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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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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).
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:
We will also determine the efficacy of the intervention in reducing substance use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | HIV testing with adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC) |
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| 2 | Placebo Comparator | HIV testing with information only |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillip O Coffin, MD, MIA | Director of Substance Use Research, HIV Prevention, San Francisco Department of Public Health | Principal Investigator |
| Jeffrey H Herbst, PhD | Centers for Disease Control and Prevention | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco Department of Public Health, AIDS Office | San Francisco | California | 94102 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23572012 | Background | 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. | |
| 23412947 | Background | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Formative Phase 1 | Individual interviews and pilot testing to develop and adapt key elements of Personal Cognitive Counseling |
| FG001 | HIV Testing With Adapted Personalized Cognitive Risk-reduction |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| PHASE 1 - Formative |
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| Standard HIV testing with information only | Behavioral | Standard HIV testing with information only |
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| Self-reported behavior during past 3 months |
| 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 |
| 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 |
| 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 |
| 24510401 | Result | 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. |
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.
| FG002 | HIV Testing With Information Only | Standard HIV testing with information only: Standard HIV testing with information only |
| COMPLETED |
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| NOT COMPLETED |
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| PHASE 2 - Randmonized Controlled Trial |
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There were no significant differences between the two study arms on baseline demographics, HIV testing, and substance use. The mean age was 33.6 years; 49% were white and 51% non-white including 26% Latino/Hispanic, 11% Asian and Pacific Islander, 10% black/African American, and 6% mixed/other race.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1 - Formative Research | Formative research through individual interviews and pilot testing to develop and adapt the key elements of Personal Cognitive Counseling |
| BG001 | 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. |
| BG002 | HIV Testing With Information Only | Standard HIV testing with information only: Standard HIV testing with information only |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Number | Self reported events in past 3 months | Self-reported behavior during past 3 months |
|
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| ||||||||||||||||||||||||||||||||||||||
| 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. | Number | Partners in past 3 months | Self-reported behavior during past 3 months |
|
| |||||||||||||||||||||||||||||||||||||||
| 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. | Number | Episodes in past 3 months | Self-reported behavior during past 3 months |
|
| |||||||||||||||||||||||||||||||||||||||
| 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. | Number | Events in past 3 months | Self-reported behavior during past 3 months |
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| 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. | Number | Self reported behavior in past 3 months | Self-reported behavior during past 3 months |
|
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| 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. | Number | Self reported behavior in past 3 months | Self-reported behavior during past 3 months |
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| 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. | Number | Self reported behavior in past 3 months | Self-reported behavior during past 3 months |
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Two years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 162 | 0 | 162 | ||
| EG001 | HIV Testing With Information Only | Standard HIV testing with information only: Standard HIV testing with information only | 1 | 164 | 0 | 164 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Psychiatric disorders | Systematic Assessment | Suicide |
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Self-report data subject to recall bias Sample is San Francisco SUMSM; may not be generalizable to other locations 42% screened as substance-dependent per SDS Inclusion of dependent MSM reduced ability to detect significant intervention effects
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Phillip Coffin, Director of Substance Abuse Research Unit | San Francisco Department of Public Health | (415) 437 6282 | phillip.coffin@sfdph.org |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| Death |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian Pacific Islander |
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| Mixed |
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| Native American |
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| Other |
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| White |
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| Mean number at 6 months |
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| Rate of change in mean value of outcome over time |
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