Drug Use, Sex, Unsafe
Conditions
Keywords
couples HIV testing; drug intervention; communication skills
Brief summary
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.
Detailed description
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: 1. CHTC as usual 2. CHTC + communication skills training videos 3. CHTC + substance use module 4. CHTC + communication skills training videos + substance use calendar 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.
Interventions
BEHAVIORALCommunication 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.
BEHAVIORALsubstance 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.
BEHAVIORALCouples HIV Testing and Counseling
CHTC delivered as per the CDC protocol.
Sponsors
National Institute on Drug Abuse (NIDA)
Hunter College of City University of New York
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Masking description
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.
Intervention model description
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).
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Both members of the couple: 1. are born male and current male gender identity; 2. identify as gay, bisexual or same-sex attracted; 3. read English at 8th grade level or better; 4. have access to the Internet; 5. agree to audio and video recording of intervention sessions; At least one member of the couple: 1. reports the use of any drug listed on the DAST-10 in the previous 30 days. 2. s identified as HIV negative during screening and baseline assessments. The couple 3. has been together for at least 3 months; 4. has engaged in oral or anal sex with one another in the past 3 months;
Exclusion criteria
1. At baseline either member of the couple reports intimate partner violence (IPV), which is defined as serious physical or sexual violence that occurs outside the context of consensual bondage or sado-masochistic sexual play, which results in concerns about safety. 2. At the first in-person meeting, staff will be empowered to deem the couple ineligible for the intervention if they identify inconsistencies between information provided in the eligibility screener and the in-person meeting (e.g., discrepancies in age or duration of relationship) or any issues that might hinder participation (e.g., attending meeting high or drunk). The couple may also be deemed ineligible if participant responses are sufficiently inconsistent to call into question the validity of their individual responses.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Respondents Reporting Any Drug Use | 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. |
| Condomless Anal Sex With Casual Partners | 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. |
| Drug Abuse Screening Test-10 Total Scores | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| 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. | 40 |
| 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. | 34 |
| 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. | 34 |
| Total | 140 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| 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
| Characteristic | CHTC + Communication Skills Videos | Total | CHTC + Video + Substance Use Module | CHTC + Substance Use Module | CHTC as Usual |
|---|---|---|---|---|---|
| Age, Continuous | 27.83 Years STANDARD_DEVIATION 7.7 | 27.01 Years STANDARD_DEVIATION 5.8 | 27.76 Years STANDARD_DEVIATION 6.07 | 26.50 Years STANDARD_DEVIATION 2.99 | 25.75 Years STANDARD_DEVIATION 4.89 |
| Condomless sex with casual partners | 8 Participants | 29 Participants | 4 Participants | 8 Participants | 9 Participants |
| Drug Abuse Screening Test-10 | 1.58 units on a scale STANDARD_DEVIATION 1.15 | 1.74 units on a scale STANDARD_DEVIATION 1.52 | 1.71 units on a scale STANDARD_DEVIATION 1.24 | 1.47 units on a scale STANDARD_DEVIATION 1.52 | 2.25 units on a scale STANDARD_DEVIATION 2.06 |
| HIV status HIV negative | 37 Participants | 129 Participants | 31 Participants | 32 Participants | 29 Participants |
| HIV status HIV positive | 3 Participants | 11 Participants | 3 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Black (non-Hispanic/Latino) | 9 Participants | 23 Participants | 4 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Latino/Hispanic | 7 Participants | 35 Participants | 7 Participants | 13 Participants | 8 Participants |
| Race/Ethnicity, Customized Multi-racial or Other | 5 Participants | 18 Participants | 6 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized White (non-Hispanic/Latino) | 19 Participants | 64 Participants | 17 Participants | 13 Participants | 15 Participants |
| Region of Enrollment United States | 40 participants | 140 participants | 34 participants | 34 participants | 32 participants |
| Reported any drug use | 34 Participants | 112 Participants | 29 Participants | 24 Participants | 25 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 40 Participants | 140 Participants | 34 Participants | 34 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 40 | 0 / 34 | 0 / 34 |
| other Total, other adverse events | 0 / 32 | 0 / 40 | 0 / 34 | 0 / 34 |
| serious Total, serious adverse events | 0 / 32 | 0 / 40 | 0 / 34 | 0 / 34 |
Outcome results
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.
