Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00230880
Status:
COMPLETED
Last Update Posted:
2012-12-05
First Post:
2005-09-29
Brief Title:
The Young Womans Reach Project Trial of an Intervention to Impact Contraceptive Behavior Unintended Pregnancy and Sexually Transmitted Infections STIs Among Adolescent Females
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Randomized Trial of an Intervention to Impact Contraceptive Behavior Unintended Pregnancy and STIs Among Adolescent Females Receiving Family Planning Clinic Services
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REACH
Brief Summary:
The New Generation Health CenterUniversity 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 NGHCUCSF 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 ResearchAssociates 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
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 therapistcounselor 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 fields 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
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 therapistcounselor 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 fields 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None