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| ID | Type | Description | Link |
|---|---|---|---|
| R34DA036419 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The proposed study developed and tested two adjunct components for use in Couples HIV Testing and Counseling (CHTC) with gay-male couples: a communication skills training video and a substance use agreement module. Phase I of the study involved the creation of intervention materials and Phase II was comprised of a small randomized controlled trial comparing the additive effects of the novel components to CHTC as usual.
Phase I: Utilizing formative qualitative data on the correspondence of sexual agreements, drug use, and sexual risk behavior, the study team created two adjunct intervention components:
Communication skills training videos: The team produced a brief (20-minute) communication skills training video. The video includes 4 scenes in which a gay couple is depicted discussing HIV risk, sexual agreements, or drug use. The scene is viewed twice. The first viewing includes common communication errors. The second viewing portrays the use of more effective interpersonal communication and a more adaptive outcome.
Substance use agreement module: The team developed a structured activity to assist couples in clarifying their understanding and goals around substance use. The module includes the completion of a calendar detailing recent substance use and structured debriefing questions.
Phase II: A randomized controlled trial to assess the feasibility, acceptability, and preliminary efficacy of novel intervention components will be conducted. The trial involves 70 couples (n = 140 individuals). Half of the couples are randomized to complete the drug calendar (the other half do not). Half of the couples are randomized to view communication skills training videos, the other half do not. The result is four intervention conditions:
Participants complete a baseline assessment (either online or in person) prior to their intervention session. All intervention sessions are completed with both members of the couple together. Follow-up assessments are completed individually online at 1, 3, and 6 months post-intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHTC as usual | Active Comparator | Participants receive couples HIV testing and counseling following the CDC approved protocol. |
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| CHTC + communication skills videos | Experimental | The couple views communication skills training videos together prior to participating in a CHTC session following the CDC approved protocol. |
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| CHTC + substance use module | Experimental | The couple completes a CHTC session which includes the substance use calendar and structured debriefing activity. This is administered following Step 5 in the standard CDC protocol, just prior to delivery of HIV test results. |
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| CHTC + video + substance use module | Experimental | The couple views communication skills training videos together prior to participating in a CHTC session which includes administration of the substance use calendar and structured debriefing activity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Communication skills training video | Behavioral | This video includes 4 scenes of gay couples discussing issues related to HIV prevention, testing, sexual agreements, and drug use. Each scene is viewed twice. The first viewing includes common communication errors. The second viewing portrays more skillful interpersonal communication and a more adaptive resolution to the conversation. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Respondents Reporting Any Drug Use | The outcome measure is a dichotomous variable indicating whether or not each participant reported any drug use in the in the 30 days prior to each follow-up assessment. The table below displays the number (and percentage) of participants who indicated the use of any drugs at each assessment wave. Assessments were conducted at 1, 3, and 6 month post intervention. | 30 days prior to assessment |
| Condomless Anal Sex With Casual Partners | The outcome measure is a dichotomous variable indicating whether or not each participant indicated the occurrence of any insertive or receptive condomless anal sex (CAS) with a casual partner in the 30 days prior to each follow-up assessment. The table below displays the number (and percentage) of participants who indicated any CAS with a casual partner at each assessment wave. Assessments were conducted at 1, 3, and 6 month post intervention. | 30 days prior to assessment |
| Drug Abuse Screening Test-10 Total Scores | The scale assesses the number of drug use related problems experienced by the participant in the 30 days prior to the assessment. Higher scores indicate a greater number of drug use related problems. Note, assessments were conducted at 1, 3, and 6 months post intervention. | 30 days prior to assessment |
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Inclusion Criteria:
Both members of the couple:
At least one member of the couple:
reports the use of any drug listed on the DAST-10 in the previous 30 days.
s identified as HIV negative during screening and baseline assessments.
