Correct Consistent Condom UseNCT01536730
A Self-Guided Intervention to Promote Condom Use Among African American Males
A study testing Homework Intervention Strategy in people with Correct Consistent Condom Use, run by Indiana University at 1 site in United States.
Trial summary
The Centers for Disease Control and Prevention has declared that AIDS is a "state of emergency" in the US for African Americans - young African American men are especially vulnerable in this epidemic. Thus, the development of effective interventions tailored to this population is a national priority. Read more about this study
- Who is it for?
- Ages 15 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Correct Consistent Condom Use
- What is being tested?
- Homework Intervention Strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Aug 2013
- 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 15 to 24 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- African American men
- 15 to 24 years of age
- able to read, write and comprehend English
- have engaged penile-vaginal intercourse (PVI) or insertive penile-anal intercourse (PAI) with a partner at least once in the past 30 days
- willing to use a condom
- does not intend to get a partner pregnant in the next 6 months
Show all 9Show fewer
- consent to participate in the study
- client of the Bell Flower Clinic in Indianapolis, IN in the past 12 months
- has maintained a cell-phone number for the past three months and is willing to use it for data collection and incur fees for voice communication or text messaging it they do not have unlimited plans
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The Centers for Disease Control and Prevention has declared that AIDS is a "state of emergency" in the US for African Americans - young African American men are especially vulnerable in this epidemic. Thus, the development of effective interventions tailored to this population is a national priority. The investigators previous preliminary studies suggest that a brief, clinic-initiated, home-based, self-guided condom use program may effectively promote the acceptance of condom use and increase the quality and consistency of condom-protected sexual behaviors. This pilot study will (1) develop and test the feasibility of this program (Homework Intervention Strategy, HIS) for young African American men attending an urban STD clinic and (2) identify variables that may mediate the efficacy of the program. The HIS has the potential to be readily translated into widespread practice, while requiring only minimal resources. Unlike previously tested interventions, the HIS can be applied to all men who use condoms, regardless of the sex of their partners or their HIV/STI status. To develop the HIS to meet the needs of these high-risk men, the proposed study will include a formative phase during which the basic intervention "instructions" which will be delivered by DVD will be refined and tailored for this population.
One hundred young African American men recruited from an urban STD clinic will be randomized to each of two groups (HIS vs. "standard of care") in a randomized 2-arm trial with 5 assessment periods over the course of 6 months. Assessments will compare the groups on frequency of unprotected sex, quality of the condom use experience, experience of condom use errors and problems, attitudes regarding condom use, condom use acceptability, and condom use self-efficacy and confidence.
- Conditions
- Correct Consistent Condom Use
- Being tested
- Homework Intervention Strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homework Intervention StrategyBehavioural
Participants assigned to intervention will receive a condom "ditty bag" containing 50 condoms (5 each of 10 types), a variety of 50 lubricants, an instructional DVD, and instructions for the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Homework Intervention Strategy | Experimental | Not described Receives: Behavioral: Homework Intervention Strategy |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in number of unprotected sex events at 2 months
Measured: 30 days
Change from baseline in number of unprotected sex events at 4 months
Measured: 30 days
Change from baseline in number of unprotected sex events at 7 months
Measured: 30 days
Secondary outcomes (6)
Change from baseline in condom use errors/problems score as measured by the Condom Use Errors/Problems Survey (CUES) at 2 months.
Measured: 30 days
Change from baseline in condom use errors/problems score as measured by the Condom Use Errors/Problems Survey (CUES) at 4 months.
Measured: 30 days
Change from baseline in condom use errors/problems score as measured by the Condom Use Errors/Problems Survey (CUES) at 7 months.
Measured: 30 days
Change from baseline in self-efficacy for correct condom use score as measured by the Correct Condom Use Self-Efficacy Scale(CCUSES) at 2 months.
Measured: 30 days
Change from baseline in self-efficacy for correct condom use score as measured by the Correct Condom Use Self-Efficacy Scale (CCUSES) at 4 months.