Time frame: 30 days prior to assessment
Population: n reported is number retained at each wave
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CHTC as Usual | Condomless Anal Sex With Casual Partners | 6 month follow-up | 3 Participants |
| CHTC as Usual | Condomless Anal Sex With Casual Partners | 1 month follow-up | 3 Participants |
| CHTC as Usual | Condomless Anal Sex With Casual Partners | 3 month follow-up | 0 Participants |
| CHTC + Communication Skills Videos | Condomless Anal Sex With Casual Partners | 1 month follow-up | 3 Participants |
| CHTC + Communication Skills Videos | Condomless Anal Sex With Casual Partners | 6 month follow-up | 4 Participants |
| CHTC + Communication Skills Videos | Condomless Anal Sex With Casual Partners | 3 month follow-up | 5 Participants |
| CHTC + Substance Use Module | Condomless Anal Sex With Casual Partners | 6 month follow-up | 10 Participants |
| CHTC + Substance Use Module | Condomless Anal Sex With Casual Partners | 1 month follow-up | 3 Participants |
| CHTC + Substance Use Module | Condomless Anal Sex With Casual Partners | 3 month follow-up | 6 Participants |
| CHTC + Video + Substance Use Module | Condomless Anal Sex With Casual Partners | 6 month follow-up | 3 Participants |
| CHTC + Video + Substance Use Module | Condomless Anal Sex With Casual Partners | 3 month follow-up | 2 Participants |
| CHTC + Video + Substance Use Module | Condomless Anal Sex With Casual Partners | 1 month follow-up | 1 Participants |
p-value: 0.995% CI: [-2.3, 2.41]multi-level latent growth curve
p-value: 0.7895% CI: [-2.23, 2.75]multi-level latent growth curve
p-value: 0.5395% CI: [-4.86, 2.51]multi-level latent growth curve
p-value: 0.1495% CI: [-0.62, 4.29]multi-level latent growth curve
p-value: 0.7695% CI: [-2.02, 2.72]multi-level latent growth curve
p-value: 0.4595% CI: [-4.62, 2.06]multi-level latent growth curve
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.
Time frame: 30 days prior to assessment
Population: n reported is the number retained at each follow-up wave.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CHTC as Usual | Drug Abuse Screening Test-10 Total Scores | 1 month follow-up | 2.52 score on a scale | Standard Deviation 2.04 |
| CHTC as Usual | Drug Abuse Screening Test-10 Total Scores | 6 month follow-up | 1.76 score on a scale | Standard Deviation 2.12 |
| CHTC as Usual | Drug Abuse Screening Test-10 Total Scores | 3 month follow-up | 1.98 score on a scale | Standard Deviation 2.01 |
| CHTC + Communication Skills Videos | Drug Abuse Screening Test-10 Total Scores | 1 month follow-up | 1.70 score on a scale | Standard Deviation 1.75 |
| CHTC + Communication Skills Videos | Drug Abuse Screening Test-10 Total Scores | 6 month follow-up | 1.70 score on a scale | Standard Deviation 1.56 |
| CHTC + Communication Skills Videos | Drug Abuse Screening Test-10 Total Scores | 3 month follow-up | 1.53 score on a scale | Standard Deviation 1.42 |
| CHTC + Substance Use Module | Drug Abuse Screening Test-10 Total Scores | 3 month follow-up | 1.40 score on a scale | Standard Deviation 1.85 |
| CHTC + Substance Use Module | Drug Abuse Screening Test-10 Total Scores | 1 month follow-up | 1.16 score on a scale | Standard Deviation 1.39 |
| CHTC + Substance Use Module | Drug Abuse Screening Test-10 Total Scores | 6 month follow-up | 1.25 score on a scale | Standard Deviation 1.73 |
| CHTC + Video + Substance Use Module | Drug Abuse Screening Test-10 Total Scores | 1 month follow-up | 1.06 score on a scale | Standard Deviation 1.18 |
