HIV/AIDS
Conditions
Keywords
HIV, telehealth, HIV testing, YMSM, couples
Brief summary
We Prevent seeks to develop and pilot test a developmentally-appropriate relationship skills session as an addition to the current Couples HIV Testing and Counseling (CHTC) intervention for young gay, bisexual and other men who have sex with men (YMSM). This project involves three phases to develop and pilot test the intervention. Phase I collected brief quantitative survey data, in-depth qualitative interview data, and cognitive interview data from YMSM and feedback from a technical expert group (TEG) to develop and refine the two-session intervention. Phase II involved conducting a one-arm pilot of the intervention condition to further refine the intervention content with a sample of 12 YMSM (6 dyads). Phase III involves conducting a randomized controlled trial (RCT) comparing the relationship-focused intervention to a control condition, which is HIV Testing, Counseling, and Referrals (CTR) alone with a sample of 320 YMSM.
Detailed description
Young (15-24 years old) gay, bisexual and other men who have sex with men (YMSM) continue to be the group most heavily impacted by HIV in the US, despite stable or declining rates of infection among other groups. HIV prevention and research efforts in the US have continued to target MSM as individuals, largely focusing on messages that encourage the uptake of prevention efforts and reducing sexual risk. Recently, there has been growing interest in structural interventions to reduce HIV risk, tackling social, economic and cultural factors that place MSM in contexts of risk. However, despite socio-ecological theory postulating the importance of individual, dyadic and social influences on HIV risk, there has been a dearth of intervention efforts focused at the dyadic level. We Prevent seeks to intervene on relationship communication skills as a pathway to HIV prevention during the critical period of adolescence. The proposed activities will develop and test a relationship skills focused HIV prevention intervention for young YMSM aged 15-24 as an addition to the current HIV Counseling, Testing, and Referrals (CTR) and Couples HIV Testing and Counseling (CHTC). At home STI test kits will also be sent in Phases II and III at baseline and one follow up. Phase I of the project included collection of data from two groups of participants: 1) 30 YMSM in in-depth interviews and 8 YMSM in cognitive interviews and 2) 7 Technical Experts (TEG), for a total sample of 45 research participants. Phase II consisted of a one-arm pilot test of the intervention condition with 6 YMSM dyads (total 12 participants). Participants completed a Baseline and 1-month follow-up assessment. Phase III involves a pilot two-arm prospective RCT in which 320 YMSM will complete a Baseline assessment and then complete assessments every 3 months for 9 months. Recruitment of all participants is in all 50 states and will be conducted through popular social media sites (e.g. Facebook). All interviews will be conducted through the HIPAA video-conferencing platforms, VSee and Zoom. Specific Aims: Phases I and II: To develop and refine a developmentally appropriate relationship skills session as an addition to the current CHTC intervention for 15-19 year old YMSM and their partners. Phase III: To conduct a randomized controlled trial (RCT) comparing the efficacy of the adapted intervention for 15-24 year old YMSM versus a control condition, which is CTR or CHTC alone.
Interventions
BEHAVIORALRelationship skills session for YMSM partnered-individuals and couples
Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners.
