An Early Phase 1 interventional study of DMPA and Sayana Press in Contraception, sponsored by FHI 360. Completed at 1 site in Pakistan. Open to female participants aged 15 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-13.
Sponsored by FHI 360 · Early Phase 1, Interventional, and Health services research
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.
FHI 360 is the lead sponsor of 59 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Urban Clinic Provider providing DMPA or Sayana Press
Drug: DMPA · Drug: Sayana Press
Urban Lay Provider providing DMPA or Sayana Press
Drug: DMPA · Drug: Sayana Press
Rural Clinic Provider providing DMPA or Sayana Press
Drug: DMPA · Drug: Sayana Press
Rural Lay Provider providing DMPA or Sayana Press
Drug: 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 DMPA.
The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press
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
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
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
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
| Milestone | Clinic Provider - Urban | Lay Provider - Urban | Clinic Provider - Rural | Lay Provider - Rural |
|---|---|---|---|---|
| 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 |
| Withdrew: Not eligible or refused injection | 37 | 44 | 5 | 6 |
| Withdrew: Did not complete exit interview | 1 | 2 | 0 | 0 |
Number of participants that were appropriately screened for injectable contraceptive use in both rural and urban settings in Pakistan.
| Participants | Clinic Provider - Urban | Lay Provider - Urban | Clinic Provider - Rural | Lay Provider - Rural |
|---|---|---|---|---|
| Screening appropriate | 155 | 136 | 49 | 51 |
| Screening not appropriate | 21 | 40 | 3 | 1 |
Number of participants that were appropriately counseled by both types of providers in both urban and rural settings.
| Participants | Clinic Providers - Urban | Lay Provider - Urban | Clinic Provider - Rural | Lay Provider - Rural |
|---|---|---|---|---|
| Counseling appropriate | 17 | 24 | 24 | 29 |
| Counseling not appropriate | 160 | 154 | 29 | 23 |
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.
| Participants | DMPA - IM Urban | DMPA - SC - Urban | DMPA-IM Rural | DMPA-SC- Rural |
|---|---|---|---|---|
| Proportion of Clients Providers Who Report Satisfaction With the DMPA Method Received From the Provider | 107 | 108 | 41 | 42 |
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.
| Participants | Clinic Provider - Urban | Lay Provider- Urban | Clinic Provider - Rural | Lay Provider - Rural |
|---|---|---|---|---|
| Proportion of Clients Who Report Satisfaction With Provider Services | 125 | 112 | 42 | 40 |
Collected over This study was cross-sectional; no adverse events data were collected.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lay Provider & DMPA | — | — | — |
| Lay Provider & Sayana Press | — | — | — |
| Clinic Provider & DMPA | — | — | — |
| Clinic Provider and Sayana Press | — | — | — |
| Age, Continuous(Years) | Clinic Provider Urban | Lay Provider Urban | Clinic Provider Rural | Lay Provider Rural | Total |
|---|---|---|---|---|---|
| Mean | 28.0 ± 5.4 | 27.1 ± 6.0 | 30.1 ± 30.1 | 29.7 ± 5.2 | 28.14 ± 5.6 |
| Sex: Female, Male(Participants) | Clinic Provider Urban | Lay Provider Urban | Clinic Provider Rural | Lay Provider Rural | Total |
|---|---|---|---|---|---|
| Female | 177 | 178 | 53 | 52 | 460 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Clinic Provider Urban | Lay Provider Urban | Clinic Provider Rural | Lay Provider Rural | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| Region of Enrollment(participants) | Clinic Provider Urban | Lay Provider Urban | Clinic Provider Rural | Lay Provider Rural | Total |
|---|---|---|---|---|---|
| Pakistan | 177 | 178 | 53 | 52 | 460 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in Jul 2018, 3 months.
Results were first posted in Apr 2021, 2 years 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Medroxyprogesterone Acetate
FHI 360