Reducing HIV Risk Among Episodic Substance Using Men Who Have Sex With Men (SUMSM)

Reducing HIV Risk Among Episodic Substance Using Men Who Have Sex With Men (SUMSM): Adaptation of the Personalized Cognitive Counseling (PCC) Intervention

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01279044

Enrollment

385

Registered

2011-01-19

Start date

2007-09-30

Completion date

2012-11-30

Last updated

2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Episodic Substance Use, HIV Infections

Keywords

HIV, MSM, SUMSM

Brief summary

The purpose of this study is to determine if persons randomized to receive adapted Personalized Cognitive Risk-reduction Counseling (PCC) will report greater reductions in unprotected anal sex behavior compared with persons who do not receive Personalized Cognitive Risk-reduction Counseling (PCC).

Detailed description

In the U.S., men who have sex with men (MSM) continue to constitute the greatest number of HIV/AIDS cases compared with other risk groups. Furthermore, many episodic substance using men who have sex with men (SUMSM) report that sex and substance use always or often go together. Studies have shown that substance use just before or during sex substantially increases HIV risk. The formative phase of this research enrolled 59 HIV-negative episodic substance using MSM to participate in interviews to inform the adaptation of the Self-Justification Elicitation Instrument (SJEI) used during Personalized Cognitive Counseling (PCC) and to subsequently, pilot the adapted SJEI. The randomized controlled trial (RCT) phase of this study enrolled 326 ethnically-diverse, HIV-negative episodic SUMSM to receive standard HIV rapid testing plus adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC) or standard HIV counseling and rapid testing only. Specific Aims: 1. To conduct formative research through individual interviews and pilot testing among a sample (n=59) of episodic substance-using men who have sex with men (SUMSM) to develop and adapt the key elements of the Personal Risk-Reduction Cognitive Counseling intervention, with a focus on eliciting and intervening on the thoughts, attitudes, and behaviors that episodic SUMSM employ when using substances and engaging in concurrent sexual risk. 2. To determine the efficacy of the adapted intervention in reducing unprotected anal sex, as compared to routine HIV testing control condition, in a randomized trial of 326 episodic SUMSM. We will also determine the efficacy of the intervention in reducing substance use.

Interventions

BEHAVIORALAdapted Personalized Cognitive Risk-reduction Counseling intervention (PCC)

The individualized, cognitive counseling intervention was designed to help participants address the self-justifications-beliefs, thoughts, and attitudes-that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.

BEHAVIORALStandard HIV testing with information only

Standard HIV testing with information only

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Reports within the past 6 months unprotected anal intercourse (UAI) with another man while under the influence of at least one or any combination of the following substance: methamphetamine, poppers, crack or powder cocaine, or alcohol if binge drinking (5 or more drinks) within 2 hours before or during sex. 2. Identifies as male. 3. HIV-negative or unknown serostatus by self-report 4. Willing and able to participate in an intervention that addresses episodic substance use and sexual risk behavior 5. Not currently in substance use treatment, a self-help program, or an HIV prevention study 6. Has not injected any substances in prior 6 months. 7. ≥ 18 years old 8. Planning to remain in the San Francisco Bay Area for the duration of study activities 9. Willing and able to provide full informed consent. Able to speak, read, and understand English.

Exclusion criteria

1. Reports within the past 6 months UAI with only one partner AND identifies that individual as a primary partner. 2. In the prior three months, weekly or more use of any of the targeted substances (meth, poppers, crack or powder cocaine), with the exception of alcohol 3. For alcohol, more than an average of 3 alcoholic drinks daily, or binge drinking more than twice weekly.

Design outcomes

Primary

Measure	Time frame	Description
Total Unprotected Anal Intercourse Events (Exclusive of Those Events With a Primary HIV-negative Partner)	Self-reported behavior during past 3 months	The outcome measure data shows the rate of change in the mean value in the number of total unprotected anal intercourse events over time. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints.
Total Unprotected Anal Intercourse Partners	Self-reported behavior during past 3 months	The outcome measure data shows the rate of change in the mean value of total unprotected anal intercourse partners over time. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints.
Unprotected Anal Intercourse Episodes With Three Most Recent Sex Partners at Each Follow-up Visit, Exclusive of Primary HIV-negative Partners.	Self-reported behavior during past 3 months	The outcome measure data shows the rate of change in the mean value of total unprotected anal intercourse episodes with three most recent sex partners over time. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints.

