Trial Outcomes & Findings for Improving Reproductive Health for Women in Opioid Medication-Assisted Treatment (OMAT) (NCT NCT02794597)
NCT ID: NCT02794597
Last Updated: 2020-11-16
Results Overview
Assess initial efficacy (family planning/clinical visits and uptake of birth control, specifically long-acting reversible contraceptives (LARCs) of the SHINE intervention, using baseline/follow up surveys and review of medical records at three and six months. Specifically, the number of participants that were using LARCs and the number of participants who had attended family visits at each time point.
COMPLETED
NA
119 participants
3 and 6 months
2020-11-16
Participant Flow
Participant milestones
| Measure |
Usual Care - Opioid Medication Assisted Treatment (OMAT)
The current standard of care for patients at these clinics is to conduct point-of-care urine pregnancy testing at treatment intake and refer positives for follow-up and clinical care. At the time of the study, neither program had standard work in place to assess pregnancy desire or contraceptive use, nor to provide information on contraceptive methods or referral to family planning (FP) services.
|
Intervention
Peer-led, behavioral sexual health intervention: Sexual Health Initiative for Navigation and Empowerment (SHINE)
Intervention: a brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing.
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
56
|
|
Overall Study
COMPLETED
|
63
|
56
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Reproductive Health for Women in Opioid Medication-Assisted Treatment (OMAT)
Baseline characteristics by cohort
| Measure |
Usual Care - Opioid Medication Assisted Treatment
n=63 Participants
The current standard of care for patients at these clinics is to conduct point-of-care urine pregnancy testing at treatment intake and refer positives for follow-up and clinical care. At the time of the study, neither program had standard work in place to assess pregnancy desire or contraceptive use, nor to provide information on contraceptive methods or referral to FP services.
|
Intervention
n=56 Participants
Peer-led, behavioral sexual health intervention
Intervention: a brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
63 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
32.1 years
STANDARD_DEVIATION 6.5 • n=99 Participants
|
32.0 years
STANDARD_DEVIATION 6.4 • n=107 Participants
|
32.1 years
STANDARD_DEVIATION 6.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
63 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 and 6 monthsAssess initial efficacy (family planning/clinical visits and uptake of birth control, specifically long-acting reversible contraceptives (LARCs) of the SHINE intervention, using baseline/follow up surveys and review of medical records at three and six months. Specifically, the number of participants that were using LARCs and the number of participants who had attended family visits at each time point.
Outcome measures
| Measure |
Usual Care - Opioid Medication Assisted Treatment
n=63 Participants
The current standard of care for patients at these clinics is to conduct point-of-care urine pregnancy testing at treatment intake and refer positives for follow-up and clinical care. At the time of the study, neither program had standard work in place to assess pregnancy desire or contraceptive use, nor to provide information on contraceptive methods or referral to FP services.
|
Intervention
n=56 Participants
Peer-led, behavioral sexual health intervention
Intervention: a brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing.
|
|---|---|---|
|
Family Planning Visit and Long-acting Reversible Contraception Use at Three and Six Month Follow-up by Condition.
3 month LARC use (# of participants)
|
2 Participants
|
7 Participants
|
|
Family Planning Visit and Long-acting Reversible Contraception Use at Three and Six Month Follow-up by Condition.
6 month LARC use (# of participants; inclusive of entire 6 month period)
|
2 Participants
|
7 Participants
|
|
Family Planning Visit and Long-acting Reversible Contraception Use at Three and Six Month Follow-up by Condition.
Family planning visits at 3 months (# of participants who had a visit)
|
8 Participants
|
17 Participants
|
|
Family Planning Visit and Long-acting Reversible Contraception Use at Three and Six Month Follow-up by Condition.
Family planning visits at 6 months (# who had a visit; inclusive of entire 6 month period)
|
9 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Participants who completed the baseline survey
Assess the impact of the SHINE intervention on overall sexual and reproductive health knowledge at baseline (based on participants who completed the baseline survey). Reported as percentage of questions answered correctly by participants.
