GonorrheaPhase 2NCT01439503
Safer Sex Program for Young African-American Men
A Phase 2 study testing Intervention in people with Gonorrhea and Chlamydia, run by Richard Crosby at 1 site in United States.
Trial summary
To evaluate the efficacy of the adapted program a randomized controlled trial enrolling 620 eligible African American men who have sex with men (MSM) will be conducted. Men in the treatment condition will be compared to men receiving the control condition comprised of standard of care counseling from the clinic plus a… Read more about this study
- Who is it for?
- Ages 15 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gonorrhea, Chlamydia, Trichomoniasis
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to 2 Apr 2018
- Phase
- Phase 2
- 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 29 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 15-29 years of age
- Identifying as an African American Male
- Males must be presenting themselves for STD testing
- Males must report recently (past 3 months) engaging in penile-anal sex with other males as a "top" (meaning the insertive partner)
Who cannot join
- Males not identifying as African American
- Males older than 29 years of age
- Males that are not patients of the STD clinic
- Males who have not engaged in penile-anal sex with other males as a "top" within the past 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Mississippi State Department of Health STD Clinic
Jackson, Mississippi, 39216
About this study
Official title: A Brief, Clinic-Based, Safer Sex Program for Young African-American Men
To evaluate the efficacy of the adapted program a randomized controlled trial enrolling 620 eligible African American men who have sex with men (MSM) will be conducted. Men in the treatment condition will be compared to men receiving the control condition comprised of standard of care counseling from the clinic plus a free bag of condoms and water-based lubricants. This two-arm trial will test four hypotheses:
Aim: To test the efficacy of a brief, clinic-based and theory-guided, intervention designed to reduce STD incidence and risk of HIV acquisition/transmission among young African American men (15-29 years old) having sex with men and presenting for STD testing.
Read more
H1. Men randomized to receive the intervention will have a lower incidence rate of laboratory-confirmed STDs at each of three follow-up assessments compared to those receiving the control condition.
H2. Men randomized to receive the intervention will report significantly fewer acts of unprotected penetrative sex (penile-vaginal or penile-anal) between follow-up assessments compared to those receiving the control condition.
H3. Men randomized to receive the intervention will report having significantly fewer unprotected penetrative sex partners (for penile-vaginal or penile-anal sex) between follow-up assessments compared to those receiving the control condition.
H4. Men randomized to receive the intervention will report having significantly fewer negative experiences with condom use between follow-up assessments compared to those receiving the control condition.
H5. Men randomized to receive the intervention will demonstrate significantly greater improvement in condom application skills, throughout the 12-month study, compared to those receiving the control condition.
Read the detailed description
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. The crisis is especially dramatic in the South and it is now apparent that young African American men who have sex with men (MSM) are exceedingly likely to be infected. Unfortunately, the ever-expanding HIV epidemic experienced by this population has not been matched by equal attention to the development of efficacious prevention programs. The proposed project expands upon an NIMH-funded study (R21 MH066682-01A1) conducted by Dr. Crosby. His study of young African American males found that a brief, clinic-based intervention reduced incidence of subsequent STDs by about 50%. This brief, one-on-one, intervention program, known as Focus on the Future (FOF), is a practical alternative to group-based safer sex programs that can be difficult to translate from science into practice. The program is now classified as a "Best Practice" intervention by CDC. This project will begin with an extensive formative phase designed to adapt FOF to MSM. The adapted program will seek to "sexualize" condoms to promote their consistent and correct use to better prevent STD/HIV. The program is uniquely flexible in that it can be applied to MSM regardless of their HIV serostatus. The adapted program will be tested by a two-arm efficacy trail. We will recruit 620 MSM (15-29 years of age) from a publicly-funded STD clinic in Jackson MS. Men in the treatment condition will be compared to men receiving the control condition comprised of standard of care counseling from the clinic plus a free ditty bag of supplies from the "condom and lube buffet" (condom/lube distribution). The trial will test four hypotheses: 1) Men randomized to receive the intervention will have a lower incidence rate of laboratory-confirmed STDs (by urine assay and rectal swab) at a 6-month and a 12-month follow-up assessment) compared to controls. 2) Men randomized to receive the intervention will report significantly fewer acts of unprotected penetrative sex (penile-vaginal or penile-anal) between follow-up assessments compared to controls. 3) Men randomized to receive the intervention will report having significantly fewer unprotected penetrative (penile-vaginal or penile-anal) sex partners between follow-up assessments compared to controls. 4) Men randomized to receive the intervention will report having significantly fewer negative experiences with condom use between follow-up assessments compared to controls. Given the dearth of evidence-based options for intervening with this vulnerable population in clinical settings, demonstrated efficacy of the adapted program has important implications for U.S. public health efforts directed towards the prevention of STD/HIV.
