Effectiveness of a Cell Phone-Based Program for Abstinence and HIV Risk Prevention
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIV-related text messaging
Nutrition-related text messaging
Sponsored by

About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV Prevention, Mobile Phone, Technology-Based Intervention, HIV, HIV Seronegativity
Eligibility Criteria
Inclusion Criteria:
- Resident of Philadelphia
- Self-identified black or African American
- English-speaking
- Cell phone user
Sites / Locations
- Motivational Educational Entertainment (MEE) Productions
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
A
B
C
Arm Description
Participants will receive HIV-related text messages
Participants will receive nutrition-related text messages
Participants will attend a 90-minute focus group to develop messages for the cell-phone program
Outcomes
Primary Outcome Measures
Condom use
Abstinence
Monogamy
Secondary Outcome Measures
Attitudes, norms, self-efficacy, and intentions to remain abstinent, remain monogamous, or use condoms
Full Information
NCT ID
NCT00601237
First Posted
January 23, 2008
Last Updated
April 1, 2015
Sponsor
University of Colorado, Denver
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00601237
Brief Title
Effectiveness of a Cell Phone-Based Program for Abstinence and HIV Risk Prevention
Official Title
Text Messaging for Abstinence and HIV Risk Prevention: The 411 on Safe Text
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV Prevention, Mobile Phone, Technology-Based Intervention, HIV, HIV Seronegativity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Participants will receive HIV-related text messages
Arm Title
B
Arm Type
Active Comparator
Arm Description
Participants will receive nutrition-related text messages
Arm Title
C
Arm Type
No Intervention
Arm Description
Participants will attend a 90-minute focus group to develop messages for the cell-phone program
Intervention Type
Behavioral
Intervention Name(s)
HIV-related text messaging
Intervention Description
Participants will receive up to 90 text messages related to abstinence, monogamy, and condom use over 3 months.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition-related text messaging
Intervention Description
Participants will receive up to 30 text messages about nutrition and healthy eating over 3 months.
Primary Outcome Measure Information:
Title
Condom use
Time Frame
Measured at baseline and Months 3 and 6
Title
Abstinence
Time Frame
Measured at baseline and Months 3 and 6
Title
Monogamy
Time Frame
Measured at baseline and Months 3 and 6
Secondary Outcome Measure Information:
Title
Attitudes, norms, self-efficacy, and intentions to remain abstinent, remain monogamous, or use condoms
Time Frame
Measured at baseline and Months 3 and 6
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Resident of Philadelphia
Self-identified black or African American
English-speaking
Cell phone user
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheana Bull, PhD
Organizational Affiliation
University of Colorado at Denver and Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Motivational Educational Entertainment (MEE) Productions
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of a Cell Phone-Based Program for Abstinence and HIV Risk Prevention
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