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

• Sponsor: FHI 360 (Other)
• Overall Status: Completed
• CT.gov ID: NCT03255941
• Collaborator: Aga Khan University (Other), Jhpiego (Other), United States Agency for International Development (USAID) (U.S. Fed), Population Welfare Department, Government of Sindh, Pakistan (Other)
• Enrollment: 460
• Location: 1
• Arms: 4
• Actual Duration (Months): 4.1
• Patients Per Site Per Month: 111.1

Study Details

Study Description

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.

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 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 460 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 FWW and will be randomly assigned to receive either intramuscular DMPA or the subcutaneous formulation, Sayana Press.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
• 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
• Actual Study Start Date: Mar 19, 2018
• Actual Primary Completion Date: Jul 15, 2018
• Actual Study Completion Date: Jul 23, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Clinic Provider - Urban Urban Clinic Provider providing DMPA or Sayana Press	Drug: DMPA; The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA.; 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: Lay Provider - Urban Urban Lay Provider providing DMPA or Sayana Press	Drug: DMPA; The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA.; 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- Rural Rural Clinic Provider providing DMPA or Sayana Press	Drug: DMPA; The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA.; 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: Lay Provider- Rural Rural Lay Provider providing DMPA or Sayana Press	Drug: DMPA; The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA.; 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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 49 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Women who voluntarily accept DMPA

Exclusion Criteria:

• Women unable to provide informed consent

• Women with contraindications to DMPA

• Women who are pregnant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aga Khan University	Karachi	Sindh	Pakistan

Sponsors and Collaborators

• FHI 360
• Aga Khan University
• Jhpiego
• United States Agency for International Development (USAID)
• Population Welfare Department, Government of Sindh, Pakistan

Investigators

• Principal Investigator: Dawn S Chin-Quee, PhD, MPH, FHI 360

Study Documents (Full-Text)

• Study Protocol - Sep 22, 2017
• Statistical Analysis Plan - Aug 15, 2018

More Information

Publications

None provided.

• Responsible Party: FHI 360
• ClinicalTrials.gov Identifier: NCT03255941
• Other Study ID Numbers: 4798-CHS-ERC-17
• First Posted: Aug 21, 2017
• Last Update Posted: Apr 13, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by FHI 360: 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

Study Results

Participant Flow

Pre-assignment Detail	461 participants were assessed for eligibility and 460 were randomized to a provider.

Arm/Group Title	Clinic Provider - Urban	Lay Provider - Urban	Clinic Provider - Rural	Lay Provider - Rural
Arm/Group Description	Family Welfare Workers that are clinically trained providers in the urban setting of Karachi	Lady Health Workers that are not clinically trained in the urban setting of Karachi	Famly Welfare Workers that are clinically trained providers in the rural setting of Thatta	Lady Health Workers that are not clinically trained providers in the rural setting of Thatta
Period Title: Overall Study
STARTED	177	178	53	52
Deemed Eligible to Receive DMPA	140	134	48	46
COMPLETED	139	132	48	46
NOT COMPLETED	38	46	5	6

Baseline Characteristics

Arm/Group Title	Clinic Provider Urban	Lay Provider Urban	Clinic Provider Rural	Lay Provider Rural	Total
Arm/Group Description	Clinic provider providing DMPA or Sayana Press The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA or Sayana Press.	Lay Provider providing DMPA or Sayana Press The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA or Sayana Press.	Clinic provider providing DMPA or Sayana Press The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA or Sayana Press.	Clinic provider providing DMPA or Sayana Press The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA or Sayana Press.	Total of all reporting groups
Overall Participants	177	178	53	52	460
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	28.0 (5.4)	27.1 (6.0)	30.1 (30.1)	29.7 (5.2)	28.14 (5.6)
Sex: Female, Male (Count of Participants)
Female	177 100%	178 100%	53 100%	52 100%	460 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Pakistan	177 100%	178 100%	53 100%	52 100%	460 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants That Were Appropriately Screened for Contraceptive Use
Description	Number of participants that were appropriately screened for injectable contraceptive use in both rural and urban settings in Pakistan.
Time Frame	3 months from randomization

