STI/HIV Intervention Behavioral Intervention Program

Prospective Cohort Trial To Assess Acceptability and Efficacy of an Adapted STI/HIV Intervention Behavioral Intervention Program in a Population of US Army Personnel and Their Medical Beneficiaries - Execution Phase

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).

Study Overview

• Status: Recruiting
• Conditions: Sexually Transmitted Infections
• Intervention / Treatment: Behavioral: STI/HIV Intervention Behavioral Intervention Program

Detailed Description

This is the Execution Phase which will be conducted as a multi-site randomized controlled trial. A previous Formative Phase study was conducted under a separate protocol which has been completed with preliminary data indicating positive outcomes. Participants in both arms will meet the same inclusion/exclusion criteria and will be randomized into the intervention and control arms at a ratio of 1:1.

The intervention arm will receive the KISS (Knocking out Infections through Safer sex and Screening) intervention program in addition to standard STI prevention counselling routinely provided by military medical treatment facilities. The control arm will receive only standard STI prevention counselling. Both arms will receive follow-up educational messages via short message service (SMS)/text messaging monthly for 10 months, and have follow-up study visits at 6 months and 12 months.

The KISS intervention is a 2-hour, small group (6-12 individuals) class-based interactive, educational session based on Social Cognitive Theory and the Theory of Gender and Power. The intervention is an adaptation of the HORIZONS intervention, which has shown efficacy are reducing sexual risk behavior and incident STIs among adolescents in the USA. HORIZONS has been reviewed by the U.S. Centers for Disease Control (CDC) Prevention Synthesis Research team and designated a CDC top-tier (Tier I) evidence-based intervention (EBI).

To enroll in the study, participants must be categorized as "high risk" as determined by a positive test for an STI within the previous 180 days or has had STI screening during this time frame (specifically gonorrhea (GC), chlamydia (CT), M. genitalium, syphilis and/or HIV).

Study subjects will be recruited from Madigan Army Medical Center (Madigan) Preventive Medicine Clinic and the Womack Army Medical Center (Womack) Preventive Medicine Clinic in Ft. Bragg, North Carolina (NC). In addition, promotional flyers for recruitment will be placed in public areas on both bases, and will be promoted through approved social media channels. Subjects may also refer up to 5 friends or colleagues for screening.

Participants enrolled in the intervention arm will complete a total of four visits and those in the control arm will complete a total of three visits. Over the course of the study, participants in both groups will be asked to provide biological specimens and complete knowledge/behavioral surveys three times (at baseline, 6 and at 12 months). Those in the intervention group will also attend the KISS EBI (Evidence Based Intervention) program. Both arms will receive monthly (months 2-11) follow up text messages, but the content will defer between the two arms. Those in the intervention arm, will receive SMS/text messages targeting prevention maintenance interventions (PMI) messages reiterating information received during the EBI session. Those in the control arm, will receive SMS/text messages that will contain general health information.

• Study Type: Interventional
• Enrollment (Anticipated): 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heather Follen, CCRC; Phone Number: 253.320.4397; Email: heather.l.follen.ctr@health.mil

Study Locations

• United States
  • North Carolina
    • Fayetteville, North Carolina, United States, 28310
      • Recruiting
      • Ft. Bragg
      • Contact: Shannon Clark; Phone Number: 910-907-8438; Email: shannon.clark8.ctr@mail.mil
      • Principal Investigator: Maureen Sevilla, PAC
  • Washington
    • Tacoma, Washington, United States, 98431
      • Recruiting
      • Madigan Army Medical Center
      • Contact: Heather Follen, AA; Phone Number: 253-320-4397; Email: heather.l.follen.ctr@mail.mil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm; 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
Active Comparator: Intervention Arm; 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; 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.; Other Names: KISS (Knocking out Infections through Safer sex and Screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of sexual partners	self-report by questionnaire	12 months
Proportion of sexual encounters protect by condom use	self-report by questionnaire	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Knowledge about STIs, HIV and prevention: post-intervention	Completion of a 20-item standardized questionnaire on STI/HIV transmission, symptoms, and prevention methods	Baseline and immediately after the intervention
Change in Knowledge about STIs, HIV and prevention: retention at 6 months	Completion of a 20-item standardized questionnaire on STI/HIV transmission, symptoms, and prevention methods	Baseline, immediately after the intervention, and at 6 months
Change in Knowledge about STIs, HIV and prevention: retention at 12 months	Completion of a 20-item standardized questionnaire on STI/HIV transmission, symptoms, and prevention methods	Baseline, immediately after the intervention, and at 12 months

Collaborators and Investigators

• Sponsor: Madigan Army Medical Center
• Investigators: Principal Investigator: Tatjana Calvano, MD, Madigan Army Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2020
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: August 21, 2020
• First Submitted That Met QC Criteria: September 10, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: HIV; STI; syphilis; gonorrhea; chlamydia; mycoplasma genitalium
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Sexually Transmitted Diseases
• Other Study ID Numbers: RV567

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Requests for data sharing may be considered on a case-by-case basis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No