Denver Health & Hospital Authority
Denver, Colorado, 80204, United States
NCT Number: NCT04162184
This study will utilize mixed methods to develop and assess the feasibility and acceptability of a health educator intervention designed to connect patients in recovery from substance use disorder to reproductive health education and services.
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Notify Me18 year–44 year
All sexes
Interventional
Not applicable
Denver, Colorado, 80204, United States
Developing effective reproductive health interventions for individuals in treatment for substance use disorder is an important public health priority. In the US nearly half (45%) of all pregnancies are unplanned and studies have consistently found this rate to be much higher among individuals in substance treatment, almost 90%. There is a paucity of research on interventions to support the family planning care of this population. The primary goal of this project is to identify an innovative delivery model to address the family planning needs of individuals of reproductive age in treatment for substance use disorder at an urban integrated safety-net health system. Through the use of mixed methods this study will address the following objectives: 1) To describe the family planning experiences and needs of individuals in treatment for substance use disorders (SUD) in a representative sample of patients and 2) To assess the feasibility and acceptability of the intervention among study participants. If found to be acceptable, efficacy should be assessed in a randomized controlled trial. A navigator model such as this is generalizable and could be easily integrated into a variety of settings.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
a brief health educator-led behavioral intervention focused on educating, identifying reproductive health needs, and linking to services if desired
Other names: SHINE Intervention
Time frame: up to 3 months
Intervention acceptability will be measured by the number of sessions completed by the health educator among participants enrolled in the study.
Time frame: up to 3 months
Intervention acceptability will be assessed by participant self-reported satisfaction with the intervention (via surveys) among those who complete the intervention sessions. Satisfaction will be assessed with 8 items on a 4-point scale describing how strongly participants agree with each statement. The response scale is coded so that a higher score reflects higher satisfaction and therefore a better outcome. Reported as mean overall score (range 1-32).
Denver Health and Hospital Authority
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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