ContraceptionEarly Phase 1NCT03255941
Clinical Study of Depo Provera Comparing Lay Health Workers and Clinically-trained Health Workers
A Early Phase 1 study testing DMPA and Sayana Press in people with Contraception, run by FHI 360 at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- DMPA and Sayana Press
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 sitePakistan
- Study dates
- 19 Mar 2018to 23 Jul 2018
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Women who voluntarily accept DMPA
Who cannot join
- Women unable to provide informed consent
- Women with contraindications to DMPA
- Women who are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Contraception
- Being tested
- DMPA, Sayana Press
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMPADrug
The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA.
Sayana PressDrug
The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press
| Study group | Role | What they receive |
|---|---|---|
| Clinic Provider - Urban | Active comparator | Urban Clinic Provider providing DMPA or Sayana Press Receives: Drug: DMPA; Drug: Sayana Press |
| Lay Provider - Urban | Active comparator | Urban Lay Provider providing DMPA or Sayana Press Receives: Drug: DMPA; Drug: Sayana Press |
| Clinic Provider- Rural | Active comparator | Rural Clinic Provider providing DMPA or Sayana Press Receives: Drug: DMPA; Drug: Sayana Press |
| Lay Provider- Rural | Active comparator | Rural Lay Provider providing DMPA or Sayana Press Receives: Drug: DMPA; Drug: Sayana Press |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months from randomization
Secondary outcomes (2)
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.
Measured: 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.
Measured: 3 months from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start19 Mar 2018
- Primary completion15 Jul 2018
- Study completion23 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- Aga Khan University, Jhpiego, United States Agency for International Development (USAID), Population Welfare Department, Government of Sindh, Pakistan
- Responsible party
- Sponsor
- Investigators
- Dawn S Chin-Quee, PhD, MPH, Principal investigator, FHI 360
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255941
- Sponsor's protocol ID
- 4798-CHS-ERC-17
- Status last verified
- Mar 2021
- First submitted
- 19 Jul 2017
- Last updated
- 13 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03255941
- Acronym / sponsor ID
- 4798-CHS-ERC-17
- Conditions
- Contraception
- 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)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- Aga Khan University, Jhpiego, United States Agency for International Development (USAID), Population Welfare Department, Government of Sindh, Pakistan
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 15 Jul 2018 (actual)
- Study completion
- 23 Jul 2018 (actual)
- First posted
- 21 Aug 2017 (actual)
- Results
- Posted 13 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Clinic Provider - Urban | Active comparator | Drug: DMPA, Drug: Sayana PressUrban Clinic Provider providing DMPA or Sayana Press |
| Lay Provider - Urban | Active comparator | Drug: DMPA, Drug: Sayana PressUrban Lay Provider providing DMPA or Sayana Press |
| Clinic Provider- Rural | Active comparator | Drug: DMPA, Drug: Sayana PressRural Clinic Provider providing DMPA or Sayana Press |
| Lay Provider- Rural | Active comparator | Drug: DMPA, Drug: Sayana PressRural Lay Provider providing DMPA or Sayana Press |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Women who voluntarily accept DMPA
Key exclusion criteria (3 listed)
- Women unable to provide informed consent
- Women with contraindications to DMPA
- Women who are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DMPAThe safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA. | Drug | Clinic Provider - Urban, Clinic Provider- Rural, Lay Provider - Urban, Lay Provider- Rural |
| Sayana PressThe safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press | Drug | Clinic Provider - Urban, Clinic Provider- Rural, Lay Provider - Urban, Lay Provider- Rural |
Primary outcome
Number of Participants That Were Appropriately Screened for Contraceptive Use
Time frame: 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.
Time frame: 3 months from randomization
Number of participants that were appropriately counseled by both types of providers in both urban and rural settings.
2 secondary outcomes
Proportion of Clients Providers Who Report Satisfaction With the DMPA Method Received From the Provider
Time frame: 3 months from randomization
Proportion of Clients Who Report Satisfaction With Provider Services
Time frame: 3 months from randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn S Chin-Quee, PhD, MPH principal investigator
FHI 360
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing DMPA and Sayana Press in people with Contraception, run by FHI 360 at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Were Appropriately Screened for Contraceptive Use (time frame: 3 months from randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.