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

'A Randomized Controlled Trial of Safety and Effectiveness of Depo Provera Intramuscular and Subcutaneous Administration Comparing Lay Lady Health Workers With Clinically-trained Family Welfare Workers in Pakistan

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: DMPA; Drug: Sayana Press

Detailed Description

FHI 360 and Jhpiego in collaboration with USAID, Aga Khan University (AKU) and the Government of Sindh province propose a randomized controlled trial (RCT) to provide evidence that could change current policies in Pakistan that forbid initiation of DMPA by Lady Health Workers (LHWs). Positive findings on the safety and effectiveness of LHW-initiation of DMPA may also prompt the WHO to consider modifying the recommendation for targeted M&E for lay health worker provision of intramuscular injectable contraceptives. The trial will compare the screening and counseling of (LHWs)-the main lay health worker cadre--with that of Family Welfare Workers (FWWs) who are clinically-trained. The Government of Sindh province also expressed interest in introducing Pfizer's subcutaneous form of Depo Provera, Sayana Press® (SP) in Pakistan, which could simplify administration of injectable contraceptives. As such, an SP arm will be included in the trial, which will be facilitated by relevant training of LHWs and FWWs by Jhpiego and stocks provided by a special USAID procurement, since the registration process for SP in Pakistan is ongoing. A successful RCT demonstrating the non-inferiority of LHWs vis á vis FWWs on first-dose initiation of Depo Provera IM (DMPA IM) and (SP) would facilitate efforts to expand CBA2I in Pakistan, and in turn improve access to family planning services for a potentially large number of underserved women.

• Study Type: Interventional
• Enrollment (Actual): 460
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Aga Khan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 49 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women who voluntarily accept DMPA

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Clinic Provider - Urban; Urban Clinic Provider providing DMPA or Sayana Press	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
ACTIVE_COMPARATOR: Lay Provider - Urban; Urban Lay Provider providing DMPA or Sayana Press	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
ACTIVE_COMPARATOR: Clinic Provider- Rural; Rural Clinic Provider providing DMPA or Sayana Press	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
ACTIVE_COMPARATOR: Lay Provider- Rural; Rural Lay Provider providing DMPA or Sayana Press	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Clients Providers Who Report Satisfaction With the DMPA Method Received From the Provider	DMPA clients served by both types of providers in both urban and rural settings will report whether or not they were satisfied with the DMPA method provided to them.	3 months from randomization
Proportion of Clients Who Report Satisfaction With Provider Services	Clients who received intramuscular or subcutaneous DMPA injections will report whether or not they were satisfied with the services provided to them by their provider.	3 months from randomization

Collaborators and Investigators

• Sponsor: FHI 360
• Collaborators: United States Agency for International Development (USAID); Aga Khan University; Jhpiego; Population Welfare Department, Government of Sindh, Pakistan
• Investigators: Principal Investigator: Dawn S Chin-Quee, PhD, MPH, FHI 360

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 19, 2018
• Primary Completion (ACTUAL): July 15, 2018
• Study Completion (ACTUAL): July 23, 2018

Study Registration Dates

• First Submitted: July 19, 2017
• First Submitted That Met QC Criteria: August 17, 2017
• First Posted (ACTUAL): August 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 13, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Contraception; Sayana; 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); CBA2I (Community-based access to injectables); Sayana (Sayana Press); JHPIEGO (Johns Hopkins Program for International Education in Gynaecology and Obstetrics)
• Other Study ID Numbers: 4798-CHS-ERC-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No