Measured: 30 days
Change from baseline in self-efficacy for correct condom use score as measured by the Correct Condom Use Self-Efficacy Scale(CCUSES) at 7 months.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Correct Consistent Condom UseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Sanders, Indiana University
- Investigators
- Stephanie A Sanders, Ph.D., Principal investigator, Indiana UniversityWilliam L Yarber, Ph.D., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536730
- Sponsor's protocol ID
- 5R21MH090892-02
- Status last verified
- Sep 2018
- First submitted
- 20 Jul 2011
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Self-Guided Intervention to Promote Condom Use Among African American Males
- ClinicalTrials.gov ID
- NCT01536730
- Acronym / sponsor ID
- 5R21MH090892-02
- Conditions
- Correct Consistent Condom Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 22 Feb 2012 (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 Centers for Disease Control and Prevention has declared that AIDS is a "state of emergency" in the US for African Americans - young African American men are especially vulnerable in this epidemic. Thus, the development of effective interventions tailored to this population is a national priority. The investigators previous preliminary studies suggest that a brief, clinic-initiated, home-based, self-guided condom use program may effectively promote the acceptance of condom use and increase the quality and consistency of condom-protected sexual behaviors. This pilot study will (1) develop and test the feasibility of this program (Homework Intervention Strategy, HIS) for young African American men attending an urban STD clinic and (2) identify variables that may mediate the efficacy of the program. The HIS has the potential to be readily translated into widespread practice, while requiring only minimal resources. Unlike previously tested interventions, the HIS can be applied to all men who use condoms, regardless of the sex of their partners or their HIV/STI status. To develop the HIS to meet the needs of these high-risk men, the proposed study will include a formative phase during which the basic intervention "instructions" which will be delivered by DVD will be refined and tailored for this population.
One hundred young African American men recruited from an urban STD clinic will be randomized to each of two groups (HIS vs. "standard of care") in a randomized 2-arm trial with 5 assessment periods over the course of 6 months. Assessments will compare the groups on frequency of unprotected sex, quality of the condom use experience, experience of condom use errors and problems, attitudes regarding condom use, condom use acceptability, and condom use self-efficacy and confidence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Homework Intervention Strategy | Experimental | Behavioral: Homework Intervention Strategy |
| Control | No intervention | – |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- African American men
- 15 to 24 years of age
- able to read, write and comprehend English
- have engaged penile-vaginal intercourse (PVI) or insertive penile-anal intercourse (PAI) with a partner at least once in the past 30 days
- willing to use a condom
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Homework Intervention StrategyParticipants assigned to intervention will receive a condom "ditty bag" containing 50 condoms (5 each of 10 types), a variety of 50 lubricants, an instructional DVD, and instructions for the intervention. | Behavioural | Homework Intervention Strategy |
Primary outcome
Change from baseline in number of unprotected sex events at 2 months
Time frame: 30 days
Change from baseline in number of unprotected sex events at 4 months
Time frame: 30 days
Change from baseline in number of unprotected sex events at 7 months
Time frame: 30 days
6 secondary outcomes
Change from baseline in condom use errors/problems score as measured by the Condom Use Errors/Problems Survey (CUES) at 2 months.
Time frame: 30 days
Change from baseline in condom use errors/problems score as measured by the Condom Use Errors/Problems Survey (CUES) at 4 months.
Time frame: 30 days
Change from baseline in condom use errors/problems score as measured by the Condom Use Errors/Problems Survey (CUES) at 7 months.
Time frame: 30 days
Change from baseline in self-efficacy for correct condom use score as measured by the Correct Condom Use Self-Efficacy Scale(CCUSES) at 2 months.
Time frame: 30 days
Change from baseline in self-efficacy for correct condom use score as measured by the Correct Condom Use Self-Efficacy Scale (CCUSES) at 4 months.
Time frame: 30 days
Change from baseline in self-efficacy for correct condom use score as measured by the Correct Condom Use Self-Efficacy Scale(CCUSES) at 7 months.
Time frame: 30 days
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 18 Sep 2018.
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.
Stephanie A Sanders, Ph.D. principal investigator
Indiana University
William L Yarber, Ph.D. principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Homework Intervention Strategy in people with Correct Consistent Condom Use, run by Indiana University 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 0 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 18 Sep 2018. 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 in number of unprotected sex events at 2 months (time frame: 30 days). 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?
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 18 Sep 2018.