Trial Outcomes & Findings for Clinical Study of Depo Provera Comparing Lay Health Workers and Clinically-trained Health Workers (NCT NCT03255941)
NCT ID: NCT03255941
Last Updated: 2021-04-13
Results Overview
Number of participants that were appropriately screened for injectable contraceptive use in both rural and urban settings in Pakistan.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
460 participants
Primary outcome timeframe
3 months from randomization
Results posted on
2021-04-13
Participant Flow
461 participants were assessed for eligibility and 460 were randomized to a provider.
Participant milestones
| Measure |
Clinic Provider - Urban
Family Welfare Workers that are clinically trained providers in the urban setting of Karachi
|
Lay Provider - Urban
Lady Health Workers that are not clinically trained in the urban setting of Karachi
|
Clinic Provider - Rural
Famly Welfare Workers that are clinically trained providers in the rural setting of Thatta
|
Lay Provider - Rural
Lady Health Workers that are not clinically trained providers in the rural setting of Thatta
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
177
|
178
|
53
|
52
|
|
Overall Study
Deemed Eligible to Receive DMPA
|
140
|
134
|
48
|
46
|
|
Overall Study
COMPLETED
|
139
|
132
|
48
|
46
|
|
Overall Study
NOT COMPLETED
|
38
|
46
|
5
|
6
|
Reasons for withdrawal
| Measure |
Clinic Provider - Urban
Family Welfare Workers that are clinically trained providers in the urban setting of Karachi
|
Lay Provider - Urban
Lady Health Workers that are not clinically trained in the urban setting of Karachi
|
Clinic Provider - Rural
Famly Welfare Workers that are clinically trained providers in the rural setting of Thatta
|
Lay Provider - Rural
Lady Health Workers that are not clinically trained providers in the rural setting of Thatta
|
|---|---|---|---|---|
|
Overall Study
Not eligible or refused injection
|
37
|
44
|
5
|
6
|
|
Overall Study
Did not complete exit interview
|
1
|
2
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Clinic Provider Urban
n=177 Participants
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 Urban
n=178 Participants
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 Rural
n=53 Participants
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 Rural
n=52 Participants
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
n=460 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
28.0 Years
STANDARD_DEVIATION 5.4 • n=177 Participants
|
27.1 Years
STANDARD_DEVIATION 6.0 • n=178 Participants
|
30.1 Years
STANDARD_DEVIATION 30.1 • n=53 Participants
|
29.7 Years
STANDARD_DEVIATION 5.2 • n=52 Participants
|
28.14 Years
STANDARD_DEVIATION 5.6 • n=460 Participants
|
|
Sex: Female, Male
Female
|
177 Participants
n=177 Participants
|
178 Participants
n=178 Participants
|
53 Participants
n=53 Participants
|
52 Participants
n=52 Participants
|
460 Participants
n=460 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=177 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=460 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Pakistan
|
177 participants
n=177 Participants
|
178 participants
n=178 Participants
|
53 participants
n=53 Participants
|
52 participants
n=52 Participants
|
460 participants
n=460 Participants
|
PRIMARY outcome
Timeframe: 3 months from randomizationPopulation: Clients of lay providers or clinic providers who are screened appropriately for injectable contraceptive use
Number of participants that were appropriately screened for injectable contraceptive use in both rural and urban settings in Pakistan.
Outcome measures
| Measure |
Clinic Provider - Urban
n=176 Participants
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.
|
Lay Provider - Urban
n=176 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
|
Clinic Provider - Rural
n=52 Participants
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
|
Lay Provider - Rural
n=52 Participants
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
|
|---|---|---|---|---|
|
Number of Participants That Were Appropriately Screened for Contraceptive Use
Screening appropriate
|
155 Participants
|
136 Participants
|
49 Participants
|
51 Participants
|
|
Number of Participants That Were Appropriately Screened for Contraceptive Use
Screening not appropriate
|
21 Participants
|
40 Participants
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 3 months from randomizationPopulation: Clients of lay and clinic providers who receive appropriate counseling for Injectable contraceptive use.
Number of participants that were appropriately counseled by both types of providers in both urban and rural settings.
Outcome measures
| Measure |
Clinic Provider - Urban
n=177 Participants
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.
|
Lay Provider - Urban
n=178 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
|
Clinic Provider - Rural
n=53 Participants
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
|
Lay Provider - Rural
n=52 Participants
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
|
|---|---|---|---|---|
|
Number of Participants That Were Appropriately Counseled for DMPA Use.
Counseling not appropriate
|
160 Participants
|
154 Participants
|
29 Participants
|
23 Participants
|
|
Number of Participants That Were Appropriately Counseled for DMPA Use.
Counseling appropriate
|
17 Participants
|
24 Participants
|
24 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 3 months from randomizationPopulation: Clients of lay and clinic providers reports of satisfaction with the DMPA method received.
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.
Outcome measures
| Measure |
Clinic Provider - Urban
n=135 Participants
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.
|
Lay Provider - Urban
n=139 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
|
Clinic Provider - Rural
n=45 Participants
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
|
Lay Provider - Rural
n=49 Participants
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
|
|---|---|---|---|---|
|
Proportion of Clients Providers Who Report Satisfaction With the DMPA Method Received From the Provider
|
107 Participants
|
108 Participants
|
41 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: 3 months from randomizationPopulation: Clients of lay and clinic providers who report satisfaction with DMPA services provided by their provider.
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.
Outcome measures
| Measure |
Clinic Provider - Urban
n=139 Participants
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.
|
Lay Provider - Urban
n=132 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
|
Clinic Provider - Rural
n=48 Participants
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
|
Lay Provider - Rural
n=46 Participants
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
|
|---|---|---|---|---|
|
Proportion of Clients Who Report Satisfaction With Provider Services
|
125 Participants
|
112 Participants
|
42 Participants
|
40 Participants
|
Adverse Events
Lay Provider & DMPA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lay Provider & Sayana Press
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clinic Provider & DMPA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clinic Provider and Sayana Press
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place