Trial of an Adapted STD Screening and Risk Reduction Intervention
Condition: Alcohol Use; Drug Use; Diagnostic Self Evaluation; Gonorrhea; Unprotected Sex; Chlamydia; Trichomonas
MeSH terms: Gonorrhea
Study type: Interventional

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.
    

Detailed description: 
      STDs including Neisseria gonorrhea, Chlamydia trachomatis and Trichomonas vaginalis, are an
      urgent problem in American Indian/Alaska Native (AI/AN) communities due to a constellation of
      risk and contextual factors affecting tribal populations. Geographic isolation and cultural
      and social stigmatization contribute to poor access to screening, counseling and education,
      and diminished opportunities for early identification of STDs. Evidence-based prevention, STD
      screening and early identification are the best public health strategies to address a
      potential epidemic among AI/ANs. However, there is currently a paucity of such strategies
      that have been demonstrated in AI/AN populations. An intervention targeting STD screening and
      related risk reduction behaviors has the potential to circumvent the continuous transference
      of disease.

      Participating Community: The Fort Apache Reservation is home to ~17,000 White Mountain Apache
      tribal members, with almost half <20 years of age. The reservation encompasses 1.7 million
      acres along northeastern Arizona. The Tribe endures notable demographic and environmental
      challenges that impact behavioral risks among community members: 61% of the population >16
      years old are either "Not in Labor Force" or unemployed. 47% of Apaches aged ≥25 have not
      received a high school diploma. The median household income is $26,973 and 47% of the
      population lives below the federal poverty line. Over half (53%)(1) of all Apache households
      are led by single mothers;(2) 75% of children are born to unwed mothers.(3) These factors
      contribute to high rates of school drop-out, substance use, high-risk sexual behavior and
      poor mental and emotional health in the void of effective interventions. Despite these
      challenges, the Apache community has successfully demonstrated the ability to adapt and
      implement effective paraprofessional-administered interventions.(4,5)

      Epidemiology of STD and Related Risk Behaviors: Recently, STD rates have increased throughout
      Arizona, and the state's AI population bears a disproportionately high burden of new
      infections.(6) In 2011, the chlamydia rate among AIs in Arizona was 6 times the rate for
      non-Hispanic Whites.(6) The rate of gonorrhea among AIs in Arizona tripled between 2009 and
      2011, a rise largely attributed to "outbreaks in tribal areas in the northeastern quadrant of
      Arizona."(6) In 2011-2012, the chlamydia rate among Apaches was 2,116/100,000 for all ages,
      nearly 5 times both Arizona and national all-ages rates. The Apache gonorrhea rate was
      749/100,000 for all ages in 2011-2012, approximately 7 and 10 times higher than national and
      Arizona all-ages rates, respectively. Previous studies indicate that among all races and
      ethnicities AI/ANs have some of the highest rates of inconsistent condom use, multiple sex
      partners and early sexual initiation.(7-10) The intersection of several behavioral risks such
      as poor mental health, drug use and binge alcohol use has shown to increase STD risk
      behaviors. A study conducted with Apache teens with recent suicidal behavior revealed high
      rates of lifetime drug use: 92% for alcohol, 88% for marijuana, 38% for crack/cocaine, and
      35% for methamphetamines, which is 3 times that of all AI/AN adolescents in 2009.
      Highlighting the intersection of risk, 48% of those that were sexually active had ever used
      cocaine compared with 17% of those not sexually active; similarly, 40% of sexually active
      participants had ever used methamphetamine compared with 17% of participants that were not
      sexually active.

      There have been scarce rigorous RCTs of behavioral health interventions among AI populations
      and none that have analyzed an EBI promoting STD screening or addressing the interrelated
      risks of substance use, poor emotional health and STDs/ HIV/AIDS. This study targets the
      shared root causes of substance use and sexual risk behaviors and aims to develop
      personalized, strengths-based risk reduction strategies tailored to participants' and the
      community's specific risk profiles.
    

Intervention name(s): Project EMPWR; Optimized Standard Care (OSC)
Intervention type(s): Behavioral; Other
Intervention description(s): Participants will receive both Adapted Project EMPWR and Optimized Standard Care (OSC).; Participants will receive Optimized Standard Care (OSC) alone.
Other intervention name(s): Intervention Condition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention