Trial Outcomes & Findings for Improving Reproductive Health for Women in Opioid Medication-Assisted Treatment (OMAT) (NCT 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.

Recruitment status

COMPLETED

Study phase

Target enrollment

119 participants

Primary outcome timeframe

3 and 6 months

Results posted on

2020-11-16

Participant Flow

Participant milestones

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

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=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	63 Participants n=5 Participants	56 Participants n=7 Participants	119 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	32.1 years STANDARD_DEVIATION 6.5 • n=5 Participants	32.0 years STANDARD_DEVIATION 6.4 • n=7 Participants	32.1 years STANDARD_DEVIATION 6.4 • n=5 Participants
Sex: Female, Male Female	63 Participants n=5 Participants	56 Participants n=7 Participants	119 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	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=5 Participants	41 Participants n=7 Participants	88 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	57 Participants n=5 Participants	42 Participants n=7 Participants	99 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	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	63 Participants n=5 Participants	56 Participants n=7 Participants	119 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 and 6 months

Outcome measures

Outcome measures
Measure	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.	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.
Family Planning Visit and Long-acting Reversible Contraception Use at Three and Six Month Follow-up by Condition. 3 month LARC use (# of participants)	7 Participants	2 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)	7 Participants	2 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)	17 Participants	8 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)	20 Participants	9 Participants

SECONDARY outcome

Timeframe: Baseline

Population: 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

Outcome measures
Measure	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.	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.
Sexual Health Knowledge at Baseline by Intervention Condition.	76.2 percentage of correct responses	78.4 percentage of correct responses

SECONDARY outcome

Timeframe: 3 months

Population: 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

Outcome measures
Measure	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.	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.
Sexual Health Knowledge at 3 Month Follow-up by Intervention Condition.	81.9 percentage of correct responses	81.6 percentage of correct responses

SECONDARY outcome

Timeframe: 6 months

Population: 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

Outcome measures
Measure	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.	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.
Sexual Health Knowledge at 6 Month Follow-up by Intervention Condition.	83.5 percentage of correct responses	81.8 percentage of correct responses

SECONDARY outcome

Timeframe: Baseline

Population: 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

Outcome measures
Measure	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.	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.
Health Belief Model Constructs (Perceived Threat of Pregnancy) at Baseline by Intervention Condition.	52 Participants	59 Participants

SECONDARY outcome

Timeframe: 3 months

Population: 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

Outcome measures
Measure	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.	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.
Health Belief Model Constructs (Perceived Threat of Pregnancy) at 3 Month Follow-up by Intervention Condition.	34 Participants	42 Participants

SECONDARY outcome

Timeframe: 6 months

Population: 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

Outcome measures
Measure	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.	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.
Health Belief Model Constructs (Perceived Threat of Pregnancy) at 6 Month Follow-up by Intervention Condition.	37 Participants	44 Participants

SECONDARY outcome

Timeframe: baseline

Population: 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

Outcome measures
Measure	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.	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.
Health Belief Model Constructs (Contraceptive Cost-benefit) at Baseline by Intervention Condition.	35.6 score on a scale Standard Deviation 8.9	37.6 score on a scale Standard Deviation 8.3

SECONDARY outcome

Timeframe: 3 months

Population: 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

Outcome measures
Measure	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.	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.
Health Belief Model Constructs (Contraceptive Cost-benefit) at 3 Month Follow-up by Intervention Condition.	40.1 score on a scale Standard Deviation 8.3	37.9 score on a scale Standard Deviation 7.6

SECONDARY outcome

Timeframe: 6 months

Population: 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

Outcome measures
Measure	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.	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.
Health Belief Model Constructs (Contraceptive Cost-benefit) at 6 Month Follow-up by Intervention Condition.	41.5 score on a scale Standard Deviation 9.8	38.7 score on a scale Standard Deviation 8.3

Adverse Events

Usual Care - Opioid Medication Assisted Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention

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

Deborah Rinehart

Denver Health & Hospital Authority

Phone: 303-602-2743

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place