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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tatjana Calvano, MD | Madigan Army Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ft. Bragg | Fayetteville | North Carolina | 28310 | United States | ||
| Madigan Army Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38346403 | Derived | 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. | |
| 35366848 | Derived |
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Requests for data sharing may be considered on a case-by-case basis
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| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| D013587 | Syphilis |
| D006069 | Gonorrhea |
| D002690 | Chlamydia Infections |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D008403 | Mass Screening |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
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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.
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|
|
| 12 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 |
| Tacoma |
| Washington |
| 98431 |
| United States |
| 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. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014211 | Treponemal Infections |
| D013145 | Spirochaetales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D016870 | Neisseriaceae Infections |
| D002694 | Chlamydiaceae Infections |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |