Trial Outcomes & Findings for Addressing Substance Use Through CVCT (NCT NCT03125915)
NCT ID: NCT03125915
Last Updated: 2021-04-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
140 participants
Primary outcome timeframe
30 days prior to assessment
Results posted on
2021-04-15
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Baseline and Intervention
STARTED
|
32
|
40
|
34
|
34
|
|
Baseline and Intervention
COMPLETED
|
32
|
40
|
34
|
34
|
|
Baseline and Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
1 Month Follow up
STARTED
|
32
|
40
|
34
|
34
|
|
1 Month Follow up
COMPLETED
|
29
|
37
|
32
|
31
|
|
1 Month Follow up
NOT COMPLETED
|
3
|
3
|
2
|
3
|
|
3 Month Follow-up
STARTED
|
32
|
40
|
34
|
34
|
|
3 Month Follow-up
COMPLETED
|
26
|
36
|
30
|
32
|
|
3 Month Follow-up
NOT COMPLETED
|
6
|
4
|
4
|
2
|
|
6 Month Follow-up
STARTED
|
32
|
40
|
34
|
34
|
|
6 Month Follow-up
COMPLETED
|
25
|
37
|
28
|
31
|
|
6 Month Follow-up
NOT COMPLETED
|
7
|
3
|
6
|
3
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
1 Month Follow up
Lost to Follow-up
|
3
|
3
|
2
|
3
|
|
3 Month Follow-up
Lost to Follow-up
|
6
|
4
|
4
|
2
|
|
6 Month Follow-up
Lost to Follow-up
|
7
|
3
|
6
|
3
|
Baseline Characteristics
Addressing Substance Use Through CVCT
Baseline characteristics by cohort
| Measure |
CHTC as Usual
n=32 Participants
Participants receive couples HIV testing and counseling following the CDC approved protocol.
Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol.
|
CHTC + Communication Skills Videos
n=40 Participants
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.
|
CHTC + Substance Use Module
n=34 Participants
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.
|
CHTC + Video + Substance Use Module
n=34 Participants
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.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
25.75 Years
STANDARD_DEVIATION 4.89 • n=5 Participants
|
27.83 Years
STANDARD_DEVIATION 7.70 • n=7 Participants
|
26.50 Years
STANDARD_DEVIATION 2.99 • n=5 Participants
|
27.76 Years
STANDARD_DEVIATION 6.07 • n=4 Participants
|
27.01 Years
STANDARD_DEVIATION 5.80 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
140 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black (non-Hispanic/Latino)
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Latino/Hispanic
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White (non-Hispanic/Latino)
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Multi-racial or Other
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
40 participants
n=7 Participants
|
34 participants
n=5 Participants
|
34 participants
n=4 Participants
|
140 participants
n=21 Participants
|
|
Reported any drug use
|
25 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
112 Participants
n=21 Participants
|
|
Condomless sex with casual partners
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Drug Abuse Screening Test-10
|
2.25 units on a scale
STANDARD_DEVIATION 2.06 • n=5 Participants
|
1.58 units on a scale
STANDARD_DEVIATION 1.15 • n=7 Participants
|
1.47 units on a scale
STANDARD_DEVIATION 1.52 • n=5 Participants
|
1.71 units on a scale
STANDARD_DEVIATION 1.24 • n=4 Participants
|
1.74 units on a scale
STANDARD_DEVIATION 1.52 • n=21 Participants
|
|
HIV status
HIV negative
|
29 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
129 Participants
n=21 Participants
|
|
HIV status
HIV positive
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 30 days prior to assessmentPopulation: 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.
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.
Outcome measures
| Measure |
CHTC as Usual
n=32 Participants
Participants receive couples HIV testing and counseling following the CDC approved protocol.
Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol.
|
CHTC + Communication Skills Videos
n=40 Participants
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.
|
CHTC + Substance Use Module
n=34 Participants
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.
|
CHTC + Video + Substance Use Module
n=34 Participants
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.
|
|---|---|---|---|---|
|
Proportion of Respondents Reporting Any Drug Use
1 month follow-up
|
25 Participants
|
26 Participants
|
18 Participants
|
17 Participants
|
|
Proportion of Respondents Reporting Any Drug Use
3 month follow-up
|
20 Participants
|
17 Participants
|
28 Participants
|
15 Participants
|
|
Proportion of Respondents Reporting Any Drug Use
6 month follow-up
|
15 Participants
|
31 Participants
|
15 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: 30 days prior to assessmentPopulation: n reported is number retained at each wave
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.
Outcome measures
| Measure |
CHTC as Usual
n=32 Participants
Participants receive couples HIV testing and counseling following the CDC approved protocol.
Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol.
|
CHTC + Communication Skills Videos
n=40 Participants
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.
|
CHTC + Substance Use Module
n=34 Participants
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.
|
CHTC + Video + Substance Use Module
n=34 Participants
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.
|
|---|---|---|---|---|
|
Condomless Anal Sex With Casual Partners
1 month follow-up
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Condomless Anal Sex With Casual Partners
3 month follow-up
|
0 Participants
|
5 Participants
|
6 Participants
|
2 Participants
|
|
Condomless Anal Sex With Casual Partners
6 month follow-up
|
3 Participants
|
4 Participants
|
10 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 30 days prior to assessmentPopulation: n reported is the number retained at each follow-up wave.
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.
Outcome measures
| Measure |
CHTC as Usual
n=32 Participants
Participants receive couples HIV testing and counseling following the CDC approved protocol.
Couples HIV Testing and Counseling: CHTC delivered as per the CDC protocol.
|
CHTC + Communication Skills Videos
n=40 Participants
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.
|
CHTC + Substance Use Module
n=34 Participants
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.
|
CHTC + Video + Substance Use Module
n=34 Participants
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.
|
|---|---|---|---|---|
|
Drug Abuse Screening Test-10 Total Scores
6 month follow-up
|
1.76 score on a scale
Standard Deviation 2.12
|
1.70 score on a scale
Standard Deviation 1.56
|
1.25 score on a scale
Standard Deviation 1.73
|
0.84 score on a scale
Standard Deviation 1.00
|
|
Drug Abuse Screening Test-10 Total Scores
1 month follow-up
|
2.52 score on a scale
Standard Deviation 2.04
|
1.70 score on a scale
Standard Deviation 1.75
|
1.16 score on a scale
Standard Deviation 1.39
|
1.06 score on a scale
Standard Deviation 1.18
|
|
Drug Abuse Screening Test-10 Total Scores
3 month follow-up
|
1.98 score on a scale
Standard Deviation 2.01
|
1.53 score on a scale
Standard Deviation 1.42
|
1.40 score on a scale
Standard Deviation 1.85
|
0.71 score on a scale
Standard Deviation 0.90
|
Adverse Events
CHTC as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CHTC + Communication Skills Videos
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CHTC + Substance Use Module
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CHTC + Video + Substance Use Module
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place