Clinical Study of Depo Provera Comparing Lay Health Workers and Clinically-trained Health Workers
Condition: Contraception
Study type: Interventional
Phase: Early Phase 1

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.
    

Intervention name(s): DMPA; Sayana Press
Intervention type(s): Drug; Drug
Intervention description(s): The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA.; The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Health Services Research
Keywords: 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