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

FHI 360

Status and phase: Completed; Early Phase 1

Conditions: Contraception

Treatments: Drug: DMPA; Drug: Sayana Press

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03255941

4798-CHS-ERC-17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 460 patients

Sex: Female

Ages: 15 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women who voluntarily accept DMPA

Exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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460 participants in 4 patient groups

Clinic Provider - Urban

Active Comparator group

Description:

Urban Clinic Provider providing DMPA or Sayana Press

Treatment:

Drug: Sayana Press

Drug: DMPA

Lay Provider - Urban

Active Comparator group

Description:

Urban Lay Provider providing DMPA or Sayana Press

Treatment:

Drug: Sayana Press

Drug: DMPA

Clinic Provider- Rural

Active Comparator group

Description:

Rural Clinic Provider providing DMPA or Sayana Press

Treatment:

Drug: Sayana Press

Drug: DMPA

Lay Provider- Rural

Active Comparator group

Description:

Rural Lay Provider providing DMPA or Sayana Press

Treatment:

Drug: Sayana Press

Drug: DMPA