Clinical trial NCT03255941: Clinical Study of Depo Provera Comparing Lay Health Workers and Clinically-trained Health Workers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Contraception
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
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: Aga Khan University
name: Jhpiego
name: United States Agency for International Development (USAID)
name: Population Welfare Department, Government of Sindh, Pakistan
First posted: 2017-08-21
Enrollment: 460
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* Women who voluntarily accept DMPA

Exclusion Criteria:

* Women unable to provide informed consent
* Women with contraindications to DMPA
* Women who are pregnant

Primary outcomes:
measure: Number of Participants That Were Appropriately Screened for Contraceptive Use
timeFrame: 3 months from randomization
measure: Number of Participants That Were Appropriately Counseled for DMPA Use.
timeFrame: 3 months from randomization
Secondary outcomes:
measure: Proportion of Clients Providers Who Report Satisfaction With the DMPA Method Received From the Provider
timeFrame: 3 months from randomization
measure: Proportion of Clients Who Report Satisfaction With Provider Services
timeFrame: 3 months from randomization
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sindh
Study officials:
affiliation: FHI 360
name: Dawn S Chin-Quee, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: