Reproductive HealthSPARQ_PACKNCT04206514
Improving Person Centered Care for Post Abortion Patients in Kenya
A study testing Person Centered Care - Post Abortion Support in people with Reproductive Health, run by University of California, San Francisco at 1 site in Kenya.
Trial summary
The purpose of this study is to understand the effect of a phone based post-abortion intervention on the experience of post-abortion care. 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
- Reproductive Health
- What is being tested?
- Person Centered Care - Post Abortion Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 371 participants
- Where
- 1 siteKenya
- Study dates
- 27 Aug 2018to 18 Dec 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Women of reproductive age
- Had an Safe Abortion (SA)/Post Abortion Care (PAC) procedure at one of six private clinics that day
- Has her own cellphone that is WhatsApp compatible and will have access to this phone for the next four weeks
- Willing to receive receive short message service (SMS) messages and phone calls from an Marie Stopes Kenya (MSK) or Innovation for Poverty Action (IPA) professional
- Able to communicate in English and/or Swahili
- Willing and able to comprehend and give informed consent
Show all 9Show fewer
- Willing to participate in a baseline survey immediately after providing consent
- Willing to be followed up by phone at two weeks and four weeks post procedure for a 15-minute survey at each time-point
- Has not already participated in this study
Who cannot join
- Is not a women of reproductive age
- Did not have an SA/PAC procedure at one of six private clinics that day
- Does not have her own cellphone that is WhatsApp compatible and will have access to this phone for the next four weeks
- Is not willing to SMS messages and phone calls from an MSK/IPA professional
- Is not able to communicate in English and/or Swahili
- Is not willing or is not able to comprehend and give informed consent
Show all 9Show fewer
- Is not willing to participate in a baseline survey immediately after providing consent
- Is not willing to be followed up by phone at two weeks and four weeks post procedure for a 15-minute survey at each time-point
- Has already participated in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strengthening Patient-Centered Accessibility, Respect, and Quality of Care for Post Abortion Care Through Peer and Nurse Based Phone Support
The purpose of this study is to understand the effect of a phone based post-abortion intervention on the experience of post-abortion care.
Read the detailed description
This study evaluates whether personalized text messages and phone calls to post abortion women can improve post abortion person-centered care, perceived social support, post-abortion family planning, and reduce perceptions of social stigma and stress. Women were randomized to one of three study arms: personalized communication with a peer counselor or nurse who received person-centered care (PCC) training, or a control arm where participants received the standard of care.
- Conditions
- Reproductive Health
- Being tested
- Person Centered Care - Post Abortion Support
- Keywords
- post abortion, person-centered care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Person Centered Care - Post Abortion SupportBehavioural
Post abortion phone based support
| Study group | Role | What they receive |
|---|---|---|
| Peer Counselor | Experimental | Participants receive personalized text messages and phone calls from a peer counselor- a women who had an abortion and was trained in post abortion care and PCC Receives: Behavioral: Person Centered Care - Post Abortion Support |
| Nurse | Experimental | Participants receive personalized text messages and phone calls from a nurse trained in post abortion care and PCC Receives: Behavioral: Person Centered Care - Post Abortion Support |
| control | No intervention | Participants receive the standard of care for post-abortion patients in Kenya. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Person-Centered Abortion Scale Score
Survey conducted with women: self-report of experiences of PCC. Possible range 0-100; higher the score, better the experience
Measured: baseline
Person-Centered Abortion Scale Score
Survey conducted with women: self-report of experiences of PCC. Possible range 0-100; higher the score, better the experience
Measured: 2 weeks post-procedure
Person-Centered Abortion Scale Score
Survey conducted with women: self-report of experiences of PCC. Possible range 0-100; higher the score, better the experience
Measured: 4 weeks post-procedure
Secondary outcomes (10)
Post abortion family planning counseling
Self-report if women received counseling on family planning (Yes/No)
