Trial record 4 of 905 for:    sexually transmitted diseases AND (woman OR women OR female)

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)

This study has been completed.
Sponsor:
Collaborators:
ETR (Education, Training, Research)Associates
William and Flora Hewlett Foundation
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00230880
First received: September 29, 2005
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Contraceptive Behavior
Sexually Transmitted Diseases
Behavioral: follow-up phone counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Randomized Trial of an Intervention to Impact Contraceptive Behavior, Unintended Pregnancy, and STIs Among Adolescent Females Receiving Family Planning Clinic Services

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Contraceptive use at time of last sexual intercourse [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Unintended pregnancy [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Sexually transmitted infections [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 800
Study Start Date: July 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
follow-up phone counseling
Behavioral: follow-up phone counseling
9 calls over 12 months
Other Name: Intense phone follow-up using motivational interviewing
No Intervention: Control
Usual care

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:

  1. feedback and counseling on personal risk,
  2. emphasis on personal responsibility for change,
  3. clear message about behavior change,
  4. a menu of behavior change options,
  5. therapist/counselor empathy,
  6. facilitation of client self-efficacy and
  7. 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:

  1. encourage condom use,
  2. 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,
  3. get STI tested annually or if at risk and
  4. 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.

  Eligibility

Ages Eligible for Study:   14 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230880

Locations
United States, California
New Generation Health Center/UCSF
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
ETR (Education, Training, Research)Associates
William and Flora Hewlett Foundation
Investigators
Principal Investigator: Tina R Raine-Bennett, MD, MPH University of California, San Francisco
Principal Investigator: Doug Kirby, PhD ETR Associates
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00230880     History of Changes
Other Study ID Numbers: OSR# 04038166
Study First Received: September 29, 2005
Last Updated: December 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Contraception behavior
Condoms
Unsafe sex
Pregnancy unwanted
Adolescent pregnancy
Condom use
Unprotected sex
Unintended pregnancy

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014