Contraception, Contraceptive Usage
Conditions
Keywords
contraception, sexhealth mobile, substance abuse
Brief summary
Pilot study aims to evaluate the effectiveness of SexHealth Mobile and improve access to highly effective contraception among women with substance use disorder (SUD) with SexHealth Mobile intervention. This intervention will consist of two existing services that will help reach women with or recovering from SUD and provide access to contraception, as well as counseling.
Detailed description
Pilot study aims to evaluate the effectiveness of SexHealth Mobile and improve access to highly effective contraception among women with substance use disorder (SUD) with SexHealth Mobile. Our study will follow a quasi-experimental design that uses an interrupted time series (i.e., usual care \[control\] then intervention care) to compare the uptake of contraception before and after implementing the SexHealth Mobile intervention. SexHealth Mobile integrates two existing services in our community: a mobile medical unit (MMU) operated by Swope Health Services and SexHealth a point-of-care contraception counseling service that our research team developed for Children's Mercy Hospital's emergency department (ED) for adolescents. Using a menu of adaptive services, SexHealth Mobile will bring contraceptive care to women with SUD (including the subset with opioid use disorder \[OUD\]) at recovery centers in the Kansas City community. Our primary hypothesis is that the current use of highly effective contraception will be greater at 1-month post-enrollment among women recruited during the intervention period (i.e., SexHealth Mobile) compared to those recruited during the usual care period. The current use and discontinuation of contraception will also be compared at 2-weeks and 3-months. Our approach consists of enrolling (n=170) eligible women are accessing health, recovery, or community services at a site we identified in our formative research work. We will aim to recruit up to 85 women during the usual care period and 85 during the intervention period. We will follow-up with participants at 2-weeks, 1-month, and 3-months after the enrollment date.
Interventions
BEHAVIORALSexHealth Mobile
It will integrate two existing services in our community: a mobile medical unit (MMU) operated by Swope Health Services, and SexHealth a point-of-care contraception counseling service that our research team developed for Children's Mercy Hospital's emergency department (ED). Using a menu of adaptive services, SexHealth Mobile will bring contraceptive care to women with SUD (including a subset of women with OUD), if they wish to receive it, at targeted recovery sites Swope currently partners with.
Sponsors
Swope Health Services
University of Kansas Medical Center
Children's Mercy Hospital Kansas City
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
Participants will be eligible if they: * are between the ages of 18-40 years * are biological females * have an unmet need for contraception (sexually active, able to become pregnant, not consistently/currently using these contraception methods \[sterilization, subdermal implant, intrauterine device, injectable, pill, patch, or ring\] * have current or recent (within the past year) problematic patterns of substance use (according to the CAGE-AID self-assessment
Exclusion criteria
Participants will be ineligible if they: * have previously enrolled in the study * are unable to provide informed consent * are pregnant at index (recruitment) visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Current Use of Highly Effective Contraception | 1 month | Participants will be asked if they acquired birth control and their current use of it at 1-month period following the recruitment visit. Did participant initiate hormonal contraception or contraceptive device at initial visit or referral? Yes/No If yes, which contraception or contraceptive device was initiated? Implant/Depo-Provera/Birth control patch/Birth control pills/Birth control ring/Emergency contraception/ Intrauterine device If participant started using hormonal contraception or contraceptive device at 2-week follow-up time, are they still using hormonal contraception or contraceptive device at 1-month? Yes/No |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Current Use of Highly Effective Contraception | 3 months | Participants will be asked if they acquired birth control and their current use of it at 2-weeks and 3-months after recruitment visit Did participant initiate hormonal contraception or contraceptive device at initial visit or referral? Yes/No If yes, which contraception or contraceptive device was initiated? Implant/Depo-Provera/Birth control patch/Birth control pills/Birth control ring/Emergency contraception/ Intrauterine device If participant started using hormonal contraception or contraceptive device at 2-week follow-up time, are they still using hormonal contraception or contraceptive device at 3-month? Yes/No |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care We will recruit up to 85 women with substance abuse disorder (or opioid abuse disorder) from recovery centers. Eligible women will complete a baseline survey and study staff will provide a referral for participants to seek more information on contraception and services. Study staff will record whether the participant accepted the referral. Follow-up will occur via phone call at 2-weeks, 1-month and 3-months post-enrollment to determine if they accessed contraceptive referral services if they initiated any contraceptive method, and if so: if they continued, changed, or discontinued this contraception method. We will recruit, complete baseline and usual care referral at recovery sites on a timely rotation that mirrors the intervention period (e.g., every fourth Friday morning at Site 1), in order to increase the chance of recruiting a comparable population. | 48 |
| SexHealth Mobile We will train Swope providers in contraceptive counseling before intervention. We will recruit up to 85 women with substance abuse disorder (or opioid abuse disorder) from recovery centers. Eligible women will complete a baseline survey. Study staff will provide a referral for participants to seek more information on contraception and services. Women will have direct access to contraceptive counseling and services on-site via the mobile medical unit if they choose to use it. Counseling will focus on presenting the most effective contraceptive methods first (i.e., LARC). If women participate in contraceptive counseling, study staff will record the uptake of contraceptive medication and clinic referral at the time of enrollment and conduct follow-up surveys at 2-weeks, 1-month, and 3-months post-enrollment. If the participant refuses contraceptive counseling on MMU, a referral will be given.
SexHealth Mobile: It will integrate two existing services in our community: a mobile medical unit (MMU) operated by Swope Health Services, and SexHealth a point-of-care contraception counseling service that our research team developed for Children's Mercy Hospital's emergency department (ED). Using a menu of adaptive services, SexHealth Mobile will bring contraceptive care to women with SUD (including a subset of women with OUD), if they wish to receive it, at targeted recovery sites Swope currently partners with. | 50 |
| Total | 98 |
Baseline characteristics
| Characteristic | Usual Care | SexHealth Mobile | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants | 50 Participants | 98 Participants |
| Age, Continuous | 30 years | 32.5 years | 31 years |
| Contraception use | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 46 Participants | 91 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 8 Participants | 9 Participants |
| Race (NIH/OMB) White | 40 Participants | 38 Participants | 78 Participants |
| Region of Enrollment United States | 48 participants | 50 participants | 98 participants |
| Sex: Female, Male Female | 48 Participants | 50 Participants | 98 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 50 |
| other Total, other adverse events | 0 / 48 | 0 / 50 |
| serious Total, serious adverse events | 0 / 48 | 0 / 50 |
Outcome results
Primary
Current Use of Highly Effective Contraception
Participants will be asked if they acquired birth control and their current use of it at 1-month period following the recruitment visit. Did participant initiate hormonal contraception or contraceptive device at initial visit or referral? Yes/No If yes, which contraception or contraceptive device was initiated? Implant/Depo-Provera/Birth control patch/Birth control pills/Birth control ring/Emergency contraception/ Intrauterine device If participant started using hormonal contraception or contraceptive device at 2-week follow-up time, are they still using hormonal contraception or contraceptive device at 1-month? Yes/No
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Current Use of Highly Effective Contraception | 2 Participants |
| SexHealth Mobile | Current Use of Highly Effective Contraception | 17 Participants |
Secondary
Current Use of Highly Effective Contraception
Participants will be asked if they acquired birth control and their current use of it at 2-weeks and 3-months after recruitment visit Did participant initiate hormonal contraception or contraceptive device at initial visit or referral? Yes/No If yes, which contraception or contraceptive device was initiated? Implant/Depo-Provera/Birth control patch/Birth control pills/Birth control ring/Emergency contraception/ Intrauterine device If participant started using hormonal contraception or contraceptive device at 2-week follow-up time, are they still using hormonal contraception or contraceptive device at 3-month? Yes/No
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Current Use of Highly Effective Contraception | 5 Participants |
| SexHealth Mobile | Current Use of Highly Effective Contraception | 9 Participants |