HIVNCT02116049
Intervention to Assist MSM Disclose HIV Status to Casual Sex Partners
A study testing Disclosure Intervention in people with HIV, run by University of South Florida at 1 site in United States.
Trial summary
Men who have sex with men (MSM) remain disproportionately represented in the national HIV/AIDS statistics. Little progress has been made in understanding the nuances of MSM sexual behavior or communication that may be perpetuating the spread of HIV. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV
- What is being tested?
- Disclosure Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-positive
- Male
- Have sex with other men
- Over the age of 18
- Sexually active in the past 90 days
- 2 or more partners in last 12 months
Show all 9Show fewer
- Indicate an interest in learning more about disclosing serostatus to casual sex partners
- Speak and understand English
- Plan on living in Tampa area for at least 1 year
Who cannot join
- Women
- HIV-negative
- Children under the age of 18
- Men who exclusively have sex with women
- Those who cannot speak and understand English
- Those who have not been sexually active or are behaviorally monogamous
Trial locations and contacts
1 site in 1 country.
About this study
Men who have sex with men (MSM) remain disproportionately represented in the national HIV/AIDS statistics. Little progress has been made in understanding the nuances of MSM sexual behavior or communication that may be perpetuating the spread of HIV. Non-disclosure of an HIV-positive status may be a key factor responsible for male-male HIV transmission. There are no known intervention programs whose primary focus is to help MSM develop requisite skills to disclose their status to casual sexual partners. The development of such interventions is essential because of the numerous repercussions for not disclosing when one is HIV-positive such as legal prosecution and the transmission of HIV. In a previous intervention development study (R21MH067494) the research team created and tested a 4 session intervention found to be promising for increasing disclosure to casual sexual partners. The purpose of the proposed research is to further refine and enhance our HIV disclosure intervention (DI) designed to increase disclosure to casual sexual partners and reduce sexual risk taking behaviors among HIV-positive MSM; assess the relative effectiveness of a disclosure intervention to an attention control case management group (ACCM) for HIV-positive MSM; examine the effects of the intervention over time; explore differential treatment responses to the disclosure intervention and ACCM on the basis of ethnicity, age, and education level as well as examine the mediating effect of baseline frequency of sexual activity, severity of substance abuse at baseline, and stigmatized fear on the relationship between intervention type and the outcome. Finally, the investigators will test how treatment engagement, retention and expectations predict subsequent disclosure and risky sexual outcomes.
- Conditions
- HIV
- Being tested
- Disclosure Intervention, Attention Control Case Management
- Keywords
- Disclosure, intervention, HIV, prevention, Disclosure Intervention, Attention Control Case Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disclosure InterventionBehavioural
The experimental condition is a 4-session + 3 month booster intervention. Session 1 includes an introduction to the project, goal setting, assessment of disclosure strategies or tactics utilized, and disclosure triggers. Session 2 focuses on the costs and benefits of disclosing to casual sexual partners and previous best and worst disclosure experiences. Session 3 begins with the delivery of the encouraging messages and review of the disclosure strategies already employed. Session 4 is a continuation of session 3 activities with an additional focus on expanding the participant's repertoire of strategies; discussion of methods of sexual negotiation, and rehearsal. The booster session includes a discussion of what strategies have been used in the preceding months, which strategies worked and how can these be enhanced, which strategies did not work with opportunities for troubleshooting, and an examination of rewards experienced or costs encountered.
Attention Control Case ManagementBehavioural
Comprehensive Risk Counseling and Services (CRCS) will be used to guide the case management activities. CRCS combines traditional case management and HIV risk-reduction in an individualized, client-centered program which focuses on the reduction of risk behavior and addresses a client's psychosocial and medical needs. CRCS focuses on seven core elements: recruitment and engagement; screening, enrolling, and assessing; prevention planning; risk reduction counseling; referrals and service coordination; monitoring; and discharge and maintenance.
