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

NCT03255941 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2021-04-13

Study results available
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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.

Conditions

  • Contraception

Interventions

DRUG

DMPA

The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA.

DRUG

Sayana Press

The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press

Sponsors & Collaborators

  • Aga Khan University

    collaborator OTHER

  • Jhpiego

    collaborator OTHER

  • United States Agency for International Development (USAID)

    collaborator FED

  • Population Welfare Department, Government of Sindh, Pakistan

    collaborator UNKNOWN

  • FHI 360

    lead OTHER

Principal Investigators

  • Dawn S Chin-Quee, PhD, MPH · FHI 360

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-19
Primary Completion
2018-07-15
Completion
2018-07-23

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03255941 on ClinicalTrials.gov