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Completed

NCT Number: NCT01279044

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

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).

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Episodic Substance Use Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

San Francisco Department of Public Health, AIDS Office

San Francisco, California, 94102, United States

About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Identifies as male.
  • HIV-negative or unknown serostatus by self-report
  • Willing and able to participate in an intervention that addresses episodic substance use and sexual risk behavior
  • Not currently in substance use treatment, a self-help program, or an HIV prevention study
  • Has not injected any substances in prior 6 months.
  • ≥ 18 years old
  • Planning to remain in the San Francisco Bay Area for the duration of study activities
  • Willing and able to provide full informed consent. Able to speak, read, and understand English.

Exclusion criteria

  • Reports within the past 6 months UAI with only one partner AND identifies that individual as a primary partner.
  • 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
  • For alcohol, more than an average of 3 alcoholic drinks daily, or binge drinking more than twice weekly.

Treatment and study plan

Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC)

Behavioral

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

Behavioral

Standard HIV testing with information only

Primary outcomes

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

    Time frame: 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.

  2. Total Unprotected Anal Intercourse Partners

    Time frame: 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.

  3. Unprotected Anal Intercourse Episodes With Three Most Recent Sex Partners at Each Follow-up Visit, Exclusive of Primary HIV-negative Partners.

    Time frame: 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 outcomes

  1. Number of Serodiscordant Unprotected Anal Intercourse (SDUAI) Events

    Time frame: 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.

  2. Number of Instertive UAI Events

    Time frame: 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.

  3. Number of Receptive UAI Events

    Time frame: 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.

  4. Number of Condom-protected Anal Intercourse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

San Francisco Department of Public Health

Other Gov

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Jan 19, 2011
Registry last updated
Oct 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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