PregnancyNCT00065078
Providing Birth Control Through Home Health Visits
A study testing Home dispensing of contraception and Family Planning Counseling in people with Pregnancy, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This study will evaluate a program that provides birth control to low income and minority women through home visits by a community health nurse. The goal of the program is to reduce unwanted pregnancies. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Home dispensing of contraception and Family Planning Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2003to 14 Jul 2005
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women of child bearing age
- Not pregnant
- Interested in delaying pregnancy using oral contraceptives or a depo-provera shot
- Had sex in the last month or are planning to have sex in the next month
- Have not used contraception during every sexual encounter within 3 months prior to study entry
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clackamas County Public Health Division
Oregon City, Oregon, 97045
About this study
Official title: Effectiveness of Nurse Home Contraceptive Dispensing
This study will evaluate a program that provides birth control to low income and minority women through home visits by a community health nurse. The goal of the program is to reduce unwanted pregnancies.
Read the detailed description
Unintended pregnancy is associated with significant public health problems, including inadequate prenatal care, low birth weight infants, infant mortality, and maternal morbidity and mortality. Children born as a result of unplanned pregnancies are at greater risk for poor outcomes such as poor mental health and developmental disabilities. This research project will determine whether providing contraception in the home can reduce the incidence of unintended pregnancy in low income and minority women. The project will also determine whether delaying a pelvic exam encourages or discourages the utilization of clinic-based preventive services to screen for sexually transmitted diseases (STDs) and cervical cancer.
Participants will be randomized to either an experimental group or a comparison group. Each participant will receive family planning counseling during a home visit by a community health nurse. Participants in the experimental group will be offered a three-month supply of oral contraceptives or a depo-provera shot; both forms of contraceptives will be delivered during home visits. Each participant will complete a survey during the initial visit and during a 1-year follow-up. The study will last approximately three years.
- Conditions
- Pregnancy
- Being tested
- Home dispensing of contraception, Family Planning Counseling
- Keywords
- Home-visits, Community nurse, Unintended pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home dispensing of contraceptionOther
Home dispensing of contraception
Family Planning CounselingOther
Family Planning Counseling
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | The control group receives only Family Planning Counseling. Receives: Other: Family Planning Counseling |
| Intervention Group | Experimental | The intervention group receives Family Planning Counseling and contraception in the home. Receives: Other: Home dispensing of contraception; Other: Family Planning Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy
Measured: Twelve month follow-up (June 2004 - July 2025)
Secondary outcomes (1)
Sexually Transmitted Disease Screening
Measured: Twelve month follow-up (June 2004 - July 2025)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2003 (estimated)
- Study start5 Jun 2003
- Primary completion14 Jul 2005
- Study completion14 Jul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Alan L Melnick, MD, MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00065078
- Sponsor's protocol ID
- IRB00002668
- Other IDs
- 5R01HD042423
- Status last verified
- May 2026
- First submitted
- 16 Jul 2003
- Last updated
- 11 May 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Nurse Home Contraceptive Dispensing
- ClinicalTrials.gov ID
- NCT00065078
- Acronym / sponsor ID
- IRB00002668
- Conditions
- Pregnancy
- Keywords
- Home-visits, Community nurse, Unintended pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 5 Jun 2003 (actual)
- Primary completion
- 14 Jul 2005 (actual)
- Study completion
- 14 Jul 2005 (actual)
- First posted
- 18 Jul 2003 (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.
This study will evaluate a program that provides birth control to low income and minority women through home visits by a community health nurse. The goal of the program is to reduce unwanted pregnancies.
Detailed description
Unintended pregnancy is associated with significant public health problems, including inadequate prenatal care, low birth weight infants, infant mortality, and maternal morbidity and mortality. Children born as a result of unplanned pregnancies are at greater risk for poor outcomes such as poor mental health and developmental disabilities. This research project will determine whether providing contraception in the home can reduce the incidence of unintended pregnancy in low income and minority women. The project will also determine whether delaying a pelvic exam encourages or discourages the utilization of clinic-based preventive services to screen for sexually transmitted diseases (STDs) and cervical cancer.
Participants will be randomized to either an experimental group or a comparison group. Each participant will receive family planning counseling during a home visit by a community health nurse. Participants in the experimental group will be offered a three-month supply of oral contraceptives or a depo-provera shot; both forms of contraceptives will be delivered during home visits. Each participant will complete a survey during the initial visit and during a 1-year follow-up. The study will last approximately three years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Other: Family Planning CounselingThe control group receives only Family Planning Counseling. |
| Intervention Group | Experimental | Other: Home dispensing of contraception, Other: Family Planning CounselingThe intervention group receives Family Planning Counseling and contraception in the home. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Women of child bearing age
- Not pregnant
- Interested in delaying pregnancy using oral contraceptives or a depo-provera shot
- Had sex in the last month or are planning to have sex in the next month
- Have not used contraception during every sexual encounter within 3 months prior to study entry
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Home dispensing of contraceptionHome dispensing of contraception | Other | Intervention Group |
| Family Planning CounselingFamily Planning Counseling | Other | Control Group, Intervention Group |
Primary outcome
Pregnancy
Time frame: Twelve month follow-up (June 2004 - July 2025)
1 secondary outcome
Sexually Transmitted Disease Screening
Time frame: Twelve month follow-up (June 2004 - July 2025)
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 11 May 2026.
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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.
Alan L Melnick, MD, MPH principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home dispensing of contraception and Family Planning Counseling in people with Pregnancy, run by Oregon Health and Science University 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 5 inclusion and 0 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 11 May 2026. 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?
Pregnancy (time frame: Twelve month follow-up (June 2004 - July 2025)). 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 11 May 2026.