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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 23, 2008

Last Updated Date

January 19, 2009

Start Date ^†

October 2008

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00601237 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

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

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Open Label, Parallel Assignment

Condition ^†

HIV Infections

Intervention ^†

Behavioral: HIV-related text messaging
Behavioral: Nutrition-related text messaging

Study Arms / Comparison Groups

Experimental: Participants will receive HIV-related text messages
Active Comparator: Participants will receive nutrition-related text messages
No Intervention: Participants will attend a 90-minute focus group to develop messages for the cell-phone program

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Estimated Enrollment ^†

108

Estimated Completion Date

December 2010

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Resident of Philadelphia
Self-identified black or African American
English-speaking
Cell phone user

Gender

Male

Ages

16 Years to 20 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00601237

Responsible Party

Sheana Bull, PhD, MPH, Associate Professor, University of Colorado at Denver and Health Sciences Center

Secondary IDs ^††

COMIRB 07-0463, DAHBR 9A-ASPA

Study Sponsor ^†

National Institute of Mental Health (NIMH)

Collaborators ^††

Investigators ^†

Principal Investigator:

Sheana Bull, PhD

University of Colorado at Denver and Health Sciences

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.