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

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ClinicalTrials.gov Identifier: NCT03255941
Recruitment Status : Completed
First Posted : August 21, 2017
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Aga Khan University
Jhpiego
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
FHI 360

Brief Summary:
This is a randomized controlled trial comparing lay Lady Health Workers with Lady Health Visitors 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 Lady Health Visitors 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.

Condition or disease Intervention/treatment Phase
Contraception Drug: DMPA Drug: Sayana Press Early Phase 1

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 Lady Health Visitors (LHVs) 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 LHVs 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 LHVs 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 461 participants
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 LHV 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
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 Lady Health Visitors in Pakistan
Actual Study Start Date : March 19, 2018
Actual Primary Completion Date : July 15, 2018
Actual Study Completion Date : July 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Active Comparator: Lay provider & DMPA
Lay provider providing DMPA
Drug: DMPA
The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA.

Active Comparator: Lay provider & Sayana Press
Lay Provider providing Sayana Press
Drug: Sayana Press
The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press

Active Comparator: Clinic provider & DMPA
Clinic provider providing DMPA
Drug: DMPA
The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA.

Active Comparator: Clinic provider and Sayana Press
Clinic provider providing Sayana Press
Drug: Sayana Press
The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press




Primary Outcome Measures :
  1. Proportion of lay providers versus proportion of clinic providers that appropriately screen women for contraceptive use [ Time Frame: 3 months from randomization ]
    Both types of providers will be observed to determine whether or not they screen DMPA clients per protocol.

  2. Proportion of lay providers versus proportion of clinic providers that demonstrate appropriate injection technique. [ Time Frame: 3 months from randomization ]
    Both types of providers will be observed to determine whether or not they perform the steps laid out in checklists for DMPA intramuscular and subcutaneous (Sayana Press) injections.


Secondary Outcome Measures :
  1. Proportion of clients providers who report satisfaction with the services received from the provider [ Time Frame: 3 months from randomization ]
    DMPA clients served by both types of providers will report whether or not they were generally satisfied with the DMPA services provided to them.

  2. Proportion of clients who report satisfaction with DMPA [ Time Frame: 3 months from randomization ]
    Clients who received intramuscular or subcutaneous DMPA injections will report whether or not they were satisfied with the contraceptive method provided to them.



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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Gender at birth
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03255941


Locations
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Pakistan
Aga Khan University
Karachi, Sindh, Pakistan
Sponsors and Collaborators
FHI 360
Aga Khan University
Jhpiego
United States Agency for International Development (USAID)
Investigators
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Principal Investigator: Dawn S Chin-Quee, PhD, MPH FHI 360

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Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT03255941     History of Changes
Other Study ID Numbers: 4798-CHS-ERC-17
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by FHI 360:
LHV (Lady Health Visitor)
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
Additional relevant MeSH terms:
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Medroxyprogesterone Acetate
Medroxyprogesterone
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral