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

NCT03255941 | Completed Early Phase 1 Results

• 1 other identifier: 4798-CHS-ERC-17
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

FWW (Family Welfare Worker); LHW (Lady Health Worker); DMPA (Depot medroxyprogesterone acetate or Depo Provera); DMPA IM (Depo Provera intramuscular injection); SP (Sayana Press subcutaneous injection); Contraception; CBA2I (Community-based access to injectables); Sayana (Sayana Press); JHPIEGO (Johns Hopkins Program for International Education in Gynaecology and Obstetrics); Sayana

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Proportion of Clients Providers Who Report Satisfaction With the DMPA Method Received From the Provider

  3 months from randomization

• Proportion of Clients Who Report Satisfaction With Provider Services

  3 months from randomization

Study Arms (4)

Clinic Provider - Urban

ACTIVE COMPARATOR

Urban Clinic Provider providing DMPA or Sayana Press

Drug: DMPA; Drug: Sayana Press

Lay Provider - Urban

ACTIVE COMPARATOR

Urban Lay Provider providing DMPA or Sayana Press

Drug: DMPA; Drug: Sayana Press

Clinic Provider- Rural

ACTIVE COMPARATOR

Rural Clinic Provider providing DMPA or Sayana Press

Drug: DMPA; Drug: Sayana Press

Lay Provider- Rural

ACTIVE COMPARATOR

Rural Lay Provider providing DMPA or Sayana Press

Drug: DMPA; Drug: Sayana Press

Interventions

DMPA DRUG

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

Clinic Provider - Urban; Clinic Provider- Rural; Lay Provider - Urban; Lay Provider- Rural

Sayana Press DRUG

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

Clinic Provider - Urban; Clinic Provider- Rural; Lay Provider - Urban; Lay Provider- Rural

Eligibility Criteria

• Age: 15 Years - 49 Years
• Gender Eligibility Details: Gender at birth
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women who voluntarily accept DMPA

You may not qualify if:

• Women unable to provide informed consent
• Women with contraindications to DMPA
• Women who are pregnant

Sponsors & Collaborators

• FHI 360: lead
• Aga Khan University: collaborator
• Jhpiego: collaborator
• United States Agency for International Development (USAID): collaborator
• Population Welfare Department, Government of Sindh, Pakistan: collaborator

Study Sites (1)

Aga Khan University

Karachi, Sindh, Pakistan

Location

MeSH Terms

Interventions

N,N-dimethyl-4-anisidine

Results Point of Contact

• Title: Mario Chen
• Organization: FHI 360

mchen@fhi360.org

919 544 7040

Study Officials

• Dawn S Chin-Quee, PhD, MPH

  FHI 360

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Women who are new users of injectable contraception will be randomly assigned to receive services from an LHW or an FWW and will be randomly assigned to receive either intramuscular DMPA or the subcutaneous formulation, Sayana Press.

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: August 21, 2017
• Study Start: March 19, 2018
• Primary Completion: July 15, 2018
• Study Completion: July 23, 2018
• Last Updated: April 13, 2021
• Results First Posted: April 13, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)