Measured: baseline
Post-abortion family planning uptake
Self-report of uptake of family planning (Yes/No/Refused to answer)
Measured: baseline
Perceived social support
Medical Outcomes Study-Social Support 15-item Scale (MOS-SSS): 18-90 where higher scores indicate greater social support
Measured: baseline
Perceived abortion stigma
The Individual Level Abortion Stigma Scale (ILAS Scale) Abbreviated 3-item Scale: 0-9 where higher scores indicate greater worry about stigma
Measured: baseline
Mental Health
Mental Health Inventory (MHI-5) scale; 0-100 with higher scores indicating better mental health
Measured: baseline
Post-abortion family planning uptake
self-report of uptake of family planning (Yes/No/Refused to answer)
Measured: 2 weeks post-procedure
Mental Health
Mental Health Inventory (MHI-5) scale; 0-100 with higher scores indicating better mental health
Measured: 2-weeks post procedure
Post-abortion family planning uptake
self-report of uptake of family planning (Yes/No/Refused to answer)
Measured: 4 weeks post-procedure
Perceived social support
Medical Outcomes Study-Social Support 15-item Scale (MOS-SSS): 18-90 where higher scores indicate greater social support
Measured: 4 weeks post-procedure
Perceived abortion stigma
The Individual Level Abortion Stigma Scale (ILAS Scale) Abbreviated 3-item Scale: 0-9 where higher scores indicate greater worry about stigma
Measured: 4 weeks post procedure
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 start27 Aug 2018
- Primary completion18 Dec 2018
- Study completion18 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Innovations for Poverty Action, Marie Stopes International
- Responsible party
- Sponsor
- Investigators
- May Sudhinaraset, PhD, Principal investigator, University of California, San Francisco/University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206514
- Sponsor's protocol ID
- 15-18008_Kenya Abortion
- Acronym
- SPARQ_PACK
- Status last verified
- Jan 2020
- First submitted
- 18 Dec 2019
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Allison S, Bauermeister JA, Bull S, Lightfoot M, Mustanski B, Shegog R, Levine D. The intersection of youth, technology, and new media with sexual health: moving the research agenda forward. J Adolesc Health. 2012 Sep;51(3):207-12. doi: 10.1016/j.jadohealth.2012.06.012.
PubMed 22921129Amirkhanian YA, Kelly JA, Kabakchieva E, McAuliffe TL, Vassileva S. Evaluation of a social network HIV prevention intervention program for young men who have sex with men in Russia and Bulgaria. AIDS Educ Prev. 2003 Jun;15(3):205-20. doi: 10.1521/aeap.15.4.205.23832.
PubMed 12866833Brookman-Amissah E, Moyo JB. Abortion law reform in sub-Saharan Africa: no turning back. Reprod Health Matters. 2004 Nov;12(24 Suppl):227-34. doi: 10.1016/s0968-8080(04)24026-5.
PubMed 15938178Bull SS, Levine DK, Black SR, Schmiege SJ, Santelli J. Social media-delivered sexual health intervention: a cluster randomized controlled trial. Am J Prev Med. 2012 Nov;43(5):467-74. doi: 10.1016/j.amepre.2012.07.022.
PubMed 23079168Ceylan A, Ertem M, Saka G, Akdeniz N. Post abortion family planning counseling as a tool to increase contraception use. BMC Public Health. 2009 Jan 15;9:20. doi: 10.1186/1471-2458-9-20.
PubMed 19146657Charles VE, Polis CB, Sridhara SK, Blum RW. Abortion and long-term mental health outcomes: a systematic review of the evidence. Contraception. 2008 Dec;78(6):436-50. doi: 10.1016/j.contraception.2008.07.005. Epub 2008 Sep 23.
PubMed 19014789Cuijpers P. Effective ingredients of school-based drug prevention programs. A systematic review. Addict Behav. 2002 Nov-Dec;27(6):1009-23. doi: 10.1016/s0306-4603(02)00295-2.
PubMed 12369469Desai M, Phillips-Howard PA, Odhiambo FO, Katana A, Ouma P, Hamel MJ, Omoto J, Macharia S, van Eijk A, Ogwang S, Slutsker L, Laserson KF. An analysis of pregnancy-related mortality in the KEMRI/CDC health and demographic surveillance system in western Kenya. PLoS One. 2013 Jul 16;8(7):e68733. doi: 10.1371/journal.pone.0068733. Print 2013.
PubMed 23874741Evens E, Otieno-Masaba R, Eichleay M, McCarraher D, Hainsworth G, Lane C, Makumi M, Onduso P. Post-abortion care services for youth and adult clients in Kenya: a comparison of services, client satisfaction and provider attitudes. J Biosoc Sci. 2014 Jan;46(1):1-15. doi: 10.1017/S0021932013000230. Epub 2013 Jun 10.
PubMed 23745828Harris GE, Larsen D. HIV peer counseling and the development of hope: perspectives from peer counselors and peer counseling recipients. AIDS Patient Care STDS. 2007 Nov;21(11):843-60. doi: 10.1089/apc.2006.0207.
PubMed 18240894Ikamari L, Izugbara C, Ochako R. Prevalence and determinants of unintended pregnancy among women in Nairobi, Kenya. BMC Pregnancy Childbirth. 2013 Mar 19;13:69. doi: 10.1186/1471-2393-13-69.
