HIV/AIDS, HIV Infections
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALWe 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.
BEHAVIORALIHTC
Individual HIV Testing and Counseling
Sponsors
Hunter College of City University of New York
Oregon Health and Science University
Wayne State University
Florida State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
15 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
* At least one partner must be HIV-negative or status unknown * THE INDEX PARTNER must be 15-24 years old * YMSM under age 18 MUST HAVE AN AGE CONCORDANT PARTNER TO PARTICIPATE IN THIS STUDY, I.E., MINORS may only participate in the study with a partner within 2 years of age OF THE MINOR SUBJECT'S AGE. THE AGE CONCORDANT PARTNER MUST BE AT LEAST FIFTEEN YEARS OLD. * INDEX PARTNER MUST BE SEXUALLY ACTIVE (ANY ACTIVITY THAT COULD LEAD TO ORGASM) * CURRENTLY SEEING SOMEONE, DATING, EXPERIMENTING WITH RELATIONSHIPS OR IN A RELATIONSHIP * HAVE HAD SEX, HOOKED UP WITH OR MADE OUT WITH THAT PERSON * Both partners must be able to communicate in English. * LIVE IN OR NEAR NEW YORK CITY OR DETROIT OR SAN DIEGO * GENDER IDENTITY AS MALE OR nonbinary, GENDERQUEER, agender OR GENDER NONCOMFORMING
Exclusion criteria
* Unstable, serious psychiatric symptoms * Current suicidal/homicidal ideation * Current or prior Intimate Partner Violence (IPV) on the part of either relationship partner * IF EITHER PARTICIPATING PARTNER FELT PRESSURED OR COERCED TO PARTICIPATE IN THE STUDY OR FELT ANYONE MADE THEM FEEL THEY HAD TO PARTICIPATE IN THEY STUDY WHEN THEY DID NOT WANT TO.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HIV Transmission Risk Behavior | baseline, month 3, month 6 | Self-reported Condomless anal sex with a casual partner |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Communication Skills | baseline, month 3, month 6 | Interpersonal Communication Competence Scale, higher scores are associated with better communication skills, range 0 - 150. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 33 |
| 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 | 37 |
| 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. | 1 |
| Total | 71 |
Baseline characteristics
| Characteristic | We Test - Index Participants | Individual HIV Testing and Counseling - Index Participants | Individual Counseling and Testing - Partner Participants | Total |
|---|---|---|---|---|
| Age, Continuous | 21.91 Years STANDARD_DEVIATION 1.86 | 22.38 Years STANDARD_DEVIATION 1.77 | 24.00 Years | 22.18 Years STANDARD_DEVIATION 1.82 |
| Current PrEP Use No | 21 Participants | 25 Participants | 1 Participants | 47 Participants |
| Current PrEP Use Yes | 12 Participants | 12 Participants | 0 Participants | 24 Participants |
| Employment No | 11 Participants | 11 Participants | 0 Participants | 22 Participants |
| Employment Yes | 22 Participants | 26 Participants | 1 Participants | 49 Participants |
| Gender Identity Cisgender Male | 26 Participants | 30 Participants | 1 Participants | 57 Participants |
| Gender Identity Transgender, gender nonconforming, or assigned male at birth | 7 Participants | 7 Participants | 0 Participants | 14 Participants |
| Health Insurance No | 5 Participants | 5 Participants | 0 Participants | 10 Participants |
| Health Insurance Yes, my guardian | 14 Participants | 16 Participants | 1 Participants | 31 Participants |
| Health Insurance Yes, my own | 14 Participants | 16 Participants | 0 Participants | 30 Participants |
| Main Partner Age | 25.45 Years STANDARD_DEVIATION 7.89 | 26.11 Years STANDARD_DEVIATION 6.59 | 24.00 Years STANDARD_DEVIATION 0 | 25.77 Years STANDARD_DEVIATION 7.14 |
| Race/Ethnicity, Customized Black | 4 Participants | 11 Participants | 0 Participants | 15 Participants |
| Race/Ethnicity, Customized Latino | 13 Participants | 9 Participants | 0 Participants | 22 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 5 Participants | 0 Participants | 8 Participants |
