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| Name | Class |
|---|---|
| Aga Khan University | OTHER |
| Jhpiego | OTHER |
| United States Agency for International Development (USAID) | FED |
| Population Welfare Department, Government of Sindh, Pakistan |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinic Provider - Urban | Active Comparator | Urban Clinic Provider providing DMPA or Sayana Press |
|
| Lay Provider - Urban | Active Comparator | Urban Lay Provider providing DMPA or Sayana Press |
|
| Clinic Provider- Rural | Active Comparator | Rural Clinic Provider providing DMPA or Sayana Press |
|
| Lay Provider- Rural | Active Comparator | Rural Lay Provider providing DMPA or Sayana Press |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DMPA | Drug | The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Were Appropriately Screened for Contraceptive Use | Number of participants that were appropriately screened for injectable contraceptive use in both rural and urban settings in Pakistan. | 3 months from randomization |
| Number of Participants That Were Appropriately Counseled for DMPA Use. | Number of participants that were appropriately counseled by both types of providers in both urban and rural settings. | 3 months from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Clients Providers Who Report Satisfaction With the DMPA Method Received From the Provider | 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. | 3 months from randomization |
| Proportion of Clients Who Report Satisfaction With Provider Services |
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Inclusion Criteria:
Exclusion Criteria:
Gender at birth
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| Name | Affiliation | Role |
|---|---|---|
| Dawn S Chin-Quee, PhD, MPH | FHI 360 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aga Khan University | Karachi | Sindh | Pakistan |
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461 participants were assessed for eligibility and 460 were randomized to a provider.
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| ID | Title | Description |
|---|---|---|
| FG000 | Clinic Provider - Urban | Family Welfare Workers that are clinically trained providers in the urban setting of Karachi |
| FG001 | Lay Provider - Urban | Lady Health Workers that are not clinically trained in the urban setting of Karachi |
| FG002 | Clinic Provider - Rural | Famly Welfare Workers that are clinically trained providers in the rural setting of Thatta |
| FG003 | Lay Provider - Rural | Lady Health Workers that are not clinically trained providers in the rural setting of Thatta |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clinic Provider 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. |
| BG001 | Lay Provider Urban |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants That Were Appropriately Screened for Contraceptive Use | Number of participants that were appropriately screened for injectable contraceptive use in both rural and urban settings in Pakistan. | Clients of lay providers or clinic providers who are screened appropriately for injectable contraceptive use | Posted | Count of Participants | Participants | 3 months from randomization |
|
This study was cross-sectional; no adverse events data were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lay Provider & DMPA | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mario Chen | FHI 360 | 919 544 7040 | 11399 | mchen@fhi360.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 22, 2017 | Jun 13, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 15, 2018 | Jun 13, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C050795 | N,N-dimethyl-4-anisidine |
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| UNKNOWN |
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.
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| Sayana Press | Drug | The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press |
|
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. |
| 3 months from randomization |
| Did not complete exit interview |
|
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. |
| BG002 | Clinic Provider 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 DMPA or Sayana Press. |
| BG003 | Lay Provider 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 DMPA or Sayana Press. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Only females as participants who accepted intramuscular or subcutaneous DMPA. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | There were 2 regions in Pakistan: Karachi which is urban and Thatta which is rural. | Number | participants |
|
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 |
| OG002 | Clinic Provider - Rural | 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 |
| OG003 | Lay Provider - Rural | 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 |
|
|
| Primary | Number of Participants That Were Appropriately Counseled for DMPA Use. | Number of participants that were appropriately counseled by both types of providers in both urban and rural settings. | Clients of lay and clinic providers who receive appropriate counseling for Injectable contraceptive use. | Posted | Count of Participants | Participants | 3 months from randomization |
|
|
|
| Secondary | Proportion of Clients Providers Who Report Satisfaction With the DMPA Method Received From the Provider | 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. | Clients of lay and clinic providers reports of satisfaction with the DMPA method received. | Posted | Count of Participants | Participants | 3 months from randomization |
|
|
|
| Secondary | Proportion of Clients Who Report Satisfaction With Provider Services | 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. | Clients of lay and clinic providers who report satisfaction with DMPA services provided by their provider. | Posted | Count of Participants | Participants | 3 months from randomization |
|
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|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Lay Provider & Sayana Press | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Clinic Provider & DMPA | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Clinic Provider and Sayana Press | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
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| Male |
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| Counseling not appropriate |
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