The couple
has been together for at least 3 months;
has engaged in oral or anal sex with one another in the past 3 months;
Exclusion Criteria:
participants must identify as male gender
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| Name | Affiliation | Role |
|---|---|---|
| Tyrel J Starks, PhD | Hunter College, CUNY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunter College | New York | New York | 10018 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31203148 | Background | Starks TJ, Robles G, Bosco SC, Doyle KM, Dellucci TV. Relationship functioning and substance use in same-sex male couples. Drug Alcohol Depend. 2019 Aug 1;201:101-108. doi: 10.1016/j.drugalcdep.2019.04.009. Epub 2019 May 23. | |
| 29651646 | Background | Starks TJ, Doyle KM, Shalhav O, John SA, Parsons JT. An Examination of Gay Couples' Motivations to Use (or Forego) Pre-exposure Prophylaxis Expressed During Couples HIV Testing and Counseling (CHTC) Sessions. Prev Sci. 2019 Jan;20(1):157-167. doi: 10.1007/s11121-018-0892-7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CHTC as Usual | Participants receive couples HIV testing and counseling following the CDC approved protocol. Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol. |
| FG001 | CHTC + Communication Skills Videos | The couple views communication skills training videos together prior to participating in a CHTC session following the CDC approved protocol. Communication skills training video: This video includes 4 scenes of gay couples discussing issues related to HIV prevention, testing, sexual agreements, and drug use. Each scene is viewed twice. The first viewing includes common communication errors. The second viewing portrays more skillful interpersonal communication and a more adaptive resolution to the conversation. Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol. |
| FG002 | CHTC + Substance Use Module | The couple completes a CHTC session which includes the substance use calendar and structured debriefing activity. This is administered following Step 5 in the standard CDC protocol, just prior to delivery of HIV test results. substance use module: This activity involves completion of a calendar detailing partners' substance use in the past month and a structured debriefing activity designed to facilitate the formation of couples' goals and limits around substance use. Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol. |
| FG003 | CHTC + Video + Substance Use Module | The couple views communication skills training videos together prior to participating in a CHTC session which includes administration of the substance use calendar and structured debriefing activity. Communication skills training video: This video includes 4 scenes of gay couples discussing issues related to HIV prevention, testing, sexual agreements, and drug use. Each scene is viewed twice. The first viewing includes common communication errors. The second viewing portrays more skillful interpersonal communication and a more adaptive resolution to the conversation. substance use module: This activity involves completion of a calendar detailing partners' substance use in the past month and a structured debriefing activity designed to facilitate the formation of couples' goals and limits around substance use. Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline and Intervention |
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| 1 Month Follow up |
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| 3 Month Follow-up |
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| 6 Month Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | CHTC as Usual | Participants receive couples HIV testing and counseling following the CDC approved protocol. Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol. |
| BG001 | CHTC + Communication Skills Videos |
| 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 | Proportion of Respondents Reporting Any Drug Use | The outcome measure is a dichotomous variable indicating whether or not each participant reported any drug use in the in the 30 days prior to each follow-up assessment. The table below displays the number (and percentage) of participants who indicated the use of any drugs at each assessment wave. Assessments were conducted at 1, 3, and 6 month post intervention. | Intent to treat analysis conducted using latent growth curve modeling to examine between-group differences in follow-up rates of drug use and trajectories of use over the follow-up period. | Posted | Count of Participants | Participants | 30 days prior to assessment |
|
Adverse events were monitored for a period of 6 months from baseline to final 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 | CHTC as Usual | Participants receive couples HIV testing and counseling following the CDC approved protocol. Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol. |
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The design does not permit inferences about effects of components delivered independently of CHTC.
The sample was recruited in a major metropolitan area and at relatively lower risk for HIV infection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tyrel Starks, Associate Professor | Hunter College, CUNY | 212-206-7919 | 934 | tstarks@hunter.cuny.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2017 | Oct 4, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D047568 | Unsafe Sex |
| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| C119825 | chitinase C |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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The study tests two independent variables in a fully-crossed factorial design. Half of the couples complete a substance use module during their CHTC session (half do not); half view communication skills training videos (half do not).
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Assignment to video condition is masked with respect to the care provider. The person conducting the CHTC session is unaware of whether couples have viewed the communication skills training video prior to the session.
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| substance use module | Behavioral | This activity involves completion of a calendar detailing partners' substance use in the past month and a structured debriefing activity designed to facilitate the formation of couples' goals and limits around substance use. |
|
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| Couples HIV Testing and Counseling | Behavioral | CHTC delivered as per the CDC protocol. |
|
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| 28745559 | Background | Starks TJ, Pawson M, Stephenson R, Sullivan P, Parsons JT. Dyadic Qualitative Analysis of Condom Use Scripts Among Emerging Adult Gay Male Couples. J Sex Marital Ther. 2018 Apr 3;44(3):269-280. doi: 10.1080/0092623X.2017.1359713. Epub 2017 Aug 25. |
| 30887190 | Result | Starks TJ, Dellucci TV, Gupta S, Robles G, Stephenson R, S Sullivan P, Parsons JT. A Pilot Randomized Trial of Intervention Components Addressing Drug Use in Couples HIV Testing and Counseling (CHTC) with Male Couples. AIDS Behav. 2019 Sep;23(9):2407-2420. doi: 10.1007/s10461-019-02455-2. |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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The couple views communication skills training videos together prior to participating in a CHTC session following the CDC approved protocol.
