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Effectiveness of a Cell Phone-Based Program for Abstinence and HIV Risk Prevention

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00601237
First received: January 23, 2008
Last updated: January 19, 2009
Last verified: January 2009

January 23, 2008
January 19, 2009
October 2008
July 2009   (final data collection date for primary outcome measure)
  • Condom use [ Time Frame: Measured at baseline and Months 3 and 6 ] [ Designated as safety issue: No ]
  • Abstinence [ Time Frame: Measured at baseline and Months 3 and 6 ] [ Designated as safety issue: No ]
  • Monogamy [ Time Frame: Measured at baseline and Months 3 and 6 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00601237 on ClinicalTrials.gov Archive Site
Attitudes, norms, self-efficacy, and intentions to remain abstinent, remain monogamous, or use condoms [ Time Frame: Measured at baseline and Months 3 and 6 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

This study will develop and test the effectiveness of a cell phone-based text messaging program to encourage abstinence, monogamy, or condom use among black urban males in Philadelphia, Pennsylvania.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
  • Behavioral: HIV-related text messaging
    Participants will receive up to 90 text messages related to abstinence, monogamy, and condom use over 3 months.
  • Behavioral: Nutrition-related text messaging
    Participants will receive up to 30 text messages about nutrition and healthy eating over 3 months.
  • Experimental: A
    Participants will receive HIV-related text messages
    Intervention: Behavioral: HIV-related text messaging
  • Active Comparator: B
    Participants will receive nutrition-related text messages
    Intervention: Behavioral: Nutrition-related text messaging
  • No Intervention: C
    Participants will attend a 90-minute focus group to develop messages for the cell-phone program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
108
December 2010
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Resident of Philadelphia
  • Self-identified black or African American
  • English-speaking
  • Cell phone user
Male
16 Years to 20 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00601237
R21 MH083318, COMIRB 07-0463, DAHBR 9A-ASPA
No
Sheana Bull, PhD, MPH, Associate Professor, University of Colorado at Denver and Health Sciences Center
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Sheana Bull, PhD University of Colorado at Denver and Health Sciences
National Institute of Mental Health (NIMH)
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP