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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03255941
Other study ID # 4798-CHS-ERC-17
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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