Communication skills training video: This video includes 4 scenes of gay couples discussing issues related to HIV prevention, testing, sexual agreements, and drug use. Each scene is viewed twice. The first viewing includes common communication errors. The second viewing portrays more skillful interpersonal communication and a more adaptive resolution to the conversation.
Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol.
| BG002 | CHTC + Substance Use Module | The couple completes a CHTC session which includes the substance use calendar and structured debriefing activity. This is administered following Step 5 in the standard CDC protocol, just prior to delivery of HIV test results. substance use module: This activity involves completion of a calendar detailing partners' substance use in the past month and a structured debriefing activity designed to facilitate the formation of couples' goals and limits around substance use. Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol. |
| BG003 | CHTC + Video + Substance Use Module | The couple views communication skills training videos together prior to participating in a CHTC session which includes administration of the substance use calendar and structured debriefing activity. Communication skills training video: This video includes 4 scenes of gay couples discussing issues related to HIV prevention, testing, sexual agreements, and drug use. Each scene is viewed twice. The first viewing includes common communication errors. The second viewing portrays more skillful interpersonal communication and a more adaptive resolution to the conversation. substance use module: This activity involves completion of a calendar detailing partners' substance use in the past month and a structured debriefing activity designed to facilitate the formation of couples' goals and limits around substance use. Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Reported any drug use | Count of Participants | Participants |
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| Condomless sex with casual partners | Count of Participants | Participants |
|
| Drug Abuse Screening Test-10 | DAST-10 total scores range from 0 to 10, with higher scores indicating more drug use related problems. | Mean | Standard Deviation | units on a scale |
|
| HIV status | Count of Participants | Participants |
|
| OG001 | CHTC + Communication Skills Videos | The couple views communication skills training videos together prior to participating in a CHTC session following the CDC approved protocol. Communication skills training video: This video includes 4 scenes of gay couples discussing issues related to HIV prevention, testing, sexual agreements, and drug use. Each scene is viewed twice. The first viewing includes common communication errors. The second viewing portrays more skillful interpersonal communication and a more adaptive resolution to the conversation. Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol. |
| OG002 | CHTC + Substance Use Module | The couple completes a CHTC session which includes the substance use calendar and structured debriefing activity. This is administered following Step 5 in the standard CDC protocol, just prior to delivery of HIV test results. substance use module: This activity involves completion of a calendar detailing partners' substance use in the past month and a structured debriefing activity designed to facilitate the formation of couples' goals and limits around substance use. Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol. |
| OG003 | CHTC + Video + Substance Use Module | The couple views communication skills training videos together prior to participating in a CHTC session which includes administration of the substance use calendar and structured debriefing activity. Communication skills training video: This video includes 4 scenes of gay couples discussing issues related to HIV prevention, testing, sexual agreements, and drug use. Each scene is viewed twice. The first viewing includes common communication errors. The second viewing portrays more skillful interpersonal communication and a more adaptive resolution to the conversation. substance use module: This activity involves completion of a calendar detailing partners' substance use in the past month and a structured debriefing activity designed to facilitate the formation of couples' goals and limits around substance use. Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol. |
|
|
|
| Primary | Condomless Anal Sex With Casual Partners | The outcome measure is a dichotomous variable indicating whether or not each participant indicated the occurrence of any insertive or receptive condomless anal sex (CAS) with a casual partner in the 30 days prior to each follow-up assessment. The table below displays the number (and percentage) of participants who indicated any CAS with a casual partner at each assessment wave. Assessments were conducted at 1, 3, and 6 month post intervention. | n reported is number retained at each wave | Posted | Count of Participants | Participants | 30 days prior to assessment |
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|
|
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| Primary | Drug Abuse Screening Test-10 Total Scores | The scale assesses the number of drug use related problems experienced by the participant in the 30 days prior to the assessment. Higher scores indicate a greater number of drug use related problems. Note, assessments were conducted at 1, 3, and 6 months post intervention. | n reported is the number retained at each follow-up wave. | Posted | Mean | Standard Deviation | score on a scale | 30 days prior to assessment |
|
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | CHTC + Communication Skills Videos | The couple views communication skills training videos together prior to participating in a CHTC session following the CDC approved protocol. Communication skills training video: This video includes 4 scenes of gay couples discussing issues related to HIV prevention, testing, sexual agreements, and drug use. Each scene is viewed twice. The first viewing includes common communication errors. The second viewing portrays more skillful interpersonal communication and a more adaptive resolution to the conversation. Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol. | 0 | 40 | 0 | 40 | 0 | 40 |