- Conditions
- Gonorrhea, Chlamydia, Trichomoniasis, Syphilis, HIV Infections
- Being tested
- Intervention
- Medical subject headings
- Gonorrhea, Chlamydia Infections, Trichomonas Infections, Syphilis, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
The intervention will consist of an education program. The education program includes providing the ability to enjoy condom use through improved skills related to finding the right "fit and feel" of condoms, using lubricants that are compatible with latex, negotiating condom use, negotiating sex, and talking with new and existing sex partners about ways to "sexualize" condoms.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Men receiving the control condition will be comprised of standard of care counseling from the clinic plus a variety of free condoms and water-based lubricants. They will also provide a specimen for STD testing, and receive text message questions for 12 weeks. The text messaging system will be used to collect self-reported dependent variables from men on a weekly basis. Texting will also serve as a constant method of contact between the PD and the enrolled men to remind them of follow-up assessments. In addition, the participants will complete the ACASI questionnaire to assess their sexual behavior, as well as demonstrate their condom application ability. |
| Treatment | Experimental | Men receiving the treatment condition will receive text messages each week after their enrollment date and this will continue for 12 weeks to collect self-reported dependent variables. Text messaging will also be used to confirm and remind men about the day of each follow-up assessment. Each participant will also provide a specimen for STD testing, as well complete the ACASI questionnaire to assess sexual behavior and demonstrate their condom application ability. These participants will also be provided with a variety of free condoms and water-based lubricants. In addition, men in the treatment condition will also be enrolled in an education program. Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of unprotected sex rather than frequency of condom use will be used as the primary outcome measure.
This will be achieved through the use of a centralized text messaging service. Once each week (throughout the 12-month observation period) men will receive questions, via text. The data from these weekly questions will be cumulated to form "3-month" variables that correspond with the STD-testing intervals between baseline and the first follow-up assessment and between the first follow-up assessment and the second one (at 6 months), as well as the "6-month" variables corresponding to the STD-testing interval between the 6-month assessment and the final assessment at 12 months.
Measured: 12 months (per participant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startSep 2012
- Primary completion25 Nov 2017
- Study completion2 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GonorrheaStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Richard Crosby
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, Richard Crosby, University of Kentucky
- Investigators
- Richard A Crosby, PhD, Principal investigator, University of KentuckyLeandro A Mena, MD, Principal investigator, University of Mississippi Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439503
- Sponsor's protocol ID
- 11-0204-F3R
- Other IDs
- 1R01MH092226-01A1
- Status last verified
- Jan 2019
- First submitted
- 20 Sep 2011
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief, Clinic-Based, Safer Sex Program for Young African-American Men
- ClinicalTrials.gov ID
- NCT01439503
- Acronym / sponsor ID
- 11-0204-F3R
- Conditions
- Gonorrhea, Chlamydia, Trichomoniasis, Syphilis, HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 620 participants (estimated)
- Lead sponsor
- Richard CrosbyUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2012
- Primary completion
- 25 Nov 2017 (actual)
- Study completion
- 2 Apr 2018 (actual)
- First posted
- 23 Sep 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.
To evaluate the efficacy of the adapted program a randomized controlled trial enrolling 620 eligible African American men who have sex with men (MSM) will be conducted. Men in the treatment condition will be compared to men receiving the control condition comprised of standard of care counseling from the clinic plus a free bag of condoms and water-based lubricants. This two-arm trial will test four hypotheses:
Aim: To test the efficacy of a brief, clinic-based and theory-guided, intervention designed to reduce STD incidence and risk of HIV acquisition/transmission among young African American men (15-29 years old) having sex with men and presenting for STD testing.
H1. Men randomized to receive the intervention will have a lower incidence rate of laboratory-confirmed STDs at each of three follow-up assessments compared to those receiving the control condition.
H2. Men randomized to receive the intervention will report significantly fewer acts of unprotected penetrative sex (penile-vaginal or penile-anal) between follow-up assessments compared to those receiving the control condition.
H3. Men randomized to receive the intervention will report having significantly fewer unprotected penetrative sex partners (for penile-vaginal or penile-anal sex) between follow-up assessments compared to those receiving the control condition.
H4. Men randomized to receive the intervention will report having significantly fewer negative experiences with condom use between follow-up assessments compared to those receiving the control condition.
H5. Men randomized to receive the intervention will demonstrate significantly greater improvement in condom application skills, throughout the 12-month study, compared to those receiving the control condition.
