- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
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 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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Förenta staterna, 19107
- Motivational Educational Entertainment (MEE) Productions
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Resident of Philadelphia
- Self-identified black or African American
- English-speaking
- Cell phone user
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Inget ingripande: C
Participants will attend a 90-minute focus group to develop messages for the cell-phone program
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Condom use
Tidsram: Measured at baseline and Months 3 and 6
|
Measured at baseline and Months 3 and 6
|
|
Abstinence
Tidsram: Measured at baseline and Months 3 and 6
|
Measured at baseline and Months 3 and 6
|
|
Monogamy
Tidsram: Measured at baseline and Months 3 and 6
|
Measured at baseline and Months 3 and 6
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Attitudes, norms, self-efficacy, and intentions to remain abstinent, remain monogamous, or use condoms
Tidsram: Measured at baseline and Months 3 and 6
|
Measured at baseline and Months 3 and 6
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Sheana Bull, PhD, University of Colorado at Denver and Health Sciences
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
- 07-0463
- DAHBR 9A-ASPA (National Institute of Mental Health)
- R21MH083318 (U.S.S. NIH-anslag/kontrakt)
- COMIRB 07-0463
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