Improving Reproductive Health for Women in Opioid Medication-Assisted Treatment (OMAT)

Contraception Clinical Trial

Official title:

Improving Reproductive Health for Women in Opioid Medication-Assisted Treatment (OMAT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02794597
• Other study ID #: 15-1236
• Secondary ID: 1R34DA039381-01A
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: August 2019

Study information

• Verified date: October 2020
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Recent research suggests that women with substance use disorders may be at a higher risk of unintended pregnancy. There is a paucity of interventions specifically focused on this population. Through using mixed methods, this study proposes to develop a brief peer-led intervention (based on the Health Belief Model) to prevent unintended pregnancies among women entering opioid medication-assisted treatment; to assess acceptability, feasibility and the initial efficacy of the behavioral intervention; and to conduct exploratory analyses to identify the Health Belief Model constructs that are most influential on use of long-acting reversible contraception methods. Future research would include testing the intervention in a larger scale trial and with other populations.

Description:

This study aims to develop a reproductive health intervention to prevent unintended pregnancy for women of child-bearing age in opioid medication-assisted treatment (OMAT). It will be conducted in two phases. The first formative phase will employ individual interviews and focus groups with women between the ages of 18 and 44 and in opioid medication-assisted treatment to better understand: pregnancy desires/motivation and perceived susceptibility and severity, contraceptive knowledge, perceived benefits/barriers, self-efficacy, social norms, behaviors, and access to contraception and family planning services, especially related to long-acting reversible contraception. This information, coupled with prior evidence and theory, will be used to develop a brief peer-led behavioral intervention.

In the second phase, we will conduct a randomized controlled trial to assess the acceptability, feasibility and the initial efficacy of the developed intervention. Women will be recruited from two opioid medication-assisted treatment facilities and once they have consented and the baseline survey is completed they will be randomized to either the behavioral intervention or usual care. Participants will complete a baseline, three and six-month post-baseline follow up survey.

For those randomized to the intervention arm, the first session will occur immediately post-consent and baseline, and the second will occur 2-4 weeks post-baseline. A trained peer-educator will deliver the behavioral intervention that will provide accurate, unbiased information about Long Acting Reversible Contraception (intrauterine devices and subdermal implants) and all other contraceptive methods (including effectiveness, advantages, and disadvantages), help women assess their needs (pregnancy desires compared to behavior), and utilize motivational interviewing to empower them to make an informed decision regarding their sexual health. For those that are interested, the peer-educator will connect women to a Denver Health Community Health Clinic or a clinic of their choosing to further explore appropriate birth control methods. The medical clinic will assess the woman and determine and dispense the most appropriate method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

• Biologically female

• 18-44 years of age

• receiving medications for opioid use disorder at one of two clinic sites

• not currently pregnant or trying to become pregnant and having no known medical reason that could prevent pregnancy

• having sex or intending to have sex with a biological male

• not currently using a LARC method.

Exclusion Criteria:

• Being too intoxicated at the time of the interview or impaired mentally due to physical or psychological problems to the point that they cannot voluntarily consent to participate in the study and/or respond to the interview

• Have a known reason why they will not be available for the intervention or the follow-up interview.

Related Conditions & MeSH terms

• Contraception

Intervention

Behavioral:
• SHINE intervention group
Includes all substance treatment services as well as the brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing: Sexual Health Initiative for Navigation and Empowerment (SHINE).

Locations

Country	Name	City	State
United States	Denver Health and Hospital Authority	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Family Planning Visit and Long-acting Reversible Contraception Use at Three and Six Month Follow-up by Condition.	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.	3 and 6 months
Secondary	Sexual Health Knowledge at Baseline by Intervention Condition.	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.	Baseline
Secondary	Sexual Health Knowledge at 3 Month Follow-up by Intervention Condition.	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.	3 months
Secondary	Sexual Health Knowledge at 6 Month Follow-up by Intervention Condition.	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.	6 months
Secondary	Health Belief Model Constructs (Perceived Threat of Pregnancy) at Baseline by Intervention Condition.	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."	Baseline
Secondary	Health Belief Model Constructs (Perceived Threat of Pregnancy) at 3 Month Follow-up by Intervention Condition.	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."	3 months
Secondary	Health Belief Model Constructs (Perceived Threat of Pregnancy) at 6 Month Follow-up by Intervention Condition.	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."	6 months
Secondary	Health Belief Model Constructs (Contraceptive Cost-benefit) at Baseline by Intervention Condition.	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).	baseline
Secondary	Health Belief Model Constructs (Contraceptive Cost-benefit) at 3 Month Follow-up by Intervention Condition.	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).	3 months
Secondary	Health Belief Model Constructs (Contraceptive Cost-benefit) at 6 Month Follow-up by Intervention Condition.	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).	6 months