| Study group | Role | What they receive |
|---|---|---|
| Attention Control Case Management | Active comparator | Comprehensive Risk Counseling and Services" (CRCS) will be used to guide the case management activities. CRCS combines traditional case management and HIV risk-reduction in an individualized, client-centered program which focuses on the reduction of risk behavior and addresses a client's psychosocial and medical needs. CRCS focuses on seven core elements: recruitment and engagement; screening, enrolling, and assessing; prevention planning; risk reduction counseling; referrals and service coordination; monitoring; and discharge and maintenance. These core elements represent the framework of the intervention, and provide enough flexibility to allow implementation that most appropriately serves the needs of clients. This project's case management will mimic the experimental condition with a meeting schedule reflective of the experimental arm plus a booster session at 3 months. Receives: Behavioral: Attention Control Case Management |
| Disclosure Intervention | Experimental | The experimental condition is a 4-session + 3 month booster intervention. Session 1 includes an introduction to the project, goal setting, assessment of disclosure strategies or tactics utilized, and disclosure triggers. Session 2 focuses on the costs and benefits of disclosing to casual sexual partners and previous best and worst disclosure experiences. Session 3 begins with the delivery of the encouraging messages and review of the disclosure strategies already employed. Session 4 is a continuation of session 3 activities with an additional focus on expanding the participant's repertoire of strategies; discussion of methods of sexual negotiation, and rehearsal. The booster session includes a discussion of what strategies have been used in the preceding months, which strategies worked and how can these be enhanced, which strategies did not work with opportunities for troubleshooting, and an examination of rewards experienced or costs encountered. Receives: Behavioral: Disclosure Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to 52 Weeks in the number/proportion of sex partners disclosed to
Disclosure to sexual partners is measured at the encounter level (last 5 sexual encounters during the prior 30 day period), and as an aggregate (number of partners disclosed to during the prior 30 day period.
Measured: Baseline, Week 7, Week 12, Week 24, Week 52
Secondary outcomes (1)
Change from baseline to 52 Weeks in HIV Transmission Risk
Ordinal measure of HIV transmission risk. The ordinal measure is constructed from information provided by the participant on the last five sexual encounters during the prior 30 days, with the highest risk assigned to encounters involving discordant anal/vaginal intercourse, unprotected, with a discordant partner (XEF)
Measured: Baseline, Week 7, Week 12, Week 24, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startAug 2009
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Julianne M Serovich, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116049
- Sponsor's protocol ID
- MH082639
- Other IDs
- R01MH082639
- Status last verified
- Apr 2015
- First submitted
- 7 Apr 2014
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Assist MSM Disclose HIV Status to Casual Sex Partners
- ClinicalTrials.gov ID
- NCT02116049
- Acronym / sponsor ID
- MH082639
- Conditions
- HIV
- Keywords
- Disclosure, intervention, HIV, prevention, Disclosure Intervention, Attention Control Case Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Men who have sex with men (MSM) remain disproportionately represented in the national HIV/AIDS statistics. Little progress has been made in understanding the nuances of MSM sexual behavior or communication that may be perpetuating the spread of HIV. Non-disclosure of an HIV-positive status may be a key factor responsible for male-male HIV transmission. There are no known intervention programs whose primary focus is to help MSM develop requisite skills to disclose their status to casual sexual partners. The development of such interventions is essential because of the numerous repercussions for not disclosing when one is HIV-positive such as legal prosecution and the transmission of HIV. In a previous intervention development study (R21MH067494) the research team created and tested a 4 session intervention found to be promising for increasing disclosure to casual sexual partners. The purpose of the proposed research is to further refine and enhance our HIV disclosure intervention (DI) designed to increase disclosure to casual sexual partners and reduce sexual risk taking behaviors among HIV-positive MSM; assess the relative effectiveness of a disclosure intervention to an attention control case management group (ACCM) for HIV-positive MSM; examine the effects of the intervention over time; explore differential treatment responses to the disclosure intervention and ACCM on the basis of ethnicity, age, and education level as well as examine the mediating effect of baseline frequency of sexual activity, severity of substance abuse at baseline, and stigmatized fear on the relationship between intervention type and the outcome. Finally, the investigators will test how treatment engagement, retention and expectations predict subsequent