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| Name | Class |
|---|---|
| Hunter College of City University of New York | OTHER |
| Oregon Health and Science University | OTHER |
| Wayne State University | OTHER |
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The purpose of this study is to compare different ways to deliver the couples HIV Testing and Counseling (CHTC) intervention that is suited for adolescents and young adults.
Investigators will conduct a comparative effectiveness trial (CET) of CHTC for adolescent-age (15-24 years) same-sex male couples. This design tests the added benefits of adjunct intervention components delivered prior to receipt of CHTC-Assertive Communication Training (ACT) videos viewed by the individual or couple together and individually delivered Motivational Interviewing-based Communication Skills Training (MI-CST). These target the development of communication skills necessary to participate fully in HIV prevention and sexual safety discussions inherent to CHTC. Youth will be randomized to receive one of two conditions: Condition 1: watch videos on ACT, participate in Communication Skills Training (MI-CST), and complete an individual HIV test, or if participating as a couple will receive CHTC, and Condition 2: Individual HIV Testing (IHTC) as usual. Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. Youth in this CET will complete follow-up assessments at 1, 3, and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| We Test - Index Participants | Experimental | Each participant will receive MI-CST + observation of ACT videos + CHTC. Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. |
|
| Individual HIV Testing and Counseling - Index Participants | Active Comparator | Individual HIV Testing and Counseling (IHTC). Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. |
|
| Individual Counseling and Testing - Partner Participants | Active Comparator | Referred partner who participates in Individual HIV Testing and Counseling with their partner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| We Test | Behavioral | This design tests the added benefits of adjunct intervention components delivered prior to receipt of CHTC-Assertive Communication Training (ACT) videos viewed by the couple separately and individually delivered Motivational Interviewing-based Communication Skills Training (MI-CST). These target the development of communication skills necessary to participate fully in HIV prevention and sexual safety discussions inherent to CHTC. |
| Measure | Description | Time Frame |
|---|---|---|
| HIV Transmission Risk Behavior | Self-reported Condomless anal sex with a casual partner | baseline, month 3, month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Communication Skills | Interpersonal Communication Competence Scale, higher scores are associated with better communication skills, range 0 - 150. | baseline, month 3, month 6 |
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Inclusion Criteria:
Exclusion Criteria:
Identifies as male, nonbinary, genderqueer or gender nonconforming.
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| Name | Affiliation | Role |
|---|---|---|
| Tyrel Starks, PhD | City University of New York | Study Chair |
| Sarah W Feldstein Ewing, PhD | University of Rhode Island | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wayne State University | Detroit | Michigan | 48202 | United States | ||
| The City University of New York |
Currently, there is no plan to share the study data at this time; however, the study team is currently in the process of developing a plan to share data, while protecting the privacy and confidentiality of participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | We Test - Index Participants | Each individual who attended We Test received MI-CST + observation of ACT videos + CHTC. Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. We Test: This design tests the added benefits of adjunct intervention components delivered prior to receipt of CHTC-Assertive Communication Training (ACT) videos viewed by the couple separately and individually delivered Motivational Interviewing-based Communication Skills Training (MI-CST). These target the development of communication skills necessary to participate fully in HIV prevention and sexual safety discussions inherent to CHTC. |
| FG001 | Individual HIV Testing and Counseling - Index Participants | Individual HIV Testing and Counseling (IHTC). Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. This includes 1 index partner who completed the intervention with their partner. IHTC: Individual HIV Testing and Counseling |
| FG002 | Individual Counseling and Testing - Partner Participants | Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. Only 1 couple chose this option. This couple attended the intervention together and received individual HIV testing and counseling. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | We Test - Index Participants | Each individual who attended We Test received MI-CST + observation of ACT videos + CHTC. Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. We Test: This design tests the added benefits of adjunct intervention components delivered prior to receipt of CHTC-Assertive Communication Training (ACT) videos viewed by the couple separately and individually delivered Motivational Interviewing-based Communication Skills Training (MI-CST). These target the development of communication skills necessary to participate fully in HIV prevention and sexual safety discussions inherent to CHTC. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | HIV Transmission Risk Behavior | Self-reported Condomless anal sex with a casual partner | Intent to treat population. Analysis only includes participants who participated in the We Test - Index arm and Individual HIV Testing and Counseling - Index arm on their own. | Posted | Count of Participants | Participants | baseline, month 3, month 6 |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | We Test - Index Participants | Each individual who attended We Test received MI-CST + observation of ACT videos + CHTC. Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. We Test: This design tests the added benefits of adjunct intervention components delivered prior to receipt of CHTC-Assertive Communication Training (ACT) videos viewed by the couple separately and individually delivered Motivational Interviewing-based Communication Skills Training (MI-CST). These target the development of communication skills necessary to participate fully in HIV prevention and sexual safety discussions inherent to CHTC. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sylvie Naar, PhD; Distinguished Endowed Professor | Florida State University | 18506442334 | sylvie.naar@med.fsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 12, 2021 | May 22, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 1, 2020 | May 22, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 12, 2021 | May 22, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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At baseline participants will be randomized to one of two conditions: Condition 1: MI-CST + observation of ACT videos + CHTC, and Condition 2: Individual HIV Testing (IHTC) as usual. Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. Youth in this CET will complete follow-up assessments at 1, 3, and 6 months.
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|
| IHTC | Behavioral | Individual HIV Testing and Counseling |
|
| New York |
| New York |
| 10018 |
| United States |
| BG001 | Individual HIV Testing and Counseling - Index Participants | Individual HIV Testing and Counseling (IHTC). Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. IHTC: Individual HIV Testing and Counseling |
| BG002 | Individual Counseling and Testing - Partner Participants | Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. Only 1 couple chose this option. This couple attended the intervention together and received individual HIV testing and counseling. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Sexual Identity | Count of Participants | Participants |
|
| Gender Identity | Count of Participants | Participants |
|
| Employment | Count of Participants | Participants |
|
| Health Insurance | Count of Participants | Participants |
|
| Current PrEP Use | Count of Participants | Participants |
|
| Main Partner Age | Mean | Standard Deviation | Years |
|
| Relationship Length (in months) | Mean | Standard Deviation | Months |
|
| OG001 | Individual HIV Testing and Counseling - Index Participants | Individual HIV Testing and Counseling (IHTC). Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. IHTC: Individual HIV Testing and Counseling |
| OG002 | Individual Counseling and Testing - Partner Participants | Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. Only 1 couple chose this option. This couple attended the intervention together and received individual HIV testing and counseling. |
|
|
|
| Secondary | Communication Skills | Interpersonal Communication Competence Scale, higher scores are associated with better communication skills, range 0 - 150. | Intent to treat population. Analysis only includes participants who participated in the We Test - Index arm and Individual HIV Testing and Counseling - Index arm on their own. | Posted | Mean | Standard Deviation | Units on a scale | baseline, month 3, month 6 |
|
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Individual HIV Testing and Counseling - Index Participants | Individual HIV Testing and Counseling (IHTC). Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. IHTC: Individual HIV Testing and Counseling | 0 | 37 | 0 | 37 | 0 | 37 |
| EG002 | Individual Counseling and Testing - Partner Participants | Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. Only 1 couple chose this option. This couple attended the intervention together and received individual HIV testing and counseling. | 0 | 1 | 0 | 1 | 0 | 1 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| 3 month |
|
|
| 6 month |
|
|
| t-test, 2 sided |
| 0.02 |
| Mean Difference (Final Values) |
| -2.5 |
| 2-Sided |
| Superiority |