Sponsors
University of North Carolina, Chapel Hill
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
15 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages 15 to 24 years (inclusive) at time of screening * Current U.S. resident * Sufficient age for sexual consent in the current state of residence (assessed at both the individual and dyadic level) * Self-identify that they are in an emotional and sexual relationship with another male * Cisgender men (assigned male sex at birth and currently identifies as male) OR transgender men (assigned female at birth and identifies as male or transgender man * Self-reports that they engaged in any kind of sexual activity (oral, vaginal, anal) in their lifetime * Has access to computer/personal device/smart phone with internet access * Self-report being HIV negative or unknown serostatus * Speak and read English
Exclusion criteria
* Younger than age for consent without parental permission in the current state of residence * Assigned female sex at birth and currently identifies as something other than male or transgender man * Assigned male sex at birth but identifies as gender other than male or transgender man * Aged 14 years or younger or 25 or older at the time of screening * HIV-positive * Not currently in an emotional and/or sexual relationship with another male * Does not speak or read English * Reports intimate partner violence in the past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sexual Risk Behavior | The number of participants who report sexual risk behavior at 3 months. | Anal or vaginal intercourse without condoms or PrEP that occurs with a person of known positive or unknown serostatus during follow-up period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIV Communication | Mean at 3 months | Participants completed the 9-item Couples Efficacy to Reduce HIV Threat scale .Participants responded to each item on 5-point Likert scale ranging from (1) strongly disagree to (5) strongly agree. The items were mean centered such that higher scores indicate that participants perceive that they can effectively communicate with their partner about HIV prevention strategies (range 1 to 5). |
| PrEP Use | The number of participants at 3 months | Current PrEP use, which a self-report measure of whether the participant is currently using PrEP (yes/no). |
| HIV Testing | The number of participants at 3-months | Self-reported HIV testing in the past 3 months |
| STI Testing | The number of participants at 3 months | Any self-reported STI testing in the past 3 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session. | 160 |
| Intervention Receive one 45-minute Relationship skills session for YMSM individuals and couples (the intervention) as an addition to the standard HIV Counseling, Testing, and Referral (CTR) or Couples HIV Testing and Counseling (CHTC) Session.
Relationship skills session for YMSM partnered-individuals and couples: Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners. | 158 |
| Total | 318 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 3-Month Follow Up | Lost to Follow-up | 39 | 38 |
| 6-Month Follow Up | Lost to Follow-up | 46 | 42 |
| 9-Month Follow Up | Lost to Follow-up | 44 | 43 |
Baseline characteristics
| Characteristic | Control | Total | Intervention |
|---|---|---|---|
| Age, Categorical <=18 years | 22 Participants | 43 Participants | 21 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 138 Participants | 275 Participants | 137 Participants |
| Age, Continuous | 21 years | 21 years | 21 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 50 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 133 Participants | 268 Participants | 135 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| HIV Communication | 4.5 units on a scale STANDARD_DEVIATION 1.1 | 4.5 units on a scale STANDARD_DEVIATION 1 | 4.4 units on a scale STANDARD_DEVIATION 0.9 |
| HIV Testing | 105 Participants | 212 Participants | 107 Participants |
| PrEP use | 14 Participants | 21 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 24 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 33 Participants | 60 Participants | 27 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 27 Participants | 50 Participants | 23 Participants |
| Race (NIH/OMB) White | 89 Participants | 184 Participants | 95 Participants |
| Region of Enrollment United States | 160 participants | 318 participants | 158 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 160 Participants | 318 Participants | 158 Participants |
| Sexual Risk Behavior | 6 Participants | 7 Participants | 1 Participants |
| STI Testing | 83 Participants | 184 Participants | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 160 | 0 / 158 |
| other Total, other adverse events | 0 / 160 | 0 / 158 |
| serious Total, serious adverse events | 0 / 160 | 0 / 158 |
Outcome results
Primary
Sexual Risk Behavior
Anal or vaginal intercourse without condoms or PrEP that occurs with a person of known positive or unknown serostatus during follow-up period.
Time frame: The number of participants who report sexual risk behavior at 6 months.
Population: Self-report of participants who reported sexual risk behavior.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Sexual Risk Behavior | 0 Participants |
| Intervention | Sexual Risk Behavior | 2 Participants |
Primary
Sexual Risk Behavior
Anal or vaginal intercourse without condoms or PrEP that occurs with a person of known positive or unknown serostatus during follow-up period.
Time frame: The number of participants who report sexual risk behavior at 3 months.
Population: Self-report of participants who reported sexual risk behavior.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Sexual Risk Behavior | 1 Participants |
| Intervention | Sexual Risk Behavior | 2 Participants |
Primary
Sexual Risk Behavior
Anal or vaginal intercourse without condoms or PrEP that occurs with a person of known positive or unknown serostatus during follow-up period.
Time frame: The number of participants who report sexual risk behavior at 9 months.
Population: Self-report of participants who reported sexual risk behavior.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Sexual Risk Behavior | 0 Participants |
| Intervention | Sexual Risk Behavior | 1 Participants |
Secondary
HIV Communication
Participants completed the 9-item Couples Efficacy to Reduce HIV Threat scale .Participants responded to each item on 5-point Likert scale ranging from (1) strongly disagree to (5) strongly agree. The items were mean centered such that higher scores indicate that participants perceive that they can effectively communicate with their partner about HIV prevention strategies (range 1 to 5).
