Unsafe SexPhase 1MINCT01499706
Telephone-delivered Behavioral Interventions to Reduce Risky Sexual Behavior in HIV-positive Late Middle-age and Older Adults
A Phase 1 study testing 1-session of telephone-administered motivational interviewing and 4-session telephone-administered motivational interviewing in people with Unsafe Sex, run by Ohio University College of Osteopathic Medicine at 1 site in United States.
Trial summary
The number of late middle-age and older adults living with HIV/AIDS in the U.S. continues to rise due largely to better clinical care and the improved efficacy of highly active antiretroviral therapy that has extended the lives of many HIV-positive persons an increase in the number of new HIV infections in older… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Unsafe Sex
- What is being tested?
- 1-session of telephone-administered motivational interviewing and 4-session telephone-administered motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Oct 2010
- Phase
- Phase 1
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-positive
- English-speaking
- Access to a land line or cellular telephone
- Unprotected anal or vaginal intercourse in the past 3 months
Who cannot join
- Sexual partner of study participant
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio University College of Osteopathic Medicine
Athens, Ohio, 45701
About this study
Official title: Phase I Clinical Trial of Telephone-delivered Motivational Interviewing to Reduce Sexual Risk Behavior in HIV-positive Persons 45-plus Years of Age
The number of late middle-age and older adults living with HIV/AIDS in the U.S. continues to rise due largely to
- better clinical care and the improved efficacy of highly active antiretroviral therapy that has extended the lives of many HIV-positive persons
- an increase in the number of new HIV infections in older persons. This study tested the efficacy of 1- and 4-session telephone-administered behavioral sexual risk reduction interventions for HIV-positive adults 45-plus years of age who engage in risky sexual behaviors.
Read the detailed description
The number of late middle-age and older adults living with HIV/AIDS in the U.S. continues to rise. In fact, it is estimated that by 2014, 50% of all HIV-positive persons will be 50 years of age or older, due largely to a) better clinical care and the improved efficacy of highly active antiretroviral therapy that has extended the lives of many HIV-positive persons and b) an increase in the number of new HIV infections in older persons. Despite escalating HIV incidence and prevalence rates in older adults, and the fact that an estimated 13% to 30% of older persons living with HIV/AIDS continue to engage in risky sexual practices, few secondary risk reduction interventions have been contextualized to meet the unique needs of sexually active HIV-infected older adults. These unique needs include biological and libidinal changes associated with aging such as erectile dysfunction and the increased use of erectile dysfunction medications in older men, sexual partnerships with younger persons, survivor guilt over outliving romantic partners, and the impact of co-morbid chronic illnesses (e.g., diabetes, osteoporosis, cancer, hepatitis C) and associated medication and/or treatment side effects on perceptions of physical attractiveness.
Many HIV-positive older adults who would benefit from face-to-face sexual risk reduction interventions live with serious comorbid health conditions that complicate travel to medical and social service appointments, have significant confidentiality concerns, and are geographically isolated from traditional risk reduction resources. As such, face-to-face interventions are an unrealistic intervention modality for many members of this group. However, risk reduction interventions delivered using distance technologies, such as regular and cellular telephones, can reach many older adults living with HIV/AIDS.
In response to the lack of age-appropriate risk reduction interventions for HIV-infected older adults who engage in high-risk sex, and the potential of telephone technology to deliver cost-effective risk reduction interventions to this group, this study tested the efficacy of 1- and 4-session telephone-administered behavioral sexual risk reduction interventions for HIV-positive adults 45-plus years of age who engage in risky sexual behaviors.
- Conditions
- Unsafe Sex
- Being tested
- 1-session of telephone-administered motivational interviewing, 4-session telephone-administered motivational interviewing
- Keywords
- Motivational Interviewing, Telephone, HIV, AIDS, Older Adults
- Medical subject headings
- Unsafe Sex, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-session of telephone-administered motivational interviewingBehavioural
Participants will receive a single session of telephone-delivered motivational interviewing to reduce sexual risk behavior.
4-session telephone-administered motivational interviewingBehavioural
Participants will receive four weekly sessions of telephone-delivered motivational interviewing to reduce sexual risk behavior.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Control | No intervention | Participants will receive standard sexual risk reduction services available to them through medical and community-based organizations |
| 1-session motivational interviewing | Experimental | Participants will receive a single session of motivational interviewing delivered over the telephone Receives: Behavioral: 1-session of telephone-administered motivational interviewing |
| 4-session motivational interviewing | Experimental | Participants will receive four weekly sessions of motivational interviewing delivered over the telephone. Receives: Behavioral: 4-session telephone-administered motivational interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported number of non-condom-protected anal and vaginal sex acts in the past 3 months from baseline to 3-month follow-up
Measured: baseline, 3-month follow-up
Change in self-reported number of non-condom-protected anal and vaginal sex acts in the past 3 months from baseline to 6-month follow-up
Measured: baseline, 6-month follow-up
Secondary outcomes (1)
Proportion of participants reporting 100% condom use for anal and vaginal sex in the past 3 months
Measured: 3-month follow-up, 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startNov 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unsafe SexStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University College of Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Travis Lovejoy, Ph.D., M.P.H., Ohio University College of Osteopathic Medicine
- Investigators
- Travis I Lovejoy, Ph.D., M.P.H., Principal investigator, Ohio University College of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499706
- Sponsor's protocol ID
- OUCOM-MI-1
- Acronym
- MI
- Status last verified
- Dec 2011
- First submitted
- 21 Dec 2011
- Last updated
- 26 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lovejoy TI, Heckman TG, Suhr JA, Anderson T, Heckman BD, France CR. Telephone-administered motivational interviewing reduces risky sexual behavior in HIV-positive late middle-age and older adults: a pilot randomized controlled trial. AIDS Behav. 2011 Nov;15(8):1623-34. doi: 10.1007/s10461-011-0016-x.