PubMed 23510090Kelly JA, Murphy DA, Sikkema KJ, McAuliffe TL, Roffman RA, Solomon LJ, Winett RA, Kalichman SC. Randomised, controlled, community-level HIV-prevention intervention for sexual-risk behaviour among homosexual men in US cities. Community HIV Prevention Research Collaborative. Lancet. 1997 Nov 22;350(9090):1500-5. doi: 10.1016/s0140-6736(97)07439-4.
PubMed 9388397Latkin CA, Sherman S, Knowlton A. HIV prevention among drug users: outcome of a network-oriented peer outreach intervention. Health Psychol. 2003 Jul;22(4):332-9. doi: 10.1037/0278-6133.22.4.332.
PubMed 12940388Lightfoot M, Comulada WS, Stover G. Computerized HIV preventive intervention for adolescents: indications of efficacy. Am J Public Health. 2007 Jun;97(6):1027-30. doi: 10.2105/AJPH.2005.072652. Epub 2006 May 2.
PubMed 16670219Magadi MA. Unplanned childbearing in Kenya: the socio-demographic correlates and the extent of repeatability among women. Soc Sci Med. 2003 Jan;56(1):167-78. doi: 10.1016/s0277-9536(02)00018-7.
PubMed 12435559
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. 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 Post Abortion Care Through Peer and Nurse Based Phone Support
- ClinicalTrials.gov ID
- NCT04206514
- Acronym / sponsor ID
- SPARQ_PACK / 15-18008_Kenya Abortion
- Conditions
- Reproductive Health
- Keywords
- post abortion, person-centered care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Innovations for Poverty Action, Marie Stopes International
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 18 Dec 2018 (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.
The purpose of this study is to understand the effect of a phone based post-abortion intervention on the experience of post-abortion care.
Detailed description
This study evaluates whether personalized text messages and phone calls to post abortion women can improve post abortion person-centered care, perceived social support, post-abortion family planning, and reduce perceptions of social stigma and stress. Women were randomized to one of three study arms: personalized communication with a peer counselor or nurse who received person-centered care (PCC) training, or a control arm where participants received the standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Peer Counselor | Experimental | Behavioral: Person Centered Care - Post Abortion SupportParticipants receive personalized text messages and phone calls from a peer counselor- a women who had an abortion and was trained in post abortion care and PCC |
| Nurse | Experimental | Behavioral: Person Centered Care - Post Abortion SupportParticipants receive personalized text messages and phone calls from a nurse trained in post abortion care and PCC |
| control | No intervention | –Participants receive the standard of care for post-abortion patients in Kenya. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Women of reproductive age
- Had an Safe Abortion (SA)/Post Abortion Care (PAC) procedure at one of six private clinics that day
- Has her own cellphone that is WhatsApp compatible and will have access to this phone for the next four weeks
- Willing to receive receive short message service (SMS) messages and phone calls from an Marie Stopes Kenya (MSK) or Innovation for Poverty Action (IPA) professional
- Able to communicate in English and/or Swahili
Key exclusion criteria (9 listed)
- Is not a women of reproductive age
- Did not have an SA/PAC procedure at one of six private clinics that day
- Does not have her own cellphone that is WhatsApp compatible and will have access to this phone for the next four weeks
- Is not willing to SMS messages and phone calls from an MSK/IPA professional
- Is not able to communicate in English and/or Swahili
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 |
|---|---|---|
| Person Centered Care - Post Abortion SupportPost abortion phone based support | Behavioural | Nurse, Peer Counselor |
Primary outcome
Person-Centered Abortion Scale Score
Time frame: baseline
Survey conducted with women: self-report of experiences of PCC. Possible range 0-100; higher the score, better the experience
Person-Centered Abortion Scale Score
Time frame: 2 weeks post-procedure
Survey conducted with women: self-report of experiences of PCC. Possible range 0-100; higher the score, better the experience
Person-Centered Abortion Scale Score
Time frame: 4 weeks post-procedure
Survey conducted with women: self-report of experiences of PCC. Possible range 0-100; higher the score, better the experience
10 secondary outcomes
Post abortion family planning counseling
Time frame: baseline
Post-abortion family planning uptake
Time frame: baseline
Perceived social support
Time frame: baseline
Perceived abortion stigma
Time frame: baseline
Mental Health
Time frame: baseline
Post-abortion family planning uptake
Time frame: 2 weeks post-procedure
Mental Health
Time frame: 2-weeks post procedure
Post-abortion family planning uptake
Time frame: 4 weeks post-procedure
Perceived social support
Time frame: 4 weeks post-procedure
Perceived abortion stigma
Time frame: 4 weeks post procedure
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 14 Jan 2020.
