Safer Sex Program for Young African-American Men
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01439503|
Recruitment Status : Recruiting
First Posted : September 23, 2011
Last Update Posted : October 30, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Gonorrhea Chlamydia Trichomoniasis Syphilis HIV Infections||Behavioral: Intervention||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||620 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Brief, Clinic-Based, Safer Sex Program for Young African-American Men|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||May 2019|
No Intervention: Control
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.
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.
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01439503
|Contact: Richard A Crosby, PhDfirstname.lastname@example.org|
|Contact: Leandro A Mena, MDemail@example.com|
|United States, Mississippi|
|Mississippi State Department of Health STD Clinic||Recruiting|
|Jackson, Mississippi, United States, 39216|
|Contact: Leandro A Mena, MD 601-984-5560 firstname.lastname@example.org|
|Principal Investigator:||Richard A Crosby, PhD||University of Kentucky|
|Principal Investigator:||Leandro A Mena, MD||University of Mississippi Health Care|