PubMed 21809048
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of Telephone-delivered Motivational Interviewing to Reduce Sexual Risk Behavior in HIV-positive Persons 45-plus Years of Age
- ClinicalTrials.gov ID
- NCT01499706
- Acronym / sponsor ID
- MI / OUCOM-MI-1
- Conditions
- Unsafe Sex
- Keywords
- Motivational Interviewing, Telephone, HIV, AIDS, Older Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ohio University College of Osteopathic MedicineUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 26 Dec 2011 (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.
The number of late middle-age and older adults living with HIV/AIDS in the U.S. continues to rise due largely to
- better clinical care and the improved efficacy of highly active antiretroviral therapy that has extended the lives of many HIV-positive persons
- an increase in the number of new HIV infections in older persons. This study tested the efficacy of 1- and 4-session telephone-administered behavioral sexual risk reduction interventions for HIV-positive adults 45-plus years of age who engage in risky sexual behaviors.
Detailed description
The number of late middle-age and older adults living with HIV/AIDS in the U.S. continues to rise. In fact, it is estimated that by 2014, 50% of all HIV-positive persons will be 50 years of age or older, due largely to a) better clinical care and the improved efficacy of highly active antiretroviral therapy that has extended the lives of many HIV-positive persons and b) an increase in the number of new HIV infections in older persons. Despite escalating HIV incidence and prevalence rates in older adults, and the fact that an estimated 13% to 30% of older persons living with HIV/AIDS continue to engage in risky sexual practices, few secondary risk reduction interventions have been contextualized to meet the unique needs of sexually active HIV-infected older adults. These unique needs include biological and libidinal changes associated with aging such as erectile dysfunction and the increased use of erectile dysfunction medications in older men, sexual partnerships with younger persons, survivor guilt over outliving romantic partners, and the impact of co-morbid chronic illnesses (e.g., diabetes, osteoporosis, cancer, hepatitis C) and associated medication and/or treatment side effects on perceptions of physical attractiveness.
Many HIV-positive older adults who would benefit from face-to-face sexual risk reduction interventions live with serious comorbid health conditions that complicate travel to medical and social service appointments, have significant confidentiality concerns, and are geographically isolated from traditional risk reduction resources. As such, face-to-face interventions are an unrealistic intervention modality for many members of this group. However, risk reduction interventions delivered using distance technologies, such as regular and cellular telephones, can reach many older adults living with HIV/AIDS.
In response to the lack of age-appropriate risk reduction interventions for HIV-infected older adults who engage in high-risk sex, and the potential of telephone technology to deliver cost-effective risk reduction interventions to this group, this study tested the efficacy of 1- and 4-session telephone-administered behavioral sexual risk reduction interventions for HIV-positive adults 45-plus years of age who engage in risky sexual behaviors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Control | No intervention | –Participants will receive standard sexual risk reduction services available to them through medical and community-based organizations |
| 1-session motivational interviewing | Experimental | Behavioral: 1-session of telephone-administered motivational interviewingParticipants will receive a single session of motivational interviewing delivered over the telephone |
| 4-session motivational interviewing | Experimental | Behavioral: 4-session telephone-administered motivational interviewingParticipants will receive four weekly sessions of motivational interviewing delivered over the telephone. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV-positive
- English-speaking
- Access to a land line or cellular telephone
- Unprotected anal or vaginal intercourse in the past 3 months
Key exclusion criteria (1 listed)
- Sexual partner of study participant
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 |
|---|---|---|
| 1-session of telephone-administered motivational interviewingParticipants will receive a single session of telephone-delivered motivational interviewing to reduce sexual risk behavior. | Behavioural | 1-session motivational interviewing |
| 4-session telephone-administered motivational interviewingParticipants will receive four weekly sessions of telephone-delivered motivational interviewing to reduce sexual risk behavior. | Behavioural | 4-session motivational interviewing |
Primary outcome
Change in self-reported number of non-condom-protected anal and vaginal sex acts in the past 3 months from baseline to 3-month follow-up
Time frame: baseline, 3-month follow-up
Change in self-reported number of non-condom-protected anal and vaginal sex acts in the past 3 months from baseline to 6-month follow-up
Time frame: baseline, 6-month follow-up
1 secondary outcome
Proportion of participants reporting 100% condom use for anal and vaginal sex in the past 3 months
Time frame: 3-month follow-up, 6-month follow-up
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 26 Dec 2011.
- Results publication: PubMed 21809048Lovejoy TI, Heckman TG, Suhr JA, Anderson T, Heckman BD, France CR. Telephone-administered motivational interviewing reduces risky sexual behavior in HIV-positive late middle-age and older adults: a pilot randomized controlled trial. AIDS Behav. 2011 Nov;15(8):1623-34. doi: 10.1007/s10461-011-0016-x.
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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.
Travis I Lovejoy, Ph.D., M.P.H. principal investigator
Ohio University College of Osteopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 1-session of telephone-administered motivational interviewing and 4-session telephone-administered motivational interviewing in people with Unsafe Sex, run by Ohio University College of Osteopathic Medicine 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 4 inclusion and 1 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 26 Dec 2011. 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 in self-reported number of non-condom-protected anal and vaginal sex acts in the past 3 months from baseline to 3-month follow-up (time frame: baseline, 3-month follow-up). The study lists 2 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 NCT01499706, which also lists 1 linked publication.
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 26 Dec 2011.