HIV InfectionsNCT00849823
HIV Prevention Program for African American Teen Males
A study testing Male Sexual Health Program and Focus on the Future Program in people with HIV Infections and Sexually Transmitted Infections, run by Richard Crosby at 1 site in United States.
Trial summary
The purpose of this study is to test if sexual health interventions can reduce the incidence of STIs among African American teens (15 to 21 years old). By doing this study, we hope to help African American teens improve their condom use skills and encourage them to use condoms more frequently. Read more about this study
- Who is it for?
- Ages 15 to 23 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexually Transmitted Infections
- What is being tested?
- Male Sexual Health Program and Focus on the Future Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Sep 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 23 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- at least 15, but not more than 23 years of age
- attending the clinic for the expressed purpose of being tested for sexually transmitted infections
- engaging in penetrative sex (penile-vaginal or penile-anal) at least once in the past 2 months
- willingness to return for the two planned follow-up assessments
Who cannot join
- self-report of being HIV positive
Trial locations and contacts
1 site in 1 country.
United States1 site
Adolescent Medicine Program, LSU School of Medicine
New Orleans, Louisiana, 70118
About this study
Official title: A Brief, Clinic-Based, HIV Prevention Program for African American Teen Males
The purpose of this study is to test if sexual health interventions can reduce the incidence of STIs among African American teens (15 to 21 years old). By doing this study, we hope to help African American teens improve their condom use skills and encourage them to use condoms more frequently. If the number of STIs in this population can be decreased, the health of African American teen males will greatly improve. We also believe that sexual partners (typically African American teen females) will also benefit.
Read the detailed description
Based on the observation that African Americans are vastly more likely than their white and Hispanic counterparts to be infected by the human immunodeficiency virus (HIV), the Centers for Disease Control and Prevention (CDC) has termed AIDS a "health crisis" for African Americans and has called for a heightened national response to this glaring racial disparity. The crisis is especially dramatic in the Southern United States. Thus, the search for effective interventions tailored to this population is a national priority. This study expands upon a previous study conducted among young African American men. In the previous study we developed and tested the efficacy of a brief, clinic-based, program designed to interactively promote safer sex for African American men (18 to 29 years of age) engaging in sex with women. Adjusted findings from the previous study provided relatively robust support for program efficacy, with men who received the intervention program being about two-thirds less likely, than controls, to acquire an STI during a 6-month period. This study expands on the work performed in the previous study by developing and testing a version for younger African American males (i.e., teen males).
The purpose of this study is to test the efficacy of a brief, clinic-based and theory-guided, intervention designed to reduce STI incidence among African American teen (15 to 20 years old) males presenting themselves for STI testing.
- Conditions
- HIV Infections, Sexually Transmitted Infections
- Being tested
- Male Sexual Health Program, Focus on the Future Program
- Keywords
- African American, Men, Condoms, Randomization, Brief Intervention, HIV, HIV Seronegativity
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Male Sexual Health ProgramBehavioural
An attention equivalent control condition entailing a 60-minute one-to-one session that will didactically teach teens about several aspects of male sexual health. The content and objectives are related only to knowledge acquisition. In addition to this program, teens randomized to the control condition will receive standard-of-care services from the clinic. This involves the provision of free condoms (one size "fits all" condoms) and a brief (nurse-delivered) counseling message to practice safer sex.
Focus on the Future ProgramBehavioural
A 60-minute, theory-guided program designed to increase the quality and frequency of teens' condom use within the context of making safer choices regarding partners and sexual behaviors. The program is explicitly designed to increase the quality and frequency of teen's condom use.
| Study group | Role | What they receive |
|---|---|---|
| Male Sexual Health Program | Active comparator | Not described Receives: Behavioral: Male Sexual Health Program |
| Focus on the Future Program | Experimental | Not described Receives: Behavioral: Focus on the Future Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of laboratory-confirmed STIs
Measured: 2- and 6-month follow-up, as well as 12-month follow-up medical records review
Self-report of unprotected penetrative sex (past 30 days)
Measured: 2- and 6-month follow-up
Self-report of number of penetrative (penile-vaginal or penile-anal) sex partners (past 30 days)
Measured: 2 and 6-month follow-up
Self-report of negative experiences with the correct use of condoms (past 30 days)
Measured: 2- and 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 posted24 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Richard Crosby
- Sponsor type
- University, hospital or other
- Collaborators
- Louisiana State University Health Sciences Center in New Orleans
- Responsible party
- Sponsor-investigator, Richard Crosby, University of Kentucky
- Investigators
- Ryan Pasternak, MD, MPH, Principal investigator, Louisiana State University Health Sciences Center in New OrleansRichard A Crosby, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849823
- Sponsor's protocol ID
- 080666
- Other IDs
- NIH Grant # 1R01MH083621
- Status last verified
- Jul 2017
- First submitted
- 23 Feb 2009
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Crosby RA, Mena L, Smith RV. Promoting positive condom use experiences among young black MSM: a randomized controlled trial of a brief, clinic-based intervention. Health Educ Res. 2018 Jun 1;33(3):197-204. doi: 10.1093/her/cyy010.
PubMed 29534210Crosby RA, Mena L, Salazar LF, Hardin JW, Brown T, Vickers Smith R. Efficacy of a Clinic-Based Safer Sex Program for Human Immunodeficiency Virus-Uninfected and Human Immunodeficiency Virus-Infected Young Black Men Who Have Sex With Men: A Randomized Controlled Trial. Sex Transm Dis. 2018 Mar;45(3):169-176. doi: 10.1097/OLQ.0000000000000721.
