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Trial of an Adapted STD Screening and Risk Reduction Intervention

NCT02513225 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2023-07-27

No results posted yet for this study

Summary

The goal of this research study is to evaluate the impact of a paraprofessional-delivered, culturally adapted, evidence-based intervention (EBI) on sexually transmitted disease (STD), substance use and poor mental/emotional health among American Indians (AI) through a Randomized Controlled Trial (RCT). These intertwining risks have produced marked disparities and have unique cultural and social determinants in Native communities. If aims are achieved, scientific knowledge and community-based practice will be advanced in areas vital to AI communities, and to STD and drug prevention science.

Prior to this study, the investigators applied findings from research protocol (IRB#00005929) and adapted a brief intervention to reduce risk and increase protective behaviors for STDs, HIV/AIDS, substance use and poor mental/emotional health, and to promote STD screening. The specific aim of the current study is to compare the efficacy of the adapted brief intervention vs. a comparison condition on participants' condom use, STD screening and treatment-seeking behaviors, substance use and emotional/mental health outcomes at 3 and 6 months post-intervention.

Conditions

  • Alcohol Use
  • Drug Use
  • Diagnostic Self Evaluation
  • Gonorrhea
  • Unprotected Sex
  • Chlamydia
  • Trichomonas

Interventions

BEHAVIORAL

Project EMPWR

Participants will receive both Adapted Project EMPWR and Optimized Standard Care (OSC).

OTHER

Optimized Standard Care (OSC)

Participants will receive Optimized Standard Care (OSC) alone.

Sponsors & Collaborators

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Lauren Tingey, MPH/MSW · Center for American Indian Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2019-07-31
Completion
2019-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02513225 on ClinicalTrials.gov