Secondary

Measure	Time frame	Description
Number of Serodiscordant Unprotected Anal Intercourse (SDUAI) Events	Self-reported behavior during past 3 months	The outcome measure data shows the rate of change in the mean value of number of serodiscordant unprotected anal intercourse events. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints. Serodiscordant defined as having partner of discordant or of unknown HIV serostatus.
Number of Condom-protected Anal Intercourse Events	Self-reported behavior during past 3 months	The outcome measure data shows the rate of change in the mean value of the number of condom-protected anal intercourse (UAI) events. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints. Serodiscordant defined as having partner of discordant or of unknown HIV serostatus.
Number of Instertive UAI Events	Self-reported behavior during past 3 months	The outcome measure data shows the rate of change in the mean value of number of instertive unprotected anal intercourse (UAI) events. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints.
Number of Receptive UAI Events	Self-reported behavior during past 3 months	The outcome measure data shows the rate of change in the mean value of the number of receptive unprotected anal intercourse (UAI) events. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints.

Countries

United States

Participant flow

Recruitment details

Recruitment involved outreach at community venues in San Francisco, including bars, clubs, grocery stores, gyms, and other venues frequented by MSM. To recruit a racially and ethnically diverse sample of episodic SUMSM, recruitment also occurred at community-based organizations serving African American, Latino, and Asian and Pacific Islander MSM.

Pre-assignment details

Potential participants completed brief telephone screening to assess initial eligibility and, if eligible, were scheduled for in-person re-screening visits. If potential participants were ineligible at the re-screening visit, they were thanked for their time and did not continue with study activities, such as randomization in the RCT.

Participants by arm

Arm	Count
Phase 1 - Formative Research Formative research through individual interviews and pilot testing to develop and adapt the key elements of Personal Cognitive Counseling	59
HIV Testing With Adapted Personalized Cognitive Risk-reduction Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications-beliefs, thoughts, and attitudes-that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.	162
HIV Testing With Information Only Standard HIV testing with information only: Standard HIV testing with information only	164
Total	385

Withdrawals & dropouts

Period	Reason	FG001	FG002
PHASE 2 - Randmonized Controlled Trial	Death	0	1
PHASE 2 - Randmonized Controlled Trial	Lost to Follow-up	8	0
PHASE 2 - Randmonized Controlled Trial	Withdrawal by Subject	3	2

Baseline characteristics

Characteristic	Total	HIV Testing With Information Only	HIV Testing With Adapted Personalized Cognitive Risk-reduction	Phase 1 - Formative Research
Age, Continuous	33.6 years	33.1 years	34 years	33 years
Ethnicity (NIH/OMB) Hispanic or Latino	97 Participants	45 Participants	34 Participants	18 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	288 Participants	119 Participants	128 Participants	41 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Asian Pacific Islander	42 participants	22 participants	14 participants	6 participants
Race/Ethnicity, Customized Black/African American	36 participants	16 participants	17 participants	3 participants
Race/Ethnicity, Customized Mixed	27 participants	12 participants	12 participants	3 participants
Race/Ethnicity, Customized Native American	3 participants	1 participants	1 participants	1 participants
Race/Ethnicity, Customized Other	73 participants	39 participants	34 participants	0 participants
Race/Ethnicity, Customized White	204 participants	74 participants	84 participants	46 participants
Region of Enrollment United States	385 participants	164 participants	162 participants	59 participants
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	385 Participants	164 Participants	162 Participants	59 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 162	0 / 164
serious Total, serious adverse events	0 / 162	1 / 164

Outcome results

Primary

Total Unprotected Anal Intercourse Events (Exclusive of Those Events With a Primary HIV-negative Partner)

The outcome measure data shows the rate of change in the mean value in the number of total unprotected anal intercourse events over time. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints.