NCT00230880

Brief Summary

The New Generation Health Center/University of California, San Francisco (UCSF) will implement an intervention to impact contraceptive behavior and reduce unintended pregnancy and sexually transmitted infections (STIs) among adolescent females who receive services at the New Generation Health Center (NGHC)/UCSF in San Francisco. Study subjects will be randomized into either standard reproductive health services or standard services plus follow-up motivational counseling telephone calls. Outcomes will be evaluated by ETR (Education, Training, Research)Associates, who will conduct follow-up surveys with all study participants at baseline, 6 months, 12 months and 18 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 3, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

December 5, 2012

Status Verified

December 1, 2012

Enrollment Period

3.9 years

First QC Date

September 29, 2005

Last Update Submit

December 3, 2012

Conditions

Contraceptive BehaviorSexually Transmitted Diseases

Keywords

Contraception behaviorCondomsUnsafe sexPregnancy unwantedAdolescent pregnancyCondom useUnprotected sexUnintended pregnancy

Outcome Measures

Primary Outcomes (1)

  • Contraceptive use at time of last sexual intercourse

    18 months

Secondary Outcomes (2)

  • Unintended pregnancy

    18 months

  • Sexually transmitted infections

    18 months

Study Arms (2)

Treatment

EXPERIMENTAL

follow-up phone counseling

Behavioral: follow-up phone counseling

Control

NO INTERVENTION

Usual care

Interventions

follow-up phone counselingBEHAVIORAL

9 calls over 12 months

Also known as: Intense phone follow-up using motivational interviewing
Treatment

Eligibility Criteria

Age14 Years - 18 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Attending a family planning clinic visit
  • At risk for unintended pregnancy (using no contraceptive method, using condoms for contraception, or not using a hormonal contraceptive method continuously for the last 3 months)

You may not qualify if:

  • Pregnant
  • Using a hormonal contraceptive method continuously for the last 3 months
  • Not willing to be contacted by phone for the intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Generation Health Center/UCSF

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Contraception BehaviorSexually Transmitted DiseasesUnsafe Sex

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehaviorCommunicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSexual Behavior

Study Officials

  • Tina R Raine-Bennett, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Doug Kirby, PhD

    ETR Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2005

First Posted

October 3, 2005

Study Start

July 1, 2005

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

December 5, 2012

Record last verified: 2012-12

Locations

US(1)