Trial Outcomes & Findings for SexHealth Mobile: Integrating a Mobile Clinic and a Point-of-care Contraception Counseling and Access (NCT NCT04227145)
NCT ID: NCT04227145
Last Updated: 2023-07-21
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
98 participants
Primary outcome timeframe
1 month
Results posted on
2023-07-21
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Baseline and Post-Intervention Surveys
STARTED
|
48
|
50
|
|
Baseline and Post-Intervention Surveys
COMPLETED
|
48
|
50
|
|
Baseline and Post-Intervention Surveys
NOT COMPLETED
|
0
|
0
|
|
Two-week Follow-up
STARTED
|
38
|
31
|
|
Two-week Follow-up
COMPLETED
|
38
|
31
|
|
Two-week Follow-up
NOT COMPLETED
|
0
|
0
|
|
One-month Follow-up
STARTED
|
37
|
37
|
|
One-month Follow-up
COMPLETED
|
37
|
37
|
|
One-month Follow-up
NOT COMPLETED
|
0
|
0
|
|
Three-month Follow-up
STARTED
|
36
|
22
|
|
Three-month Follow-up
COMPLETED
|
36
|
22
|
|
Three-month Follow-up
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SexHealth Mobile: Integrating a Mobile Clinic and a Point-of-care Contraception Counseling and Access
Baseline characteristics by cohort
| Measure |
Usual Care
n=48 Participants
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.
|
SexHealth Mobile
n=50 Participants
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.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30 years
n=5 Participants
|
32.5 years
n=7 Participants
|
31 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
50 participants
n=7 Participants
|
98 participants
n=5 Participants
|
|
Contraception use
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthParticipants 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
Outcome measures
| Measure |
Usual Care
n=37 Participants
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.
|
SexHealth Mobile
n=33 Participants
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.
|
|---|---|---|
|
Current Use of Highly Effective Contraception
|
2 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 3 monthsParticipants 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
Outcome measures
| Measure |
Usual Care
n=36 Participants
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.
|
SexHealth Mobile
n=22 Participants
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.
|
|---|---|---|
|
Current Use of Highly Effective Contraception
|
5 Participants
|
9 Participants
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SexHealth Mobile
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place