Contraception
Conditions
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
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.
Interventions
DRUGDMPA
The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA.
DRUGSayana Press
The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press
Sponsors
Aga Khan University
Jhpiego
United States Agency for International Development (USAID)
Population Welfare Department, Government of Sindh, Pakistan
FHI 360
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 49 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Pakistan
Participant flow
Pre-assignment details
461 participants were assessed for eligibility and 460 were randomized to a provider.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 177 |
| Lay Provider 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 DMPA or Sayana Press. | 178 |
| 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. | 53 |
| 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. | 52 |
| Total | 460 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Did not complete exit interview | 1 | 2 | 0 | 0 |
| Overall Study | Not eligible or refused injection | 37 | 44 | 5 | 6 |
Baseline characteristics
| Characteristic | Lay Provider Urban | Clinic Provider Rural | Lay Provider Rural | Total | Clinic Provider Urban |
|---|---|---|---|---|---|
| Age, Continuous | 27.1 Years STANDARD_DEVIATION 6 | 30.1 Years STANDARD_DEVIATION 30.1 | 29.7 Years STANDARD_DEVIATION 5.2 | 28.14 Years STANDARD_DEVIATION 5.6 | 28.0 Years STANDARD_DEVIATION 5.4 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants | — |
| Region of Enrollment Pakistan | 178 participants | 53 participants | 52 participants | 460 participants | 177 participants |
| Sex: Female, Male Female | 178 Participants | 53 Participants | 52 Participants | 460 Participants | 177 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 3 months from randomization
Population: Clients of lay and clinic providers who receive appropriate counseling for Injectable contraceptive use.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Clinic Provider - Urban | Number of Participants That Were Appropriately Counseled for DMPA Use. | Counseling not appropriate | 160 Participants |
| Clinic Provider - Urban | Number of Participants That Were Appropriately Counseled for DMPA Use. | Counseling appropriate | 17 Participants |
| Lay Provider - Urban | Number of Participants That Were Appropriately Counseled for DMPA Use. | Counseling not appropriate | 154 Participants |
| Lay Provider - Urban | Number of Participants That Were Appropriately Counseled for DMPA Use. | Counseling appropriate | 24 Participants |
| Clinic Provider - Rural | Number of Participants That Were Appropriately Counseled for DMPA Use. | Counseling not appropriate | 29 Participants |
| Clinic Provider - Rural | Number of Participants That Were Appropriately Counseled for DMPA Use. | Counseling appropriate | 24 Participants |
| Lay Provider - Rural | Number of Participants That Were Appropriately Counseled for DMPA Use. | Counseling appropriate | 29 Participants |
| Lay Provider - Rural | Number of Participants That Were Appropriately Counseled for DMPA Use. | Counseling not appropriate | 23 Participants |
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.
Time frame: 3 months from randomization
Population: Clients of lay providers or clinic providers who are screened appropriately for injectable contraceptive use
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Clinic Provider - Urban | Number of Participants That Were Appropriately Screened for Contraceptive Use | Screening appropriate | 155 Participants |
| Clinic Provider - Urban | Number of Participants That Were Appropriately Screened for Contraceptive Use | Screening not appropriate | 21 Participants |
| Lay Provider - Urban | Number of Participants That Were Appropriately Screened for Contraceptive Use | Screening appropriate | 136 Participants |
| Lay Provider - Urban | Number of Participants That Were Appropriately Screened for Contraceptive Use | Screening not appropriate | 40 Participants |
| Clinic Provider - Rural | Number of Participants That Were Appropriately Screened for Contraceptive Use | Screening not appropriate | 3 Participants |
| Clinic Provider - Rural | Number of Participants That Were Appropriately Screened for Contraceptive Use | Screening appropriate | 49 Participants |
| Lay Provider - Rural | Number of Participants That Were Appropriately Screened for Contraceptive Use | Screening not appropriate | 1 Participants |
| Lay Provider - Rural | Number of Participants That Were Appropriately Screened for Contraceptive Use | Screening appropriate | 51 Participants |
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.
Time frame: 3 months from randomization
Population: Clients of lay and clinic providers reports of satisfaction with the DMPA method received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinic Provider - Urban | Proportion of Clients Providers Who Report Satisfaction With the DMPA Method Received From the Provider | 107 Participants |
| Lay Provider - Urban | Proportion of Clients Providers Who Report Satisfaction With the DMPA Method Received From the Provider | 108 Participants |
| Clinic Provider - Rural | Proportion of Clients Providers Who Report Satisfaction With the DMPA Method Received From the Provider | 41 Participants |
| Lay Provider - Rural | Proportion of Clients Providers Who Report Satisfaction With the DMPA Method Received From the Provider | 42 Participants |
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.
Time frame: 3 months from randomization
Population: Clients of lay and clinic providers who report satisfaction with DMPA services provided by their provider.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinic Provider - Urban | Proportion of Clients Who Report Satisfaction With Provider Services | 125 Participants |
| Lay Provider - Urban | Proportion of Clients Who Report Satisfaction With Provider Services | 112 Participants |
| Clinic Provider - Rural | Proportion of Clients Who Report Satisfaction With Provider Services | 42 Participants |
| Lay Provider - Rural | Proportion of Clients Who Report Satisfaction With Provider Services | 40 Participants |