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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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'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

Conditions
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Contraception

Intervention / Treatment
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* Drug: DMPA
* Drug: Sayana Press


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who voluntarily accept DMPA Exclusion Criteria: Women unable to provide informed consent Women with contraindications to DMPA Women who are pregnant

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clinic Provider - Urban<br>Urban Clinic Provider providing DMPA or Sayana Press | Drug: DMPA<br>* The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA.<br>Drug: Sayana Press<br>* The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press<br>|
| Active Comparator: Lay Provider - Urban<br>Urban Lay Provider providing DMPA or Sayana Press | Drug: DMPA<br>* The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA.<br>Drug: Sayana Press<br>* The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press<br>|
| Active Comparator: Clinic Provider- Rural<br>Rural Clinic Provider providing DMPA or Sayana Press | Drug: DMPA<br>* The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA.<br>Drug: Sayana Press<br>* The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press<br>|
| Active Comparator: Lay Provider- Rural<br>Rural Lay Provider providing DMPA or Sayana Press | Drug: DMPA<br>* The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA.<br>Drug: Sayana Press<br>* The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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