Clinical trial NCT01279044: Reducing HIV Risk Among Episodic Substance Using Men Who Have Sex With Men (SUMSM)
Official title: Reducing HIV Risk Among Episodic Substance Using Men Who Have Sex With Men (SUMSM): Adaptation of the Personalized Cognitive Counseling (PCC) Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV Infections
Episodic Substance Use
Keywords: HIV
MSM
SUMSM
Lead sponsor: San Francisco Department of Public Health
Sponsor class: OTHER_GOV
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2011-01-19
Enrollment: 385
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total Unprotected Anal Intercourse Events (Exclusive of Those Events With a Primary HIV-negative Partner)
timeFrame: Self-reported behavior during past 3 months
measure: Total Unprotected Anal Intercourse Partners
timeFrame: Self-reported behavior during past 3 months
measure: Unprotected Anal Intercourse Episodes With Three Most Recent Sex Partners at Each Follow-up Visit, Exclusive of Primary HIV-negative Partners.
timeFrame: Self-reported behavior during past 3 months
Secondary outcomes:
measure: Number of Serodiscordant Unprotected Anal Intercourse (SDUAI) Events
timeFrame: Self-reported behavior during past 3 months
measure: Number of Instertive UAI Events
timeFrame: Self-reported behavior during past 3 months
measure: Number of Receptive UAI Events
timeFrame: Self-reported behavior during past 3 months
measure: Number of Condom-protected Anal Intercourse Events
timeFrame: Self-reported behavior during past 3 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Department of Public Health, AIDS Office
state: California
Study officials:
affiliation: Director of Substance Use Research, HIV Prevention, San Francisco Department of Public Health
name: Phillip O Coffin, MD, MIA
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention
name: Jeffrey H Herbst, PhD
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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 Behav. 2014 Jul;18(7):1390-400. doi: 10.1007/s10461-014-0712-4.