Outcome Measure Data

Analysis Population Description

Clients of lay providers or clinic providers who are screened appropriately for injectable contraceptive use

Arm/Group Title	Clinic Provider - Urban	Lay Provider - Urban	Clinic Provider - Rural	Lay Provider - Rural
Arm/Group Description	Urban Clinic Provider providing DMPA or Sayana Press The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA or Sayana Press.	Urban Lay Provider providing DMPA or 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 or DMPA	Rural Clinic Provider providing DMPA or 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 or DMPA	Rural Lay Provider providing DMPA or 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 or DMPA
Measure Participants	176	176	52	52
Screening appropriate	155 87.6%	136 76.4%	49 92.5%	51 98.1%
Screening not appropriate	21 11.9%	40 22.5%	3 5.7%	1 1.9%

2. Primary Outcome

Title	Number of Participants That Were Appropriately Counseled for DMPA Use.
Description	Number of participants that were appropriately counseled by both types of providers in both urban and rural settings.
Time Frame	3 months from randomization

Outcome Measure Data

Analysis Population Description

Clients of lay and clinic providers who receive appropriate counseling for Injectable contraceptive use.

Arm/Group Title	Clinic Providers - Urban	Lay Provider - Urban	Clinic Provider - Rural	Lay Provider - Rural
Arm/Group Description	Appropriateness of counseling by Urban Clinic providers.	Appropriateness of counseling by Urban Lay providers.	Appropriateness of counseling by Rural Clinical Providers	Appropriateness of counseling by Rural Lay Providers
Measure Participants	177	178	53	52
Counseling appropriate	17 9.6%	24 13.5%	24 45.3%	29 55.8%
Counseling not appropriate	160 90.4%	154 86.5%	29 54.7%	23 44.2%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Clients of lay and clinic providers reports of satisfaction with the DMPA method received.

Arm/Group Title	DMPA - IM Urban	DMPA - SC - Urban	DMPA-IM Rural	DMPA-SC- Rural
Arm/Group Description	Provider providing DMPA- Intra muscular Proportion of clients highly satisfied with their DMPA Method	Provider providing DMPA - sub cutaneous Prop[portion of clients highly satisfied with the DMPA method provided to them	Provider providing DMPA- Intra muscular Proportion of clients highly satisfied with their DMPA Method	Provider providing DMPA - sub cutaneous Prop[portion of clients highly satisfied with the DMPA method provided to them
Measure Participants	135	139	45	49
Count of Participants [Participants]	107 60.5%	108 60.7%	41 77.4%	42 80.8%

4. Secondary Outcome

Title	Proportion of Clients Who Report Satisfaction With Provider Services
Description	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.
Time Frame	3 months from randomization

Outcome Measure Data

Analysis Population Description

Clients of lay and clinic providers who report satisfaction with DMPA services provided by their provider.

Arm/Group Title	Clinic Provider - Urban	Lay Provider- Urban	Clinic Provider - Rural	Lay Provider - Rural
Arm/Group Description	Urban Clinic provider providing DMPA services	Urban Lay provider providing DMPA services	Rural Clinic provider providing DMPA services	Lay rural provider providing DMPA services
Measure Participants	139	132	48	46
Count of Participants [Participants]	125 70.6%	112 62.9%	42 79.2%	40 76.9%

Adverse Events

Time Frame	This study was cross-sectional; no adverse events data were collected.
Arm/Group Title	Lay Provider & DMPA		Lay Provider & Sayana Press		Clinic Provider & DMPA		Clinic Provider and Sayana Press
Arm/Group Description	Lay provider providing DMPA DMPA: The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA.		Lay Provider providing Sayana Press 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		Clinic provider providing DMPA DMPA: The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA.		Clinic provider providing Sayana Press 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
All Cause Mortality
	Lay Provider & DMPA		Lay Provider & Sayana Press		Clinic Provider & DMPA		Clinic Provider and Sayana Press
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Lay Provider & DMPA		Lay Provider & Sayana Press		Clinic Provider & DMPA		Clinic Provider and Sayana Press
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Lay Provider & DMPA		Lay Provider & Sayana Press		Clinic Provider & DMPA		Clinic Provider and Sayana Press
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.