Reproductive HealthSPARQ_ACINCT04307641
Improving Person Centered Care for Abortion Clients in India
A study testing 2 Page Information Sheet in people with Reproductive Health, run by University of California, San Francisco.
Trial summary
The purpose of this study is to understand the effect of providing pharmacists in UP, India with additional information about medication abortion. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Reproductive Health
- What is being tested?
- 2 Page Information Sheet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pharmacist providing medication abortion within Lucknow, Kanpur, Unnao
- Agreed to participate
Who cannot join
- Pharmacists not providing medication abortion within Lucknow, Kanpur, Unnao
- Did not agree to participate
About this study
Official title: Strengthening Patient-Centered Accessibility, Respect, and Quality of Care for Abortion Clients in UP, India
The purpose of this study is to understand the effect of providing pharmacists in UP, India with additional information about medication abortion.
Read the detailed description
This study evaluates whether providing pharmacists with additional information about medication abortion can improve abortion person-centered care for women accessing MA at these sites.
- Conditions
- Reproductive Health
- Being tested
- 2 Page Information Sheet
- Keywords
- abortion, person-centered care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 Page Information SheetBehavioural
2 page information sheet about medication abortion
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Pharmacists who received in the intervention. Receives: Behavioral: 2 Page Information Sheet |
| Control | No intervention | Pharmacists who did not received in the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knowledge about medication abortion
self-reported survey (dose, time, side effects, complications)
Measured: baseline compared to 6-months after intervention
Secondary outcomes (2)
Provider behavior when providing medication abortion (MA) to clients
Information provided to mystery clients regarding MA (dose, time, side effects, complications)
Measured: 3-months post intervention
Interest and satisfaction with intervention
self-reported survey on interest and satisfaction
Measured: 6-months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start1 Nov 2016
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive HealthStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Foundation of India
- Responsible party
- Sponsor
- Investigators
- Nadia Diamond-Smith, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307641
- Sponsor's protocol ID
- 15-18008_India Abortion
- Acronym
- SPARQ_ACI
- Status last verified
- Mar 2020
- First submitted
- 10 Mar 2020
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data from this evaluation will be shared on the data repository Dryad.
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Patient-Centered Accessibility, Respect, and Quality of Care for Abortion Clients in UP, India
- ClinicalTrials.gov ID
- NCT04307641
- Acronym / sponsor ID
- SPARQ_ACI / 15-18008_India Abortion
- Conditions
- Reproductive Health
- Keywords
- abortion, person-centered care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Public Health Foundation of India
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to understand the effect of providing pharmacists in UP, India with additional information about medication abortion.
Detailed description
This study evaluates whether providing pharmacists with additional information about medication abortion can improve abortion person-centered care for women accessing MA at these sites.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: 2 Page Information SheetPharmacists who received in the intervention. |
| Control | No intervention | –Pharmacists who did not received in the intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pharmacist providing medication abortion within Lucknow, Kanpur, Unnao
- Agreed to participate
Key exclusion criteria (2 listed)
- Pharmacists not providing medication abortion within Lucknow, Kanpur, Unnao
- Did not agree to participate
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 |
|---|---|---|
| 2 Page Information Sheet2 page information sheet about medication abortion | Behavioural | Intervention |
Primary outcome
Change in knowledge about medication abortion
Time frame: baseline compared to 6-months after intervention
self-reported survey (dose, time, side effects, complications)
2 secondary outcomes
Provider behavior when providing medication abortion (MA) to clients
Time frame: 3-months post intervention
Interest and satisfaction with intervention
Time frame: 6-months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: Yes. The data from this evaluation will be shared on the data repository Dryad.
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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.
Nadia Diamond-Smith, PhD principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing 2 Page Information Sheet in people with Reproductive Health, run by University of California, San Francisco.
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 2 inclusion and 2 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 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in knowledge about medication abortion (time frame: baseline compared to 6-months after intervention). 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 24 May 2023.