PubMed 29419709Crosby R, Salazar LF. Reduction of condom use errors from a brief, clinic-based intervention: a secondary analysis of data from a randomised, controlled trial of young black males. Sex Transm Infect. 2015 Mar;91(2):111-5. doi: 10.1136/sextrans-2013-051492. Epub 2014 Jun 4.
PubMed 24898858
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief, Clinic-Based, HIV Prevention Program for African American Teen Males
- ClinicalTrials.gov ID
- NCT00849823
- Acronym / sponsor ID
- 080666
- Conditions
- HIV Infections, Sexually Transmitted Infections
- Keywords
- African American, Men, Condoms, Randomization, Brief Intervention, HIV, HIV Seronegativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- Richard CrosbyUniversity, hospital or other
- Collaborators
- Louisiana State University Health Sciences Center in New Orleans
- Study start
- Feb 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 24 Feb 2009 (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 purpose of this study is to test if sexual health interventions can reduce the incidence of STIs among African American teens (15 to 21 years old). By doing this study, we hope to help African American teens improve their condom use skills and encourage them to use condoms more frequently. If the number of STIs in this population can be decreased, the health of African American teen males will greatly improve. We also believe that sexual partners (typically African American teen females) will also benefit.
Detailed description
Based on the observation that African Americans are vastly more likely than their white and Hispanic counterparts to be infected by the human immunodeficiency virus (HIV), the Centers for Disease Control and Prevention (CDC) has termed AIDS a "health crisis" for African Americans and has called for a heightened national response to this glaring racial disparity. The crisis is especially dramatic in the Southern United States. Thus, the search for effective interventions tailored to this population is a national priority. This study expands upon a previous study conducted among young African American men. In the previous study we developed and tested the efficacy of a brief, clinic-based, program designed to interactively promote safer sex for African American men (18 to 29 years of age) engaging in sex with women. Adjusted findings from the previous study provided relatively robust support for program efficacy, with men who received the intervention program being about two-thirds less likely, than controls, to acquire an STI during a 6-month period. This study expands on the work performed in the previous study by developing and testing a version for younger African American males (i.e., teen males).
The purpose of this study is to test the efficacy of a brief, clinic-based and theory-guided, intervention designed to reduce STI incidence among African American teen (15 to 20 years old) males presenting themselves for STI testing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male Sexual Health Program | Active comparator | Behavioral: Male Sexual Health Program |
| Focus on the Future Program | Experimental | Behavioral: Focus on the Future Program |
Who may qualify
- Ages
- 15 to 23 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- at least 15, but not more than 23 years of age
- attending the clinic for the expressed purpose of being tested for sexually transmitted infections
- engaging in penetrative sex (penile-vaginal or penile-anal) at least once in the past 2 months
- willingness to return for the two planned follow-up assessments
Key exclusion criteria (1 listed)
- self-report of being HIV positive
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 |
|---|---|---|
| Male Sexual Health ProgramAn attention equivalent control condition entailing a 60-minute one-to-one session that will didactically teach teens about several aspects of male sexual health. The content and objectives are related only to knowledge acquisition. In addition to this program, teens randomized to the control condition will receive standard-of-care services from the clinic. This involves the provision of free condoms (one size "fits all" condoms) and a brief (nurse-delivered) counseling message to practice safer sex. | Behavioural | Male Sexual Health Program |
| Focus on the Future ProgramA 60-minute, theory-guided program designed to increase the quality and frequency of teens' condom use within the context of making safer choices regarding partners and sexual behaviors. The program is explicitly designed to increase the quality and frequency of teen's condom use. | Behavioural | Focus on the Future Program |
Primary outcome
Incidence rate of laboratory-confirmed STIs
Time frame: 2- and 6-month follow-up, as well as 12-month follow-up medical records review
Self-report of unprotected penetrative sex (past 30 days)
Time frame: 2- and 6-month follow-up
Self-report of number of penetrative (penile-vaginal or penile-anal) sex partners (past 30 days)
Time frame: 2 and 6-month follow-up
Self-report of negative experiences with the correct use of condoms (past 30 days)
Time frame: 2- and 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 14 Jul 2017.
- Derived from this study: PubMed 29534210Crosby RA, Mena L, Smith RV. Promoting positive condom use experiences among young black MSM: a randomized controlled trial of a brief, clinic-based intervention. Health Educ Res. 2018 Jun 1;33(3):197-204. doi: 10.1093/her/cyy010.
- Derived from this study: PubMed 29419709Crosby RA, Mena L, Salazar LF, Hardin JW, Brown T, Vickers Smith R. Efficacy of a Clinic-Based Safer Sex Program for Human Immunodeficiency Virus-Uninfected and Human Immunodeficiency Virus-Infected Young Black Men Who Have Sex With Men: A Randomized Controlled Trial. Sex Transm Dis. 2018 Mar;45(3):169-176. doi: 10.1097/OLQ.0000000000000721.
- Derived from this study: PubMed 24898858Crosby R, Salazar LF. Reduction of condom use errors from a brief, clinic-based intervention: a secondary analysis of data from a randomised, controlled trial of young black males. Sex Transm Infect. 2015 Mar;91(2):111-5. doi: 10.1136/sextrans-2013-051492. Epub 2014 Jun 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.
Ryan Pasternak, MD, MPH principal investigator
Louisiana State University Health Sciences Center in New Orleans
Richard A Crosby, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Male Sexual Health Program and Focus on the Future Program in people with HIV Infections and Sexually Transmitted Infections, run by Richard Crosby 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 14 Jul 2017. 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?
Incidence rate of laboratory-confirmed STIs (time frame: 2- and 6-month follow-up, as well as 12-month follow-up medical records review). The study lists 4 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 NCT00849823, 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 14 Jul 2017.