Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02945670
Other study ID # Merck IIS# 55000
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2, 2017
Est. completion date March 30, 2017

Study information

Verified date May 2020
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to learn what women of childbearing age think of Long Acting Reversible Contraception. A variety of myths regarding LARCs have been described in the literature. This study is designed to asses women's cultural belief's regarding LARCs. Investigators are looking to collect information from women in general, rather than solely who are seeking contraception. Investigators will be recruiting women ages 18-45 years from seven family health centers affiliated with UPMC. Participants will be asked to a attend a 60-90 minutes focus group session. During the session the facilitator will try to engage participants in a discussion about contraception in general. They will also be asked to complete a short demographic survey of 8-12 questions. Data from focus groups will be assessed for recurring themes which will be used to create a cultural survey instrument that will be used in the second phase of the study.


Description:

Following approval by the University of Pittsburgh institutional review board (IRB), female participants between 18 and 45 years of age seeking care for contraception or other women's health services were recruited from seven Family Health Centers (FHCs) partnered with the Department of Family Medicine. The participants agreed to participate in one 2 hour facilitated focus group session (recorded for later transcription) to discuss their perceptions about contraception.

Recordings were transcribed and de-identified. The resulting texts were coded by a team. Concepts and themes that arose from the coding were analyzed to inform the development of a survey on the topic of perspectives on contraception.

Qualitative analysis of the transcripts and coding was carried out and results were shared in pubic fora.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date March 30, 2017
Est. primary completion date March 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Female

- Age 18-45 years

- Not pregnant

Exclusion Criteria:

- Pregnancy

- Male

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Focus Group
We had recruited 64 women and completed 7 focus group sessions

Locations

Country Name City State
United States Latterman Family Health Center McKeesport Pennsylvania
United States New Kensington Family Health Center New Kensington Pennsylvania
United States Lawrenceville Family Health Center Pittsburgh Pennsylvania
United States Shadyside Family Health Center Pittsburgh Pennsylvania
United States Squirrel Hill Family Practice Pittsburgh Pennsylvania
United States UPMC Bloomfiled-Garfield FHC Pittsburgh Pennsylvania
United States UPMC Matilda Theiss Health Center Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (16)

Cuddeback M, Ifthikhar R, Narayanan A. Assessment of Cultural Acceptability of Long Acting Reversible Contraception in a Diverse, Urban Population. North American Primary Care Research Group Annual Meeting - Toronto, ON / NOV. 2019. (https://www.napcrg.or

Damle LF, Gohari AC, McEvoy AK, Desale SY, Gomez-Lobo V. Early initiation of postpartum contraception: does it decrease rapid repeat pregnancy in adolescents? J Pediatr Adolesc Gynecol. 2015 Feb;28(1):57-62. doi: 10.1016/j.jpag.2014.04.005. Epub 2014 May 5. — View Citation

Doescher MP, Saver BG, Franks P, Fiscella K. Racial and ethnic disparities in perceptions of physician style and trust. Arch Fam Med. 2000 Nov-Dec;9(10):1156-63. — View Citation

Greenberg KB, Makino KK, Coles MS. Factors associated with provision of long-acting reversible contraception among adolescent health care providers. J Adolesc Health. 2013 Mar;52(3):372-4. doi: 10.1016/j.jadohealth.2012.11.003. — View Citation

Harper CC, Blum M, de Bocanegra HT, Darney PD, Speidel JJ, Policar M, Drey EA. Challenges in translating evidence to practice: the provision of intrauterine contraception. Obstet Gynecol. 2008 Jun;111(6):1359-69. doi: 10.1097/AOG.0b013e318173fd83. — View Citation

Kissling E, Valenciano M, Larrauri A, Oroszi B, Cohen JM, Nunes B, Pitigoi D, Rizzo C, Rebolledo J, Paradowska-Stankiewicz I, Jiménez-Jorge S, Horváth JK, Daviaud I, Guiomar R, Necula G, Bella A, O'Donnell J, Gluchowska M, Ciancio BC, Nicoll A, Moren A. Low and decreasing vaccine effectiveness against influenza A(H3) in 2011/12 among vaccination target groups in Europe: results from the I-MOVE multicentre case-control study. Euro Surveill. 2013 Jan 31;18(5). pii: 20390. — View Citation

Lin C, South-Paul JE, Maier JS, deBorja L, Al Aaraj Y, Burley C, Mena J,.Using Focus Group to Explore Cultural Acceptability of Long Acting Contraception in a Diverse, Urban Population. North American Primary Care Research Group Annual Meeting - NOV 2017

