- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00601237
Effectiveness of a Cell Phone-Based Program for Abstinence and HIV Risk Prevention
Text Messaging for Abstinence and HIV Risk Prevention: The 411 on Safe Text
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Sexually transmitted diseases (STDs), including HIV infections, are most commonly spread through unprotected sexual intercourse. STDs are a primary health issue, 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 information, safe sexual practices, including correct condom use, are not commonly followed 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. A cell phone-based text messaging program designed to promote safer sex practices may provide an effective and easy means of delivery of treatment. This study will develop and test the effectiveness of a cell phone-based text messaging program to sustain abstinence, monogamy, or condom use among black urban males in Philadelphia, Pennsylvania.
Participation in this study will be divided into two phases. In the first study phase, participants will partake in a 90-minute focus group to help develop text message content and plans for treatment delivery. The next study phase will be a pilot test of the program developed in the first phase. Participants will be assigned to receive text messages concerning either HIV prevention or general nutrition. Participants receiving the HIV prevention text messages will be sent up to 90 text messages related to abstinence, monogamy, and condom use over a 3-month period. Participants will also be able to join interactive phone activities related to HIV. Participants receiving the nutritional text messages will be sent up to 30 messages about nutrition and healthy eating over the same period of time. Participants will complete telephone surveys at baseline and Months 3 and 6. The surveys will assess measures of abstinence, monogamy and condom use attitudes, norms, self-efficacy, and risk behaviors.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19107
- Motivational Educational Entertainment (MEE) Productions
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Resident of Philadelphia
- Self-identified black or African American
- English-speaking
- Cell phone user
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: A
Participants will receive HIV-related text messages
|
Participants will receive up to 90 text messages related to abstinence, monogamy, and condom use over 3 months.
|
|
Aktiv komparator: B
Participants will receive nutrition-related text messages
|
Participants will receive up to 30 text messages about nutrition and healthy eating over 3 months.
|
|
Ingen inngripen: C
Participants will attend a 90-minute focus group to develop messages for the cell-phone program
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Condom use
Tidsramme: Measured at baseline and Months 3 and 6
|
Measured at baseline and Months 3 and 6
|
|
Abstinence
Tidsramme: Measured at baseline and Months 3 and 6
|
Measured at baseline and Months 3 and 6
|
|
Monogamy
Tidsramme: Measured at baseline and Months 3 and 6
|
Measured at baseline and Months 3 and 6
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Attitudes, norms, self-efficacy, and intentions to remain abstinent, remain monogamous, or use condoms
Tidsramme: Measured at baseline and Months 3 and 6
|
Measured at baseline and Months 3 and 6
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Sheana Bull, PhD, University of Colorado at Denver and Health Sciences
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 07-0463
- DAHBR 9A-ASPA (National Institute of Mental Health)
- R21MH083318 (U.S. NIH-stipend/kontrakt)
- COMIRB 07-0463
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