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ViolencePhase 3NCT01459458

Family Planning-based Partner Abuse Intervention to Reduce Unintended Pregnancy

A Phase 3 study testing Family Planning-based Partner Violence Intervention in people with Violence and Pregnancy, run by University of Pittsburgh at 1 site 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

This is a community-based participatory study to test a brief intervention to reduce risk for intimate partner violence (IPV) and associated unintended pregnancy among young, medically underserved women attending family planning (FP) clinics. Read more about this study

Who is it for?
Ages 16 to 29 years, women onlyHealthy volunteers can take part
Conditions the study is for
Violence, Pregnancy
What is being tested?
Family Planning-based Partner Violence Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,687 participants
Where
1 siteUnited States
Study dates
Oct 2011to Sep 2015
Phase
Phase 3
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 16 to 29 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • female clients
  • ages 16-29
  • English or Spanish speaking
  • able to provide their own consent
  • plan to be in area for the next 12 months
  • willing to be contacted for follow up survey and able to provide additional contact information

Who cannot join

  • female clients not of the specified age range
  • neither English nor Spanish speaking
  • clients who are intoxicated or otherwise not able to provide their own consent

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Western Pennsylvania Family Planning Clinics

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

This is a community-based participatory study to test a brief intervention to reduce risk for intimate partner violence (IPV) and associated unintended pregnancy among young, medically underserved women attending family planning (FP) clinics. Women ages 16-29 years utilizing FP clinics report higher rates of IPV compared to their same-age peers, experiences associated with unintended pregnancy. A critical mechanism connecting IPV with poor reproductive health is abusive partners' control of women's reproduction through condom refusal, pressuring women to get pregnant, and birth control sabotage, a phenomenon described as reproductive coercion. In the investigative team's pilot intervention study 53% of young women using FP clinics reported ever experiencing IPV, and 25% reported reproductive coercion, the combination of which was strongly associated with unintended pregnancy. The proposed reproductive coercion/partner violence intervention was developed collaboratively by community-based practitioners, advocates, and researchers, with significant input from FP clients. Designed to be implemented within routine FP care, maximizing feasibility and sustainability of this program, the intervention provides 1) client education and assessment regarding IPV and reproductive coercion; 2) discussion of harm reduction behaviors to reduce risk for unintended pregnancy and IPV victimization, and 3) supported referrals to IPV victim services. This is a full-scale RCT to assess the effects of this innovative program on IPV, reproductive coercion and unintended pregnancy, major health threats for medically underserved women. Evaluation of this intervention will involve random assignment of 25 FP clinics (unit of randomization) in Western PA to either intervention or control (i.e., standard-of-care) conditions. Female FP clients ages 16-29 (N=3600) will be assessed at baseline, 12-20 weeks (FU1), and 12 months (FU2) to assess intervention effects on knowledge and behaviors related to IPV, reproductive coercion and related harm reduction, as well as unintended pregnancy. Data will be collected via audio computer-assisted self-interview in English or Spanish. Chart extraction will track clinic utilization, pregnancy testing, and diagnosed pregnancies. Regression models appropriate for longitudinal data from cluster-randomized trials will be used to estimate intervention effects.

Conditions
Violence, Pregnancy
Being tested
Family Planning-based Partner Violence Intervention
Keywords
intimate partner violence, gender-based violence, domestic violence, unintended pregnancy

What participants receive

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

  • Family Planning-based Partner Violence InterventionBehavioural

    The intervention includes three major components:

    1. Enhanced Screening and Education: scripted questions to assess for reproductive coercion and pregnancy risk combined with intimate partner violence (IPV) assessment and education regarding how IPV may affect women's reproductive health with the assistance of a safety/educational card created for this intervention.
    2. Harm Reduction Counseling: assisting clients in identifying and planning strategies to reduce their risk for future unintended pregnancies and IPV.
    3. Supported Referral: educating all clients regarding local resources for victims of IPV and problem-solving regarding barriers to acquisition of these resources as needed.
Study groups in NCT01459458
Study groupRoleWhat they receive
Clinics trained in brief interventionExperimentalFemale clients ages 16-29 seeking care in 11 reproductive health clinics in Western Pennsylvania where clinic providers are trained to implement the brief partner violence/reproductive coercion intervention.
Receives: Behavioral: Family Planning-based Partner Violence Intervention
Control sites providing standard of careNo interventionFemale clients ages 16-29 seeking care in 14 reproductive health clinics in Western Pennsylvania where clinic providers are providing standard domestic violence screening per usual standard of care.

