- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00314028
Effectiveness of HIV Risk Reduction Program Among African American Men
Promoting HIV Risk Reduction Among African American Men
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Sexually transmitted diseases (STDs), including HIV infections, are most commonly spread through unprotected sexual intercourse. STDs are a major health concern, especially among young ethnic minorities in the United States. The rate of STDs is significantly greater in urban areas where ethnic minorities, particularly African-American males, are commonly represented. Despite this knowledge, safe sexual practices, including correct condom use, are not the norm among minority males. It is believed that educational outreach designed to motivate and inform on the correct use of condoms will be effective in encouraging safer sex practices. This study will test the effectiveness of a brief clinic-based program designed to promote the correct use of condoms among young African-American men newly diagnosed with an STD.
Participants in this single blind study will be randomly assigned to an experimental or control group. Upon being diagnosed with an STD, men in both groups will receive standard of care follow-up treatment. Men in the experimental group will also receive a one-on-one educational session on condom use. The educational session will be led by a health educator and will last about 30 minutes, depending on the existing skills and learning abilities of the participants. Using information provided by the participants on past experience with condoms, the health educator will attempt to correct misunderstandings about and problems with condom use. Upon enrollment, all men will respond to a series of pre-recorded questions and will be required to demonstrate their ability to apply condoms to a penile model. The same questions and procedure will be repeated 3 months later.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Identifies as African American
- Clinically diagnosed with an STD
- Reports at least one episode of condom use with a female within 3 months of study entry (this requirement does not restrict men who also have sex with men from study participation)
- Fluent in English
Exclusion Criteria:
- Known HIV infection
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 1
Standard of care treatment
|
Standard of care treatment is the normal treatment that someone would receive for the particular sexually transmitted disease or virus.
|
|
Experimentell: 2
Educational program designed to motivate and provide information on the correct use of condoms
|
Standard of care treatment is the normal treatment that someone would receive for the particular sexually transmitted disease or virus.
Focus on the Future is an educational program designed to promote proper condom use.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Frequency of unprotected penile vaginal sex
Tidsram: Measured at Month 3
|
Measured at Month 3
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Frequency of condom use errors and problems
Tidsram: Measured at Month 3
|
Measured at Month 3
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studiestol: Andrew Forsythe, PhD, National Institute of Mental Health (NIMH)
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- R21MH066682 (U.S.S. NIH-anslag/kontrakt)
- DAHBR 9A-ASPQ (NIMH)
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