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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
  Purpose

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.


Condition Intervention
HIV Infections
Behavioral: HIV-related text messaging
Behavioral: Nutrition-related text messaging

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Text Messaging for Abstinence and HIV Risk Prevention: The 411 on Safe Text

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 108
Study Start Date: October 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Participants will receive HIV-related text messages
Behavioral: HIV-related text messaging
Participants will receive up to 90 text messages related to abstinence, monogamy, and condom use over 3 months.
Active Comparator: B
Participants will receive nutrition-related text messages
Behavioral: Nutrition-related text messaging
Participants will receive up to 30 text messages about nutrition and healthy eating over 3 months.
No Intervention: C
Participants will attend a 90-minute focus group to develop messages for the cell-phone program

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years to 20 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Resident of Philadelphia
  • Self-identified black or African American
  • English-speaking
  • Cell phone user
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601237

Locations
United States, Pennsylvania
Motivational Educational Entertainment (MEE) Productions
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Investigators
Principal Investigator: Sheana Bull, PhD University of Colorado at Denver and Health Sciences
  More Information

No publications provided

Responsible Party: Sheana Bull, PhD, MPH, Associate Professor, University of Colorado at Denver and Health Sciences Center
ClinicalTrials.gov Identifier: NCT00601237     History of Changes
Other Study ID Numbers: R21 MH083318, COMIRB 07-0463, DAHBR 9A-ASPA
Study First Received: January 23, 2008
Last Updated: January 19, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
HIV Prevention
Mobile Phone
Technology-Based Intervention
HIV
HIV Seronegativity

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 23, 2014