What is being measured

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

  1. Change in partner violence victimization (summary score)

    baseline-adjusted differences in post-intervention partner violence victimization up to 12 months {pooled analysis of FU 1 (12-20 weeks) and FU 2 (12 month) score}

    Measured: baseline to 12 months

  2. Change in reproductive coercion (summary score)

    baseline-adjusted differences in post-intervention levels of reproductive coercion up to 12 months {pooled analysis of FU 1 (12-20 weeks) and FU 2 (12 month) score}

    Measured: baseline to12 months

Secondary outcomes (5)

  1. Unintended pregnancy

    incidence of unintended pregnancy

    Measured: 12 months

  2. Change in recognition of abusive behaviors (mean score)

    baseline-adjusted differences in mean post-intervention levels of recognition of what constitutes abusive behavior up to 12 months {pooled analysis of FU 1 (12-20 weeks) and FU 2 (12 month) score}

    Measured: baseline to 12 months

  3. Change in harm reduction self-efficacy (mean score)

    baseline-adjusted differences in mean post-intervention levels of self-efficacy regarding uptake of harm reduction strategies up to 12 months {pooled analysis of FU 1 (12-20 weeks) and FU 2 (12 month) score}

    Measured: baseline to 12 months

  4. Knowledge regarding violence victimization resources

    post-intervention levels of knowledge about violence victimization related resources up to 12 months {pooled analysis of FU 1 (12-20 weeks) and FU 2 (12 month) score}

    Measured: up to 12 months

  5. Harm reduction strategies uptake (summary score)

    post-intervention levels of uptake of harm reduction strategies up to 12 months {pooled analysis of FU 1 (12-20 weeks) and FU 2 (12 month) score}

    Measured: up to 12 months

Timeline

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

  1. First posted25 Oct 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionFeb 2014
  4. Study completionSep 2015

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,687 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01459458
Sponsor's protocol ID
11050458
Other IDs
NICHD
Status last verified
Nov 2015
First submitted
10 Oct 2011
Last updated
2 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Kalra N, Hooker L, Reisenhofer S, Di Tanna GL, Garcia-Moreno C. Training healthcare providers to respond to intimate partner violence against women. Cochrane Database Syst Rev. 2021 May 31;5(5):CD012423. doi: 10.1002/14651858.CD012423.pub2.

    PubMed 34057734

  • Hill AL, Miller E, Borrero S, Zelazny S, Miller-Walfish S, Talis J, Switzer GE, Abebe KZ, Chang JC. Family Planning Providers' Assessment of Intimate Partner Violence and Substance Use. J Womens Health (Larchmt). 2021 Sep;30(9):1225-1232. doi: 10.1089/jwh.2020.8699. Epub 2021 Jan 18.

    PubMed 33464993

  • Miller E, Tancredi DJ, Decker MR, McCauley HL, Jones KA, Anderson H, James L, Silverman JG. A family planning clinic-based intervention to address reproductive coercion: a cluster randomized controlled trial. Contraception. 2016 Jul;94(1):58-67. doi: 10.1016/j.contraception.2016.02.009. Epub 2016 Feb 15.

    PubMed 26892333

  • Tancredi DJ, Silverman JG, Decker MR, McCauley HL, Anderson HA, Jones KA, Ciaravino S, Hicks A, Raible C, Zelazny S, James L, Miller E. Cluster randomized controlled trial protocol: addressing reproductive coercion in health settings (ARCHES). BMC Womens Health. 2015 Aug 6;15:57. doi: 10.1186/s12905-015-0216-z.

    PubMed 26245752

  • Miller E, McCauley HL, Tancredi DJ, Decker MR, Anderson H, Silverman JG. Recent reproductive coercion and unintended pregnancy among female family planning clients. Contraception. 2014 Feb;89(2):122-8. doi: 10.1016/j.contraception.2013.10.011. Epub 2013 Dec 10.

    PubMed 24331859

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Family Planning-based Partner Violence Intervention in people with Violence and Pregnancy, run by University of Pittsburgh at 1 site 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 6 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 2 Dec 2015. 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 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Change in partner violence victimization (summary score) (time frame: baseline to 12 months). 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 NCT01459458, which also lists 5 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 2 Dec 2015.

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