HIV InfectionsPhase 1/2NCT01279044

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

A Phase 1/2 study testing Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC) and Standard HIV testing with information only in people with HIV Infections and Episodic Substance Use, run by San Francisco Department of Public Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: HIV Infections, Episodic Substance Use
What is being tested?: Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC) and Standard HIV testing with information only
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 385 participants
Where: 1 siteUnited States
Study dates: Sep 2007to Nov 2012
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Show all 9Show fewer

≥ 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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

San Francisco Department of Public Health, AIDS Office
San Francisco, California, 94102

Other trials in United States

About this study

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

Read the 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:

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.

Conditions: HIV Infections, Episodic Substance Use
Being tested: Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC), Standard HIV testing with information only
Keywords: HIV, MSM, SUMSM
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC)Behavioural
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 onlyBehavioural
Standard HIV testing with information only

Study groups in NCT01279044
Study group	Role	What they receive
1	Active comparator	HIV testing with adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC) Receives: Behavioral: Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC)
2	Placebo comparator	HIV testing with information only Receives: Behavioral: Standard HIV testing with information only

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Self-reported behavior during past 3 months

Secondary outcomes (4)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Self-reported behavior during past 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2007Nov 2012

First posted19 Jan 2011 (estimated)
Study startSep 2007
Primary completionNov 2012
Study completionNov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 385 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01279044
Sponsor's protocol ID: 1UR6PS000684-01
Status last verified: Sep 2014
First submitted: 18 Jan 2011
Last updated: 7 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 23572012
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.
PubMed 23412947
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.
PubMed 24510401

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reducing HIV Risk Among Episodic Substance Using Men Who Have Sex With Men (SUMSM): Adaptation of the Personalized Cognitive Counseling (PCC) Intervention
ClinicalTrials.gov ID: NCT01279044
Acronym / sponsor ID: 1UR6PS000684-01
Conditions: HIV Infections, Episodic Substance Use
Keywords: HIV, MSM, SUMSM
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 385 participants (actual)
Lead sponsor: San Francisco Department of Public HealthOther government
Collaborators: Centers for Disease Control and Prevention
Study start: Sep 2007
Primary completion: Nov 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 19 Jan 2011 (estimated)
Results: Posted 7 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Behavioral: Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC)HIV testing with adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC)
2	Placebo comparator	Behavioral: Standard HIV testing with information onlyHIV testing with information only

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	1
Standard HIV testing with information onlyStandard HIV testing with information only	Behavioural	2

Primary outcome

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.
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.
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.

4 secondary outcomes

Number of Serodiscordant Unprotected Anal Intercourse (SDUAI) Events
Time frame: Self-reported behavior during past 3 months
Number of Instertive UAI Events
Time frame: Self-reported behavior during past 3 months
Number of Receptive UAI Events
Time frame: Self-reported behavior during past 3 months
Number of Condom-protected Anal Intercourse Events
Time frame: Self-reported behavior during past 3 months

Results and safety

Results posted to the registry on 7 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Formative Phase 1	59	59
HIV Testing With Adapted Personalized Cognitive Risk-reduction	0	0
HIV Testing With Information Only	0	0

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

Time frame: Self-reported behavior during past 3 months. Number. Unit: Self reported events in past 3 months

Measure	HIV Testing With Adapted Personalized Cognitive Risk-reduction n = 162	HIV Testing With Information Only n = 164
Mean number at baseline	4.23	3.91
Mean number at 3 months	3.41	2.05
Mean number at 6 months	1.83	1.96
Rate of change in mean value of outcome over time	0.47	0.45

Primary outcome: Total Unprotected Anal Intercourse Partners

Time frame: Self-reported behavior during past 3 months. Number. Unit: Partners in past 3 months

Measure	HIV Testing With Adapted Personalized Cognitive Risk-reduction n = 162	HIV Testing With Information Only n = 164
Mean number of partners at baseline	2.71	2.60
Mean number of partners at 3 months	1.54	1.37
Mean number of partners at 6 months	1.27	1.16
Rate of change in mean value of outcome over time	0.46	0.43

Primary outcome: 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. Number. Unit: Episodes in past 3 months

Measure	HIV Testing With Adapted Personalized Cognitive Risk-reduction n = 162	HIV Testing With Information Only n = 164
Mean number of episodes at baseline	1.97	2.31
Mean number of episodes at 3 months	1.12	1.11
Mean number of episodes at 6 months	0.83	1.20
Rate of change in mean value of outcome over time	0.39	0.52

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Two years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HIV Testing With Adapted Personalized Cognitive Risk-reduction	0 of 162 (0%)	0 of 162 (0%)	Not reported
HIV Testing With Information Only	1 of 164 (0.6%)	0 of 164 (0%)	Not reported

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23572012Santos 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.
Background: PubMed 23412947Knight 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.
Results publication: PubMed 24510401Coffin 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Phillip O Coffin, MD, MIA principal investigator

Director of Substance Use Research, HIV Prevention, San Francisco Department of Public Health

Jeffrey H Herbst, PhD study director

Centers for Disease Control and Prevention

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01279044, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2014.