| EG002 | CHTC + Substance Use Module | The couple completes a CHTC session which includes the substance use calendar and structured debriefing activity. This is administered following Step 5 in the standard CDC protocol, just prior to delivery of HIV test results. substance use module: This activity involves completion of a calendar detailing partners' substance use in the past month and a structured debriefing activity designed to facilitate the formation of couples' goals and limits around substance use. Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol. | 0 | 34 | 0 | 34 | 0 | 34 |
| EG003 | CHTC + Video + Substance Use Module | The couple views communication skills training videos together prior to participating in a CHTC session which includes administration of the substance use calendar and structured debriefing activity. Communication skills training video: This video includes 4 scenes of gay couples discussing issues related to HIV prevention, testing, sexual agreements, and drug use. Each scene is viewed twice. The first viewing includes common communication errors. The second viewing portrays more skillful interpersonal communication and a more adaptive resolution to the conversation. substance use module: This activity involves completion of a calendar detailing partners' substance use in the past month and a structured debriefing activity designed to facilitate the formation of couples' goals and limits around substance use. Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol. | 0 | 34 | 0 | 34 | 0 | 34 |
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| D005159 | Health Care Facilities Workforce and Services |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| 3 month follow-up |
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| 6 month follow-up |
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| multi-level latent growth curve | 0.78 | A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution. | Beta | 0.26 | 2-Sided | 95 | -2.23 | 2.75 | Effects of CT video on the latent intercept factor among those who did not view SUM. | Superiority |
| multi-level latent growth curve | 0.53 | A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution. | Beta | -1.18 | 2-Sided | 95 | -4.86 | 2.51 | Effects of the interaction between SUM and CT video on the latent intercept. | Superiority |
| multi-level latent growth curve | 0.14 | A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution. | Beta | 1.83 | 2-Sided | 95 | -0.62 | 4.29 | Effect of SUM on the latent slope factor among those who did not view CT Videos. | Superiority |
| multi-level latent growth curve | 0.76 | A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution. | Beta | 0.35 | 2-Sided | 95 | -2.02 | 2.72 | Effects of CT Video on latent slope factor among those who did not complete the SUM. | Superiority |
| multi-level latent growth curve | 0.45 | A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution. | Beta | -1.28 | 2-Sided | 95 | -4.62 | 2.06 | Effects of the interaction between SUM and CT videos in the prediction of the latent slope factor. | Superiority |
|
| 3 month follow-up |
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| 6 month follow-up |
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| multi-level latent growth curve | 0.10 | A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution. | Beta | -0.49 | 2-Sided | 95 | -1.07 | 0.09 | 1-month follow-up, effect of SUM among those who did not view CT videos. | Superiority |
| multi-level latent growth curve | 0.63 | A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution. | Beta | -0.15 | 2-Sided | 95 | -0.77 | 0.47 | 1-month follow-up, effects of CT video among those who completed SUM. | Superiority |
| multi-level latent growth curve | 0.19 | A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution. | Beta | -0.41 | 2-Sided | 95 | -1.01 | 0.20 | 1-month follow-up, effects of CT video among those who did not complete SUM. | Superiority |
| multi-level latent growth curve | 0.01 | A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution. | Beta | -0.64 | 2-Sided | 95 | -1.13 | -0.15 | 3-month follow-up, effect of SUM among those who completed the CT video. | Superiority |
| multi-level latent growth curve | 0.12 | A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution. | Beta | -0.49 | 2-Sided | 95 | -1.11 | 0.12 | 3-month follow-up, effects of SUM among those who did not complete CT video. | Superiority |
| multi-level latent growth curve | 0.23 | A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution. | Beta | -0.34 | 2-Sided | 95 | -0.89 | 0.21 | 3-month follow-up, effects of CT video among those who completed SUM. | Superiority |
| multi-level latent growth curve | 0.51 | A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution. | Beta | -0.19 | 2-Sided | 95 | -0.76 | 0.38 | 3-month follow-up, effect of CT video among those who did not complete SUM. | Superiority |
| multi-level latent growth curve | 0.003 | A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution. | Beta | -0.79 | 2-Sided | 95 | -1.32 | -0.27 | 6-month follow-up, effects of SUM among those who viewed CT videos. | Superiority |
| multi-level latent growth curve | 0.49 | A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution. | Beta | -0.25 | 2-Sided | 95 | -0.96 | 0.46 | 6-month follow-up, effect of SUM among those who did not view the CT video. | Superiority |
| multi-level latent growth curve | 0.10 | A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution. | Beta | -0.53 | 2-Sided | 95 | -1.16 | 0.11 | 6-month follow-up, effect of CT video among those who completed SUM. | Superiority |
| multi-level latent growth curve | 0.96 | A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution. | Beta | -0.02 | 2-Sided | 95 | -0.60 | 0.64 | 6-month follow-up, effect of CT video among those who did not complete SUM. | Superiority |