Trial of an Adapted STD Screening and Risk Reduction Intervention

NCT02513225 | Completed

• 1 other identifier: 14020838
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (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.

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

The 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.

Behavioral: Project EMPWR; Other: Optimized Standard Care (OSC)

Control

OTHER

The 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.

Other: Optimized Standard Care (OSC)

Interventions

Project EMPWR BEHAVIORAL

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

Also known as: Intervention Condition

Intervention

Optimized Standard Care (OSC) OTHER

Participants will receive Optimized Standard Care (OSC) alone.

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead

Study Sites (1)

Fort Apache Reservation

Fort Apache, Arizona, 85926, United States

Location

Related Publications (1)

• 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.

  PMID: 27129956 DERIVED

MeSH Terms

Conditions

Alcohol Drinking; Gonorrhea; Unsafe Sex; Chlamydia Infections; Trichomonas Infections

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Sexual Behavior; Chlamydiaceae Infections; Protozoan Infections; Parasitic Diseases

Study Officials

• Lauren Tingey, MPH/MSW

  Center for American Indian Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2015
• First Posted: July 31, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)