STI/HIV Intervention Behavioral Intervention Program

NCT04547413 | Completed

• 1 other identifier: RV567
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 2

Brief Summary

The hypothesis is that a behavioral intervention tool adapted for the US military population will be acceptable and associated with a decrease in incident sexually transmitted infection (STI)/HIV rates and high-risk sexual behaviors, and increased self-reported condom use compared to the standard of care at the Joint Base Lewis-McChord (JBLM) Preventive Medicine clinic and the Fort Bragg Department of Public Health (part of Womack Army Medical Center).

Conditions

Sexually Transmitted Infections

Keywords

STI; HIV; syphilis; gonorrhea; chlamydia; mycoplasma genitalium

Outcome Measures

Primary Outcomes (2)

• Incident sexually transmitted infections

  Biological testing for syphilis, chlamydia trachomatis, neisseria gonorrhea, mycoplasma genitalium, and HIV

  12 months

• Acceptability of the intervention

  participant feedback and rating of the intervention session

  immediately after the intervention

Secondary Outcomes (2)

• Number of sexual partners

  12 months

• Proportion of sexual encounters protect by condom use

  12 months

Other Outcomes (3)

• Change in Knowledge about STIs, HIV and prevention: post-intervention

  Baseline and immediately after the intervention

• Change in Knowledge about STIs, HIV and prevention: retention at 6 months

  Baseline, immediately after the intervention, and at 6 months

• Change in Knowledge about STIs, HIV and prevention: retention at 12 months

  Baseline, immediately after the intervention, and at 12 months

Study Arms (2)

Control Arm

NO INTERVENTION

Control Arm will will complete a total of three visits: Visit 1 (Day 1): Recruitment/Baseline Biological Testing, if needed; completion of baseline study surveys including Knowledge Assessment Monthly: Prevention Maintenance Intervention Messages from months 2-11 Visit 3 (Day 180): 6 Month Follow-up biological testing and study survey Visit 4 (Day 365): 12 Month Follow-up biological testing and study surveys

Intervention Arm

ACTIVE COMPARATOR

Intervention Arm will will complete a total of four visits: Visit 1 (Day 1): Recruitment/Baseline Biological Testing, if needed; completion of baseline study surveys including Knowledge Assessment Visit 2 (Day 2-30): Group Intervention Session, Feedback form, and post-intervention knowledge assessment (for intervention arm only) Monthly: Prevention Maintenance Intervention Messages from months 2-11 Visit 3 (Day 180): 6 Month Follow-up biological testing and study survey Visit 4 (Day 365): 12 Month Follow-up biological testing and study surveys

Behavioral: STI/HIV Intervention Behavioral Intervention Program

Interventions

STI/HIV Intervention Behavioral Intervention Program BEHAVIORAL

In addition to standard of care STi/HIV counselling, participants in the intervention arm will also attend a 2-hour educational class and will receive monthly SMS/text messages to reinforce the content of the class.

Also known as: KISS (Knocking out Infections through Safer sex and Screening

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 - 30 years
• Army active duty or Army medical beneficiary
• Eligible to receive care at a military healthcare clinic for at least 12 months from enrollment
• HIV negative
• Not scheduled for military deployment or transfer within 3 months of enrolment
• Not pregnant, regardless of marital status
• Not trying to become pregnant or impregnate a partner, regardless of marital status
• Be classified as "high risk" either through a positive STI diagnosis in the last 180 days or has had STI screening during this timeframe.
• Self reports vaginal, oral, and/or anal sexual contact in the last 30 days.

You may not qualify if:

• Under 18 or over 30 years of age
• Not Army active duty or Army medical beneficiary
• Not eligible to receive care at a military healthcare clinic for study duration (next 12 months)
• HIV positive
• Military deployment or transfer scheduled within 3 months of enrollment
• Are pregnant, regardless of marital status
• Are trying to become pregnant or impregnate someone, regardless of marital status
• Has not had a positive STI diagnosis or STI screening within the last 180 days
• Does not self-report vaginal, anal, and/or oral sexual contact in the last 30 days

Sponsors & Collaborators

• Madigan Army Medical Center: lead

Study Sites (2)

Ft. Bragg

Fayetteville, North Carolina, 28310, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Related Publications (2)

• Romo ML, Moreland SC, Yates AM, Crowell TA, Sevilla M, MacArthur JL, Faestel P, Kunz A, Ake JA, Calvano T, Colby DJ. Prevalence of Urogenital Mycoplasma genitalium Infection at 2 US Army Medical Facilities. Sex Transm Dis. 2024 May 1;51(5):367-373. doi: 10.1097/OLQ.0000000000001947. Epub 2024 Feb 10.

  PMID: 38346403 DERIVED

• Kunz A, Moodley A, Colby DJ, Soltis M, Robb-McGrath W, Fairchok A, Faestel P, Jungels A, Bender AA, Kamau E, Wingood G, DiClemente R, Scott P. Feasibility, acceptability, and short-term impact of a brief sexually transmitted infection intervention targeting U.S. Military personnel and family members. BMC Public Health. 2022 Apr 2;22(1):640. doi: 10.1186/s12889-022-13096-x.

  PMID: 35366848 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases; Syphilis; Gonorrhea; Chlamydia Infections

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Neisseriaceae Infections; Chlamydiaceae Infections

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Tatjana Calvano, MD

  Madigan Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: This is a randomized, controlled trial of a behavioral intervention designed to increase the use of safer sexual practices and to reduce incident STi rates. The intervention is a 2-hour class based program and therefore is not blinded. Outcome measures of sexual behavior and incident STIs will be measured at 6 and 12 months after the intervention.

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: September 14, 2020
• Study Start: November 4, 2020
• Primary Completion: March 10, 2024
• Study Completion: March 10, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)