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

Contraception Clinical Trial

Official title:

'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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03255941
• Other study ID #: 4798-CHS-ERC-17
• Status: Completed
• Phase: Early Phase 1
• Start date: March 19, 2018
• Est. completion date: July 23, 2018

Study information

• Verified date: March 2021
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: July 23, 2018
• Est. primary completion date: July 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

Inclusion Criteria:

• Women who voluntarily accept DMPA

Exclusion Criteria:

• Women unable to provide informed consent

• Women with contraindications to DMPA

• Women who are pregnant

Related Conditions & MeSH terms

• Contraception

Intervention

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

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi	Sindh

Sponsors (5)

Lead Sponsor	Collaborator
FHI 360	Aga Khan University, Jhpiego, Population Welfare Department, Government of Sindh, Pakistan, United States Agency for International Development (USAID)

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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