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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01279044
• Other study ID #: 1UR6PS000684-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 18, 2011
• Last updated: September 30, 2014
• Start date: September 2007
• Est. completion date: November 2012

Study information

• Verified date: September 2014
• Source: San Francisco Department of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Episodic Substance Use
• HIV Infections

Intervention

Behavioral:
• 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.
• Standard HIV testing with information only
Standard HIV testing with information only

Locations

Country	Name	City	State
United States	San Francisco Department of Public Health, AIDS Office	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
San Francisco Department of Public Health	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (3)

Coffin PO, Santos GM, Colfax G, Das M, Matheson T, DeMicco E, Dilley J, Vittinghoff E, Raiford JL, Carry M, Herbst JH. Adapted personalized cognitive counseling for episodic substance-using men who have sex with men: a randomized controlled trial. AIDS Be — View Citation

Knight KR, Das M, DeMicco E, Raiford JL, Matheson T, Shook A, Antunez E, Santos GM, Dadasovich R, Dilley JW, Colfax GN, Herbst JH. A roadmap for adapting an evidence-based HIV prevention intervention: personal cognitive counseling (PCC) for episodic substance-using men who have sex with men. Prev Sci. 2014 Jun;15(3):364-75. doi: 10.1007/s11121-013-0364-z. — View Citation

Santos GM, Coffin PO, Das M, Matheson T, DeMicco E, Raiford JL, Vittinghoff E, Dilley JW, Colfax G, Herbst JH. Dose-response associations between number and frequency of substance use and high-risk sexual behaviors among HIV-negative substance-using men who have sex with men (SUMSM) in San Francisco. J Acquir Immune Defic Syndr. 2013 Aug 1;63(4):540-4. doi: 10.1097/QAI.0b013e318293f10b. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Self-reported behavior during past 3 months	No
Primary	Total Unprotected Anal Intercourse Partners	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.	Self-reported behavior during past 3 months	No
Primary	Unprotected Anal Intercourse Episodes With Three Most Recent Sex Partners at Each Follow-up Visit, Exclusive of Primary HIV-negative Partners.	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.	Self-reported behavior during past 3 months	No
Secondary	Number of Serodiscordant Unprotected Anal Intercourse (SDUAI) Events	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.	Self-reported behavior during past 3 months	No
Secondary	Number of Instertive UAI Events	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.	Self-reported behavior during past 3 months	No
Secondary	Number of Receptive UAI Events	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.	Self-reported behavior during past 3 months	No
Secondary	Number of Condom-protected Anal Intercourse Events	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.	Self-reported behavior during past 3 months	No