Outcome measures
| Measure |
Usual Care - Opioid Medication Assisted Treatment
n=63 Participants
The current standard of care for patients at these clinics is to conduct point-of-care urine pregnancy testing at treatment intake and refer positives for follow-up and clinical care. At the time of the study, neither program had standard work in place to assess pregnancy desire or contraceptive use, nor to provide information on contraceptive methods or referral to FP services.
|
Intervention
n=56 Participants
Peer-led, behavioral sexual health intervention
Intervention: a brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing.
|
|---|---|---|
|
Sexual Health Knowledge at Baseline by Intervention Condition.
|
78.4 percentage of correct responses
|
76.2 percentage of correct responses
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Participants who completed the 3 month follow-up survey
Assess the impact of the SHINE intervention on overall sexual and reproductive health knowledge at 3 month follow-up (based on participants who completed the 3 month follow-up survey). Reported as percentage of questions answered correctly by participants.
Outcome measures
| Measure |
Usual Care - Opioid Medication Assisted Treatment
n=50 Participants
The current standard of care for patients at these clinics is to conduct point-of-care urine pregnancy testing at treatment intake and refer positives for follow-up and clinical care. At the time of the study, neither program had standard work in place to assess pregnancy desire or contraceptive use, nor to provide information on contraceptive methods or referral to FP services.
|
Intervention
n=38 Participants
Peer-led, behavioral sexual health intervention
Intervention: a brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing.
|
|---|---|---|
|
Sexual Health Knowledge at 3 Month Follow-up by Intervention Condition.
|
81.6 percentage of correct responses
|
81.9 percentage of correct responses
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants who completed the 6 month follow-up survey
Assess the impact of the SHINE intervention on overall sexual and reproductive health knowledge at 6 month follow-up (based on participants who completed the 6 month follow-up survey). Reported as percentage of questions answered correctly by participants.
Outcome measures
| Measure |
Usual Care - Opioid Medication Assisted Treatment
n=50 Participants
The current standard of care for patients at these clinics is to conduct point-of-care urine pregnancy testing at treatment intake and refer positives for follow-up and clinical care. At the time of the study, neither program had standard work in place to assess pregnancy desire or contraceptive use, nor to provide information on contraceptive methods or referral to FP services.
|
Intervention
n=39 Participants
Peer-led, behavioral sexual health intervention
Intervention: a brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing.
|
|---|---|---|
|
Sexual Health Knowledge at 6 Month Follow-up by Intervention Condition.
|
81.8 percentage of correct responses
|
83.5 percentage of correct responses
|
SECONDARY outcome
Timeframe: BaselinePopulation: Participants who completed the baseline survey
Assess the impact of the SHINE intervention on perceived threat of pregnancy at baseline (based on participants who completed the baseline survey). Reported as number of participants who indicated agreement with the statement, "If I do not use birth control and have unprotected sex, I could get pregnant."
Outcome measures
| Measure |
Usual Care - Opioid Medication Assisted Treatment
n=63 Participants
The current standard of care for patients at these clinics is to conduct point-of-care urine pregnancy testing at treatment intake and refer positives for follow-up and clinical care. At the time of the study, neither program had standard work in place to assess pregnancy desire or contraceptive use, nor to provide information on contraceptive methods or referral to FP services.
|
Intervention
n=56 Participants
Peer-led, behavioral sexual health intervention
Intervention: a brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing.
|
|---|---|---|
|
Health Belief Model Constructs (Perceived Threat of Pregnancy) at Baseline by Intervention Condition.
|
59 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Participants who completed the 3 month follow-up survey
Assess the impact of the SHINE intervention on perceived threat of pregnancy at 3 month follow-up (based on participants who completed the 3 month follow-up survey). Reported as number of participants who indicated agreement with the statement, "If I do not use birth control and have unprotected sex, I could get pregnant."
Outcome measures
| Measure |
Usual Care - Opioid Medication Assisted Treatment
n=50 Participants
The current standard of care for patients at these clinics is to conduct point-of-care urine pregnancy testing at treatment intake and refer positives for follow-up and clinical care. At the time of the study, neither program had standard work in place to assess pregnancy desire or contraceptive use, nor to provide information on contraceptive methods or referral to FP services.
|
Intervention
n=38 Participants
Peer-led, behavioral sexual health intervention
Intervention: a brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing.
|
|---|---|---|
|
Health Belief Model Constructs (Perceived Threat of Pregnancy) at 3 Month Follow-up by Intervention Condition.
|
42 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants who completed the 6 month follow-up survey
Assess the impact of the SHINE intervention on perceived threat of pregnancy at 6 month follow-up (based on participants who completed the 6 month follow-up survey). Reported as the number of participants who indicated agreement with the statement, "If I do not use birth control and have unprotected sex, I could get pregnant."
