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Alcohol UseNCT02513225

Trial of an Adapted STD Screening and Risk Reduction Intervention

A study testing Project EMPWR in people with Alcohol Use and Drug Use, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Alcohol Use, Drug Use, Diagnostic Self Evaluation
What is being tested?
Project EMPWR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
1 siteUnited States
Study dates
Jul 2015to Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Self-identified adults of American Indian ethnicity, who are members of the White Mountain Apache community
  • Ages 18 to 49;
  • Written informed consent to participate in the study;
  • Currently sexually active;
  • At least one episode of binge substance use or suicidal ideation recorded in the Apache community-based surveillance system in the past 90 days;
  • Participant must agree to be audio recorded during intervention sessions

Who cannot join

  • Inability to participate in full intervention (e.g., planned move, residential treatment, etc.)
  • Severe risk for suicide (i.e., suicide attempt within past 6 months) or
  • Unwilling to be randomized

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Fort Apache Reservation

    Fort Apache, Arizona, 85926

Other trials in United States

About this study

Official title: Randomized Controlled Trial of an Adapted STD Screening and Risk Reduction Intervention

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.

Read the 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.

Being tested
Project EMPWR, Optimized Standard Care (OSC)
Medical subject headings
Alcohol Drinking, Gonorrhea, Unsafe Sex, Chlamydia Infections, Trichomonas Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Project EMPWRBehavioural

    Also called Intervention Condition

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

  • Optimized Standard Care (OSC)Other

    Participants will receive Optimized Standard Care (OSC) alone.

Study groups in NCT02513225
Study groupRoleWhat they receive
InterventionExperimentalThe adapted Project EMPWR will be comprised of 2 sessions delivered approximately 7-10 days apart by a trained Apache paraprofessional interventionist. In the first session, interventionists will use curriculum to help participants understand their personal risk factors for STDs including HIV/AIDS (i.e., substance use, mental and emotional health, sexual health, etc.) and develop an achievable personalized risk-reduction plan that emphasizes individual and community-based strengths and resources.The second counseling session will consist of the disclosure of results (if tested) and the provision of social support to help participants develop a longer-term risk-reduction plan. At visit two, participants in both groups will be offered a STD screening protocol test.
Receives: Behavioral: Project EMPWR; Other: Optimized Standard Care (OSC)
ControlOtherThe comparison condition will consist of Optimized Standard Care (OSC) alone. All participants will receive OSC at the first visit. OSC includes the distribution of educational pamphlets and provision of information on substance use, signs and symptoms of mental health problems, and information about STD screening resources. At visit two, participants in both groups will be offered a STD screening protocol test.
Receives: Other: Optimized Standard Care (OSC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self reported condom use

    Change in self reported condom use at last sex, between intervention and control groups between baseline and 6 months post-intervention.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionJul 2019
  4. Study completionJul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02513225
Sponsor's protocol ID
14020838
Status last verified
Jul 2023
First submitted
9 Jul 2015
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Chambers R, Tingey L, Beach A, Barlow A, Rompalo A. Testing the efficacy of a brief sexual risk reduction intervention among high-risk American Indian adults: study protocol for a randomized controlled trial. BMC Public Health. 2016 Apr 29;16:366. doi: 10.1186/s12889-016-3040-y.

    PubMed 27129956

Questions about this trial

What is this clinical trial studying?

A study testing Project EMPWR in people with Alcohol Use and Drug Use, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self reported condom use (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02513225, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.

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