Phase 2
Completed N=59
Reducing HIV Risk Among Episodic Substance Using Men Who Have Sex With Men (SUMSM)
HIV · Episodic Substance Use
Source: ClinicalTrials.gov NCT01279044 ↗
Enrolled (actual)
59
Serious AEs
0.3%
Results posted
Oct 2014
Primary outcomePrimary: Total Unprotected Anal Intercourse Events (Exclusive of Those Events With a Primary HIV-negative Partner) — 4.23; 3.91; 3.41; 2.05 Self reported events in past 3 months
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Unprotected Anal Intercourse Events (Exclusive of Those Events With a Primary HIV-negative Partner) |
4.23; 3.91; 3.41; 2.05; 1.83; 1.96 | — |
| PRIMARY Total Unprotected Anal Intercourse Partners |
2.71; 2.60; 1.54; 1.37; 1.27; 1.16 | — |
| PRIMARY Unprotected Anal Intercourse Episodes With Three Most Recent Sex Partners at Each Follow-up Visit, Exclusive of Primary HIV-negative Partners. |
1.97; 2.31; 1.12; 1.11; 0.83; 1.20 | — |
| SECONDARY Number of Serodiscordant Unprotected Anal Intercourse (SDUAI) Events |
1.06; 1.13; 0.43; 0.49; 0.34; 0.55 | — |
| SECONDARY Number of Instertive UAI Events |
2.84; 2.44; 2.80; 1.32; 1.37; 1.14 | — |
| SECONDARY Number of Receptive UAI Events |
1.39; 1.48; 0.61; 0.73; 0.45; 0.82 | — |
| SECONDARY Number of Condom-protected Anal Intercourse Events |
3.78; 2.83; 1.67; 2.13; 2.11; 1.29 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01279044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.