Contraceptive BehaviorREACHNCT00230880
The Young Woman's Reach Project: Trial of an Intervention to Impact Contraceptive Behavior, Unintended Pregnancy, and Sexually Transmitted Infections (STIs) Among Adolescent Females
A study testing follow-up phone counseling in people with Contraceptive Behavior and Sexually Transmitted Diseases, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 18 years, women only
- Conditions the study is for
- Contraceptive Behavior, Sexually Transmitted Diseases
- What is being tested?
- follow-up phone counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Jun 2009
- Phase
- Interventional
- 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 14 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- Pregnant
- Using a hormonal contraceptive method continuously for the last 3 months
- Not willing to be contacted by phone for the intervention.
Trial locations and contacts
1 site in 1 country.
United States1 site
New Generation Health Center/UCSF
San Francisco, California, 94110
About this study
Official title: Randomized Trial of an Intervention to Impact Contraceptive Behavior, Unintended Pregnancy, and STIs Among Adolescent Females Receiving Family Planning Clinic Services
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.
Read the 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.
- Being tested
- follow-up phone counseling
- Keywords
- Contraception behavior, Condoms, Unsafe sex, Pregnancy unwanted, Adolescent pregnancy, Condom use, Unprotected sex, Unintended pregnancy
- Medical subject headings
- Contraception Behavior, Sexually Transmitted Diseases, Unsafe Sex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follow-up phone counselingBehavioural
Also called Intense phone follow-up using motivational interviewing
9 calls over 12 months
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | follow-up phone counseling Receives: Behavioral: follow-up phone counseling |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contraceptive use at time of last sexual intercourse
Measured: 18 months
Secondary outcomes (2)
Unintended pregnancy
Measured: 18 months
Sexually transmitted infections
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2005 (estimated)
- Study startJul 2005
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraceptive BehaviorStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- ETR Associates, William and Flora Hewlett Foundation
- Responsible party
- Sponsor
- Investigators
- Tina R Raine-Bennett, MD, MPH, Principal investigator, University of California, San FranciscoDoug Kirby, PhD, Principal investigator, ETR Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230880
- Sponsor's protocol ID
- OSR# 04038166
- Acronym
- REACH
- Status last verified
- Dec 2012
- First submitted
- 29 Sep 2005
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of an Intervention to Impact Contraceptive Behavior, Unintended Pregnancy, and STIs Among Adolescent Females Receiving Family Planning Clinic Services
- ClinicalTrials.gov ID
- NCT00230880
- Acronym / sponsor ID
- REACH / OSR# 04038166
- Keywords
- Contraception behavior, Condoms, Unsafe sex, Pregnancy unwanted, Adolescent pregnancy, Condom use, Unprotected sex, Unintended pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- ETR Associates, William and Flora Hewlett Foundation
- Study start
- Jul 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 3 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: follow-up phone counselingfollow-up phone counseling |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- Pregnant
- Using a hormonal contraceptive method continuously for the last 3 months
- Not willing to be contacted by phone for the intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| follow-up phone counselingAlso: Intense phone follow-up using motivational interviewing9 calls over 12 months | Behavioural | Treatment |
Primary outcome
Contraceptive use at time of last sexual intercourse
Time frame: 18 months
2 secondary outcomes
Unintended pregnancy
Time frame: 18 months
Sexually transmitted infections
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tina R Raine-Bennett, MD, MPH principal investigator
University of California, San Francisco
Doug Kirby, PhD principal investigator
ETR Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing follow-up phone counseling in people with Contraceptive Behavior and Sexually Transmitted Diseases, run by University of California, San Francisco 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 2 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 5 Dec 2012. 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.
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?
Contraceptive use at time of last sexual intercourse (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2012.