drugset / Trial / NCT03255941
Clinical Study of Depo Provera Comparing Lay Health Workers and Clinically-trained Health Workers
Phase 0
Completed
460 enrolled
FHI 360
Aga Khan University · collabJhpiego · collabPopulation Welfare Department, Government of Sindh, Pakistan · collabUnited States Agency for International Development (USAID) · collab
RandomizedParallel-groupOpen-labelHealth-services research
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.
Timeline
- Start
- 2018-03-19
- Primary completion
- 2018-07-15
- Completion
- 2018-07-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | DMPA | Unknown | — | Intramuscular |
Indications
No indication recorded.