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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH102098 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Though technology is integrated into the lives of our target population, use of any particular technology will depend on the content delivered, aesthetic appeal, and overall design. Based on the completion and analysis of data from Phase 1, the investigators were able to obtain feedback on HIV-negative male couples' attitudes toward the original content in the prevention toolkit modules. The research team, along with the web-developers, used this feedback to specifically tailor the content of the modules to fit the unique needs of the intervention's target population: at risk HIV-negative male couples. For Phase 2, the investigators conducted focus groups at each site to help identify strengths and potential areas for improvement of the prevention toolkit, which will be incorporated before piloting it in the intervention for Phase 3 of this project. After assessing the acceptability of the prevention toolkit, including the content of modules, aesthetic appeal, and overall design with HIV-negative male couples target population, the research team will pilot test whether the RCT with the prevention toolkit will help reduce HIV risk through formation and adherence to a sexual agreement, reduction in occurrences of condomless anal sex with casual sex partners, and increase testing behaviors among at-risk HIV-negative male couples. The interactive website, herein referred to as the "HIV prevention toolkit" will contain unique modules about sexual agreements and effective HIV prevention strategies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Couples assigned to the control group will be directed to the website that only has the following: 1) module about learning about effective HIV prevention strategies, 2) sexual health resource center, and 3) a link to download a corresponding smartphone app that will include the sexual health resource center. |
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| Intervention group | Active Comparator | Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Male Couples Agreement Project | Behavioral | Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center. |
| Measure | Description | Time Frame |
|---|---|---|
| Formation of a Sexual Agreement at 6 Months | Self-reports of yes/no to forming a sexual agreement via electronic survey | 6 month |
| Adherence to a Sexual Agreement at 6 Months | Self-report of yes/no of adhering to a sexual agreement | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Formation of a Sexual Agreement at 3 Months | Self-reports of yes/no to forming a sexual agreement via electronic survey | 3 month |
| Adherence to a Sexual Agreement | Self-reports of yes/no to adhering to a sexual agreement via electronic survey |
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Inclusion Criteria:
Eligible male couples:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason W Mitchell, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Building | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32044754 | Derived | Mitchell JW, Lee JY, Wu Y, Sullivan PS, Stephenson R. Feasibility and Acceptability of an Electronic Health HIV Prevention Toolkit Intervention With Concordant HIV-Negative, Same-Sex Male Couples on Sexual Agreement Outcomes: Pilot Randomized Controlled Trial. JMIR Form Res. 2020 Feb 13;4(2):e16807. doi: 10.2196/16807. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Couples assigned to the control group will be directed to the website that only has the following: 1) module about learning about effective HIV prevention strategies, 2) sexual health resource center, and 3) a link to download a corresponding smartphone app that will include the sexual health resource center. |
| FG001 | Intervention Group | Couples assigned to the intervention group will first, as individuals, view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Couples assigned to the control group will be directed to the website that only has the following: 1) module about learning about effective HIV prevention strategies, 2) sexual health resource center, and 3) a link to download a corresponding smartphone app that will include the sexual health resource center. |
| BG001 |
| 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, 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 | Formation of a Sexual Agreement at 6 Months | Self-reports of yes/no to forming a sexual agreement via electronic survey | For control, 115 men (52 dyads both partners provided data and 11 "dyads" where only one partner provided data) provided outcome data. For intervention, 98 men (45 dyads where both partners provided data and 8 "dyads" where only one partner provided data) provided outcome data. Only dyads where both partners provided data were included. | Posted | Count of Participants | Participants | 6 month |
|
6-months from baseline
