NCT03125915

Addressing Substance Use Through CVCT

Completed NA Results posted Last updated 15 April 2021

What this trial tests

NA trial testing Communication skills training video in Sex, Unsafe in 140 participants. Completed in 1 February 2018.

Timeline

1 April 2014

Primary endpoint
1 February 2018

1 February 2018

Quick facts

Lead sponsor	Hunter College of City University of New York
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	prevention
Enrollment	140
Start date	1 April 2014
Primary completion	1 February 2018
Estimated completion	1 February 2018
Sites	1 location across United States

Drugs / interventions tested

• Communication skills training video
• substance use module
• Couples HIV Testing and Counseling

Conditions studied

• Sex, Unsafe — all drugs for Sex, Unsafe →
• Drug Use — all drugs for Drug Use →

Sponsor

Hunter College of City University of New York

Who can join

Adults 18 to 60, male only, with Sex, Unsafe or Drug Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Respondents Reporting Any Drug Use Primary · 30 days prior to assessment

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.

1 month follow-up

Group	Value	95% CI
CHTC as Usual	25
CHTC + Communication Skills Videos	26
CHTC + Substance Use Module	18
CHTC + Video + Substance Use Module	17

3 month follow-up

Group	Value	95% CI
CHTC as Usual	20
CHTC + Communication Skills Videos	17
CHTC + Substance Use Module	28
CHTC + Video + Substance Use Module	15

6 month follow-up

Group	Value	95% CI
CHTC as Usual	15
CHTC + Communication Skills Videos	31
CHTC + Substance Use Module	15
CHTC + Video + Substance Use Module	17

Condomless Anal Sex With Casual Partners Primary · 30 days prior to assessment

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.

1 month follow-up

Group	Value	95% CI
CHTC as Usual	3
CHTC + Communication Skills Videos	3
CHTC + Substance Use Module	3
CHTC + Video + Substance Use Module	1

3 month follow-up

Group	Value	95% CI
CHTC as Usual	0
CHTC + Communication Skills Videos	5
CHTC + Substance Use Module	6
CHTC + Video + Substance Use Module	2

6 month follow-up

Group	Value	95% CI
CHTC as Usual	3
CHTC + Communication Skills Videos	4
CHTC + Substance Use Module	10
CHTC + Video + Substance Use Module	3

Drug Abuse Screening Test-10 Total Scores Primary · 30 days prior to assessment

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.

1 month follow-up

Group	Value	95% CI
CHTC as Usual	2.52	± 2.04
CHTC + Communication Skills Videos	1.70	± 1.75
CHTC + Substance Use Module	1.16	± 1.39
CHTC + Video + Substance Use Module	1.06	± 1.18

3 month follow-up

Group	Value	95% CI
CHTC as Usual	1.98	± 2.01
CHTC + Communication Skills Videos	1.53	± 1.42
CHTC + Substance Use Module	1.40	± 1.85
CHTC + Video + Substance Use Module	0.71	± 0.90

6 month follow-up

Group	Value	95% CI
CHTC as Usual	1.76	± 2.12
CHTC + Communication Skills Videos	1.70	± 1.56
CHTC + Substance Use Module	1.25	± 1.73
CHTC + Video + Substance Use Module	0.84	± 1.00

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.