| Race/Ethnicity, Customized White | 13 Participants | 12 Participants | 1 Participants | 26 Participants |
| Relationship Length (in months) | 19.21 Months STANDARD_DEVIATION 25.03 | 21.14 Months STANDARD_DEVIATION 26.56 | 2.00 Months STANDARD_DEVIATION 0 | 19.97 Months STANDARD_DEVIATION 25.59 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 33 Participants | 37 Participants | 1 Participants | 71 Participants |
| Sexual Identity Gay | 23 Participants | 25 Participants | 1 Participants | 49 Participants |
| Sexual Identity Other/Queer | 10 Participants | 12 Participants | 0 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 37 | 0 / 1 |
| other Total, other adverse events | 0 / 33 | 0 / 37 | 0 / 1 |
| serious Total, serious adverse events | 0 / 33 | 0 / 37 | 0 / 1 |
Outcome results
Primary
HIV Transmission Risk Behavior
Self-reported Condomless anal sex with a casual partner
Time frame: baseline, month 3, month 6
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| We Test - Index Participants | HIV Transmission Risk Behavior | 3 month | 4 Participants |
| We Test - Index Participants | HIV Transmission Risk Behavior | Baseline | 9 Participants |
| We Test - Index Participants | HIV Transmission Risk Behavior | 6 month | 4 Participants |
| Individual HIV Testing and Counseling - Index Participants | HIV Transmission Risk Behavior | 3 month | 8 Participants |
| Individual HIV Testing and Counseling - Index Participants | HIV Transmission Risk Behavior | Baseline | 11 Participants |
| Individual HIV Testing and Counseling - Index Participants | HIV Transmission Risk Behavior | 6 month | 6 Participants |
| Individual Counseling and Testing - Partner Participants | HIV Transmission Risk Behavior | Baseline | 0 Participants |
| Individual Counseling and Testing - Partner Participants | HIV Transmission Risk Behavior | 6 month | 0 Participants |
| Individual Counseling and Testing - Partner Participants | HIV Transmission Risk Behavior | 3 month | 0 Participants |
Comparison: Analysis only includes participants who participated in the We Test - Index arm and Individual HIV Testing and Counseling - Index arm on their own.p-value: 0.2Negative Binomial Regression
Comparison: Analysis only includes participants who participated in the We Test - Index arm and Individual HIV Testing and Counseling - Index arm on their own.p-value: 0.58Negative Binomial Regression
Secondary
Communication Skills
Interpersonal Communication Competence Scale, higher scores are associated with better communication skills, range 0 - 150.
Time frame: baseline, month 3, month 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| We Test - Index Participants | Communication Skills | 3 month | 125.04 Units on a scale | Standard Deviation 10.04 |
| We Test - Index Participants | Communication Skills | Baseline | 123 Units on a scale | Standard Deviation 11.01 |
| We Test - Index Participants | Communication Skills | 6 month | 125.27 Units on a scale | Standard Deviation 12.81 |
| Individual HIV Testing and Counseling - Index Participants | Communication Skills | 3 month | 119.04 Units on a scale | Standard Deviation 12.97 |
| Individual HIV Testing and Counseling - Index Participants | Communication Skills | Baseline | 121.19 Units on a scale | Standard Deviation 12.78 |
| Individual HIV Testing and Counseling - Index Participants | Communication Skills | 6 month | 117.68 Units on a scale | Standard Deviation 11.3 |
| Individual Counseling and Testing - Partner Participants | Communication Skills | 6 month | 129.00 Units on a scale | — |
| Individual Counseling and Testing - Partner Participants | Communication Skills | Baseline | 129.00 Units on a scale | — |
Comparison: Analysis only includes participants who participated in the We Test - Index arm and Individual HIV Testing and Counseling - Index arm on their own.p-value: 0.08t-test, 2 sided
Comparison: Analysis only includes participants who participated in the We Test - Index arm and Individual HIV Testing and Counseling - Index arm on their own.p-value: 0.02t-test, 2 sided