Time frame: Mean at 3 months
Population: Self-report to scale
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | HIV Communication | 4.6 score on a scale | Standard Deviation 1 |
| Intervention | HIV Communication | 4.6 score on a scale | Standard Deviation 0.9 |
Secondary
HIV Communication
Participants completed the 9-item Couples Efficacy to Reduce HIV Threat scale. Participants responded to each item on 5-point Likert scale ranging from (1) strongly disagree to (5) strongly agree. The items were mean centered such that higher scores indicate that participants perceive that they can effectively communicate with their partner about HIV prevention strategies (range 1 to 5).
Time frame: Mean at 6 months
Population: Self-report on a scale
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | HIV Communication | 4.5 score on a scale | Standard Deviation 0.8 |
| Intervention | HIV Communication | 4.9 score on a scale | Standard Deviation 0.9 |
Secondary
HIV Communication
Participants completed the 9-item Couples Efficacy to Reduce HIV Threat scale. Participants responded to each item on 5-point Likert scale ranging from (1) strongly disagree to (5) strongly agree. The items were mean centered such that higher scores indicate that participants perceive that they can effectively communicate with their partner about HIV prevention strategies (range 1 to 5).
Time frame: Mean at 9 months
Population: Self-report on a scale
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | HIV Communication | 4.8 score on a scale | Standard Deviation 0.8 |
| Intervention | HIV Communication | 5.0 score on a scale | Standard Deviation 0.6 |
Secondary
HIV Testing
Self-reported HIV testing in the past 3 months
Time frame: The number of participants at 9 months
Population: Self-report of participants who reported that they had an HIV test in the past 3 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | HIV Testing | 43 Participants |
| Intervention | HIV Testing | 42 Participants |
Secondary
HIV Testing
Self-reported HIV testing in the past 3 months
Time frame: The number of participants at 3-months
Population: Self-report of participants who had an HIV test in the past 3 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | HIV Testing | 73 Participants |
| Intervention | HIV Testing | 70 Participants |
Secondary
HIV Testing
Self-reported HIV testing in the past 3 months
Time frame: The number of participants at 6 months
Population: Self-report of participants who had an HIV test in the past 3 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | HIV Testing | 33 Participants |
| Intervention | HIV Testing | 35 Participants |
Secondary
PrEP Use
Current PrEP use, which a self-report measure of whether the participant is currently using PrEP (yes/no)
Time frame: The number of participants at 9 months
Population: Self-report of participants who self-reported that they were currently taking PrEP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | PrEP Use | 14 Participants |
| Intervention | PrEP Use | 10 Participants |
Secondary
PrEP Use
Current PrEP use, which a self-report measure of whether the participant is currently using PrEP (yes/no).
Time frame: The number of participants at 3 months
Population: Self-report of participants who reported that they were currently taking PrEP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | PrEP Use | 6 Participants |
| Intervention | PrEP Use | 6 Participants |
Secondary
PrEP Use
Current PrEP use, which a self-report measure of whether the participant is currently using PrEP (yes/no)
Time frame: The number of participants at 6 months
Population: Self-report of participants who reported that they were currently taking PrEP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | PrEP Use | 9 Participants |
| Intervention | PrEP Use | 6 Participants |
Secondary
STI Testing
Any self-reported STI testing in the past 3 months
Time frame: The number of participants at 6 months
Population: Self-report of participants who had an STI test in the past 3 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | STI Testing | 20 Participants |
| Intervention | STI Testing | 24 Participants |
Secondary
STI Testing
Any self-reported STI testing in the past 3 months
Time frame: The number of participants at 9 months
Population: Self-report of participants who reported that they had an STI test in the past 3 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | STI Testing | 28 Participants |
| Intervention | STI Testing | 35 Participants |
Secondary
STI Testing
Any self-reported STI testing in the past 3 months
Time frame: The number of participants at 3 months
Population: Self-report of participants who reported that they had an STI test in the past 3 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | STI Testing | 32 Participants |
| Intervention | STI Testing | 27 Participants |