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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34DA039381-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid Medication-Assisted Treatment only | No Intervention | Usual care - Opioid Medication Assisted Treatment | |
| Intervention | Experimental | Peer led, behavioral sexual health intervention: Sexual Health Initiative for Navigation and Empowerment (SHINE). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHINE intervention group | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Rinehart, PhD | Denver Health and Hospital Authority | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Health and Hospital Authority | Denver | Colorado | 80204 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35100081 | Derived | Stowell MA, Thomas-Gale T, Jones HE, Binswanger I, Rinehart DJ. Perspectives among women receiving medications for opioid use disorder: Implications for development of a peer navigation intervention to improve access to family planning services. Subst Abus. 2022;43(1):722-732. doi: 10.1080/08897077.2021.2007514. | |
| 34116817 | Derived | Rinehart DJ, Stowell M, Collings A, Durfee MJ, Thomas-Gale T, Jones HE, Binswanger I. Increasing access to family planning services among women receiving medications for opioid use disorder: A pilot randomized trial examining a peer-led navigation intervention. J Subst Abuse Treat. 2021 Jul;126:108318. doi: 10.1016/j.jsat.2021.108318. Epub 2021 Feb 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care - Opioid Medication Assisted Treatment | 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 3 and 6 months |
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6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care - Opioid Medication Assisted Treatment | 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. |
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Larger sample size needed to detect significant differences in long-acting reversible contraceptive use. The primary study site and where we referred participants for family planning services provides access to low-cost sexual health education and contraception, which may not exist elsewhere.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deborah Rinehart | Denver Health & Hospital Authority | 303-602-2743 | deborah.rinehart@dhha.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 9, 2018 | Sep 1, 2020 | Prot_SAP_000.pdf |
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| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| BG001 | Intervention | Peer-led, behavioral sexual health intervention Intervention: a brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Intervention | Peer-led, behavioral sexual health intervention Intervention: a brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing. |
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| 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. | Participants who completed the baseline survey | Posted | Number | percentage of correct responses | Baseline |
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| 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. | Participants who completed the 3 month follow-up survey | Posted | Number | percentage of correct responses | 3 months |
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| 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. | Participants who completed the 6 month follow-up survey | Posted | Number | percentage of correct responses | 6 months |
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| 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." | Participants who completed the baseline survey | Posted | Count of Participants | Participants | Baseline |
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| 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." | Participants who completed the 3 month follow-up survey | Posted | Count of Participants | Participants | 3 months |
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| 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." | Participants who completed the 6 month follow-up survey | Posted | Count of Participants | Participants | 6 months |
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| 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). | Participants who completed the baseline survey | Posted | Mean | Standard Deviation | score on a scale | baseline |
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| 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). | Participants who completed the 3 month follow-up survey | Posted | Mean | Standard Deviation | score on a scale | 3 months |
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| 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). | Participants who completed the 6 month follow-up survey | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| 0 |
| 63 |
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| 63 |
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| 63 |
| EG001 | Intervention | Peer-led, behavioral sexual health intervention Intervention: a brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing. | 0 | 56 | 0 | 56 | 0 | 56 |
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