriately Counseled for DMPA Use. |
17; 24; 24; 29; 160; 154 | — |
| SECONDARY Proportion of Clients Providers Who Report Satisfaction With the DMPA Method Received From the Provider |
107; 108; 41; 42 | — |
| SECONDARY Proportion of Clients Who Report Satisfaction With Provider Services |
125; 112; 42; 40 | — |
Eligibility Criteria
Inclusion Criteria
- Women who voluntarily accept DMPA
Exclusion Criteria
- Women unable to provide informed consent
- Women with contraindications to DMPA
- Women who are pregnant
Data sourced from ClinicalTrials.gov (NCT03255941). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.