- Background: PubMed 22921129Allison S, Bauermeister JA, Bull S, Lightfoot M, Mustanski B, Shegog R, Levine D. The intersection of youth, technology, and new media with sexual health: moving the research agenda forward. J Adolesc Health. 2012 Sep;51(3):207-12. doi: 10.1016/j.jadohealth.2012.06.012.
- Background: PubMed 12866833Amirkhanian YA, Kelly JA, Kabakchieva E, McAuliffe TL, Vassileva S. Evaluation of a social network HIV prevention intervention program for young men who have sex with men in Russia and Bulgaria. AIDS Educ Prev. 2003 Jun;15(3):205-20. doi: 10.1521/aeap.15.4.205.23832.
- Background: PubMed 15938178Brookman-Amissah E, Moyo JB. Abortion law reform in sub-Saharan Africa: no turning back. Reprod Health Matters. 2004 Nov;12(24 Suppl):227-34. doi: 10.1016/s0968-8080(04)24026-5.
- Background: PubMed 23079168Bull SS, Levine DK, Black SR, Schmiege SJ, Santelli J. Social media-delivered sexual health intervention: a cluster randomized controlled trial. Am J Prev Med. 2012 Nov;43(5):467-74. doi: 10.1016/j.amepre.2012.07.022.
- Background: PubMed 19146657Ceylan A, Ertem M, Saka G, Akdeniz N. Post abortion family planning counseling as a tool to increase contraception use. BMC Public Health. 2009 Jan 15;9:20. doi: 10.1186/1471-2458-9-20.
- Background: PubMed 19014789Charles VE, Polis CB, Sridhara SK, Blum RW. Abortion and long-term mental health outcomes: a systematic review of the evidence. Contraception. 2008 Dec;78(6):436-50. doi: 10.1016/j.contraception.2008.07.005. Epub 2008 Sep 23.
- Background: PubMed 12369469Cuijpers P. Effective ingredients of school-based drug prevention programs. A systematic review. Addict Behav. 2002 Nov-Dec;27(6):1009-23. doi: 10.1016/s0306-4603(02)00295-2.
- Background: PubMed 23874741Desai M, Phillips-Howard PA, Odhiambo FO, Katana A, Ouma P, Hamel MJ, Omoto J, Macharia S, van Eijk A, Ogwang S, Slutsker L, Laserson KF. An analysis of pregnancy-related mortality in the KEMRI/CDC health and demographic surveillance system in western Kenya. PLoS One. 2013 Jul 16;8(7):e68733. doi: 10.1371/journal.pone.0068733. Print 2013.
- Background: PubMed 23745828Evens E, Otieno-Masaba R, Eichleay M, McCarraher D, Hainsworth G, Lane C, Makumi M, Onduso P. Post-abortion care services for youth and adult clients in Kenya: a comparison of services, client satisfaction and provider attitudes. J Biosoc Sci. 2014 Jan;46(1):1-15. doi: 10.1017/S0021932013000230. Epub 2013 Jun 10.
- Background: PubMed 18240894Harris GE, Larsen D. HIV peer counseling and the development of hope: perspectives from peer counselors and peer counseling recipients. AIDS Patient Care STDS. 2007 Nov;21(11):843-60. doi: 10.1089/apc.2006.0207.
- Background: PubMed 23510090Ikamari L, Izugbara C, Ochako R. Prevalence and determinants of unintended pregnancy among women in Nairobi, Kenya. BMC Pregnancy Childbirth. 2013 Mar 19;13:69. doi: 10.1186/1471-2393-13-69.
- Background: PubMed 9388397Kelly JA, Murphy DA, Sikkema KJ, McAuliffe TL, Roffman RA, Solomon LJ, Winett RA, Kalichman SC. Randomised, controlled, community-level HIV-prevention intervention for sexual-risk behaviour among homosexual men in US cities. Community HIV Prevention Research Collaborative. Lancet. 1997 Nov 22;350(9090):1500-5. doi: 10.1016/s0140-6736(97)07439-4.
- 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.
May Sudhinaraset, PhD principal investigator
University of California, San Francisco/University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Person Centered Care - Post Abortion Support in people with Reproductive Health, run by University of California, San Francisco at 1 site in Kenya.
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 9 inclusion and 9 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 14 Jan 2020. 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 Kenya. 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 Abortion Scale Score (time frame: baseline). The study lists 3 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 NCT04206514, which also lists 25 linked publications.
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 14 Jan 2020.