Outcome measures
| Measure |
Usual Care - Opioid Medication Assisted Treatment
n=50 Participants
The current standard of care for patients at these clinics is to conduct point-of-care urine pregnancy testing at treatment intake and refer positives for follow-up and clinical care. At the time of the study, neither program had standard work in place to assess pregnancy desire or contraceptive use, nor to provide information on contraceptive methods or referral to FP services.
|
Intervention
n=39 Participants
Peer-led, behavioral sexual health intervention
Intervention: a brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing.
|
|---|---|---|
|
Health Belief Model Constructs (Perceived Threat of Pregnancy) at 6 Month Follow-up by Intervention Condition.
|
44 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: baselinePopulation: Participants who completed the baseline survey
Assess the impact of the SHINE intervention on contraceptive cost-benefit at baseline (based on participants who completed the baseline survey). Perceived contraceptive costs and benefits were assessed with 14 items on a five-point scale describing how strongly participants agreed to each statement. The response scale was coded so that a higher score reflected higher benefits and lower costs and was the desired direction over time. Reported as mean overall score (range 0-56).
Outcome measures
| Measure |
Usual Care - Opioid Medication Assisted Treatment
n=63 Participants
The current standard of care for patients at these clinics is to conduct point-of-care urine pregnancy testing at treatment intake and refer positives for follow-up and clinical care. At the time of the study, neither program had standard work in place to assess pregnancy desire or contraceptive use, nor to provide information on contraceptive methods or referral to FP services.
|
Intervention
n=56 Participants
Peer-led, behavioral sexual health intervention
Intervention: a brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing.
|
|---|---|---|
|
Health Belief Model Constructs (Contraceptive Cost-benefit) at Baseline by Intervention Condition.
|
37.6 score on a scale
Standard Deviation 8.3
|
35.6 score on a scale
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Participants who completed the 3 month follow-up survey
Assess the impact of the SHINE intervention on contraceptive cost-benefit at 3 month follow-up (based on participants who completed the 3 month follow-up survey). Perceived contraceptive costs and benefits were assessed with 14 items on a five-point scale describing how strongly participants agreed to each statement. The response scale was coded so that a higher score reflected higher benefits and lower costs and was the desired direction over time. Reported as mean overall score (range 0-56).
Outcome measures
| Measure |
Usual Care - Opioid Medication Assisted Treatment
n=50 Participants
The current standard of care for patients at these clinics is to conduct point-of-care urine pregnancy testing at treatment intake and refer positives for follow-up and clinical care. At the time of the study, neither program had standard work in place to assess pregnancy desire or contraceptive use, nor to provide information on contraceptive methods or referral to FP services.
|
Intervention
n=38 Participants
Peer-led, behavioral sexual health intervention
Intervention: a brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing.
|
|---|---|---|
|
Health Belief Model Constructs (Contraceptive Cost-benefit) at 3 Month Follow-up by Intervention Condition.
|
37.9 score on a scale
Standard Deviation 7.6
|
40.1 score on a scale
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants who completed the 6 month follow-up survey
Assess the impact of the SHINE intervention on contraceptive cost-benefit at 6 month follow-up (based on participants who completed the 6 month follow-up survey). Perceived contraceptive costs and benefits were assessed with 14 items on a five-point scale describing how strongly participants agreed to each statement. The response scale was coded so that a higher score reflected higher benefits and lower costs and was the desired direction over time. Reported as mean overall score (range 0-56).
Outcome measures
| Measure |
Usual Care - Opioid Medication Assisted Treatment
n=50 Participants
The current standard of care for patients at these clinics is to conduct point-of-care urine pregnancy testing at treatment intake and refer positives for follow-up and clinical care. At the time of the study, neither program had standard work in place to assess pregnancy desire or contraceptive use, nor to provide information on contraceptive methods or referral to FP services.
|
Intervention
n=39 Participants
Peer-led, behavioral sexual health intervention
Intervention: a brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing.
|
|---|---|---|
|
Health Belief Model Constructs (Contraceptive Cost-benefit) at 6 Month Follow-up by Intervention Condition.
|
38.7 score on a scale
Standard Deviation 8.3
|
41.5 score on a scale
Standard Deviation 9.8
|
Adverse Events
Usual Care - Opioid Medication Assisted Treatment
Intervention
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