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ContraceptionNCT02945670

Using Focus Group to Explore Cultural Acceptability of Contraception

An observational study of Contraception, run by University of Pittsburgh at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception
What is being tested?
Focus Group
How many people
64 participants
Where
7 sitesUnited States
Study dates
2 Jan 2017to 30 Mar 2017
Phase
Observational
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 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Women age 18-45 years and not pregnant at the time of enrollment

Who may be able to join

  • Female
  • Age 18-45 years
  • Not pregnant

Who cannot join

  • Pregnancy
  • Male

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Latterman Family Health Center

    McKeesport, Pennsylvania, 15132

  • New Kensington Family Health Center

    New Kensington, Pennsylvania, 15068

  • UPMC Matilda Theiss Health Center

    Pittsburgh, Pennsylvania, 15213

  • Squirrel Hill Family Practice

    Pittsburgh, Pennsylvania, 15217

  • UPMC Bloomfiled-Garfield FHC

    Pittsburgh, Pennsylvania, 15224

  • Lawrenceville Family Health Center

    Pittsburgh, Pennsylvania, 15232

  • Shadyside Family Health Center

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: Using Focus Group to Explore Cultural Acceptability of Long Acting Contraception in a Diverse, Urban Population.

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.

Read the detailed 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.

Conditions
Contraception
Being tested
Focus Group

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Focus GroupBehavioural

    We had recruited 64 women and completed 7 focus group sessions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2016 (estimated)
  2. Study start2 Jan 2017
  3. Primary completion30 Mar 2017
  4. Study completion30 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02945670
Sponsor's protocol ID
Merck IIS# 55000
Status last verified
May 2020
First submitted
23 Oct 2016
Last updated
8 May 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22018123

  • 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.

    PubMed 20541171

  • 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.

    PubMed 25856258

  • 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.

    PubMed 18515520

  • Stanwood NL, Bradley KA. Young pregnant women's knowledge of modern intrauterine devices. Obstet Gynecol. 2006 Dec;108(6):1417-22. doi: 10.1097/01.AOG.0000245447.56585.a0.

    PubMed 17138775

  • 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.

    PubMed 23763968

  • 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.

    PubMed 25555302

  • 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.

    PubMed 25369357

  • 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.

    PubMed 23427785

  • 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.

    PubMed 23508599

  • 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.

    PubMed 23535052

  • 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.

    PubMed 22051784

  • 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. doi: 10.1001/archfami.9.10.1156.

    PubMed 11115223

  • Kissling E, Valenciano M, Larrauri A, Oroszi B, Cohen JM, Nunes B, Pitigoi D, Rizzo C, Rebolledo J, Paradowska-Stankiewicz I, Jimenez-Jorge S, Horvath 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):20390. doi: 10.2807/ese.18.05.20390-en.

    PubMed 23399425

  • 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 / Montreal, QB (https://www.napcrg.org/conferences/43/sessions/20937)

Questions about this trial

What is this clinical trial studying?

An observational study of Contraception, run by University of Pittsburgh at 7 sites in United States.

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 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 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. 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?

Level of acceptance of contraception among diverse women (time frame: Three months). 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 NCT02945670, which also lists 16 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 8 May 2020.

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