Family PlanningSPARQ_FPINCT04206527
Improving Person-Centered Care for Family Planning in India
A study testing Training of AHSAs on PCC for FP and Enhanced FP training in people with Family Planning, run by University of California, San Francisco at 1 site in India.
Trial summary
To evaluate the impact of a training to ASHAs on person-centered care (PCC) for family planning (FP). Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Family Planning
- What is being tested?
- Training of AHSAs on PCC for FP and Enhanced FP training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,104 participants
- Where
- 1 siteIndia
- Study dates
- 26 Apr 2019to 24 Jun 2019
- 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-49
- Consented/agreed to participate
- Has met with a control or intervention ASHA at least once in the previous three months
Who cannot join
- Not a women aged 18-49
- Did not consent/agree to participate
- Has not met with a control or intervention ASHA at least once in the previous three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strengthening People-centered Accessibility, Respect, and Quality for Family Planning Services in India
To evaluate the impact of a training to ASHAs on person-centered care (PCC) for family planning (FP).
Read the detailed description
ASHAs will be provided with a training on family planning (FP) counseling and method options. Half of the group will receive additional trainings on person-centered care (PCC) principles and respectful care while the other half of the group will not receive this additional training. Women working with both the control ASHAs (FP trained) and Interventions ASHAs (FP+PCC trained) will be surveyed following their interactions with the ASHA to understand the quality of their experience with the ASHA and whether the woman has taken up a FP method of her choice following interaction with the ASHA.
- Conditions
- Family Planning
- Being tested
- Training of AHSAs on PCC for FP, Enhanced FP training
- Keywords
- Person-Centered Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training of AHSAs on PCC for FPBehavioural
ASHAs provided with training on FP methods and counseling plus PCC for FP
Enhanced FP trainingBehavioural
Participation in an enhanced FP training including PCC
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Women | Experimental | Women who receive enhanced FP counseling from an ASHA Receives: Behavioral: Training of AHSAs on PCC for FP |
| Control - Women | No intervention | Women who receive standard FP counseling from an ASHA |
| Intervention - ASHA | Experimental | ASHA who receive enhanced FP counseling training Receives: Behavioral: Enhanced FP training |
| Control ASHA | No intervention | ASHA who receive standard FP training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Person-centered Family Planning Scale Score
Survey conducted with women: self-report of experiences of care. Possible range 0-43; higher the score the better the experience of care
Measured: 3-months after first FP counseling with ASHA
Experience of providing FP counseling
In-depth interviews with ASHAs from intervention and control arms to understand experience providing FP counseling
Measured: at least 3-months after FP training
Secondary outcomes (1)
Uptake of Family Planning
Self-report of uptake of a FP method; Yes/No/I Don't remember
Measured: 3-months after first FP counseling with ASHA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start26 Apr 2019
- Primary completion24 Jun 2019
- Study completion24 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Family PlanningStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Population Services International
- Responsible party
- Sponsor
- Investigators
- Nadia Diamond-Smith, PhD, Study director, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206527
- Sponsor's protocol ID
- 18-25950
- Acronym
- SPARQ_FPI
- Status last verified
- Dec 2019
- First submitted
- 17 Dec 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Diamond-Smith N, McDonell C, Sahu AB, Roy KP, Giessler K. A mixed-methods evaluation of the impact of a person-centered family planning intervention for community health workers on family planning outcomes in India. BMC Health Serv Res. 2020 Dec 11;20(1):1139. doi: 10.1186/s12913-020-05995-9.
PubMed 33308230
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening People-centered Accessibility, Respect, and Quality for Family Planning Services in India
- ClinicalTrials.gov ID
- NCT04206527
- Acronym / sponsor ID
- SPARQ_FPI / 18-25950
- Conditions
- Family Planning
- Keywords
- Person-Centered Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,104 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Population Services International
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 24 Jun 2019 (actual)
- Study completion
- 24 Jun 2019 (actual)
- First posted
- 20 Dec 2019 (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.
To evaluate the impact of a training to ASHAs on person-centered care (PCC) for family planning (FP).
Detailed description
ASHAs will be provided with a training on family planning (FP) counseling and method options. Half of the group will receive additional trainings on person-centered care (PCC) principles and respectful care while the other half of the group will not receive this additional training. Women working with both the control ASHAs (FP trained) and Interventions ASHAs (FP+PCC trained) will be surveyed following their interactions with the ASHA to understand the quality of their experience with the ASHA and whether the woman has taken up a FP method of her choice following interaction with the ASHA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention - Women | Experimental | Behavioral: Training of AHSAs on PCC for FPWomen who receive enhanced FP counseling from an ASHA |
| Control - Women | No intervention | –Women who receive standard FP counseling from an ASHA |
| Intervention - ASHA | Experimental | Behavioral: Enhanced FP trainingASHA who receive enhanced FP counseling training |
| Control ASHA | No intervention | –ASHA who receive standard FP training |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged 18-49
- Consented/agreed to participate
- Has met with a control or intervention ASHA at least once in the previous three months
Key exclusion criteria (3 listed)
- Not a women aged 18-49
- Did not consent/agree to participate
- Has not met with a control or intervention ASHA at least once in the previous three months
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 |
|---|---|---|
| Training of AHSAs on PCC for FPASHAs provided with training on FP methods and counseling plus PCC for FP | Behavioural | Intervention - Women |
| Enhanced FP trainingParticipation in an enhanced FP training including PCC | Behavioural | Intervention - ASHA |
Primary outcome
Person-centered Family Planning Scale Score
Time frame: 3-months after first FP counseling with ASHA
Survey conducted with women: self-report of experiences of care. Possible range 0-43; higher the score the better the experience of care
Experience of providing FP counseling
Time frame: at least 3-months after FP training
In-depth interviews with ASHAs from intervention and control arms to understand experience providing FP counseling
1 secondary outcome
Uptake of Family Planning
Time frame: 3-months after first FP counseling with ASHA
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 20 Dec 2019.
- Derived from this study: PubMed 33308230Diamond-Smith N, McDonell C, Sahu AB, Roy KP, Giessler K. A mixed-methods evaluation of the impact of a person-centered family planning intervention for community health workers on family planning outcomes in India. BMC Health Serv Res. 2020 Dec 11;20(1):1139. doi: 10.1186/s12913-020-05995-9.
- 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.
Nadia Diamond-Smith, PhD study director
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training of AHSAs on PCC for FP and Enhanced FP training in people with Family Planning, run by University of California, San Francisco at 1 site in India.
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 3 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 20 Dec 2019. 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 India. 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.
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?
Person-centered Family Planning Scale Score (time frame: 3-months after first FP counseling with ASHA). 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?
On the ClinicalTrials.gov record for NCT04206527, which also lists 1 linked publication.
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 20 Dec 2019.