Clinical Study of Depo Provera Comparing Lay Health Workers and Clinically-trained Health Workers

• Status: Completed
• Trial end date: 2018-07-23
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: FHI 360
• Collaborators: Aga Khan University; Jhpiego; Population Welfare Department, Government of Sindh, Pakistan; United States Agency for International Development (USAID)
• Treatments: Medroxyprogesterone; Medroxyprogesterone Acetate

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