Mestad R, Secura G, Allsworth JE, Madden T, Zhao Q, Peipert JF. Acceptance of long-acting reversible contraceptive methods by adolescent participants in the Contraceptive CHOICE Project. Contraception. 2011 Nov;84(5):493-8. doi: 10.1016/j.contraception.2011.03.001. Epub 2011 Apr 27. — View Citation

Okpo E, Allerton L, Brechin S. 'But you can't reverse a hysterectomy!' Perceptions of long acting reversible contraception (LARC) among young women aged 16-24 years: a qualitative study. Public Health. 2014 Oct;128(10):934-9. doi: 10.1016/j.puhe.2014.08.012. Epub 2014 Oct 22. — View Citation

Romero L, Pazol K, Warner L, Gavin L, Moskosky S, Besera G, Loyola Briceno AC, Jatlaoui T, Barfield W; Centers for Disease Control and Prevention (CDC). Vital signs: trends in use of long-acting reversible contraception among teens aged 15-19 years seeking contraceptive services—United States, 2005-2013. MMWR Morb Mortal Wkly Rep. 2015 Apr 10;64(13):363-9. — View Citation

Roncancio AM, Ward KK, Berenson AB. The use of effective contraception among young Hispanic women: the role of acculturation. J Pediatr Adolesc Gynecol. 2012 Feb;25(1):35-8. doi: 10.1016/j.jpag.2011.08.008. Epub 2011 Nov 3. — View Citation

Rubin SE, Davis K, McKee MD. New york city physicians' views of providing long-acting reversible contraception to adolescents. Ann Fam Med. 2013 Mar-Apr;11(2):130-6. doi: 10.1370/afm.1450. — View Citation

Russo JA, Miller E, Gold MA. Myths and misconceptions about long-acting reversible contraception (LARC). J Adolesc Health. 2013 Apr;52(4 Suppl):S14-21. doi: 10.1016/j.jadohealth.2013.02.003. Review. — View Citation

Secura GM, Allsworth JE, Madden T, Mullersman JL, Peipert JF. The Contraceptive CHOICE Project: reducing barriers to long-acting reversible contraception. Am J Obstet Gynecol. 2010 Aug;203(2):115.e1-7. doi: 10.1016/j.ajog.2010.04.017. Epub 2010 Jun 11. — View Citation

Stanwood NL, Bradley KA. Young pregnant women's knowledge of modern intrauterine devices. Obstet Gynecol. 2006 Dec;108(6):1417-22. — View Citation

Whitaker AK, Sisco KM, Tomlinson AN, Dude AM, Martins SL. Use of the intrauterine device among adolescent and young adult women in the United States from 2002 to 2010. J Adolesc Health. 2013 Sep;53(3):401-6. doi: 10.1016/j.jadohealth.2013.04.011. Epub 2013 Jun 12. — View Citation

* Note: There are 16 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Level of acceptance of contraception among diverse women Level of acceptance: 1-Totally not accepted 2-May accept 3-Neither accept/not accept 4-Accept with preservation 5-Totally accept Three months
See also
  Status Clinical Trial Phase
Completed NCT02577601 - Impact of Combined Hormonal Contraceptives on UPA Phase 4
Completed NCT03153644 - Improving Contraceptive Care for Women With Medical Conditions
Completed NCT04112095 - Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use Phase 3
Recruiting NCT05521646 - Implementing Best Practice Postpartum Contraceptive Services Through a Quality Improvement Initiative N/A
Active, not recruiting NCT04291001 - Ovarian Function With ENG Implant and UPA Use Early Phase 1
Completed NCT04568980 - Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
Completed NCT03438682 - Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization
Active, not recruiting NCT01948882 - Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women N/A
Enrolling by invitation NCT04997499 - Adolescent Subcutaneous (SQ) Injection Video Validation N/A
Recruiting NCT03589040 - Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant Phase 2
Completed NCT04463680 - Rifampin and the Contraceptive Implant Phase 4
Completed NCT03154125 - Sayana® Press Extension Study Phase 3
Withdrawn NCT03725358 - A Cluster-RCT to Increase the Uptake of LARCs Among Adolescent Females and Young Women in Cameroon. N/A
Completed NCT02957630 - "E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study" Phase 1/Phase 2
Completed NCT02456584 - Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods Phase 1
Completed NCT02718222 - Impact and Performance of Institutionalizing Immediate Post-partum IUD Services N/A
Recruiting NCT02121067 - LNG-IUS at 2 Weeks Postpartum Phase 4
Terminated NCT02169869 - Immediate Postplacental IUD Insertion N/A
Recruiting NCT02292056 - Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions N/A
Withdrawn NCT01930994 - Kenya Sino-implant (II) PK Study N/A