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The Young Woman's Reach Project: Trial of an Intervention to Impact Contraceptive Behavior, Unintended Pregnancy, and Sexually Transmitted Infections (STIs) Among Adolescent Females (REACH)

Primary Purpose

Contraceptive Behavior, Sexually Transmitted Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
follow-up phone counseling
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Contraceptive Behavior focused on measuring Contraception behavior, Condoms, Unsafe sex, Pregnancy unwanted, Adolescent pregnancy, Condom use, Unprotected sex, Unintended pregnancy

Eligibility Criteria

14 Years - 18 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion Criteria: Pregnant Using a hormonal contraceptive method continuously for the last 3 months Not willing to be contacted by phone for the intervention.

Sites / Locations

  • New Generation Health Center/UCSF

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm Description

follow-up phone counseling

Usual care

Outcomes

Primary Outcome Measures

Contraceptive use at time of last sexual intercourse

Secondary Outcome Measures

Unintended pregnancy
Sexually transmitted infections

Full Information

First Posted
September 29, 2005
Last Updated
December 3, 2012
Sponsor
University of California, San Francisco
Collaborators
ETR Associates, William and Flora Hewlett Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00230880
Brief Title
The Young Woman's Reach Project: Trial of an Intervention to Impact Contraceptive Behavior, Unintended Pregnancy, and Sexually Transmitted Infections (STIs) Among Adolescent Females
Acronym
REACH
Official Title
Randomized Trial of an Intervention to Impact Contraceptive Behavior, Unintended Pregnancy, and STIs Among Adolescent Females Receiving Family Planning Clinic Services
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
ETR Associates, William and Flora Hewlett Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The United States has one of the highest teen pregnancy rates of any western industrialized nation. In 1999, the last year for which state pregnancy data are available, California had the seventh highest pregnancy rate in the country. Within San Francisco, the Mission and Bayview Hunters Point districts have rates that are almost three times and two times higher than the state average respectively. In addition to high rates of unintended pregnancy, residents in the Bayview Hunters Point district experience STI transmission rate much higher than that of other neighborhoods. Currently there is very little research on the impact of different types of reproductive health clinic protocols on adolescent contraceptive use. Different outcomes have been found in the few studies that do exist on this topic. Hercog-Baron found that follow-up phone calls did not affect contraceptive use; however, explained that most youth stopped using contraception after the first three months of supply had run out and no calls were made beyond that time-frame. Authors suggested that the intervention may be more effective with a longer duration of follow-up. Alternatively, another study reported that their program substantially reduced teen pregnancy rates over time. Although the intervention had many components, the authors reported that the staff credited the positive relationships they created between the health educator and each student, and the frequent reminders contributed to the reduction in sexual risk-taking and pregnancy. A review by Miller and Sanchez concluded that the following seven elements of brief interventions induced positive change in a variety of health areas: feedback and counseling on personal risk, emphasis on personal responsibility for change, clear message about behavior change, a menu of behavior change options, therapist/counselor empathy, facilitation of client self-efficacy and use of a "motivational interviewing style". To the extent feasible, these elements will be incorporated into the Project REACH phone calls. Although there is very little data available in this area, the studies summarized above suggest that multiple contacts over time, even though brief, can have an impact. The NGHC will improve its reproductive health services by expanding current services to include a series of follow-up phone calls. The main purpose of these calls will be to assess how well patients are doing, to discuss any questions or problems they have had with their methods, and to enforce the four main messages: encourage condom use, encourage patients to return to the clinic for hormonal methods of contraception if they are likely to remain sexually active or want to change their method of contraception, get STI tested annually or if at risk and use the clinic as a resource and return for reproductive health needs. Clinics in San Francisco and around the country do not know whether conducting follow-up calls improves contraception compliance, increases STI testing or decreases unintended pregnancy. This study will significantly increase the field's knowledge of the feasibility and impact of conducting follow-up calls with youth over an extended period of time after they come to the clinic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contraceptive Behavior, Sexually Transmitted Diseases
Keywords
Contraception behavior, Condoms, Unsafe sex, Pregnancy unwanted, Adolescent pregnancy, Condom use, Unprotected sex, Unintended pregnancy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
follow-up phone counseling
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
follow-up phone counseling
Other Intervention Name(s)
Intense phone follow-up using motivational interviewing
Intervention Description
9 calls over 12 months
Primary Outcome Measure Information:
Title
Contraceptive use at time of last sexual intercourse
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Unintended pregnancy
Time Frame
18 months
Title
Sexually transmitted infections
Time Frame
18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: Pregnant Using a hormonal contraceptive method continuously for the last 3 months Not willing to be contacted by phone for the intervention.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tina R Raine-Bennett, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Doug Kirby, PhD
Organizational Affiliation
ETR Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Generation Health Center/UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Young Woman's Reach Project: Trial of an Intervention to Impact Contraceptive Behavior, Unintended Pregnancy, and Sexually Transmitted Infections (STIs) Among Adolescent Females

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