disclosure and risky sexual outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention Control Case Management | Active comparator | Behavioral: Attention Control Case ManagementComprehensive Risk Counseling and Services" (CRCS) will be used to guide the case management activities. CRCS combines traditional case management and HIV risk-reduction in an individualized, client-centered program which focuses on the reduction of risk behavior and addresses a client's psychosocial and medical needs. CRCS focuses on seven core elements: recruitment and engagement; screening, enrolling, and assessing; prevention planning; risk reduction counseling; referrals and service coordination; monitoring; and discharge and maintenance. These core elements represent the framework of the intervention, and provide enough flexibility to allow implementation that most appropriately serves the needs of clients. This project's case management will mimic the experimental condition with a meeting schedule reflective of the experimental arm plus a booster session at 3 months. |
| Disclosure Intervention | Experimental | Behavioral: Disclosure InterventionThe experimental condition is a 4-session + 3 month booster intervention. Session 1 includes an introduction to the project, goal setting, assessment of disclosure strategies or tactics utilized, and disclosure triggers. Session 2 focuses on the costs and benefits of disclosing to casual sexual partners and previous best and worst disclosure experiences. Session 3 begins with the delivery of the encouraging messages and review of the disclosure strategies already employed. Session 4 is a continuation of session 3 activities with an additional focus on expanding the participant's repertoire of strategies; discussion of methods of sexual negotiation, and rehearsal. The booster session includes a discussion of what strategies have been used in the preceding months, which strategies worked and how can these be enhanced, which strategies did not work with opportunities for troubleshooting, and an examination of rewards experienced or costs encountered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- HIV-positive
- Male
- Have sex with other men
- Over the age of 18
- Sexually active in the past 90 days
Key exclusion criteria (6 listed)
- Women
- HIV-negative
- Children under the age of 18
- Men who exclusively have sex with women
- Those who cannot speak and understand English
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 |
|---|---|---|
| Disclosure InterventionThe experimental condition is a 4-session + 3 month booster intervention. Session 1 includes an introduction to the project, goal setting, assessment of disclosure strategies or tactics utilized, and disclosure triggers. Session 2 focuses on the costs and benefits of disclosing to casual sexual partners and previous best and worst disclosure experiences. Session 3 begins with the delivery of the encouraging messages and review of the disclosure strategies already employed. Session 4 is a continuation of session 3 activities with an additional focus on expanding the participant's repertoire of strategies; discussion of methods of sexual negotiation, and rehearsal. The booster session includes a discussion of what strategies have been used in the preceding months, which strategies worked and how can these be enhanced, which strategies did not work with opportunities for troubleshooting, and an examination of rewards experienced or costs encountered. | Behavioural | Disclosure Intervention |
| Attention Control Case ManagementComprehensive Risk Counseling and Services (CRCS) will be used to guide the case management activities. CRCS combines traditional case management and HIV risk-reduction in an individualized, client-centered program which focuses on the reduction of risk behavior and addresses a client's psychosocial and medical needs. CRCS focuses on seven core elements: recruitment and engagement; screening, enrolling, and assessing; prevention planning; risk reduction counseling; referrals and service coordination; monitoring; and discharge and maintenance. | Behavioural | Attention Control Case Management |
Primary outcome
Change from baseline to 52 Weeks in the number/proportion of sex partners disclosed to
Time frame: Baseline, Week 7, Week 12, Week 24, Week 52
Disclosure to sexual partners is measured at the encounter level (last 5 sexual encounters during the prior 30 day period), and as an aggregate (number of partners disclosed to during the prior 30 day period.
1 secondary outcome
Change from baseline to 52 Weeks in HIV Transmission Risk
Time frame: Baseline, Week 7, Week 12, Week 24, Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
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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.
Julianne M Serovich, PhD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disclosure Intervention in people with HIV, run by University of South Florida at 1 site in United States.
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 6 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 Apr 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline to 52 Weeks in the number/proportion of sex partners disclosed to (time frame: Baseline, Week 7, Week 12, Week 24, Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2015.