HIV InfectionsNCT00080093
Increasing Condom Use in People at Risk for HIV Infection
A study testing Individual feedback and specially-tailored manuals and General HIV information feedback and the best-available information in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
Trial summary
This study will evaluate a new program designed to increase condom use in both women and men. Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Individual feedback and specially-tailored manuals and General HIV information feedback and the best-available information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 534 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Dec 2008
- 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 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- HIV uninfected
- Sexually active
- At risk for HIV (as determined by study officials)
- Speaks English
- Seen at a participating clinic
Who cannot join
- Pregnant
About this study
Official title: Increasing Condom Use With a Stage-Matched Intervention
This study will evaluate a new program designed to increase condom use in both women and men.
Read the detailed description
As heterosexual HIV transmission increases, effective behavioral interventions to increase condom use are needed. Interventions should be low cost and accessible to large segments of the at-risk population. This study will evaluate the efficacy of a behavioral intervention designed to increase condom use in at-risk, heterosexually active women and men. The intervention is computer-delivered and will be provided in health care settings. The study will also examine additional psychosocial mediators of condom use by testing the predictive efficacy of the Multifaceted Model of HIV Risk.
Participants will be recruited from four health clinic sites that serve local ethnic minority communities. The participants will be randomly assigned to either an individualized intervention designed to increase condom use or to an HIV information comparison group. All participants will receive comparable group-specific informational materials at study entry and at Months 2 and 4. Participants in the intervention group will receive individualized feedback and specially-tailored manuals. Participants in the HIV information comparison group will receive general HIV information feedback and the best-available informational manual.
Assessments for both groups will be conducted at study entry and at Months 6, 12, and 18. At study entry, participants will complete paper and pencil questionnaires lasting about 30 minutes. There will also be computer question sessions at study entry and at Months 2 and 4. Participants will be asked about condom use, contraceptive use, risk behaviors, sexual transmitted disease (STD) history, and personal relationships. Telephone follow-ups at Months 6, 12, and 18 will take approximately 20 to 30 minutes.
- Conditions
- HIV Infections
- Being tested
- Individual feedback and specially-tailored manuals, General HIV information feedback and the best-available information
- Keywords
- Condom, HIV Seronegativity, HIV Prevention, Behavioral Intervention
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual feedback and specially-tailored manualsBehavioural
Individual feedback and specially-tailored manuals
General HIV information feedback and the best-available informationBehavioural
General HIV information feedback and the best-available information
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive individual feedback and specially-tailored manuals at study entry and at Months 2 and 4 Receives: Behavioral: Individual feedback and specially-tailored manuals |
| 2 | Experimental | Participants will receive general HIV information feedback and the best-available informational manual at study entry and at Months 2 and 4 Receives: Behavioral: General HIV information feedback and the best-available information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of condom use
Measured: At 30 days and 2 months before each assessment
Number of occurances of unprotected sex
Measured: At 30 days before each assessment
Stage of change for condom use with main and nonmain partners, and men and women
Measured: Throughout study
Secondary outcomes (3)
Frequency of condom use with main and nonmain partners, and men and women
Measured: Throughout Study
Number and ratios of protected sex occasions with main and nonmain partners, and men and women
Measured: Throughout study
Stage of change for condom use with main and nonmain partners, and men and women
Measured: Throughout Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2004 (estimated)
- Study startJan 2006
- Primary completionOct 2007
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- 534 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Patricia Morokoff, PhD, Principal investigator, University of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080093
- Sponsor's protocol ID
- R01AI041323
- Other IDs
- R01AI041323
- Status last verified
- Sep 2008
- First submitted
- 23 Mar 2004
- Last updated
- 26 Sep 2008
- Results posted
- No
Publications
Cho S, Harlow L, Morokoff P, Redding C, Rossi J, Mayer K, Koblin B. Predicting 3-Wave LGCM of Condom Use in High-Risk Community Sample. Annual Meeting of the American Psychological Association, San Francisco, CA, 2007.
