Improving Person Centered Care for Post Abortion Patients in Kenya

Reproductive Health Clinical Trial

— SPARQ_PACK  

Official title:

Strengthening Patient-Centered Accessibility, Respect, and Quality of Care for Post Abortion Care Through Peer and Nurse Based Phone Support

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04206514
• Other study ID #: 15-18008_Kenya Abortion
• Status: Completed
• Phase: N/A
• Start date: August 27, 2018
• Est. completion date: December 18, 2018

Study information

• Verified date: January 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 371
• Est. completion date: December 18, 2018
• Est. primary completion date: December 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

Inclusion Criteria:

• 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

• 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

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Reproductive Health

Intervention

Behavioral:
• Person Centered Care - Post Abortion Support
Post abortion phone based support

Locations

Country	Name	City	State
Kenya	Marie Stopes International Kenya	Nairobi

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Innovations for Poverty Action, Marie Stopes International

Country where clinical trial is conducted

Kenya, 

References & Publications (25)

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. — View Citation

Amirkhanian 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. — View Citation

Brookman-Amissah E, Moyo JB. Abortion law reform in sub-Saharan Africa: no turning back. Reprod Health Matters. 2004 Nov;12(24 Suppl):227-34. — View Citation

Bull 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. — View Citation

Ceylan 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. — View Citation

Charles 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. Review. — View Citation

Cuijpers P. Effective ingredients of school-based drug prevention programs. A systematic review. Addict Behav. 2002 Nov-Dec;27(6):1009-23. Review. — View Citation

Desai 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. — View Citation

Evens 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. — View Citation

Harris 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. — View Citation

Ikamari 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. — View Citation

Kelly 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. — View Citation

Latkin 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. — View Citation

Lightfoot M, Comulada WS, Stover G. Computerized HIV preventive intervention for adolescents: indications of efficacy. Am J Public Health. 2007 Jun;97(6):1027-30. Epub 2006 May 2. — View Citation

Magadi 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. — View Citation

Mellanby AR, Newcombe RG, Rees J, Tripp JH. A comparative study of peer-led and adult-led school sex education. Health Educ Res. 2001 Aug;16(4):481-92. — View Citation

Mohamed SF, Izugbara C, Moore AM, Mutua M, Kimani-Murage EW, Ziraba AK, Bankole A, Singh SD, Egesa C. The estimated incidence of induced abortion in Kenya: a cross-sectional study. BMC Pregnancy Childbirth. 2015 Aug 21;15:185. doi: 10.1186/s12884-015-0621-1. — View Citation

Oyieke JB, Obore S, Kigondu CS. Millennium development goal 5: a review of maternal mortality at the Kenyatta National Hospital, Nairobi. East Afr Med J. 2006 Jan;83(1):4-9. — View Citation

Pulerwitz J, Michaelis A, Verma R, Weiss E. Addressing gender dynamics and engaging men in HIV programs: lessons learned from Horizons research. Public Health Rep. 2010 Mar-Apr;125(2):282-92. — View Citation

Steinberg JR, Tschann JM, Furgerson D, Harper CC. Psychosocial factors and pre-abortion psychological health: The significance of stigma. Soc Sci Med. 2016 Feb;150:67-75. doi: 10.1016/j.socscimed.2015.12.007. Epub 2015 Dec 12. — View Citation

Teti M, Rubinstein S, Lloyd L, Aaron E, Merron-Brainerd J, Spencer S, Ricksecker A, Gold M. The Protect and Respect program: a sexual risk reduction intervention for women living with HIV/AIDS. AIDS Behav. 2007 Sep;11(5 Suppl):S106-16. Epub 2007 Jun 29. — View Citation

Turner G, Shepherd J. A method in search of a theory: peer education and health promotion. Health Educ Res. 1999 Apr;14(2):235-47. Review. — View Citation

Upadhyay UD, Cockrill K, Freedman LR. Informing abortion counseling: an examination of evidence-based practices used in emotional care for other stigmatized and sensitive health issues. Patient Educ Couns. 2010 Dec;81(3):415-21. doi: 10.1016/j.pec.2010.08.026. — View Citation

Yegon EK, Kabanya PM, Echoka E, Osur J. Understanding abortion-related stigma and incidence of unsafe abortion: experiences from community members in Machakos and Trans Nzoia counties Kenya. Pan Afr Med J. 2016 Jul 20;24:258. eCollection 2016. — View Citation

Ziraba AK, Madise N, Mills S, Kyobutungi C, Ezeh A. Maternal mortality in the informal settlements of Nairobi city: what do we know? Reprod Health. 2009 Apr 22;6:6. doi: 10.1186/1742-4755-6-6. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline
Primary	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	2 weeks post-procedure
Primary	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	4 weeks post-procedure
Secondary	Post abortion family planning counseling	Self-report if women received counseling on family planning (Yes/No)	baseline
Secondary	Post-abortion family planning uptake	Self-report of uptake of family planning (Yes/No/Refused to answer)	baseline
Secondary	Perceived social support	Medical Outcomes Study-Social Support 15-item Scale (MOS-SSS): 18-90 where higher scores indicate greater social support	baseline
Secondary	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	baseline
Secondary	Mental Health	Mental Health Inventory (MHI-5) scale; 0-100 with higher scores indicating better mental health	baseline
Secondary	Post-abortion family planning uptake	self-report of uptake of family planning (Yes/No/Refused to answer)	2 weeks post-procedure
Secondary	Mental Health	Mental Health Inventory (MHI-5) scale; 0-100 with higher scores indicating better mental health	2-weeks post procedure
Secondary	Post-abortion family planning uptake	self-report of uptake of family planning (Yes/No/Refused to answer)	4 weeks post-procedure
Secondary	Perceived social support	Medical Outcomes Study-Social Support 15-item Scale (MOS-SSS): 18-90 where higher scores indicate greater social support	4 weeks post-procedure
Secondary	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	4 weeks post procedure