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| ID | Type | Description | Link |
|---|---|---|---|
| 5U19HD089881-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session. | |
| Intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relationship skills session for YMSM partnered-individuals and couples | Behavioral | Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The number of participants who report sexual risk behavior at 3 months. |
| 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. | The number of participants who report sexual risk behavior at 6 months. |
| 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. | The number of participants who report sexual risk behavior at 9 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Rob Stephenson, PhD | University of Michigan | Principal Investigator |
| Kristi Gamarel, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Sexuality and Health Disparities | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30602433 | Derived | Gamarel KE, Darbes LA, Hightow-Weidman L, Sullivan P, Stephenson R. The Development and Testing of a Relationship Skills Intervention to Improve HIV Prevention Uptake Among Young Gay, Bisexual, and Other Men Who Have Sex With Men and Their Primary Partners (We Prevent): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Jan 2;8(1):e10370. doi: 10.2196/10370. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 3-Month Follow Up |
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| 6-Month Follow Up |
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| 9-Month Follow Up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 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. | Self-report of participants who reported sexual risk behavior. | Posted | Count of Participants | Participants | The number of participants who report sexual risk behavior at 3 months. |
|
9 months
Systemic assessment, which included standard questionnaire and regular investigator assessment.
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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 | Control | Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rob Stephenson | University of Michigan | 734-763-1188 | rbsteph@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Nov 23, 2020 | Jun 27, 2022 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 23, 2020 | Jun 27, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D005191 | Family Characteristics |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
| D015991 | Epidemiologic Measurements |
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| Mean at 3 months |
| 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). | Mean at 6 months |
| 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). | Mean at 9 months |
| PrEP Use | Current PrEP use, which a self-report measure of whether the participant is currently using PrEP (yes/no). | The number of participants at 3 months |
| PrEP Use | Current PrEP use, which a self-report measure of whether the participant is currently using PrEP (yes/no) | The number of participants at 6 months |
| PrEP Use | Current PrEP use, which a self-report measure of whether the participant is currently using PrEP (yes/no) | The number of participants at 9 months |
| HIV Testing | Self-reported HIV testing in the past 3 months | The number of participants at 3-months |
| HIV Testing | Self-reported HIV testing in the past 3 months | The number of participants at 6 months |
| HIV Testing | Self-reported HIV testing in the past 3 months | The number of participants at 9 months |
| STI Testing | Any self-reported STI testing in the past 3 months | The number of participants at 3 months |
| STI Testing | Any self-reported STI testing in the past 3 months | The number of participants at 6 months |
| STI Testing | Any self-reported STI testing in the past 3 months | The number of participants at 9 months |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Sexual Risk Behavior | Count of Participants | Participants |
|
| HIV Communication | Participants completed the 9-item Couples Efficacy to Reduce HIV Threat scale (Salazar, Stephenson, Sullivan, & Tarver, 2013). 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; sample α = 0.84). | Mean | Standard Deviation | units on a scale |
|
| PrEP use | Count of Participants | Participants |
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| HIV Testing | Count of Participants | Participants |
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| STI Testing | Count of Participants | Participants |
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| 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. | Self-report of participants who reported sexual risk behavior. | Posted | Count of Participants | Participants | The number of participants who report sexual risk behavior at 6 months. |
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|
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| 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. | Self-report of participants who reported sexual risk behavior. | Posted | Count of Participants | Participants | The number of participants who report sexual risk behavior at 9 months. |
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|
|
| 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). | Self-report to scale | Posted | Mean | Standard Deviation | score on a scale | Mean at 3 months |
|
|
|
| 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). | Self-report on a scale | Posted | Mean | Standard Deviation | score on a scale | Mean at 6 months |
|
|
|
| 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). | Self-report on a scale | Posted | Mean | Standard Deviation | score on a scale | Mean at 9 months |
|
|
|
| Secondary | PrEP Use | Current PrEP use, which a self-report measure of whether the participant is currently using PrEP (yes/no). | Self-report of participants who reported that they were currently taking PrEP. | Posted | Count of Participants | Participants | The number of participants at 3 months |
|
|
|
| Secondary | PrEP Use | Current PrEP use, which a self-report measure of whether the participant is currently using PrEP (yes/no) | Self-report of participants who reported that they were currently taking PrEP. | Posted | Count of Participants | Participants | The number of participants at 6 months |
|
|
|
| Secondary | PrEP Use | Current PrEP use, which a self-report measure of whether the participant is currently using PrEP (yes/no) | Self-report of participants who self-reported that they were currently taking PrEP. | Posted | Count of Participants | Participants | The number of participants at 9 months |
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| Secondary | HIV Testing | Self-reported HIV testing in the past 3 months | Self-report of participants who had an HIV test in the past 3 months. | Posted | Count of Participants | Participants | The number of participants at 3-months |
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| Secondary | HIV Testing | Self-reported HIV testing in the past 3 months | Self-report of participants who had an HIV test in the past 3 months. | Posted | Count of Participants | Participants | The number of participants at 6 months |
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| Secondary | HIV Testing | Self-reported HIV testing in the past 3 months | Self-report of participants who reported that they had an HIV test in the past 3 months. | Posted | Count of Participants | Participants | The number of participants at 9 months |
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| Secondary | STI Testing | Any self-reported STI testing in the past 3 months | Self-report of participants who reported that they had an STI test in the past 3 months. | Posted | Count of Participants | Participants | The number of participants at 3 months |
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| Secondary | STI Testing | Any self-reported STI testing in the past 3 months | Self-report of participants who had an STI test in the past 3 months. | Posted | Count of Participants | Participants | The number of participants at 6 months |
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| Secondary | STI Testing | Any self-reported STI testing in the past 3 months | Self-report of participants who reported that they had an STI test in the past 3 months. | Posted | Count of Participants | Participants | The number of participants at 9 months |
|
|
|
| 0 |
| 160 |
| 0 |
| 160 |
| 0 |
| 160 |
| EG001 | 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. | 0 | 158 | 0 | 158 | 0 | 158 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| 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 |
| D011634 |
| Public Health |
| D004778 | Environment and Public Health |