Cho S, Morokoff P, Redding C, Harlow L, Rossi J, Mayer K, Koblin B. Empirically Investigating Gender in a Multifaceted Model of HIV Risk. 19th Annual Meeting of the American Psychological Society, Washington, DC, 2007.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Condom Use With a Stage-Matched Intervention
- ClinicalTrials.gov ID
- NCT00080093
- Acronym / sponsor ID
- R01AI041323
- Conditions
- HIV Infections
- Keywords
- Condom, HIV Seronegativity, HIV Prevention, Behavioral Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 534 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jan 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Dec 2008 (estimated)
- First posted
- 24 Mar 2004 (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.
This study will evaluate a new program designed to increase condom use in both women and men.
Detailed description
As heterosexual HIV transmission increases, effective behavioral interventions to increase condom use are needed. Interventions should be low cost and accessible to large segments of the at-risk population. This study will evaluate the efficacy of a behavioral intervention designed to increase condom use in at-risk, heterosexually active women and men. The intervention is computer-delivered and will be provided in health care settings. The study will also examine additional psychosocial mediators of condom use by testing the predictive efficacy of the Multifaceted Model of HIV Risk.
Participants will be recruited from four health clinic sites that serve local ethnic minority communities. The participants will be randomly assigned to either an individualized intervention designed to increase condom use or to an HIV information comparison group. All participants will receive comparable group-specific informational materials at study entry and at Months 2 and 4. Participants in the intervention group will receive individualized feedback and specially-tailored manuals. Participants in the HIV information comparison group will receive general HIV information feedback and the best-available informational manual.
Assessments for both groups will be conducted at study entry and at Months 6, 12, and 18. At study entry, participants will complete paper and pencil questionnaires lasting about 30 minutes. There will also be computer question sessions at study entry and at Months 2 and 4. Participants will be asked about condom use, contraceptive use, risk behaviors, sexual transmitted disease (STD) history, and personal relationships. Telephone follow-ups at Months 6, 12, and 18 will take approximately 20 to 30 minutes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Individual feedback and specially-tailored manualsParticipants will receive individual feedback and specially-tailored manuals at study entry and at Months 2 and 4 |
| 2 | Experimental | Behavioral: General HIV information feedback and the best-available informationParticipants will receive general HIV information feedback and the best-available informational manual at study entry and at Months 2 and 4 |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- HIV uninfected
- Sexually active
- At risk for HIV (as determined by study officials)
- Speaks English
- Seen at a participating clinic
Key exclusion criteria (1 listed)
- Pregnant
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 |
|---|---|---|
| Individual feedback and specially-tailored manualsIndividual feedback and specially-tailored manuals | Behavioural | 1 |
| General HIV information feedback and the best-available informationGeneral HIV information feedback and the best-available information | Behavioural | 2 |
Primary outcome
Frequency of condom use
Time frame: At 30 days and 2 months before each assessment
Number of occurances of unprotected sex
Time frame: At 30 days before each assessment
Stage of change for condom use with main and nonmain partners, and men and women
Time frame: Throughout study
3 secondary outcomes
Frequency of condom use with main and nonmain partners, and men and women
Time frame: Throughout Study
Number and ratios of protected sex occasions with main and nonmain partners, and men and women
Time frame: Throughout study
Stage of change for condom use with main and nonmain partners, and men and women
Time frame: Throughout Study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2008.
- Results publicationCho S, Harlow L, Morokoff P, Redding C, Rossi J, Mayer K, Koblin B. Predicting 3-Wave LGCM of Condom Use in High-Risk Community Sample. Annual Meeting of the American Psychological Association, San Francisco, CA, 2007.
- Results publicationCho S, Morokoff P, Redding C, Harlow L, Rossi J, Mayer K, Koblin B. Empirically Investigating Gender in a Multifaceted Model of HIV Risk. 19th Annual Meeting of the American Psychological Society, Washington, DC, 2007.
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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.
Patricia Morokoff, PhD principal investigator
University of Rhode Island
Questions about this trial
What is this clinical trial studying?
A study testing Individual feedback and specially-tailored manuals and General HIV information feedback and the best-available information in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
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 5 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: status not confirmed, as of the sponsor's last update on 26 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Frequency of condom use (time frame: At 30 days and 2 months before each assessment). 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 NCT00080093, which also lists 2 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 26 Sep 2008.