| CHTC + Video + Substance Use Module | Drug Abuse Screening Test-10 Total Scores | 6 month follow-up | 0.84 score on a scale | Standard Deviation 1 |
| CHTC + Video + Substance Use Module | Drug Abuse Screening Test-10 Total Scores | 3 month follow-up | 0.71 score on a scale | Standard Deviation 0.9 |
p-value: 0.0295% CI: [-1.39, -0.11]multi-level latent growth curve
p-value: 0.195% CI: [-1.07, 0.09]multi-level latent growth curve
p-value: 0.6395% CI: [-0.77, 0.47]multi-level latent growth curve
p-value: 0.1995% CI: [-1.01, 0.2]multi-level latent growth curve
p-value: 0.0195% CI: [-1.13, -0.15]multi-level latent growth curve
p-value: 0.1295% CI: [-1.11, 0.12]multi-level latent growth curve
p-value: 0.2395% CI: [-0.89, 0.21]multi-level latent growth curve
p-value: 0.5195% CI: [-0.76, 0.38]multi-level latent growth curve
p-value: 0.00395% CI: [-1.32, -0.27]multi-level latent growth curve
p-value: 0.4995% CI: [-0.96, 0.46]multi-level latent growth curve
p-value: 0.195% CI: [-1.16, 0.11]multi-level latent growth curve
p-value: 0.9695% CI: [-0.6, 0.64]multi-level latent growth curve
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.
Time frame: 30 days prior to assessment
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CHTC as Usual | Proportion of Respondents Reporting Any Drug Use | 1 month follow-up | 25 Participants |
| CHTC as Usual | Proportion of Respondents Reporting Any Drug Use | 6 month follow-up | 15 Participants |
| CHTC as Usual | Proportion of Respondents Reporting Any Drug Use | 3 month follow-up | 20 Participants |
| CHTC + Communication Skills Videos | Proportion of Respondents Reporting Any Drug Use | 1 month follow-up | 26 Participants |
| CHTC + Communication Skills Videos | Proportion of Respondents Reporting Any Drug Use | 6 month follow-up | 31 Participants |
| CHTC + Communication Skills Videos | Proportion of Respondents Reporting Any Drug Use | 3 month follow-up | 17 Participants |
| CHTC + Substance Use Module | Proportion of Respondents Reporting Any Drug Use | 3 month follow-up | 28 Participants |
| CHTC + Substance Use Module | Proportion of Respondents Reporting Any Drug Use | 1 month follow-up | 18 Participants |
| CHTC + Substance Use Module | Proportion of Respondents Reporting Any Drug Use | 6 month follow-up | 15 Participants |
| CHTC + Video + Substance Use Module | Proportion of Respondents Reporting Any Drug Use | 1 month follow-up | 17 Participants |
| CHTC + Video + Substance Use Module | Proportion of Respondents Reporting Any Drug Use | 6 month follow-up | 17 Participants |
| CHTC + Video + Substance Use Module | Proportion of Respondents Reporting Any Drug Use | 3 month follow-up | 15 Participants |
p-value: 0.0395% CI: [-6.78, -0.46]multi-leve latent growth curve
p-value: 0.1895% CI: [-4.1, 0.76]multi-level latent growth curve
p-value: 0.7595% CI: [-2.5, 1.8]multi-level latent growth curve
p-value: 0.1495% CI: [-5.37, 0.77]multi-level latent growth curve
p-value: 0.01395% CI: [-5, -0.58]multi-level latent growth curve
p-value: 0.195% CI: [-4.56, 0.38]multi-level latent growth curve
Comparison: 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.p-value: 0.7895% CI: [-2.35, 3.16]multi-level latent growth curve
p-value: 0.7595% CI: [-2.12, 1.53]multi-level latent growth curve
p-value: 0.01495% CI: [-7.06, -0.81]multi-level latent growth curve
p-value: 0.6795% CI: [-3.16, 2.03]multi-level latent growth curve
p-value: 0.8395% CI: [-2.39, 1.91]multi-level latent growth curve
p-value: 0.0595% CI: [-0.004, 6.25]multi-level latent growth curve