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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 Group | Couples assigned to the control group will be directed to the website that only has the following: 1) module about learning about effective HIV prevention strategies, 2) sexual health resource center, and 3) a link to download a corresponding smartphone app that will include the sexual health resource center. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason W. Mitchell, PhD, MPH | University of Hawaii | 8082196729 | jasonmit@hawaii.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 23, 2015 | Jan 24, 2019 | ICF_000.pdf |
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|
| 3 month |
| Had Condomless Anal Sex With Casual Male Sex Partner During Months 0-3 | Self-reports of yes/no of any anal sex with casual male sex partner between months and month 3 via electronic survey | 3 month |
| Had Condomless Anal Sex With Casual Male Sex Partner Reported at Month 6 | Self-reports of yes/no any anal sex with casual male sex partner, measured at month 6 via electronic survey (about the previous 3 months, i.e., timeframe between months 3-6). | month 6 |
| Test for HIV During Past 3 Months (Months 0-3) | Self-reports of yes/no via electronic survey taken at 3 month. | 3 month |
| Test for HIV During the Last 3 Months (Months 3-6) | Self-reports of yes/no any test for HIV at month 6 assessment, collected via electronic survey for timeframe between months 3 and 6. | month 6 |
| Intervention Group |
Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Sexual orientation | Count of Participants | Participants |
|
| Region of residence | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Employment | Count of Participants | Participants |
|
| Length of current relationship | Count of Participants | Participants |
|
| Relationship status | Count of Participants | Participants |
|
| Relationship type | Count of Participants | Participants |
|
| Had sex with casual male partner (outside relationship) | Count of Participants | Participants |
|
| HIV testing frequency (before relationship) | Count of Participants | Participants |
|
| HIV testing frequency (since in relationship) | Count of Participants | Participants |
|
| When started having anal sex in relationship | Mean | Standard Deviation | weeks |
|
| When started having condomless anal sex in relationship | Mean | Standard Deviation | weeks |
|
| OG001 | Intervention Group | Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center. |
|
|
| Primary | Adherence to a Sexual Agreement at 6 Months | Self-report of yes/no of adhering to a sexual agreement | Participants who provided data in outcome 1 as having a concordant agreement were analyzed. | Posted | Count of Participants | Participants | 6 month |
|
|
|
| Secondary | Formation of a Sexual Agreement at 3 Months | Self-reports of yes/no to forming a sexual agreement via electronic survey | 206 partnered men represent 44 dyads in the intervention arm and 59 dyads in the control arm, respectively. Couple-level findings are reported at the individual level. | Posted | Count of Participants | Participants | 3 month |
|
|
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| Secondary | Adherence to a Sexual Agreement | Self-reports of yes/no to adhering to a sexual agreement via electronic survey | Participants who provided data in outcome 3 as having a concordant agreement were analyzed. | Posted | Count of Participants | Participants | 3 month |
|
|
|
| Secondary | Had Condomless Anal Sex With Casual Male Sex Partner During Months 0-3 | Self-reports of yes/no of any anal sex with casual male sex partner between months and month 3 via electronic survey | 9 of 125 participants in control did not provide data, and 9 of 92 participants in intervention did not provide data. | Posted | Count of Participants | Participants | 3 month |
|
|
|
| Secondary | Had Condomless Anal Sex With Casual Male Sex Partner Reported at Month 6 | Self-reports of yes/no any anal sex with casual male sex partner, measured at month 6 via electronic survey (about the previous 3 months, i.e., timeframe between months 3-6). | Of control participants, only 104 of 115 provided data for this outcome. Of intervention participants, only 90 of 98 provided data for this outcome. | Posted | Count of Participants | Participants | month 6 |
|
|
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| Secondary | Test for HIV During Past 3 Months (Months 0-3) | Self-reports of yes/no via electronic survey taken at 3 month. | Posted | Count of Participants | Participants | 3 month |
|
|
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| Secondary | Test for HIV During the Last 3 Months (Months 3-6) | Self-reports of yes/no any test for HIV at month 6 assessment, collected via electronic survey for timeframe between months 3 and 6. | 213 partnered men who completed 6-month assessment | Posted | Count of Participants | Participants | month 6 |
|
|
|
| 0 |
| 162 |
| 0 |
| 162 |
| 0 |
| 162 |
| EG001 | Intervention Group | Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center. | 0 | 136 | 0 | 136 | 0 | 136 |
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