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

Early Phase 1

Completed

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.

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Clinic Provider - Urban	Sayana Press	Urban Clinic Provider providing DMPA or Sayana Press
Lay Provider - Urban	Sayana Press	Urban Lay Provider providing DMPA or Sayana Press
Clinic Provider- Rural	Sayana Press	Rural Clinic Provider providing DMPA or Sayana Press
Lay Provider- Rural	DMPA	Rural Lay Provider providing DMPA or Sayana Press
Lay Provider- Rural	Sayana Press	Rural Lay Provider providing DMPA or Sayana Press
Lay Provider - Urban	DMPA	Urban Lay Provider providing DMPA or Sayana Press
Clinic Provider- Rural	DMPA	Rural Clinic Provider providing DMPA or Sayana Press
Clinic Provider - Urban	DMPA	Urban Clinic Provider providing DMPA or Sayana Press

Primary Outcome Measures

Name	Time	Method
Number of Participants That Were Appropriately Screened for Contraceptive Use	3 months from randomization	Number of participants that were appropriately screened for injectable contraceptive use in both rural and urban settings in Pakistan.
Number of Participants That Were Appropriately Counseled for DMPA Use.	3 months from randomization	Number of participants that were appropriately counseled by both types of providers in both urban and rural settings.

Secondary Outcome Measures

Name	Time	Method
Proportion of Clients Who Report Satisfaction With Provider Services	3 months from randomization	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.
Proportion of Clients Providers Who Report Satisfaction With the DMPA Method Received From the Provider	3 months from randomization	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.