Detailed description
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. The crisis is especially dramatic in the South and it is now apparent that young African American men who have sex with men (MSM) are exceedingly likely to be infected. Unfortunately, the ever-expanding HIV epidemic experienced by this population has not been matched by equal attention to the development of efficacious prevention programs. The proposed project expands upon an NIMH-funded study (R21 MH066682-01A1) conducted by Dr. Crosby. His study of young African American males found that a brief, clinic-based intervention reduced incidence of subsequent STDs by about 50%. This brief, one-on-one, intervention program, known as Focus on the Future (FOF), is a practical alternative to group-based safer sex programs that can be difficult to translate from science into practice. The program is now classified as a "Best Practice" intervention by CDC. This project will begin with an extensive formative phase designed to adapt FOF to MSM. The adapted program will seek to "sexualize" condoms to promote their consistent and correct use to better prevent STD/HIV. The program is uniquely flexible in that it can be applied to MSM regardless of their HIV serostatus. The adapted program will be tested by a two-arm efficacy trail. We will recruit 620 MSM (15-29 years of age) from a publicly-funded STD clinic in Jackson MS. Men in the treatment condition will be compared to men receiving the control condition comprised of standard of care counseling from the clinic plus a free ditty bag of supplies from the "condom and lube buffet" (condom/lube distribution). The trial will test four hypotheses: 1) Men randomized to receive the intervention will have a lower incidence rate of laboratory-confirmed STDs (by urine assay and rectal swab) at a 6-month and a 12-month follow-up assessment) compared to controls. 2) Men randomized to receive the intervention will report significantly fewer acts of unprotected penetrative sex (penile-vaginal or penile-anal) between follow-up assessments compared to controls. 3) Men randomized to receive the intervention will report having significantly fewer unprotected penetrative (penile-vaginal or penile-anal) sex partners between follow-up assessments compared to controls. 4) Men randomized to receive the intervention will report having significantly fewer negative experiences with condom use between follow-up assessments compared to controls. Given the dearth of evidence-based options for intervening with this vulnerable population in clinical settings, demonstrated efficacy of the adapted program has important implications for U.S. public health efforts directed towards the prevention of STD/HIV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Men receiving the control condition will be comprised of standard of care counseling from the clinic plus a variety of free condoms and water-based lubricants. They will also provide a specimen for STD testing, and receive text message questions for 12 weeks. The text messaging system will be used to collect self-reported dependent variables from men on a weekly basis. Texting will also serve as a constant method of contact between the PD and the enrolled men to remind them of follow-up assessments. In addition, the participants will complete the ACASI questionnaire to assess their sexual behavior, as well as demonstrate their condom application ability. |
| Treatment | Experimental | Behavioral: InterventionMen receiving the treatment condition will receive text messages each week after their enrollment date and this will continue for 12 weeks to collect self-reported dependent variables. Text messaging will also be used to confirm and remind men about the day of each follow-up assessment. Each participant will also provide a specimen for STD testing, as well complete the ACASI questionnaire to assess sexual behavior and demonstrate their condom application ability. These participants will also be provided with a variety of free condoms and water-based lubricants. In addition, men in the treatment condition will also be enrolled in an education program. |
Who may qualify
- Ages
- 15 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 15-29 years of age
- Identifying as an African American Male
- Males must be presenting themselves for STD testing
- Males must report recently (past 3 months) engaging in penile-anal sex with other males as a "top" (meaning the insertive partner)
Key exclusion criteria (4 listed)
- Males not identifying as African American
- Males older than 29 years of age
- Males that are not patients of the STD clinic
- Males who have not engaged in penile-anal sex with other males as a "top" within the past 3 months
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 |
|---|---|---|
| InterventionThe intervention will consist of an education program. The education program includes providing the ability to enjoy condom use through improved skills related to finding the right "fit and feel" of condoms, using lubricants that are compatible with latex, negotiating condom use, negotiating sex, and talking with new and existing sex partners about ways to "sexualize" condoms. | Behavioural | Treatment |
Primary outcome
The frequency of unprotected sex rather than frequency of condom use will be used as the primary outcome measure.
Time frame: 12 months (per participant)
This will be achieved through the use of a centralized text messaging service. Once each week (throughout the 12-month observation period) men will receive questions, via text. The data from these weekly questions will be cumulated to form "3-month" variables that correspond with the STD-testing intervals between baseline and the first follow-up assessment and between the first follow-up assessment and the second one (at 6 months), as well as the "6-month" variables corresponding to the STD-testing interval between the 6-month assessment and the final assessment at 12 months.
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 21 Feb 2019.
Related trials for Gonorrhea
Active, not recruitingPhase 4
Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM
Gonorrhea Male, Chlamydia (Male)
Not yet recruiting
Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study
HIV, Syphilis
Not yet recruiting
Optimizing Antibiotic Prescription in STI Clinics Using Rapid POCT
Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection
Not yet recruitingPhase 3
A Clinical Study to Assess the Efficacy of Weekly Doxycycline Prophylaxis to Reduce Bacterial Sexually Transmitted Infections (STI) in Young African Women
Sexually Transmitted Infection (STI), Gonorrhea
RecruitingPhase 4
Doxycycline Prophylaxis for Prevention of Sexually Transmitted Infections
Gonorrhea, Chlamydia
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.
Richard A Crosby, PhD principal investigator
University of Kentucky
Leandro A Mena, MD principal investigator
University of Mississippi Health Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intervention in people with Gonorrhea and Chlamydia, 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 4 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 21 Feb 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The frequency of unprotected sex rather than frequency of condom use will be used as the primary outcome measure. (time frame: 12 months (per participant)). 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 21 Feb 2019.